JP2018528411A - Systems, devices, and methods for collecting, transporting and handling bodily fluid samples - Google Patents

Abstract

Body fluid sample collection systems, devices, and methods are provided. The sample is collected at a first location and subjected to a first sample processing step. The sample can be transported to a second location and subjected to a second sample processing step that does not introduce contaminants into the plasma portion of the sample formed from the first processing step. The In one embodiment described herein, an apparatus for collecting a bodily fluid sample is provided. In an embodiment, the body fluid may be blood. In embodiments where blood is collected, this embodiment may be useful for accurately collecting small volumes of bodily fluid samples often associated with non-venous blood collection.

Description

(Background of the Invention)
Blood samples for use in clinical tests are often obtained by means of venipuncture, which typically involves inserting a hypodermic needle into a subject's vein. Blood drawn by the hypodermic needle is drawn directly into the syringe barrel or drawn into one or more sealed vials for subsequent processing. If venipuncture can be difficult, or is not feasible, such as in a newborn, a non-venous puncture, such as a heel puncture or other alternative site puncture, will remove a blood sample for testing. Can be used for After the blood sample is collected, the withdrawn sample is typically packaged and transported to a processing center for analysis.

  Unfortunately, conventional body fluid sample collection and testing techniques have drawbacks. For example, except for the most basic tests, currently available blood tests typically require that a significantly higher volume of blood be drawn from the subject. Because of the high volume of blood, drawing blood from an alternative sample site in a subject that is less painful and / or less invasive will not produce the volume of blood required for conventional testing methodologies It is not preferable. In some cases, patient anxiety associated with venipuncture may reduce patient compliance with patient testing protocols. Furthermore, the transport of small volumes of sample fluid while maintaining integrity can be problematic.

(Summary of the Invention)
At least some of the disadvantages associated with the prior art are overcome by at least some or all of the embodiments described in this disclosure. Although embodiments herein are typically described in the context of obtaining, but not limited to, blood samples, embodiments herein are not limited to blood samples and are for analysis. It should be understood that other fluids or body samples may be adapted to obtain.

  In one embodiment described herein, an apparatus for collecting a bodily fluid sample is provided. In an embodiment, the body fluid may be blood. In embodiments where blood is collected, this embodiment may be useful for accurately collecting small volumes of bodily fluid samples often associated with non-venous blood collection. In one non-limiting example, the sample volume is about 1 mL or less. Optionally, the sample volume is about 900 μL or less. Optionally, the sample volume is about 800 μL or less. Optionally, the sample volume is about 700 μL or less. Optionally, the sample volume is about 600 μL or less. Optionally, the sample volume is about 500 μL or less. Optionally, the sample volume is about 400 μL or less. Optionally, the sample volume is about 300 μL or less. Optionally, the sample volume is about 200 μL or less. Optionally, the sample volume is about 100 μL or less. Optionally, the sample volume is about 90 μL or less. Optionally, the sample volume is about 80 μL or less. Optionally, the sample volume is about 70 μL or less. Optionally, the sample volume is about 60 μL or less. Optionally, the sample volume is about 50 μL or less.

  In one non-limiting example, the instrument can then be used to divide a bodily fluid sample directly into two or more different parts, which are then placed in respective sample containers. In one non-limiting example, the instrument has a first portion having at least two sample collection channels configured to draw a fluid sample into the sample collection channel via a first type of motive force. One of the sample collection channels has an inner coating designed to mix with the fluid sample, and another one of the sample collection channels is chemically distinct from the inner coating Has an inner coating. The sample collection device includes a second portion including a plurality of sample containers for receiving a bodily fluid sample collected in the sample collection channel, the sample container being operated for fluid communication with the collection channel When the fluid communication is established, the container moves a second motive force, different from the first motive force, from the channel into the sample container through a second motive force. To provide for. The sample container may be arranged such that no mixing occurs between the fluid sample and the container. This device is used to collect blood or other body fluids. Although venous blood collection is relatively quick, it may take a longer time period to obtain the desired amount of sample that can be used for non-venous blood collection, and the channel Early introduction of substances such as anticoagulants that can be coated may prevent premature clotting of the channel during collection.

  In another embodiment described herein, an apparatus for collecting a bodily fluid sample is provided. The instrument includes a first portion that includes a plurality of sample collection channels, wherein at least two of the channels simultaneously deliver a fluid sample to each of the at least two sample collection channels via a first type of motive force. Configured to pull out. The instrument may also include a second portion including a plurality of sample containers for receiving bodily fluid samples collected at the sample collection channel, the sample container being a fluid with which the sample container is in contact with the sample collection channel. It can have a first state that is not in connection, and can also have a second state that is engageable because the sample container is operably in fluid communication with the collection channel, and fluid communication is established. As soon as the sample container moves a bodily fluid sample from the channel into the sample container, the sample container provides a second motive force different from the first motive force. In embodiments, the driving force for moving bodily fluids is capillary action, reduced pressure (eg, a vacuum or partial vacuum that draws liquid into a site with reduced pressure), pressurized (eg, forced fluid from a portion with increased pressure) Expelling), substances that draw fluid by capillary action, or derived from other means.

  In a further embodiment described herein, at least two samples configured to simultaneously draw a fluid sample into each of at least two sample collection channels via a first type of motive force. By using a sample collection device having a collection channel, a method is provided for metering a minimum amount of sample into at least two channels. After verifying that a desired amount of sample fluid is in the collection channel, fluid communication is established between the sample collection channel and the sample container to move the bodily fluid sample from the channel into the container. The container provides a second motive force for collecting the sample that is different from the first motive force. In some alternative embodiments, devices that use only a single channel for collecting bodily fluids or devices that have multiple channels but do not collect them simultaneously are not excluded. Optionally, collection of sample fluid is accomplished without the use of capillarity absorbing material.

  In one embodiment, there is a separate time between sample collection and introduction of the sample into the sample preparation equipment. In one non-limiting example, the process is a discontinuous process. The sample collection occurs at one processing station and then the sample is transported to a second station. This second station may be in a building with the sample. Optionally, the second station is configured such that the sample is transported on foot, transported, transported by flight, transported, transported to reach a second location. It may be in another location that needs to be placed in the equipment or placed in the shipping container. In this way, there is a separate interruption in processing to allow time associated with sample transport.

  In another embodiment of the present specification, a separation gel is provided that separates cells, or other solid or semi-solid parts, from a cell-free fraction of whole blood of the sample. It can be contained in a container. Such a gel or other separating material may be included in the sample container before, during, or after the sample is introduced into the sample container. The separation material is composed of cells and solutions so that, during separation such as centrifugation, the material flows to a position between the solution and the non-solution sample layer, so that the sample components can be separated. There may be a specific gravity between the elements. Following centrifugation, the separating material stops flowing and remains a soft barrier between the layers. In some embodiments, the separating material can be further processed to cure to a more rigid barrier. In one non-limiting example, the separating material is a UV curable material such as, but not limited to, a thixotropic gel of a gelling agent based on sorbitol in a diacrylate oligomer. The sample container may have a complete container or, optionally, a UV curable material exposed to ultraviolet light, such as, but not limited to, 10-30 seconds to cure the material. Have in that part. Such curing can include cross-linking of the material in a UV curable material. Optionally, the UV curable material can be used in conjunction with a conventional separating gel material so that only one side (solution side or solid side) can contact the UV curable material. Optionally, a UV curable material can be used with a third material so that the UV curable material is between the two separate materials and is not in direct contact with the solution and non-solution portions of the sample.

  A sample of bodily fluid may be collected by the devices disclosed and described herein. Methods for collecting bodily fluids using these devices are disclosed and described herein. A sample of bodily fluid, eg, a sample collected by the devices and / or methods disclosed and described herein, may be transported from the sample collection location to one or more other sites.

  In at least one embodiment described herein, a method is provided for physically transporting a small volume of bodily fluid in the form of a liquid from one location to another. As a non-limiting example, the sample is collected in liquid form at the collection site, transported in liquid form, and arrives at the analysis site in liquid form. In many embodiments, the liquid form during transport may be a porous matrix, a material that absorbs by capillary action, a reticulated material, or similar that prevents the sample from being extracted at the destination site. Not retained by the substance. In one embodiment, the small volume of sample in each sample container is in the range of about 1 ml to about 500 microliters. Optionally, the small volume is in the range of about 500 microliters to about 250 microliters. Optionally, the small volume is about 250 microliters to about 100 microliters. Optionally, the small volume is in the range of about 100 microliters to about 50 microliters. Optionally, the small volume is in the range of about 80 microliters to about 40 microliters. Optionally, the small volume is in the range of about 40 microliters to about 1 microliter. Optionally, the small volume is in the range of about 1 microliter to about 0.3 microliter. Optionally, the small volume is in the range of about 0.3 microliters or less.

  The transport container disclosed and described herein may include components configured to receive and hold a sample container. In embodiments, a component configured to receive and hold sample containers can be configured to receive and hold multiple sample containers. In embodiments, such components may include a flat sheet, such as a dish. In embodiments, such a component (eg, a flat sheet) can include an opening having an inner surface configured to receive a sample container (eg, a slot, aperture, or receptacle). In an embodiment, the transport container may include a component that includes a plurality of openings (eg, slots, apertures or receptacles), each having an inner surface configured to receive a sample container. In embodiments, such an inner surface can be at least partially complementary to the outer surface of the sample container, or a portion thereof.

  In another embodiment described herein, the shipping container can provide a dense sample container per unit area in a fixed manner during shipping, but at the destination location. Can be removed. In one non-limiting example, the sample containers are arranged in an array with at least 6 sample containers per square inch when the array is viewed from top to bottom. Optionally, there are at least 8 sample containers per square inch when the array is viewed from top to bottom. Optionally, use a large bag with at least 10 sample containers per square inch when the array is viewed from top to bottom, in which the sample containers can move freely in an unrestrained manner. In some embodiments, the transport containers may include a specific sample container, such as from the same subject, to an adjacent sample container so that they can be visually identified that they are from a common subject. In contrast, they may be held close to each other with respect to horizontal or other spacing. Optionally, the transport container has an opening for receiving a carrier that holds one or more sample containers together, the containers having common features such as, but not limited to, from the same subject. Have.

  In an embodiment, the sample container is adapted to assist in maintaining the sample in liquid form. In an embodiment, the sample is processed in a manner adapted to maintain the sample in liquid form in a sample container prior to arrival. For example, the sample container can include an anticoagulant, or the sample can be treated with the anticoagulant before, during, or during transport or placement of the sample into the sample container. In embodiments, the anticoagulant is selected from the group consisting of heparin (eg, lithium heparin or sodium heparin), ethylenediaminetetraacetic acid, 4-hydroxycoumarin, vitamin K antagonist (VKA) or other additives. it can. In addition to high density per unit area, some embodiments of the transport container also include highly diverse samples, including samples from multiple different subjects. As a non-limiting example, the shipping container is packed until all of the available openings in the shipping container are filled, such as 4 samples from one subject, 2 samples from another subject, etc. be able to.

  Each of the samples can have a separate destination for individually selected analysis and, at least in one embodiment, is not grouped in the shipping container based on the tests performed. I want you to understand. As a non-limiting example, not all of the samples in the transport container are collected for the same test. Conventional inspection systems can only be grouped together for the transport of those samples that have destinations for exactly the same inspection. In at least one embodiment herein, there is a variety of samples, each of which can be allocated for its own set of tests. In such embodiments, the grouping within the shipping container is not limited to only samples that are targeted for the same test. This further simplifies sample processing because sample transport does not need to be further isolated based on the tests being performed. Some embodiments of the transport container include samples from at least three or more different patients. Some embodiments of the transport container include samples from at least 5 different patients. Some embodiments of the transport container include samples from at least 10 different patients. Some embodiments of the transport container include samples from at least 20 different patients.

  As a non-limiting example, one embodiment described herein may optionally use a tray having a slot for holding the sample container and / or sample container holder. In one embodiment, the tray can double as a holding device while waiting for more samples or stored in a cooling chamber while waiting for transport. In some embodiments, because the tray can be removed from the shipping container, in one embodiment, the tray can itself be cleaned and sterilized. In some embodiments, the trays in the shipping container may be held in a manner that is parallel to the shipping container cover. Optionally, the tray can be held in the transport container so as to be at a certain angle relative to the transport container. Optionally, the tray is non-removably secured to the shipping container. Optionally, the tray is formed integrally with the transport container itself. Optionally, multiple trays of the same or different size or configuration may be placed in the shipping container.

  In yet another embodiment described herein, a small volume sample container is shipped using an integrated temperature control unit and / or a transport container with a material that provides active and / or passive cooling. A method for providing is provided. In one embodiment, the thermal control material may be, but is not limited to, an embedded phase change material (PCM) that maintains the temperature in advance or at a desired temperature. As a non-limiting example, the phase change material can counter temperature changes near the critical temperature at which the material undergoes a phase change. When the PCM is embedded, the container and passive cooling element may be the same. Optionally, the transport container may use an active cooling system. Optionally, the transport container active cooling system can be used to maintain and / or extend the cooling time associated with passive cooling components. In embodiments, the shipping container can include a material having a high heat capacity (ie, higher compared to a material such as a plastic or polymeric material), and at least a portion of the shipping container for an extended period of time. While including a mass of such a high heat capacity material effective to maintain at or near the desired temperature.

  Optionally, the method comprises a single step of moving a plurality of sample containers from different subjects from a controlled temperature storage area to a transport container. As a non-limiting example, this single step can move 24 or more sample containers simultaneously from a storage location to a fixed location within the transport container. Optionally, this single step can move more than 36 sample containers simultaneously from a storage location to a fixed location within the transport container. Optionally, this single step can move 48 or more sample containers simultaneously from a storage location to a fixed location within the transport container. In such an embodiment, the tray is initially controlled, but not limited to, a controlled thermal such as a refrigerator where samples from various subjects are collected over time until the desired number is reached. Can be in the environment. In one such embodiment, the tray holding the sample container in the transport container may be the same as the tray holding the sample container in a storage area. Optionally, the tray can be the same as a holding holder that holds the sample prior to loading into the shipping container. Since the same tray holding the sample container is used in the transport container, the risk of sample loss during transport, the risk of being left in an uncontrolled thermal environment, etc. is reduced. Because all of the sample containers in the tray are collected in a controlled thermal storage area and then moved in a single step, all of the samples are transferred to the controlled thermal storage. From substantially storage areas, substantially the same thermal exposure is experienced while being transported into the transport container. Because the sample containers are subjected to substantially the same thermal exposure, less variation between samples due to thermal exposure time results.

  Optionally, the method includes using an individually addressable sample container configuration. Optionally, groups of sample containers, such as in a common carrier, can be addressed in a given group. Optionally, even sample containers in a common carrier can be individually addressed. While not a requirement for all embodiments herein, it can be particularly useful when loading and / or removing sample sample containers and / or sample holders from a tray.

  Some embodiments may use additional containers (outerboxes) outside the shipping container to provide additional physical protection and / or thermal control capabilities. One or more of the shipping containers can be placed in an outer box, and this combination can be shipped from one location to a destination location. As a non-limiting example, it can be in the form of a corrugated plastic outer box, which is configured to at least partially enclose or enclose the shipping container. In an embodiment, the outer box provides thermal insulation to the shipping container enclosed therein. Some embodiments may use a closed cell extruded polystyrene outer packaging box. Some embodiments of the outer box may be formed from thermoformed panels. In some embodiments of the outer box, a grip, handle, paddle, wheel, latch, support, and / or retention, manipulation, safety, protection, transport, or otherwise position and orientation control, and / or Or it may have more useful features by accessing the contents of the outer box. Some exterior box embodiments may have their own active and / or passive thermal control unit. In an embodiment, the outer box provides cooling and thermal insulation for one or more shipping containers enclosed therein. One or more embodiments of the outer box may be configured to house one or more shipping containers. Optionally, the container may also provide additional thermal control to the shipping container by providing a thermally controlled environment in the range between the desired temperatures for the shipping container therein. Optionally, this temperature is between about 1-10 ° C, optionally between 2-8 ° C, or between 2-6 ° C.

  In yet another embodiment described herein, a method is provided for thermally characterizing the shipping container after a series of cooling cycles. As a non-limiting example, after a certain number of cycles, the shipping container may be thermally characterized to ensure that the container remains within the desired range.

  Some container and / or tray embodiments may include a thermal change indicator. In one non-limiting example, the indicator is integrated into a visible surface on the shipping container, tray, and / or outer box. In one non-limiting example, thermochromic ink is used as an indicator of temperature change, particularly when the thermal change results in a temperature outside the desired range. In one embodiment, the indicator may be configured to change the color of the entire box and / or tray. The changes can be reversible or irreversible. Optionally, the indicator is located only at selected locations on the shipping container and / or tray, not the entire container or tray.

  In one embodiment described herein, the method comprises collecting a body fluid sample on a body surface of a subject, the collected sample being stored in one or more sample containers; at least two or more samples Providing a shipping container for storing the container in a first orientation; and arranging for shipping the sample container in the shipping container from a first location to a second location; Each of the sample containers is not contained in a substance drawn up by a capillary or a matrix substance, but retains a form that can be removed from the sample container in a liquid state for further processing, while retaining most of its body fluid sample. A method is provided that keeps arriving at a second location and that the amount of each sample in the sample container does not exceed about 2 ml. In embodiments, the sample volume in each of the sample containers does not exceed about 1 ml, or does not exceed about 500 μL, or does not exceed about 250 μL, does not exceed about 100 μL, or does not exceed about 50 μL or less.

  In another embodiment described herein, a method is provided for shipping a plurality of sample containers, the method comprising: storing at least five or more containers each containing a capillary blood sample. Providing a container configured for; and arranging for shipping the sample container in the transport container from a first location to a second location, each of the sample containers comprising a capillary tube To the second location with the majority of the body fluid sample retained while remaining in a liquid form that can be removed from the sample container for further processing without being included in the material or matrix material And a method is provided wherein the amount of each sample in the sample container does not exceed about 2 ml. In embodiments, the sample volume in each of the sample containers does not exceed about 1 ml, or does not exceed about 500 μL, or does not exceed about 250 μL, does not exceed about 100 μL, or does not exceed about 50 μL or less.

  In another embodiment described herein, a method is provided for shipping a plurality of sample containers for containing biological samples, the method comprising: containing at least five or more of the sample containers Providing a container configured to, wherein the amount of each sample in the sample container does not exceed about 2 ml; and shipping the sample container from a first location to a second location Each of the sample containers retains the majority of its biological sample while remaining in a liquid form that can be removed from the sample container for further processing without being included in the material drawn by the capillary. And arrive at the second place. In embodiments, the sample volume in each of the sample containers does not exceed about 1 ml, or does not exceed about 500 μL, or does not exceed about 250 μL, does not exceed about 100 μL, or does not exceed about 50 μL or less.

  In another embodiment described herein, there is provided a method for shipping a plurality of sample containers containing capillary blood, the method comprising: containing at least five or more sample containers; Providing a container having a thermally controlled internal region, said container keeping said internal region between 1-10 ° C. during transport and not freezing the blood sample Wherein at least one cooling surface of the container is directed to the sample container and configured to house the sample container in a controlled shape for controlled transmission of thermal cooling. Including a container having a thermally controlled interior region; and shipping the container from a first location to a second location, wherein the sample container is previously subjected to further processing. May removed from the sample container, a liquid, not included in the material drawn up by a capillary, it arrives at a second location while keeping most of the capillary blood sample.

  In another embodiment described herein, a method for shipping a plurality of blood sample containers is provided, the method configured to house ten or more sample containers in an array shape, Shipping containers having a thermally controlled interior, each of which holds a large portion of a blood sample in a form that is free of free-flowing, non-capillary drawn material, and each In each of the containers, there is about 1 mL or less of blood, and each of the containers has at least partially a vacuum pressure interior; the sample containers have a controlled distance from the cooling surface and There is at least one preferential thermal path from the surface to the sample, held in an array shape for placement in orientation.

  In another embodiment described herein, a method is provided for shipping a plurality of 1 ml or less sample containers, wherein the method anti-coagulates the sample prior to transferring the sample into the sample container. Mixing with a blood agent; associating each of the sample containers with a subject and a required panel of sample tests; and a thermally controlled container containing the 1 ml or less sample container in an array configuration Each of the containers holds a majority of its sample in a form that is free from the free-flowing material drawn by the capillary, each container having at least two, respectively, And in the matrix, at least a first sample includes a first anticoagulant and a first container The sample comprises a second anticoagulant.

  In another embodiment described herein, a) a plurality of sample containers having a controlled uniform thermal profile, a high heat fusion material configured to be in thermal communication with the sample containers. Having a temperature controlled transport container, wherein the substance does not cause freezing of the sample fluid in the sample container; b) the transport container of the thermal profile is at least at the top of the transport container And placing it in a cavity for the product defined by the bottom wall; c) placing an active cooling device in thermal communication with the cavity, whereby the cooling device is When activated, the sorption cooling device is adapted to cool the cavity, and the sorption cooling device includes an absorbent arranged to dissipate heat generated in the absorbent outside the product cavity. d) activating the cooling device to initiate cooling of the cavity; e) transporting the transport container from a first location to a second location; and f) removing the product from the cavity. A method is provided.

  In another embodiment described herein, a method is provided for shipping a plurality of 1 ml or less sample containers, the method comprising: thermally controlling, storing the plurality of 1 ml or less samples in an array shape. Each of the containers holds a large portion of its sample in a form that is free from the free-flowing, wicked material, and the containers are in their respective containers. At least two containers associated with each subject, wherein in the matrix, at least the first sample comprises a first anticoagulant and the second sample comprises a second Contains anticoagulants.

  It should be understood that any embodiment herein may be adapted to have one or more of the following features. In one non-limiting example, the bodily fluid sample is blood. Optionally, the body fluid sample is capillary blood. Optionally, collecting the bodily fluid sample includes performing at least one puncture on the subject to collect the bodily fluid, and not the puncture vein puncture. Optionally, collecting includes using at least one microneedle to perform at least one puncture on the subject. Optionally, collecting includes using at least one lancet to perform at least one puncture on the subject.

  Optionally, the puncture is formed by piercing the fingertip. Optionally, the puncture is formed by piercing the skin on the subject's forearm. Optionally, it is formed by piercing the skin on the limb of the puncture subject. Optionally, the puncture is formed by piercing the ear of at least one subject. Optionally, the surface is the subject's skin. Optionally, alternative sites other than the other fingers can be targeted to obtain at least one biological sample from the subject. Optionally, a solid, non-core penetrating member can be used to release the biological sample from the subject. Optionally, other embodiments include but are not limited to hollow needles or other hollow penetrating members that cause the release of liquid biological samples and non-liquid samples such as but not limited to tissue. For both to obtain in the hollow member. Some embodiments can have at least one hollow penetrating member and at least one non-hollow penetrating member. Some embodiments may use a blade to form a wound. While a puncture-type motion can be used, a cutting-type motion can also be used. Any of these penetrating members can be configured for use against one or more of the target sites.

  Optionally, the transport container initially has an interior that is below atmospheric pressure. Optionally, the pressure below the atmospheric pressure is at least a partial vacuum. Optionally, the interior of the shipping container is at a pressure below atmospheric pressure, at least at a pressure below ambient pressure. Optionally, a pressure below the atmospheric pressure is selected to provide sufficient force to draw a desired volume of sample into the sample container. Optionally, the transport container contains at least five or more sample containers. Optionally, the transport container delivers bodily fluid samples from a plurality of different subjects. Optionally, determine which tests are to be performed on the bodily fluid sample therein. Optionally, the shipping container is placed in another container during shipping. Optionally, the method further comprises pre-processing the sample in the sample container prior to shipping to a second location. Optionally, at least a portion of the sample can be collected and dried, such as but not limited to a paper sample collector. Above the collector for the sample, there may be a plurality of “spots” to be collected on such a paper sample collection member and then transported. The dried sample can be transported with a container having a liquid sample. Both may be encoded by at least one identifier associated with both collectors having the same identifier or the same subject.

  Optionally, the transport container has an array density of sample containers of at least about 4 containers per square inch. Optionally, the cooling surface in the transport container provides a temperature profile within a desired range for the sample container in the container. Optionally, the sample containers are individually addressable. Optionally, the method further comprises using a cooled tray to hold the sample container in a cooling chamber prior to loading the sample container into the container, and the same tray comprises the Used to hold the sample container in a container, the sample is placed in the container with a cooled tray. Optionally, the sample container is arranged such that at least two containers are in a container with sample body fluid from the same subject, wherein in the matrix, at least the first sample is a first anticoagulant. And the second sample contains a second anticoagulant. Optionally, the fluid sample comprises capillary blood for use in FDA-approved or FDA-certified assay equipment and operations or testing in a CLIA-certified clinical laboratory. Optionally, the fluid sample comprises FDA approved or FDA certified assay equipment and procedures or blood for use in a test by a CLIA certified clinical laboratory. Optionally, a housing is provided that provides a hot thermal fusion material that provides a controlled thermal profile and at least one cooling surface facing the container. Optionally, the high heat fusion material is embedded in the material used to form the container. Optionally, the controlled thermal profile, high heat fusion material comprises about 30% to 50% of the material used to form the container. Optionally, the controlled thermal profile, high heat fusion material comprises about 10% to 30% of the material used to form the container. Optionally, the method further comprises a metallic material housing having a resting temperature below room temperature.

  Optionally, the method further comprises scanning an information storage unit on each sample at the receiving site and automatically placing the container in the cartridge. Optionally, the method retains the same tray in a refrigerated instrument prior to transport and sample containers in an array shape when in the transport container during transport. It further includes using. Optionally, the method further comprises using a tray to hold the sample container containing a highly thermally conductive material. Optionally, the tray further comprises a plurality of slots having a shape having a shape for holding the sample container holder in a preferential orientation. Optionally, the tray is configured for direct engagement with the sample container holder. Optionally, a tray locking mechanism is used to hold the tray in the container, and the tray locking mechanism releases the tray only when a magnetic force is applied. Optionally, the method includes maintaining the temperature range between 2 ° C and 8 ° C during transport. Optionally, the method further comprises a temperature control material that exceeds the freezing temperature but is maintained at about 10 ° C. or less during transport. Optionally, the method includes using a temperature threshold sensor to display when the sample container reaches a threshold level. Optionally, the method further comprises scanning a container in the tray to determine whether a processing step has not been performed on the sample; a processor to perform or re-execute the step Is used. Optionally, the method further comprises a single step loading of the sample container into the tray and then a single step filling of the tray into the transport container.

  Optionally, the transport container has a first surface configured to define a controlled thermal profile, a thermal conduction path to a hot thermal fusion material in the transport container. Optionally, the first surface is configured for direct contact with another surface cooled by a sorption cooling device. Optionally, the method includes simultaneous barcode scanning of the sample containers in the tray. Optionally, the method includes scanning a bar code in a row of sample containers in the tray. Optionally, the method includes scanning a bar code below the row of sample containers. Optionally, the method includes shipping a plurality of the sample containers in an inverted orientation. Optionally, the method includes shipping a plurality of the sample containers in which blood cells and plasma are separated by a barrier material. Optionally, the method includes unlocking and opening and opening the transport container in which at least one hinge holds the two pieces together. Optionally, the tray includes a magnetic contact point for removing at least one of the trays from the container. Optionally, a computer controlled end effector is used to load and / or remove the sample container from the transport container, and a reader is attached to one or more sample containers before, during, or after removal. Information is acquired from at least one information storage unit. It should be understood that the transport container is often used for transport, but also when used as a storage container for the tray and / or sample container when the transport container is not used for hot water filling. Thus, the use of the container is not limited to transportation, and other suitable uses for any embodiment are not excluded.

  In yet another embodiment of the present specification, a thermally controlled transport container is provided for use in shipping a plurality of sample containers, the transport container comprising: a top, a bottom, And at least one of the top, bottom and side walls includes a phase change material; sized to fit within the cavity and configured to hold a plurality of sample containers A frame having a side wall configured to contact the side wall of the sample container, wherein the container includes a first anticoagulant at least in the matrix for each patient. And a second sample with a second anticoagulant.

  In another embodiment described herein, a thermally controlled transport container is provided for use in shipping a plurality of sample containers, the transport container: a) containing the product therein A bottom container portion including a bottom wall and at least a first side wall defining a cavity adapted for; b) including a top surface and a bottom surface, and said container for defining a product cavity A top container portion adapted for coupling with a bottom portion, the top container portion forming a top wall for the container; at least one of the top, bottom and side walls includes a phase change material.

  In another embodiment described herein, a thermally controlled transport container is provided for use in shipping a plurality of sample containers, the transport container: a) containing the product therein A bottom container portion including a bottom wall and at least a first side wall defining a cavity adapted for; b) including a top surface and a bottom surface, and said container for defining a product cavity A top container portion adapted for coupling with a bottom portion, said top container portion forming a top wall for said container; c) a space for positioning said sample container in a predetermined orientation A holder for defining a plurality of sample containers to hold; at least one of the top, bottom and sidewalls comprising a phase change material.

  In another embodiment described herein, a transport container is provided for shipping sample containers, the container comprising: a generally rectangular floor; a general protruding from a longitudinal edge of the floor A side parallel to the side; a generally parallel end protruding from the edge of the end of the floor and bridging both sides; can be fitted over the side and end, and together with them and the floor A cover forming a generally closed space; including a sample container holder removably connected to the floor within the container and configured to define a space for holding the container. Optionally, the container holding the space is configured to hold a degassed blood collection tube having an internal volume of about 2 ml or less. In at least one embodiment, the container holding the space is not limited, but has an internal volume of about 1 ml or less, or about 500 μL or less, or about 250 μL or less, or about 100 μL or less, or about 50 μL or less. Configured to hold a container such as an aspirated collection tube.

  In another embodiment described herein, a thermally controlled transport container is provided for use in shipping a plurality of sample containers, the transport container comprising: a plurality of sample containers, at least one fixed Means for holding in the oriented orientation; and means for thermally controlling the temperature of the sample container within a desired range of about 0 ° C. to 10 ° C .; holding the plurality of sample containers Means for removably from the transport container. Optionally, the container holding the space is configured to hold a degassed blood collection tube having an internal volume of about 2 ml or less. In embodiments, the container holding the space holds a degassed collection tube having an internal volume of about 1 ml or less, or about 500 μL or less, or about 250 μL or less, or about 100 μL or less, or about 50 μL or less. Configured for.

  It should be understood that some embodiments may include a kit that includes a shipping container listed in any of the above. Optionally, the kit includes a shipping container and instructions for its use.

  In one embodiment described herein, a method for providing a whole blood sample and / or a portion thereof from a sender to a recipient is described. The method includes: (a) a whole blood sample and / or a separation thereof in a fluid state in a volume of about 200 microliters (μL) or less; and (b) at least a whole blood sample and / or a separation thereof is a recipient. Including one or more channels containing one or more reagents for storing one or more analytes in a whole blood sample and / or one or more analytes thereof for analysis until Transporting the package, and precise placement of the sample container in the package results in delivery to the recipient of the container. As a non-limiting example, the sample container may be transported using a courier service, a delivery person, or other shipping service.

  In one embodiment described herein, a method for preparing a whole blood sample for delivery to a sample processing station is described. The method includes depositing a sample container having a fluid state and a whole blood sample in a volume of about 200 μL or less to process a whole blood sample to process the whole blood sample. The sample container can be prepared by: (a) collecting a whole blood sample from a subject with the aid of a capillary channel; and (b) placing the whole blood sample in the sample container, The whole blood sample is stored in a fluid state with a capillary channel and / or one or more reagents contained in the sample container.

  It should be understood that any embodiment herein may be adapted to have one or more of the following features. As a non-limiting example, the sample may be in a semi-solid or gel state in some embodiments. This can occur after the sample has been placed in the sample container. Optionally, the delivery service is a postal delivery service. Optionally, the blood sample is taken from the subject at a point of care location. Optionally, the point of care location is the subject's home. Optionally, the point of care location is a health care provider location.

  In another embodiment described herein, a method of processing a whole blood sample includes receiving a sample container having a whole blood sample of about 200 μL or less from a delivery service at a processing station, the sample container comprising: Receiving the whole blood sample in a fluid state at a processing station; and performing at least one preanalytical and / or analytical assay on the whole blood sample in a fluid state at the processing station.

  It should be understood that any embodiment herein may be adapted to have one or more of the following features. As a non-limiting example, the assay has one or more steps. Optionally, the sample container is housed in a housing having one or more environmental control zones. Optionally, the housing is adapted to control the humidity of each of the environmental control zones. Optionally, the housing is adapted to control the pressure of each of the environmental control zones.

  In yet another embodiment described herein, a computer-implemented method for queuing blood samples for processing at a processing location is provided. The method includes: (a) identifying geolocation information of a transport container having a blood or other bodily fluid sample with the aid of a geolocation system having a computer processor; (b) with the aid of a computer processor; And (c) providing a notification for a preparation operation for processing of the sample at the processing location based on the estimated delivery time.

  In yet another embodiment described herein, a method for preparing a whole blood sample for delivery to a sample processing station is described. The method includes depositing a sample container having a whole blood sample in a fluid state at a delivery service to deliver the sample container to the sample processing location for processing the whole blood sample; Is prepared by (a) collecting the whole blood sample from a subject using an instrument and (b) placing the whole blood sample in the sample container.

  Optionally, depositing may include picking up and / or unloading the sample container. Optionally, processing may include pre-analysis, analysis and post-analysis processing of the sample. Optionally, the delivery service may include a subject delivery service or a third party delivery service. Optionally, the whole blood sample is stored in a fluid state with one or more reagents contained in a capillary channel or in the sample container.

  In yet another embodiment described herein, a method is provided for processing a whole blood sample at a processing station. The method includes receiving, at a processing station, a sample container having a whole blood sample from a delivery service, the sample comprising: (a) collecting the whole blood sample from a subject using a collection device; and (b ) Prepared by placing the whole blood sample in the sample container. The method also includes performing at least one pre-analysis or analytical assay on the whole blood sample at a processing station.

  It should be understood that any embodiment herein may be adapted to have one or more of the following features. As a non-limiting example, with the aid of a computer processor, it provides time from estimated delivery time to completion. Optionally, the method includes queuing the sample container for processing in response to an estimate of the time of delivery of the sample container to the processing location. Optionally, the geolocation information of the sample container is identified with the aid of a communication network.

  In one embodiment described herein, a computer-implemented method is described that provides an estimated time for completion of processing of a blood sample. The method includes receiving, by a delivery service, information about a transport container for processing being transported to a processing station, the transport container having a blood sample drawn from a subject. The method also includes calculating the position of the blood sample in a processing queue at a processing station with the aid of a computer processor, the prediction being (i) blood or other bodily fluid from another subject Information about the position of the sample in the processing queue, and (ii) other sample containers with blood samples from other subjects in relation to the sample container with blood samples drawn from the subject Based on information about geographical location. The method includes predicting the time at which the blood sample is processed at the processing station from delivery of the sample container to the processing station by the delivery service; and the prediction and processing of the sample container to the processing station. Based on the estimated delivery time, the subject or a health care provider associated with the subject is provided with an estimated time to process a blood sample from the subject, the estimated time Is measured from the time the sample container is deposited with the delivery service. Optionally, the sample is transported to multiple processing stations. As used herein. It should be understood that processing should be interpreted broadly and can include pre-analytical, analytical, and / or post-analytical steps.

  In yet another embodiment described herein, a computer-implemented method is provided for providing an estimated time to complete processing of a blood sample from a subject. The method includes receiving information about a transport container for sample processing being transported to a processing station by a delivery service, the transport container having a blood sample drawn from a subject. The method also includes calculating the position of the blood sample in a processing queue at a processing station with the aid of a computer processor, the prediction being (i) blood or other bodily fluid from another subject Information about the position of the sample in the processing queue, and (ii) other sample containers with blood samples from other subjects in relation to the sample container with blood samples drawn from the subject Based on information about geographical location. The method includes predicting the time at which the blood sample is processed at the processing station from delivery of the sample container to the processing station by the delivery service; and the prediction and processing of the sample container to the processing station. Based on the estimated delivery time, when delivered to the processing station, the processing station allocates one or more resources for processing the blood sample.

  It should be understood that any embodiment herein may be adapted to have one or more of the following features. As a non-limiting example, the shipping container has an information storage unit that allows the shipping container to be identified by the delivery service and / or the processing location. Optionally, the information storage unit is a radio frequency identification (RFID) tag. Optionally, the information storage unit is a barcode. Optionally, the information storage unit is a microchip. Optionally, the transport container may be the temperature of the body fluid sample (eg, blood sample), the pressure of the sample container, the pH of the sample, the turbidity of the sample, the viscosity of the sample, or other characteristics of the sample. One or more sensors for collecting one or more of the. Optionally, the processing location processes the collected bodily fluid sample in an on-demand format. Optionally, the transport container includes a geographical location device for providing the location of the sample container. Optionally, the anticoagulant is selected from the group consisting of heparin, ethylenediaminetetraacetic acid, anticoagulant, or other additives. Optionally, the transport container is configured to hold a degassed blood collection tube, wherein the container holds space therein, and is at most about 30% vacuum, or at most about 40% vacuum, Or degassed with a partial vacuum of up to about 50% vacuum, or up to about 60% vacuum, or up to about 70% vacuum, or up to about 80% vacuum, or up to about 90% vacuum Configured to hold a sample collection tube.

  In embodiments comprising a first container and a second container as described herein, in certain embodiments, the internal volume of the first container and the second container is 1000, 750, 500, 400, 300, 250, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2 micro Liters or less. In embodiments including a first container and a second container as described herein, in certain embodiments, both the internal volume of the first container and the internal volume of the second container are 1000, 750. , 500, 400, 300, 250, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3 Or no more than 2 microliters. In embodiments that include one or more containers described herein, in certain embodiments, the internal volume of each of the one or more containers is 1000, 750, 500, 400, 300, 250, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2 microliters or less. In embodiments that include one or more containers described herein, in certain embodiments, any internal volume of each of the one or more containers is 1000, 750, 500, 400, 300, 250, 200. , 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, or 2 microliters.

  In embodiments including a first container and a second container, each of which includes a portion of a small volume body fluid sample as described herein, in certain embodiments, the first container is also a second container. , 500, 400, 300, 250, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, Does not include a portion of a small volume fluid sample having a volume greater than 4, 3, or 2 microliters.

  In embodiments comprising a container containing a small volume of bodily fluid sample as described herein, in certain embodiments, the volume of the small volume of bodily fluid sample in the container is 500, 400, 300, 250, 200. , 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, or 2 microliters.

  In embodiments including one or more containers containing a bodily fluid sample as described herein, in certain embodiments, at least one of the one or more containers containing a bodily fluid sample is of the internal volume of the container, A bodily fluid sample that meets at least 99, 98, 97, 96, 95, 90, 85, 80, 75, 70, 60, 50, 40, 30, 20, 10, or 5%. In embodiments comprising one or more containers comprising a bodily fluid sample as described herein, in certain embodiments, all of the one or more containers are at least 99, 98, of the internal volume of the container. Contains bodily fluid samples that meet 97, 96, 95, 90, 85, 80, 75, 70, 60, 50, 40, 30, 20, 10, or 5%.

  In embodiments described herein that include a sample collection site and a sample reception site, in embodiments, the sample collection site and sample reception site are in the same room, building, campus, or collection of buildings. possible. In embodiments described herein that include a sample collection site and a sample reception site, in embodiments, the sample collection site and sample reception site may be in different rooms, buildings, campuses, or collections of buildings. In embodiments, the sample collection site and the sample receiving site are at least 1 meter, 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 kilometer, 5 kilometers, 10 kilometers, 15 kilometers, 20 kilometers, 30 kilometers, It can be 50 kilometers, 100 kilometers, or 500 kilometers away. In embodiments, the sample collection site and sample receiving site are 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 kilometer, 5 kilometers, 10 kilometers, 15 kilometers, 20 kilometers, 30 kilometers, 50 kilometers, 100 It can be less than a kilometer, 500 kilometers, or 1000 kilometers away. In embodiments, the sample collection site and the sample receiving site are at least 1 meter, 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 kilometer, 5 kilometers, 10 kilometers, 15 kilometers, 20 kilometers, 30 kilometers, 50 kilometers, 100 kilometers, or 500 kilometers, and 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 kilometer, 5 kilometers, 10 kilometers, 15 kilometers, 20 kilometers, 30 kilometers, 50 kilometers, 100 kilometers, Can be less than 500 kilometers, or 1000 kilometers away. In embodiments, the first location described herein may be a sample collection site and the second location described herein may be a sample receiving site.

  In embodiments described herein including a container that includes at least a portion of a small volume of bodily fluid sample that is transported from a sample collection site to a sample receiving site, in an embodiment, the bodily fluid sample comprises: It can be maintained in liquid form during transport. In an embodiment described herein comprising two or more containers each transported from a sample collection site to a sample receiving site, comprising at least a portion of a small volume body fluid sample, The bodily fluid sample in each of the containers can be maintained in a liquid form during transport of the container.

  In embodiments described herein that include one or more containers transported from a sample collection site to a sample receiving site, in embodiments, the one or more containers are transported in a transport container. obtain. In embodiments described herein that include one or more containers transported in a transport container, in embodiments, the one or more containers are disposed in an array in the transport container. And the array is at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, per square inch when viewed from above 30, 35, 40, 50, or 100 containers may be included.

  In embodiments that include the transport of one or more containers in a transport container as described herein, in embodiments, the transport container is at least 1, 2, 3, 4, 5, 6, 7, 8, It may contain bodily fluid samples from 9, 10, 15, 20, 25, 30, 35, 40, 50, or 100 different subjects.

  In embodiments described herein that include a container that includes at least a portion of a body fluid sample, in embodiments, the container may include an anticoagulant. In embodiments that include two or more containers that include a portion of a body fluid sample from a subject, in embodiments, at least one or all of the containers may include an anticoagulant. In embodiments, each of the two or more containers comprising a portion of a body fluid sample from a subject and further comprising an anticoagulant comprises the same anticoagulant or a different anticoagulant in said container. obtain. The anticoagulant in the container can be, for example, heparin or EDTA.

  In a method described herein comprising transporting a bodily fluid sample in one or more containers from a sample collection site to a sample receiving site, in an embodiment, the bodily fluid sample is transferred to the bodily fluid at the sample receiving site. 48 hours, 36 hours, 24 hours, 16 hours, 12 hours, 8 hours, 7 hours, 6 hours, 5 hours, 4 hours, 3 hours, 2 hours, 60 minutes, 45 minutes after the sample is obtained from the subject. Arrive in less than 30 minutes, 20 minutes, 15 minutes, 10 minutes, or 5 minutes.

  In an embodiment described herein, in an embodiment comprising transporting at least one container from a sample collection site to a sample receiving site, the method further comprises centrifuging the container prior to transport. . In an embodiment described herein, the method comprising transporting a plurality of containers from a sample collection site to a sample receiving site, wherein the method comprises centrifuging the plurality of containers prior to transport. Is further included.

  In a method for transporting at least a first container from a sample collection site to a sample receiving site as described herein, in an embodiment, at the sample receiving site and prior to removing a sample from the first container, The first container is inserted into a sample processing device that includes an automated fluid handling device. In a method described herein comprising transporting at least a first container and a second container from a sample collection site to a sample receiving site, in embodiments, the sample is received at the sample receiving site and the first Prior to removal from the first and second containers, the first and second containers are inserted into a sample processing device that includes an automated fluid handling device. In embodiments, when a container containing a sample is inserted into a sample processing device that includes an automated fluid handling device, the sample can be removed from the container by the automated fluid handling device. In an embodiment, prior to inserting a container containing a sample into a sample processing device including an automated fluid handling device, is inserted into a cartridge, and the cartridge is then inserted into the sample processing device. The cartridge can contain a container containing any number of samples, such as at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 50, or 100 containers. The cartridge may further include one or more reagents for performing one or more clinical tests on the sample. In an embodiment, the cartridge may contain all reagents necessary for all tests to be performed on the sample in the cartridge.

  In embodiments, a portion of the portion of the body fluid sample in the container may be any amount. For example, in embodiments, a portion of the portion of the body fluid sample in the first container may be part of the original sample in the first container or a portion of the diluted sample in the first container. In another example, in an embodiment, a portion of the body fluid sample portion of the second container may be part of the original sample of the second container or a portion of the diluted sample of the second container. .

  In embodiments provided herein, wherein the embodiment includes transport from one sample collection site to a sample receiving site of one or more containers each containing at least a portion of a bodily fluid sample, in embodiments, any number of clinical tests One or more steps may be performed by a portion of at least a portion of the bodily fluid sample in the container. For example, in the embodiment, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 200, One or more steps of 300, 400, 500, or 1000 or more different clinical tests may be performed by a portion of at least a portion of the body fluid sample. Each different clinical test can use a separate portion of the bodily fluid sample, or in embodiments, two or more different clinical tests can be performed by a particular portion of the bodily fluid sample. The different clinical tests can be the same type, different types, or a mixture of the same and different types. The one or more containers may be, for example, a first container or a first container and a second container.

  In embodiments, where a body fluid sample from a subject transported according to the system or method provided herein is used for more than one clinical test, each of the clinical tests is 50, Less than 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.5, 0.1, 0.05, or 0.01 equivalents An undiluted body fluid sample (eg, undiluted whole blood, saliva, or urine) may be used.

  In embodiments including obtaining a plurality of containers collectively containing a small volume of bodily fluid sample from a subject at a sample collection site provided herein, in embodiments, the plurality obtained from the subject. The total volume of the small volume body fluid sample in all of the containers is 500, 400, 300, 250, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, No more than 15, 10, 9, 8, 7, 6, 5, 4, 3, or 2 microliters.

  Transporting a container comprising at least a portion of a body fluid sample from a sample collection site to a sample receiving site provided herein, removing the original sample from the container at the sample receiving site, and then In embodiments that involve generating a diluted sample from an original sample, in embodiments, the dilution is performed step by step or continuously. In an embodiment, the diluted sample is 1000, 900, 800, 700, 600, 500, 400, 300, 250, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25. , 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, or 2 microliters of total volume. In an embodiment, the diluted sample is at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 50, 100, 200, 300, 400 relative to the original sample. , 500, 1000, 5,000, 10,000, 50,000, or 100,000 times.

  As provided herein, transporting at least a first container and a second container, each containing a portion of a small volume of bodily fluid sample obtained from a subject, from a sample collection site to a sample receiving site. In embodiments including, in the embodiment, at the sample receiving site, the original sample of the first container can be removed from the first container, and the original sample of the second container is the second Can be removed from the container. From the original sample from the first container, a diluted sample of the first container can be generated. From the original sample from the second container, a diluted sample of the second container can be generated. The diluted sample of the first container and the diluted sample of the second container can have the same or different volumes and dilutions. In embodiments, a plurality of different diluted samples may be made from one or both of the original sample of the first container or the original sample of the second container. The different diluted samples can be of different types and can be used for one or more different clinical tests. In embodiments, the diluted sample of the first container is at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, compared to the original sample of the first container. Can be diluted 50, 100, 200, 300, 400, 500, 1000, 5,000, 10,000, 50,000, or 100,000, and 1000, 900, 800, 700, 600, 500 , 400, 300, 250, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, or The total volume less than 2 microliters and the second container diluted sample is at least 2, 3, 4, 5, 6, 7, 8, compared to the original sample in the second container 9, 10, 1 20, 50, 100, 200, 300, 400, 500, 1000, 5,000, 10,000, 50,000, or 100,000 times, and 1000, 900, 800, 700, 600, 500, 400, 300, 250, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, Have a total volume of less than 3, or 2 microliters.

  In an embodiment provided herein, wherein a container is obtained at a sample collection site, wherein the container contains a small volume of bodily fluid sample obtained from a subject. The volume of body fluid sample is 500, 400, 300, 250, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, It can be less than 6, 5, 4, 3, or 2 microliters.

  Obtaining a container at a sample collection site provided herein, said container containing a small volume of bodily fluid sample obtained from a subject, and transporting said container from said sample collection site to a sample receiving site In some embodiments, the small volume body fluid sample is 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 40, 50, 60, It can be divided into any number of parts, such as 70, 80, 90, 100, 200, 300, 400, 500, or 1000 different parts. The portions can be diluted to the same or varying amounts and, for example, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 40, It can be used for 50, 60, 70, 80, 90, 100, 200, 300, 400, 500, or 1000 or more different clinical tests.

  In an embodiment provided herein, wherein at least a container containing at least a portion of a small volume of bodily fluid sample from a subject at a sample collection site is obtained, Collecting a bodily fluid sample from the subject (eg, fingertip puncture or venous blood collection).

  In embodiments provided herein that include performing at least a portion of a clinical test in an assay unit, in an embodiment, the assay unit is movable by a fluid handling device or the like. In embodiments that include more than one assay unit, in embodiments, the assay unit may be independently movable.

  In embodiments provided herein that include transporting one or more containers containing bodily fluid samples, in some embodiments, the containers are characterized by the containers described herein, or You can have any of the other containers suitable for storage of bodily fluids. In some embodiments, the container is a bodily fluid sample by any of the devices or any other suitable technique for filling a container having a small internal volume, as provided herein. Can be filled. For example, in certain embodiments, containers to be transported according to the systems or methods provided herein can be filled with a syringe or pipette tip.

  Optionally, at least one embodiment of the sample collection device herein can separate a single blood sample into different vessels for different analytical pre-treatments, via a fluid path in the device. And / or via different injection ports on the device.

  In at least another embodiment described herein, there is provided a method for use with a bodily fluid sample from a subject, comprising: a plurality of sample containers from a first location to a second location. Each of the sample containers contains about 500 μL or less of sample, and each of the sample containers has an internal volume of about 600 μL or less, and the plurality of sample containers are transported to the transport container Achieved by using a first frame dimensioned to fit, each first frame engaging at least one of the sample containers and holding the sample container in a desired orientation Including a plurality of openings sized and shaped to obtain data from each of the sample containers; Providing a ram at the second location; using data from the sample container to determine which of the processing frames receive which of the sample containers; and provided from the sample container Moving the sample container from a transport frame to a processing frame based on data and sorting information; and handling the processing frame to process the sample container processing frame simultaneously.

  Optionally, obtaining data includes scanning multiple sample container IDs simultaneously. Optionally, scanning occurs when the container is in the transport frame. Optionally, scanning includes scanning the lower surface of the transport container. Optionally, determining which processing frame receives which of the sample containers includes referencing data to at least one database on the server. Optionally, determining includes adapting the container ID to the subject ID. Optionally, determining includes adapting the container ID with a pretreatment procedure. Optionally, at least some of the sample containers include a sample having a first anticoagulant and at least some of the other sample containers have a second, different anticoagulant.

  In one embodiment, a method for use with a body fluid sample from a subject is provided, comprising: transporting a plurality of sample containers from a first location to a second location, wherein Each of the sample containers contains no more than about 500 μL, but more than about 30 μL of a body fluid sample, and each of the sample containers has an internal volume of no more than about 600 μL, to form a body fluid sample to form a first processed sample To a first accelerated settling force of at least about 1400 g or more; transporting a first processed sample from a first location to a second location; and At a second location, subject to a second accelerated settling force greater than about 10 g but not greater than about 500 g.

  Any of the embodiments herein may be configured for one or more of the following features. In one embodiment, the first processed sample comprises a first anticoagulant. Optionally, said first treated sample comprises a heparin based anticoagulant. Optionally, the first processed sample comprises a plasma portion separated from the formed blood component portion by a separation gel. Optionally, the second processed sample does not drive the electrolyte separation gel from the formed blood component portion to the plasma portion. Optionally, the second processed sample does not drive the passage of a liquid separation gel from the formed blood component portion to the plasma portion. . Optionally, the first accelerated settling force is provided via centrifugation. Optionally, the second accelerated settling force is provided via centrifugation. Optionally, a plurality of samples are transported from a first location to a second location, each of the samples undergoing a first accelerated sedimentation on an independent basis, and the plurality of samples Two accelerated sinks are received simultaneously as a group. Optionally, a plurality of samples in the sample container are transported from a first location to a second location, undergoing a first accelerated sedimentation on an independent base, and the plurality of samples are Accelerated settling takes place simultaneously in a single tray as a group. Optionally, a plurality of samples are transported from a first location to a second location, each of said samples undergoing a first accelerated sedimentation on an independent basis, and said plurality of samples are second Are accelerated simultaneously in at least one centrifuge tray as a group.

  Optionally, the dead volume around the sample in each of the containers containing the sample is about 60 μL or less. Optionally, the dead volume around the sample in each of the containers containing the sample is about 50 μL or less. Optionally, the dead volume around the sample in each of the containers containing the sample is about 40 μL or less. Optionally, the dead volume around the sample in each of the containers containing the sample is about 30 μL or less. Optionally, the dead volume around the sample in each of the containers containing the sample is about 20 μL or less. Optionally, the dead volume around the sample in each of the containers containing the sample is about 10 μL or less. Optionally, at least some of the sample containers comprise a sample having a first anticoagulant and at least some of the sample containers comprise a second, different anticoagulant.

  Any of the embodiments herein may be configured for one or more of the following features. In one embodiment, the method comprises collecting capillary blood from a subject, wherein the blood is collected in a plurality of vessels, but less than 500 microliters per device, but at least about 10 microliters per device. Over. Optionally, collecting whole blood, said blood being collected in a plurality of vessels, less than 400 microliters per vessel, but more than at least about 10 microliters per vessel. Optionally, collecting whole blood, said blood being collected in a plurality of vessels, but less than 300 microliters per vessel, but at least about 10 microliters per vessel. Optionally, collecting whole blood, said blood being collected in a plurality of vessels, but less than 200 microliters per vessel, but at least about 10 microliters per vessel. Optionally, collecting whole blood, said blood being collected in a plurality of vessels, less than 100 microliters per vessel, but more than at least about 10 microliters per vessel. Optionally, transporting a fluid sample in the method liquid from a first location to a second location. Optionally, the method includes transporting a fluid sample in a liquid from a first location to a second location, wherein the sample is at least 1500 g at the first location and the second location. Centrifuging at less than 400 g but more than 10 g. Optionally, the method includes transporting a fluid sample in a liquid from a first location to a second location, such as, but not limited to, centrifugation at the first location. Applying a first accelerated settling force of at least 1400 g and applying a settling force of less than 400 g but greater than 10 g at said second location. Optionally, the method includes transporting a fluid sample in a liquid from a first location to a second location, such as, but not limited to, centrifugation at the first location. Applying a first accelerated settling force of at least 1400 g, and applying a settling force of less than 500 g but greater than 10 g at said second location. Optionally, the method includes transporting a fluid sample in a liquid from a first location to a second location, such as, but not limited to, centrifugation at the first location. Centrifuging at least 1500 g, and centrifuging at less than 400 g but above 10 g in the second location, wherein the sample is about 50 to about 200 microliters. Optionally, the method includes transporting a fluid sample in a liquid from a first location to a second location, such as, but not limited to, centrifugation at the first location. Centrifuging at least 1500 g, and centrifuging less than 400 g but more than 10 g in the second location, wherein the sample is about 50 to about 300 microliters. Optionally, the method includes transporting a fluid sample in a liquid from a first location to a second location, such as, but not limited to, centrifugation at the first location. Centrifuging at least 1500 g and centrifuging less than 400 g but more than 10 g in the second location, wherein the sample is about 20 to about 180 microliters. Optionally, the method includes transporting a fluid sample in a liquid from a first location to a second location, centrifuging the sample at at least 1500 g at the first location, and Centrifuging at less than 400 g but greater than 10 g at the second location, wherein the sample is about 20 to about 200 microliters and 5-30 microliters when filled with the sample In a vessel with dead volume. Optionally, an apparatus including a shipping container is provided. Optionally, the method comprises centrifuging the sample at at least 1400 g at the first location and centrifuging at less than 500 g at the second location. Optionally, a system is provided that includes a processor programmed to determine at least a desired sample dilution and at least a desired number of aliquots for the sample.

  Optionally, a method is provided that includes at least one technical feature from any disclosed embodiment.

  Optionally, a method is provided that includes at least any two technical features from any disclosed embodiment, even if originally described in another embodiment.

  Optionally, an apparatus is provided that includes at least one technical feature from any disclosed embodiment.

  Optionally, an apparatus is provided that includes at least any two technical features from any disclosed embodiment, even if originally described in another embodiment.

  Optionally, a system is provided that includes at least one technical feature from any disclosed embodiment.

  Optionally, a system is provided that includes at least any two technical features from any disclosed embodiment, even if originally described in another embodiment.

  This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This summary is not intended to identify key features or essential characteristics of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.

(Incorporation by reference)
All publications, patents, and patent applications mentioned in this specification are shown as if clearly and individually, because each individual publication, patent, and patent application is incorporated by reference. To the same extent as those herein incorporated by reference.

1A-1B show perspective views of a sample collection device according to one embodiment described herein.

2A-2C show perspective views of an uncapped sample collection device, according to one embodiment described herein.

3A-3B show side and cross-sectional views of a sample collection device according to one embodiment described herein.

4A-4B illustrate side and cross-sectional views of a sample collection device, according to one embodiment described herein.

5A-5B show perspective views of a sample collection device according to one embodiment described herein.

6A-6B show side views of a sample collection device, according to one embodiment described herein.

7A-8B show side and cross-sectional views of a sample collection device, according to one embodiment described herein. 7A-8B show side and cross-sectional views of a sample collection device, according to one embodiment described herein.

9A-9C show side cross-sectional views of various stages of use of a sample collection device, according to one embodiment described herein.

10A-10B show perspective views of a sample collection device according to one embodiment described herein.

11A-11Z show diagrams of various examples of sample collection devices according to one embodiment described herein. 11A-11Z show diagrams of various examples of sample collection devices according to one embodiment described herein. 11A-11Z show diagrams of various examples of sample collection devices according to one embodiment described herein. 11A-11Z show diagrams of various examples of sample collection devices according to one embodiment described herein. 11A-11Z show diagrams of various examples of sample collection devices according to one embodiment described herein. 11A-11Z show diagrams of various examples of sample collection devices according to one embodiment described herein. 11A-11Z show diagrams of various examples of sample collection devices according to one embodiment described herein. 11A-11Z show diagrams of various examples of sample collection devices according to one embodiment described herein. 11A-11Z show diagrams of various examples of sample collection devices according to one embodiment described herein. 11A-11Z show diagrams of various examples of sample collection devices according to one embodiment described herein.

FIG. 12 shows a schematic of the tip portion of the sleeve and the tip portion of the sleeve associated with one embodiment described herein and the balance of forces associated therewith.

FIGS. 13-13D show diagrams of various collection devices with upward collection locations according to embodiments described herein. FIGS. 13-13D show diagrams of various collection devices with upward collection locations according to embodiments described herein.

FIGS. 14-15 illustrate various views of a collection device having a single collection location according to one embodiment described herein. FIGS. 14-15 illustrate various views of a collection device having a single collection location according to one embodiment described herein.

16-17 show perspective and end views of a sample collection device having a container with an identifier according to one embodiment described herein. 16-17 show perspective and end views of a sample collection device having a container with an identifier according to one embodiment described herein.

18A-18G show various views of a sample container, according to embodiments described herein. 18A-18G show various views of a sample container, according to embodiments described herein. 18A-18G show various views of a sample container, according to embodiments described herein.

19A-19C show views of various embodiments of the front end face of the sample collection device.

20-21 illustrate various embodiments of a sample collection device having an integrated tissue penetrating member. 20-21 illustrate various embodiments of a sample collection device having an integrated tissue penetrating member.

FIG. 22 shows a perspective view of a collection device for use with various blood vessels or other tissue penetrators and sample collectors according to embodiments described herein.

FIGS. 23-28 show various views of a sample collection device for use with various sample collectors according to embodiments described herein. FIGS. 23-28 show various views of a sample collection device for use with various sample collectors according to embodiments described herein. FIGS. 23-28 show various views of a sample collection device for use with various sample collectors according to embodiments described herein. FIGS. 23-28 show various views of a sample collection device for use with various sample collectors according to embodiments described herein. FIGS. 23-28 show various views of a sample collection device for use with various sample collectors according to embodiments described herein. FIGS. 23-28 show various views of a sample collection device for use with various sample collectors according to embodiments described herein.

Figures 29A-29C show schematic diagrams of various embodiments described herein.

30-31 are schematic diagrams of methods according to embodiments described herein. 30-31 are schematic diagrams of methods according to embodiments described herein.

FIG. 32 shows a schematic diagram of one embodiment of the system described herein.

Figures 33-37 illustrate yet another embodiment of the collection device described herein. Figures 33-37 illustrate yet another embodiment of the collection device described herein. Figures 33-37 illustrate yet another embodiment of the collection device described herein. Figures 33-37 illustrate yet another embodiment of the collection device described herein. Figures 33-37 illustrate yet another embodiment of the collection device described herein.

38A-39 show various views of a thermally controlled shipping container transport device in accordance with at least one embodiment described herein. 38A-39 show various views of a thermally controlled shipping container transport device in accordance with at least one embodiment described herein.

40A-40C show schematic diagrams of various embodiments described herein. 40A-40C show schematic diagrams of various embodiments described herein.

FIG. 41 shows a perspective view of a portion of a transport container having a plurality of sample containers therein, according to at least one embodiment described herein.

FIG. 42 shows an exploded perspective view of a portion of a transport container having a plurality of sample containers therein, according to at least one embodiment described herein.

FIG. 43 shows a perspective view of a shipping container according to yet another embodiment described herein.

FIG. 44 shows a schematic diagram of a sample collection and transport process according to one embodiment described herein.

FIG. 45 shows a schematic diagram of a sample collection and transport process according to another embodiment described herein.

FIG. 46 illustrates a sample collection device according to one embodiment described herein.

FIG. 47 shows a schematic diagram of one system for removing a sample container from a transport container according to one embodiment described herein.

FIG. 48 is a graph showing the stability of an analyte in a sample in a container provided herein.

49-51 illustrate a non-limiting example of a test according to at least one embodiment described herein. 49-51 illustrate a non-limiting example of a test according to at least one embodiment described herein. 49-51 illustrate a non-limiting example of a test according to at least one embodiment described herein.

52-55 show various views of devices and systems according to embodiments herein. 52-55 show various views of devices and systems according to embodiments herein. 52-55 show various views of devices and systems according to embodiments herein. 52-55 show various views of devices and systems according to embodiments herein. 52-55 show various views of devices and systems according to embodiments herein. 52-55 show various views of devices and systems according to embodiments herein.

56-59 illustrate various views of a sample transport device, according to at least some embodiments herein. 56-59 illustrate various views of a sample transport device, according to at least some embodiments herein. 56-59 illustrate various views of a sample transport device, according to at least some embodiments herein. 56-59 illustrate various views of a sample transport device, according to at least some embodiments herein.

(Detailed description of the invention)
It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention as claimed. As used herein and in the appended claims, the singular forms “a”, “an”, “the”, and “the”, as defined above, unless the context clearly indicates otherwise. Note that it includes multiple meanings. Thus, for example, reference to “a material” can include a mixture of substances, “a compound” can include a plurality of compounds, and so forth. References referred to in this specification are hereby incorporated by reference in their entirety to the extent that they do not conflict with the teachings explicitly set forth herein.

  In this specification and in the claims that follow, reference will be made to a series of terms that are defined to have the following meanings:

  “Optional” or “optionally” occurs when this description occurs because the situation described subsequently can include cases where it occurs and does not occur It means that it is not necessary. For example, if the instrument optionally includes characteristics for the sample collection unit, this may or may not be present, and therefore this description is Includes both structures that have sample collection units and structures that do not have sample collection units.

  As used herein, the term “substantially” means more than “minimal” or “slight” amount; and “substantially” means “minimally” ”, Or“ slightly ”more. Thus, for example, the phrase “substantially different” as used herein means that a person skilled in the art statistically determines the difference between two numerical values within the context of the property measured by that value. It means that there is a sufficiently high degree of difference between two numbers that can be considered significant. Thus, the difference between two values that are sufficiently different from each other is typically greater than about 10%, and greater than about 20%, greater than about 30%, about 40%, as a function of reference value or comparator value. Can be greater than, or greater than about 50%.

  As used herein, a “sample” can be, but is not limited to, a blood sample, or a portion of a blood sample, and can be any suitable size or volume, and preferably a small size Or of volume. In some embodiments of the assays and methods disclosed herein, measurements can be performed using a small volume of blood sample or a portion of the blood sample that does not exceed a small volume, the small volume being less than about 5 mL. Or less than about 2 mL; or less than about 1 mL; or less than about 500 μL; or less than about 250 μL; or less than about 100 μL; or less than about 75 μL Or less than about 35 μL; or less than about 25 μL; or less than about 20 μL; or less than about 15 μL; or less than about 10 μL; or less than about 8 μL; Or less than about 6 μL; or less than about 5 μL; or less than about 4 μL; or less than 3 μL; or Including less than 2 μL; or including less than about 1 μL; or including less than about 0.8 μL; or including approximately 0.5 μL; or including approximately 0.3 μL; or including approximately 0.2 μL; Containing 1 μL; or containing about 0.05 μL; or containing about 0.01 μL.

  As used herein, the term “point of service location” means that a subject has a service (eg, examination, monitoring, treatment, diagnosis, guidance, sample collection, ID confirmation, medical service, non-medical service, etc.). Including, but not limited to, the subject's home, where the subject works, the location of the health care provider (eg, doctor), hospital, emergency room, operating room, clinic, health Care specialist offices, clinical laboratories, retail stores [eg pharmacies (eg retail pharmacies, clinical pharmacies, hospital pharmacies), drug stores, supermarkets, grocery stores, etc.], transport vehicles (eg private cars, boats) , Truck, bus, aircraft, motorcycle, ambulance, mobile unit, fire truck / truck, lifesaving ambulance, judicial vehicle, police vehicle, or subject Vehicles set to move from one point to another), mobile medical care units, mobile units, schools, day care centers, baggage inspection fields, battlefields, health support living houses, government offices, office buildings, tents, body fluid samples Acquisition facility (eg blood collection center), location at or near the entrance of the subject where the subject may want access, location on or near the device where the subject may wish to access, location where the subject may wish to access Location (for example, the location of the computer if the subject wants to access the computer), the location where the sample processing equipment receives the sample, or any other point of interest described elsewhere herein. A service location may be included.

  As used herein, “body fluid” (body fluid) refers to any fluid obtained or obtainable from a subject. Body fluid refers to, for example, blood, urine, saliva, tears, sweat, body secretions, body excretion, or any fluid that originates from or is obtained from a subject. In particular, body fluids include, without limitation, blood, serum, plasma, bone marrow, saliva, urine, gastric fluid, spinal fluid, tears, feces, mucus, sweat, earwax, fat, glandular secretions, cerebrospinal fluid, semen, vaginal fluid , Including interstitial fluid derived from tumor tissue, ocular fluid, placental fluid, amniotic fluid, umbilical cord blood, lymph fluid, cavity fluid, sputum, pus, meconium, breast milk and / or other secretions or excretion .

  As used herein, a “body fluid sample collector” or any other collection mechanism can be disposable. For example, the body fluid collector can be used once and discarded. The bodily fluid collector has one or more disposable components. Alternatively, the body fluid collector may be reusable. The body fluid collector can be reused any number of times. In some cases, the body fluid collector may include both reusable and disposable components.

  As used herein, a “sample collection unit” and / or any portion of the instrument has the ability to receive a single type of sample, or multiple types of samples. For example, the sample collection unit is capable of receiving two different types of body fluids (eg blood, tears). In another example, the sample collection unit is capable of receiving two different types of biological samples (eg, urine samples, stool samples). The multiple types of samples may or may not be fluid, solid, and / or semi-solid. For example, the sample collection unit has the ability to receive one or more, two or more, or three or more of body fluids, secretions and / or tissue samples.

  As used herein, “non-wicked, non-matrixed form” means that the liquid or suspension changes the form of the liquid or suspension. The integrity of the sample in liquid form, such as a webbing, mesh, fiber pad, absorbent material, absorbent structure, fiber permeation network, etc. that captures the components in the sample, and the sample Is not absorbed or drawn to the extent that it is not extracted in liquid form while maintaining sample integrity for sample analysis.

  As used herein, the term “sample handling system” is intended to assist in imaging, detecting, positioning, repositioning, holding, sucking, and depositing a sample. Refers to configured equipment or system. In one embodiment, a robot that has the ability to perform pipetting is a sample handling system. In another embodiment, a pipette is a sample handling system that may or may not have (other) robot capabilities. Samples processed by the sample handling system may or may not contain fluids. The sampling handling system may have the ability to transport bodily fluids, secretions, or tissues. The sampling handling system may transport one or more substances that need not be samples in the instrument. For example, for example, the sample handling system may transport a powder that can react with one or more samples. In some cases, the sample handling system is a fluid handling system. The fluid handling system may include pipettes and various types of valves or pipettes that may include, but are not limited to positive displacement pipettes, air displacement pipettes and suction pipettes. The sample handling system can transport samples or other materials with the aid of robots as described elsewhere herein.

  The term “healthcare provider” as used herein refers to a physician or other health care professional who provides medical treatment and / or medical advice to a subject. A health care professional may include a person or entity associated with a health care system. Examples of health care professionals include physicians (including practitioners and specialists), surgeons, dentists, audiologists, medical language hearingians, physician assistants, nurses, midwives, pharmacists, nutritionists, therapists, psychologists, Chiropractor, clinic staff, physical therapist, blood collection technician, occupational therapist, optometrist, emergency medical technician, emergency medical staff, medical laboratory technician, medical prosthetic technician, X-ray technician, social worker, and a wide variety May include other human resources trained to provide specific types of healthcare services. A health care professional may or may not be eligible to write a prescription. Healthcare professionals may work at or belong to hospitals, health care locations and other service delivery points, or may receive academic training or research and management at the same time. Certain health care professionals can provide care and treatment services for patients at private or public residences, community centers, meetinghouses or mobile units. Community health workers may work outside of formal health care facilities. Health care service managers, medical records and health information technicians, and other support personnel may be health care professionals or may be attached to health care providers. A health care professional can be an individual or institution that provides preventive, therapeutic, enlightenment, or rehabilitation health care services to an individual, family, or community.

  In some embodiments, the “healthcare provider” is already familiar with the subject or may be in communication with the subject. The subject may be a patient of the health care professional. In some cases, the health care professional may be prescribing the subject to undergo a clinical test. The healthcare professional may instruct or suggest to undergo a clinical test performed at a point-of-service location or clinical laboratory. In one example, the health care professional may be the subject's physician. The health care professional can be selected or connected to the subject by any type of physician (general practitioner, referred practitioner or the patient's attending physician, optionally via telemedicine services, and / or specialist ). The health care professional may be a medical care professional.

  The term “rack” as used herein refers to a frame or enclosure for mounting multiple modules. The rack is configured to allow modules to be tightened or engaged with the rack. In some cases, the various dimensions of the rack are standardized. In one embodiment, the spacing between modules is at least about 0.5 inch, or 1 inch, or 2 inches, or 3 inches, or 4 inches, or 5 inches, or 6 inches, or 7 inches, or 8 inches. Or as a multiple of 9 inches, or 10 inches, or 11 inches, or 12 inches.

  The term “cell” as used in the context of a biological sample includes, but is not limited to, vesicles (such as liposomes), cells, viral particles, and substances bound to small particles such as beads, nanoparticles, or microspheres. In general, samples of the same size as individual cells containing are included. Properties include, but are not limited to: size; shape; temporal and dynamic changes such as cell motility or proliferation; granularity; whether the cell membrane is complete; internal cell contents; Such as, but not limited to, protein content, protein modification, nucleic acid content, nucleic acid modification, organelle content, nuclear structure, nuclear content, internal cell structure, internal follicle content, ion concentration, and steroids or drugs, etc. The presence of small molecules; and cell surface (both cell membrane and cell wall) markers, including proteins, lipids, carbohydrates, and modifications thereof.

  As used herein, “sample” refers to the entire original sample or any portion thereof, unless the context clearly indicates otherwise.

  The present invention provides systems and methods for multi-purpose analysis of samples or health parameters. The sample is collected and one or more sample preparation steps, assay steps, and / or detection steps can occur on the instrument. The various aspects of the invention described herein may be applied to any of the specific applications, systems, and devices described. The present invention may be applied as a stand-alone system or method, or as part of an integrated system, such as a system that includes point-of-service healthcare. In some embodiments, the system may include externally directed imaging techniques such as ultrasound or MRI, or external peripherals for integrated imaging and other health tests or services. Can be integrated. It should be understood that different aspects of the present invention are recognized and implemented individually, collectively, or in combination with each other.

  With reference to FIGS. 1A-1B, one embodiment 100 of a sample collection device will be described. In this non-limiting example, the sample collection device 100 can include a collection device body 120, a support 130, and a base 140. In some cases, a cap 110 may optionally be provided. In one embodiment, the cap can be used to cover the tip with blood after collection in order to protect the opening and keep it clean. Optionally or alternatively, the cap can also be used to limit the flow rate during movement of sample fluid to the sample container by controlling the amount of openings provided in the capillary. Some embodiments may include a vent path (permanently open or operably closable) in the cap, while others do not. Optionally, the collection instrument body 120 has a first portion of the instrument having one or more collection paths, such as, but not limited to, collection channels 122a, 122b therein that are capable of receiving sample B. 100 may be included. FIG. 1A shows that sample B only partially fills the channels 122a, 122b, but in some embodiments, partial filling is not ruled out, but in most embodiments the channel is It should be understood that sample B is completely filled when the filling process is complete. In this embodiment, the base 140 is one or more filling measuring instruments 142a such as, but not limited to, an optical measuring instrument that can indicate whether the sample has reached one or more containers contained in the base. 142b. This display can be by means of visual display, but it should be understood that sound, vibration, etc., or other display methods can be used instead of or in combination with the display method. The meter can be on at least one container. There may be variations and alternatives to the embodiments described herein, and any single embodiment should not be construed to encompass the complete invention.

  Although not shown for ease of illustration, the support 130 may also include one or more fill meters that indicate whether a desired fill level has been reached in the channels 122a and 122b. This can be used in place of or in combination with the fill meter 142a, 142b. Of course, the one or more paths of the fill meter can be located in other parts and are not limited to being on the support 130. This indication of the fill level in one or more of the channels 122a and 122b is by means of a visual indication, but sound, vibration, etc., or other indication methods may be used instead of or in combination with the indication method. It should be understood that it can be used. The meter may be on at least one of the collection paths. Optionally, the meter can be on all collection paths.

  In this embodiment, the support 130 can be used to couple to the body 120, and the base 140 is used to form an integrated device. Although the device body 120, support 130, and base 140 are described as separate parts, one or more of those parts are integrally formed and described herein to simplify manufacturing. It should be understood that such integration is not excluded.

  In some embodiments herein, the cap 110 may optionally be provided. In one non-limiting example, the cap can be fitted over a portion of the collection device body 120. The cap 110 may be removable from the collection device body 120. In some cases, the cap 110 can be completely separated from the collection device body 120 or can be a collection device such as, but not limited to, hinged or otherwise coupled to the collection device. A portion coupled to the body can be retained. The cap 110 may cover a portion of the collection device body 120 that includes the exposed end of one or more channels therein. The cap 110 prevents objects such as air, fluid, or particulates from entering the channel in the device body when the cap is in place. Optionally, the cap 110 can be attached to the collection body 120 using any technique known in the art or later developed. For example, the cap may be snap-fitted, twist-fitted, friction-fitted, struck, with a magnetic portion, tied, utilizing a resilient portion, and / or removably collected It can be coupled to the instrument body. The cap may form a fluid tight seal with the collection device body. The cap may be formed from an opaque, transparent, or translucent material.

  In one embodiment, the collection device body 120 of the sample collection device may include at least one or more portions of a collection path, such as but not limited to channels 122a, 122b therein. It should be understood that non-channel collection paths are not excluded. The collection device body may be coupled with a support 130 that may include one or more channel portions therein. The collection device body may be permanently fixed to the support or may be removable with respect to the support. In some cases, the collection device body and the support may be formed as a single integrated piece. Alternatively, the collection device body and support can be formed as separate pieces. During operation of the device, the collection device and support do not move relative to each other.

  Optionally, the collection device body 120 may be formed in whole or in part by an optically transmissive material. For example, the collection device body may be formed of a transparent or translucent material. Optionally, only a selected portion of the body can be transparent or translucent to visualize the fluid collection channel. Optionally, the body includes an opaque material, but openings and / or windows may be formed in the body to indicate the level of filling therein. The collection device body allows a user to view the channels 122a, 122b in and / or through the device body. The channel may be formed of a transparent or translucent material that allows the user to see how the sample B has moved through the channel. The channels can have substantially the same length. In some cases, the support 130 may be formed of an opaque material, a transparent material, or a translucent material. The support may or may not have the same optical properties as the collection device body. The support may be formed from a material different from the collection device body or from the same material as the collection device body.

The collection device body 120 may have any shape or size. In some embodiments, the collection device body has a circular, elliptical, triangular, quadrangular (eg, square, rectangular, trapezoidal), pentagonal, hexagonal, octagonal, or any other cross-sectional shape. obtain. The cross-sectional shape may remain the same or vary along the length of the collection device body. In some cases, the collection device main body, about ^{10cm 2, 7cm 2, 5cm 2} , 4cm 2, 3cm 2, 2.5cm 2, 2cm 2, 1.5cm 2, 1cm 2, 0.8cm 2, 0. 5 cm ^2, may have a 0.3 cm ² or 0.1 cm ² or less of the cross-sectional area. The cross-sectional area may remain the same or vary along the length of the collection instrument body 120. The collection device body may have a length of about 20 cm, 15 cm, 12 cm, 10 cm, 9 cm, 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3 cm, 2 cm, 1 cm, 0.5 cm, or 0.1 cm or less. The collection device body 120 may have a length that is larger or smaller than the cap, support, or base, or may have a length that is equal to the cap, support, or base. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed to encompass the complete invention.

  In one embodiment, the collection path, such as but not limited to channels 122a, 122b, may have a selected cross-sectional shape. Some embodiments of the channel may have the same cross-sectional shape along the entire length of the channel. Optionally, the cross-sectional shape may remain the same along the length or may vary. For example, some embodiments may have one shape at one location and different shapes at one or more different locations along the channel. Some embodiments may have one channel with one cross-sectional shape and at least one other channel with a different cross-sectional shape. As non-limiting examples, some may have an oval, triangular, square (eg, square, rectangular, trapezoidal), pentagonal, hexagonal, octagonal, or any other cross-sectional shape. The cross-sectional shape can be the same or can vary for the body, support, and base. Some embodiments may select a shape to maximize the volume of liquid that can be retained in the channel of a particular channel width and / or height. Some have one of the channels 122a, 122b with one cross-sectional shape, while another channel has a different cross-sectional shape. In one embodiment, the cross-sectional shape of the channel can help maximize the demands therein, but can optionally also optimize the capillary pull force on the blood. This makes it possible to maximize the filling rate. It should be understood that in some embodiments, the cross-sectional shape of the channel directly affects capillary forces. As a non-limiting example, a constant volume of sample can be accommodated in a shallow but wide channel, or a rounded channel, both containing the same volume, but one with a filling rate relative to the other. It may be desirable in terms of factors related to the performance of the channel, with a low possibility of air entrapment.

The channel can have any shape or size, but some implementations are configured to be able to exhibit capillary action while the channel is in contact with the sample fluid. In some cases, the channel is about 10 mm ² , 7 mm ² , 5 mm ² , 4 mm ² , 3 mm ² , 2.5 mm ² , 2 mm ² , 1.5 mm ² , 1 mm ² , 0.8 mm ² , 0.5 mm ^2. , 0.3 mm ^2, or 0.1 mm ² may have the following cross-sectional area. The size of the cross-section can remain the same along the length or can vary. Some embodiments can be adjusted for greater forces along a particular length and then for lesser forces at different lengths. Along the length, the shape of the cross-section may continue to be the same or may vary. Some channels are straight in shape. Some embodiments may have only curved or other shaped path shapes, or in combination with straight portions. Some may have different orientations within the device body 120. For example, if the device is held substantially horizontal, one or more channels will tilt downward, tilt upward, or not tilt at all while removing fluid from the initial collection point on the device. be able to.

  The channels 122a and 122b may be supported by the device body 120 and / or the support 130. In some cases, the entire length of the channel may be included in the instrument body and support combination. In some cases, a portion of the channel can be in the instrument body and a portion of the channel can be in the support. The position of the channel may be fixed by the device body and / or the support. In some embodiments, the channel may be defined as a lumen in a hollow needle. In some embodiments, the channel is defined for only three sides and at least one side is open. Optionally, a cover layer separated from the body may define the side surface that is otherwise open. Some embodiments may define different aspects of the channel with different materials. All of these materials can be provided by the body or they can be provided by different pieces of the collection device. Some embodiments may have all of the channels in the same plane. Optionally, some may have a shape that incorporates at least a portion of the channel into a different plane and / or orientation. Optionally, some channels can be in essentially different planes and / or orientations.

  In some cases, multiple channels may be provided. In some embodiments, one channel branches into two or more channels. Optionally, some channels branch into a larger number of channels. Some channels may include a control mechanism such as, but not limited to, a valve to direct flow to the channel. At least a portion of the channels may be substantially parallel to each other. Alternatively, no part of the channel need be parallel to each other. In some cases, at least a portion of the channel is not parallel to one another. Optionally, the channel can be slightly curved. Optionally, the channel may have one cross-sectional area at one location and a smaller cross-sectional area at different locations along the channel. Optionally, the channel may have one cross-sectional area at one location and a larger cross-sectional area at different locations along the channel. For some embodiments of the Y-shaped design, the channel is positioned to properly define the sample for each vial so that the sample is not pulled or subject to cross-contamination from other channels. It may be desirable to have a configured vent. As a non-limiting example, one embodiment with a vent is shown in FIG.

  A base 140 may be provided in the sample collection device. The base may be coupled to the support 130. In some cases, a portion of the base may be insertable into the support and / or a portion of the support may be insertable into the base. The base may have the ability to move relative to the support. In some cases, the sample collection device may have a longitudinal axis that extends along the length of the sample collection device. The base and / or support can move relative to each other in the direction of the longitudinal axis. The base and / or support may move a limited distance relative to each other. Alternatively, the base can be fixed with respect to the support. The base may be provided at an end opposite the end of the sample collection device that includes the cap 110 of the sample collection device. Optionally, some embodiments may include an integrated base / container portion so that there is no longer a separate container assembled into the base piece. There may be variations and alternatives to the embodiments described herein, and any single embodiment should not be construed to encompass the complete invention.

  Base 140 may house one or more containers therein. The container can be in fluid communication with the channel and / or can be brought into fluid communication with the channel. The end of the channel can be in the container or can be provided in the container. The base may include one or more optical instruments 142a, 142b that may provide a visual indication of whether the sample has reached one or more containers housed within the base. In some embodiments, the optical meter may be an optical window that allows a user to view the interior of the base. The optical window may be formed from a transparent and / or translucent material. Alternatively, the optical window may be an opening that has no material in it. The optical window may allow direct viewing of the container in the base. The container in the base may be formed from a transparent and / or translucent material that allows a user to see if a sample has reached the base container. For example, when blood reaches the container via the channel, the container can visually display the blood therein. In other embodiments, the optical meter may include other characteristics that indicate that the container has been filled. For example, one or more sensors can be provided in the base or container that can determine whether a sufficient amount of sample has been loaded into the container. The one or more sensors may provide a signal to an optical meter on the base of whether the sample has been provided to the container and / or a certain amount of sample has been provided to the container. For example, the optical meter may provide a display, including but not limited to, an indication that the container is fully filled, LCD display, light display (eg, LED display), plasma screen display, etc. Can be included. In an alternative embodiment, an optical meter need not be provided, but is not limited to an alternative meter such as an audio meter or a temperature-controlled meter when the container is filled. Can be provided to display.

  2A-2C provide an illustration of a sample collection device 200 without the cap 110. FIG. The sample collection device 200 may include a body 220, a support 230, and a base 240. The body can be coupled to the support. In this embodiment, the base 240 may be coupled to the support at the end opposite to the end coupled to the body. The body may support and / or include at least a portion of at least one, two, or more channels 222a, 222b. The channel has the ability to receive samples 224a, 224b from the sample receiving end 226 of the instrument.

  The body 220 can have a hollow portion 225 therein. Alternatively, the body can be formed from a non-hollow piece. The channels 222a and 222b may be integrally formed in the main body. For example, they can be a passage through a non-hollow part of the body. The passage can be drilled or formed using lithographic techniques. Alternatively, the channel may be a separate structure that can be supported by the body. For example, the channel can be formed from one or more tubes that can be supported by the body. In some cases, the channel can be held in place by a non-hollow portion of the body and can pass through one or more hollow portions of the body. Optionally, the body 220 can be formed from two joined pieces that define the channels 222a and 222b therein.

  The channels 222a, 222b may include one or more features or characteristics referred to elsewhere in this specification. At least a portion of the channels may be parallel to each other. Alternatively, the channels can be at an angle relative to each other. In some embodiments, the channel may have a first end, which may be a sample receiving end 226 of the sample collection device. The first end of the channel may be an open end capable of receiving a sample. In some embodiments, each end of the channel may be provided to a sample receiving end of the sample collection device. One, two, or more channels may have a first end at the sample receiving end of the sample collection device. Separate channels can be used to minimize the risk of blood cross-contamination between one channel and another. Optionally, the channels may have an upside down Y shape starting from a common channel and branching into two or more separate channels. This Y shape may be useful in situations where contamination is not a problem. Optionally, an alternative method for the Y shape is a straight channel and has the sample collection container moving sequentially to engage the same needle from the straight channel.

  In some cases, multiple channels may be provided. The ends of the channel at the sample receiving end may be in close proximity to each other. The ends of the channel at the sample receiving end may be adjacent to each other. The ends of the channel at the sample receiving end may be in contact with each other, or about 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, from edge to edge or from center to center, The distance is 8 mm, 9 mm, 10 mm, 12 mm, 15 mm, or 20 mm. The channels may diverge from each other from the sample receiving end. For example, the other ends of the channel opposite the end of the channel at the sample receiving end may be further away from each other. They can be about 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 12 mm, 15 mm, 20 mm, 25 mm, or 30 mm from edge to edge or from center to center.

  In some embodiments, the body 220 can have an elongated shape. The body may have one or more tapered portions 228 at or near the sample receiving end 226. The sides of the body converge at the sample receiving end. The tapered portion and / or the sample receiving end may be curved. Alternatively, an edge can be provided. A tapering surface may be provided at any angle with respect to the longitudinal axis of the instrument. For example, the tapered portion may be about 5 degrees, 10 degrees, 15 degrees, 30 degrees, 45 degrees, 60 degrees, or 75 degrees with respect to the longitudinal axis.

  The sample receiving end 226 of the instrument can be in contact with a sample. The sample can be provided directly from the subject. The sample receiving end may be in contact with a subject or with a sample that is in contact with or being released from the subject. For example, the sample receiving end may be in contact with a blood drop on a subject's finger. Blood can enter the channel. The blood can be transported through the channel by capillary action, pressure differential, gravity, or any other driving force. The blood may travel through the channel from a sample receiving end to a sample delivery end. The sample delivery end can be in fluid communication or provided with fluid communication with one or more containers housed within the base of the device. The sample can pass from the channel to the container. The sample can be driven into the container by pressure differential, capillary action, gravity, friction, and / or any other motive force. Optionally, the sample can also be blood introduced by a pipette, syringe or the like. 2B shows that sample B only partially fills the channels 222a, 222b, but in most embodiments, the channel is completely filled with sample B when the filling process is complete. I want you to understand.

  3A-3B show an example of a sample collection device before the channels 322a, 322b are brought into fluid communication with one or more containers 346a, 346b housed within the base 340 of the device. The sample collection device may include a cap 310, a body 320, a support 330, and a base 340. The body and / or support can support and / or include at least a portion of one, two, or more channels. The base may support and / or contain one, two, or more containers.

  In one embodiment, the body 320 and / or the support 330 may support one or more channels 322a, 322b in the sample collection device. In one example, two channels are provided, but the description of the two-channel embodiment is not limited to any number of channels, such as, but not limited to, 1, 3, 4, 5, 6, or more channels. Applicable to channels. Each of the channels may have a first end 323a, 323b that may be provided at a sample receiving end 326 of the instrument. The first end of each channel may be open. The channel can open to the outside air. If the first end of the channel contacts a fluid such as blood, the fluid can be drawn into the channel. Blood is drawn by capillary action, or any other technique described elsewhere herein. The blood may travel along the length of the channel to the respective second end 325a, 325b of the channel. The channels can be fluidly separated from each other. For example, fluid can enter the first channel 322a via the first end 323a, pass through the length of the channel, and exit at 325a from the first channel. Similarly, fluid can enter the second channel 322b via the first end 323b, pass through the length of the channel, and exit the second channel at the second end 325b. The first and second channels may be fluidly separated so that fluid from the first channel does not pass through the second channel and vice versa. In some embodiments, the fluid may travel to the channel second end without first exiting.

  The channels 322a and 322b may have a branch shape. For example, the first ends 323a, 323b of the channel may be closer to each other than between the second ends 325a, 325b of the channel. More space may be provided between the second ends of the channels than between the first ends of the channels. The first ends of the channels may or may not touch each other. The first ends of the channels may be adjacent to each other.

  A base 340 may be coupled to the sample collection instrument support 330. The base 340 may or may not be in direct contact with the support. During use of the device, the base can move relative to the support. In some embodiments, the base may slide longitudinally with respect to the support. In some cases, the base can slide longitudinally without rotating relative to the support. In some cases, the base can slide coaxially without rotating with the support. In some cases, the base can rotate while moving relative to the support. A portion of the base may mate with a portion of the support or vice versa. For example, a portion of the base can be inserted into a portion of the support and / or a portion of the support can be inserted into the base. One or more stop features may be provided in the base and / or its frame to provide a controlled degree of movement between the base and the support. This stop feature may include a shelf, a protrusion or a groove.

  The base 340 may have the ability to support one or more containers 346a, 346b. The base may have a housing that at least partially surrounds one or more containers. In some cases, the container may be completely enclosed when the base engages the support 330. The base may have one or more indentations, protrusions, grooves, or shaped features to receive the container. The base may be formed to have a shape that is complementary to the shape of the container. The container may be maintained in an upright position relative to the base.

  As many containers as the number of channels may be provided. For example, N channels may be provided, followed by N containers, where N is a positive integer (eg, 1, 2, 3, 4, 5, 6, 7, 8 Or more). Each channel corresponds to a respective container. In one example, the sample collection device may have a first container and a second container simultaneously with the first channel and the second channel, respectively. The first channel 322a is in communication with the first container 346a or can be configured to be brought into communication, and the second channel 322b is in communication with the second container 346b. It can be configured to be in a state or brought into communication.

  In some embodiments, each container may have a body 349a, 349b and a cap 348a, 348b. In some cases, the container body may be formed from a transparent or translucent material. The container body allows the sample provided in the container body to be visible when viewed from the outside of the container. The container body may have a tubular shape. In some cases, the container body may have a cylindrical portion. The bottom of the container can be flat, tapered, rounded, or any combination thereof. The container may include an open end and a closed end. The open end may be the uppermost end of the container at the end of the container closer to one or more channels. The closed end may be the bottom end of the container at the end of the container that is further from one or more channels. Various container embodiments may be described in more detail elsewhere herein.

  Base 340 may have one or more optical measuring instruments such as optical windows 342a, 342b. The optical window may be disposed on the containers 346a, 346b. In some cases, the optical window may be disposed in the container body. A single window may provide a view to a single container or multiple containers. In one embodiment, the same number of optical windows as the container can be provided. Each optical window may correspond to a respective container. Both the optical window and the container may be formed of an optically transmissive material that allows a user to see from the outside of the sample collection device whether a sample has reached the container.

  In some embodiments, there may be an optical window of the channels 322a and 322b through which a user can observe whether a desired fill level has been reached in the channel. In some embodiments where the body 320 is completely transparent or translucent, there may be a marker or meter pointing along the channel to note when the desired fill level has been reached.

  The container can be sized to accommodate a small volume of fluid sample. In some embodiments, the container is 5 ml, 4 ml, 3 ml, 2 ml, 1.5 mL, 1 mL, 900 μL, 800 μL, 700 μL, 600 μL, 500 μL, 400 μL, 300 μL, 250 μL, 200 μL, 150 μL, 100 μL, 80 μL, 50 μL. , 30 μL, 25 μL, 20 μL, 10 μL, 7 μL, 5 μL, 3 μL, 2 μL, 1 μL, 750 nL, 500 nL, 250 nL, 200 nL, 150 nL, 100 nL, 50 nL, 10 nL, 5 nL, or 1 nL. The container may be configured to contain a few drops of blood, a drop of blood, or a portion of a drop of blood.

  The container may include caps 348a, 348b. The lid may be configured to fit over the open end of the container. The cap may block the open end of the container. The cap may fluidly seal the container. The cap may form a liquid tight seal with the container body. For example, the cap can be gas and / or liquid impervious. Alternatively, the cap may allow certain gases and / or liquids to pass through. In some cases, the cap is gas permeable while liquid impermeable. The cap may be impermeable to the sample. For example, the cap can be impermeable to whole blood, serum or plasma. In some cases, a portion of the cap may fit within a portion of the container body. The cap may form a fastener with the container body. The cap may include a lip or shelf that can protrude over a portion of the container body. The lip or shelf may prevent the cap from sliding into the container body. In some cases, a portion of the cap can lie over the top and / or sides of the container body. Any description of the container herein can be applied in combination with the sample collection device. Optionally, some embodiments may include additional portions, such as a cap holder, in the container assembly. In one embodiment, the purpose of the cap holder is to maintain a tight seal between the cap and the container. In one embodiment, the cap holder engages an accessory, lip, indent, or other accessory location on the outside of the container to hold the cap in place. Optionally, some embodiments may combine the functions of the cap and the cap holder into one component.

  One or more engagement assemblies may be provided. The engagement assembly may include components that exert a force, such as a channel holder 350 and / or a spring 352 or a stretchable material. In one embodiment, the holder 350 can keep the adapter channel 354 secured to the support. As described elsewhere herein, the adapter channel 354 can be formed integrally with the collection channel, or can be a stand-alone piece, a portion of the collection channel, or of the container. It can be a separate element that can be part. In one embodiment, the holder 350 may prevent the adapter channel 354 from sliding relative to the support. The holder 350 may optionally provide a support on which a component that exerts a force, such as a spring, rests.

  In one embodiment, the engagement assemblies each include a spring 352 that can exert a force because the base 340 can be in an extended state when the spring is in its natural state. obtain. A space may be provided between the containers 346a, 346b and the engagement assembly when the base is in the extended state. In some cases, the second end of the channel may or may not contact the cap of the container when the base 340 is in the extended state. The second ends 325a, 325b of the channel may be in a position that is not in fluid communication with the interior of the container.

  The sample collection device can include any number of engagement assemblies. For example, as many engagement assemblies as the number of channels may be provided. Each channel may have an engagement assembly. For example, if a first channel and a second channel are provided, a first engagement assembly can be provided for the first channel, and for the second channel A second engagement assembly may be provided. The same number of engagement assemblies and containers can be provided.

  In one embodiment, the engagement assembly may house an adapter channel 354 such as, but not limited to, an elongated member with angled, tapered or pointed ends 327a and 327b. It should be understood that in some embodiments, the ends 327a and 327b are part of a needle formed separately from the channels 322a and 322b and can then be coupled to the channels 322a and 322b. The needle may be formed from the same or different material as the body that defines the channels 322a and 322b. For example, metal can be used to form the needle, and a polymer or plastic material can be used to form the body that defines the channels 322a and 322b. Optionally, some embodiments may form the ends 327a and 327b on a member that is integrally formed with the channels 322a and 322b. In some cases, the second end of the channel may be configured to penetrate material such as the caps 348a, 348b of the container. In some embodiments, a portion of the adapter channel 354 can be inserted into the collection channel, or a portion of the collection channel can be inserted into the adapter channel, or the two Can be configured to align in the same plane. Optionally, some embodiments may integrally form the adapter channel 354 with the collection channel 322. Although FIG. 3B (and 4B) shows sample B as only partially filling the channels 122a, 122b, in most embodiments, when the filling process is complete, the channel is filled with sample B. It should be understood that it is completely filled. There may be variations and alternatives to the embodiments described herein, and any single embodiment should not be construed to encompass the complete invention.

  4A-4B show an example of a sample collection device 40 having channels 422a, 422b in fluid communication with containers 446a, 446b within the device. The sample collection device can include a cap 410, a body 420, a support 430, and a base 440. The body and / or support may support and / or include at least a portion of one, two, or more channels. The base may support and / or contain one, two, or more containers.

  In one embodiment, the body 420 and / or the support 430 may support one or more channels 422a, 422b in the sample collection device. For example, a first channel and a second channel can be provided. Each of the channels may have a first end 423a, 423b that may be provided to a sample receiving end 426 of the instrument. The first end of each channel may be open. The channel can open to the outside air. If the first end of the channel contacts a fluid such as blood, the fluid can be drawn into the channel. Blood is drawn by capillary action, or any other technique described elsewhere herein. The blood may travel along the length of the channel to the respective second end 425a, 425b of the channel. In some embodiments, the fluid may reach the second end of the channel by capillary action, or any other technique described elsewhere herein. In other embodiments, the fluid need not reach the second end of the channel. The channels can be fluidly separated from each other.

  In some embodiments, if the channel is not in fluid communication with the interior of the container 446a, 446b, the fluid may pass to the second end of the channel without exiting. For example, the fluid can be withdrawn by capillary action that can cause the fluid to flow into the channel to the end of the channel or close to it without exiting the channel.

  A base 440 may be coupled to the sample collection instrument support 430. During use of the device, the base can move relative to the support. In some embodiments, the base may slide longitudinally with respect to the support. In one embodiment, the base is compressed (i) a portion that is extended when the channel is not in fluid communication with the interior of the container, and (ii) a is in fluid communication with the interior of the container. Can have a portion. The sample collection device can be provided in an initially stretched state, as shown in FIG. After the sample has been collected and flowed through the length of the channel, the user pushes the base as shown in FIG. 4 to provide the sample collection device with its compressed state . Once the base is pushed in, it can remain naturally pushed in, or it can spring back to its extended state once the pressing force is removed. In some cases, the base can be withdrawn to the extended state or fully withdrawn to provide access to the container therein.

  The base 440 may have the ability to support one or more containers 446a, 446b. The base may have a housing that at least partially surrounds one or more containers. In some cases, the container can be completely enclosed when the base engages the support 430. The base may have one or more indentations, protrusions, grooves, or shaped features to receive the container. The base may be formed to have a shape that is complementary to the shape of the container. The container may be maintained in an upright position relative to the base.

    As many containers as the number of channels may be provided. Each channel corresponds to a respective container. In one example, the sample collection device may have a first container and a second container simultaneously with the first channel and the second channel, respectively. The first channel 422a is in communication with the first container 446a or can be configured to be brought into communication and the second channel 422b is in communication with the second container 446b. It can be configured to be in a state or brought into communication. The first channel may not be in fluid communication with the first container initially, and the second channel may not be in fluid communication with the second container initially. When the base is pushed against the support, the first and second channels can be brought into fluid communication with the interior of the first and second containers, respectively. The first and second channels can be brought into fluid communication simultaneously with the first and second containers. Alternatively, they need not be brought into fluid communication at the same time. The timing of the fluid communication may depend on the height of the container and / or the length of the channel. The timing of the fluid communication may depend on the relative distance between the second end of the channel and the container.

  In some embodiments, each container may have a body 449a, 449b and a cap 448a, 448b. The container body may have a tubular shape. In some cases, the container body may have a cylindrical portion. The bottom of the container can be flat, tapered, rounded, or any combination thereof. The container may include an open end and a closed end. The open end may be the uppermost end of the container at the end of the container closer to one or more channels. The closed end may be the bottom end of the container at the end of the container that is further from one or more channels. Various container embodiments may be described in more detail elsewhere herein.

  Base 440 may have one or more optical measuring instruments, such as optical windows 442a, 442b. The optical window may be disposed over the containers 446a, 446b. In some cases, the optical window may be disposed in the container body. Both the optical window and the container may be formed of an optically transmissive material that allows a user to see if a sample has reached the container from outside the sample collection device. In some embodiments, the container may incorporate markings on the container itself to indicate filling level requirements.

  The container may include caps 448a, 448b. The cap may be configured to fit over the open end of the container. The cap may block the open end of the container. The cap may fluidly seal the container. For example, the cap can be gas and / or liquid impervious. In some cases, a portion of the cap may fit into a portion of the container body. The cap may include a lip or shelf that can protrude over a portion of the container body. In some embodiments, the cap may have a hollow or depression. The hollow or depression may help guide the second end of the channel to the center of the cap. In some cases, the second end of the channels 425a, 425b can lie over the cap of the container when the sample collection device is in the extended state. The second end of the channel may or may not contact the cap of the container. In some cases, the second end of the channel may rest in the hollow or depression of the cap. In some cases, the second end of the channel can partially penetrate the cap without reaching the interior of the container. Optionally, some embodiments of the cap may include a crimp piece to maintain a vacuum.

  The second end of the channel may have angled, tapered or pointed ends 427a and 427b. In some embodiments, the ends 427a and 427b can be part of a needle that is formed separately from the channels 422a and 422b and then coupled to the channels 422a and 422b. The needle may be formed from the same or different material as the body that defines the channels 422a and 422b. Optionally, some embodiments may form the ends 427a and 427b on a member that is integrally formed with the channels 422a and 422b. In some cases, the second end of the channel may be configured to penetrate material such as the caps 448a, 448b of the container. The cap may be formed from a material that can prevent the sample from passing through in the absence of a penetrating member. The cap may be formed from a single non-hollow piece. Alternatively, the cap may have a cut, opening, hole, thin section, or any other feature that can receive a penetrating member. A cut or other opening may have the ability to hold a sample therein if the penetrating member is not in the cut or opening or if the penetrating member is removed from the cut or opening. In some cases, the cap may be formed from a self-healing material so that when the penetrating member is removed, the opening formed by the penetrating member can be closed. The second end of the channel may be a penetrating member that passes through the cap and reaches the interior of the container. It will be apparent that in some embodiments, the penetrating member can be a hollow needle that allows the sample to pass through and is not simply a needle for penetrating. In some embodiments, the penetrating tip may be of a non-coring design, such as but not limited to a tapered cannula, from the cap material.

  One or more engagement assemblies may be provided. The engagement assembly may include components that exert a force, such as a channel holder 450 and / or a spring 452 or a stretchable material. In one embodiment, the holder 450 can keep the adapter channel 454 secured to the support. As described elsewhere herein, the adapter channel 454 can be formed integrally with the collection channel, or can be a stand-alone piece, a portion of the collection channel, or a portion of the container. It can be a separate element that can be part. In one embodiment, the holder 450 may prevent the adapter channel 454 from sliding relative to the support. The holder 450 may optionally provide a support on which a component that exerts a force, such as a spring, rests.

  In one embodiment, the engagement assemblies each include a spring 452 that can exert a force because the base 340 can be in an extended state when the spring is in its natural state. obtain. Space may be provided between the containers 446a, 446b and the engagement assembly when the base is in the extended state. In some cases, the second ends 425a, 425b of the channel may be in a position that is not in fluid communication with the interior of the container when the base 440 is in an extended state.

  The sample collection device can include any number of engagement assemblies. For example, as many engagement assemblies as the number of channels may be provided. Each channel may have an engagement assembly. For example, if a first channel and a second channel are provided, a first engagement assembly can be provided for the first channel, and for the second channel A second engagement assembly may be provided. The same number of engagement assemblies and containers can be provided. In one embodiment, the same number of engagement assemblies and containers may be provided.

  When the base is press-fit, the spring 452 can be compressed. The second ends 425a, 425b of the channel may penetrate the cap of the container. The second end of the channel can enter the interior of the container. In some cases, force may be provided to drive the fluid from the channel into the container. For example, a pressure differential can be created between the first and second ends of the channel. Positive pressure may be provided at the first ends 423a, 423b of the channel and / or negative pressure may be provided at the second end of the channel. The positive pressure can be positive with respect to the second end of the channel and / or outside air. The negative pressure may be negative with respect to the channel first end and / or ambient air. In one embodiment, the container may have a vacuum therein. When the second end of the channel penetrates the container, the negative pressure in the container draws the sample into the container. In an alternative embodiment, the sample can be driven by capillary forces, gravity, or any other motive force to enter the container. There may be variations and alternatives to the embodiments described herein, and any single embodiment should not be construed to encompass the complete invention.

  In some cases, different types of dynamics may be used at different stages of sample collection. Thus, one type of motive force can be used to extract the sample into the channel, and then a different type of motive force can be used to move a sample from the channel into the container. For example, capillary forces can pull the sample into the channel, and pressure differences can drive the sample from the channel into the container. Any combination of motive forces can be used to draw a sample into the channel and the container. In some embodiments, the motive force for extracting a sample into the channel is different from the motive force used to extract a different sample into the container. In some alternative embodiments, the motive force is the same for each stage. In some embodiments, the driving forces are applied sequentially or at defined time intervals. As a non-limiting example, the motive force for withdrawing the sample into the container is not applied until at least one channel reaches a minimum fill level. Optionally, the motive force for withdrawing the sample into the container is not applied until each of the at least two channels reaches a minimum fill level. Optionally, the motive force for withdrawing the sample into the vessel is not applied until each of the channels of all channels reaches a minimum fill level. In some embodiments, the motive forces are applied simultaneously.

  Some embodiments may use a source of pressurized gas coupled to the sample collection device and configured to push collected body fluids from one or more channels into respective containers. Optionally, a vacuum source not associated with the container may be used to draw sample fluid toward the container.

  In some additional embodiments of the channel, once the channel is filled, there can be sufficient capillary force in it, and since this force is greater than gravity, the sample is It can be configured so that it cannot escape from the channel simply based on gravity. An additional driving force is used to break the retention of the channel by capillary action. Optionally, as described elsewhere herein, a device, such as but not limited to a sleeve, can contain bodily fluid exiting the channel at the end closest to the container, and thus Loss can be minimized until transfer to the container.

  Optionally, other materials such as, but not limited to, lysospheres, sponges, or other motive providers can be used to provide the motive to draw the sample into the container. If multiple forces are used, this is the primary, secondary, or tertiary motive force for withdrawing the sample into the container. Optionally, some embodiments may include a push-type motive force provider, such as but not limited to a plunger, to move the sample in a desired manner.

  Some time elapses since the sample is introduced into the channel and moves along the length of the channel. A user can introduce a sample into the sample collection device and wait for the sample to travel the length of the channel. One or more optical instruments may be provided that indicate whether the sample has reached a desired fill level, such as but not limited to the end of the channel. In another embodiment, the user can wait a predetermined time before pushing in the base. The user determines that the sample has moved a sufficient length of the channel and / or the base is pushed in after a sufficient time has elapsed since the sample was introduced. After the base is pushed in, the channel is brought into fluid communication with the container, and a sample can flow from the channel into the container. An optical meter can be provided so that the user can know when the container is filled.

  As soon as the containers are filled, they can be transported to the desired location using the systems and methods described elsewhere herein. In some cases, the entire sample collection device can be transported. The cap may be placed on the sample collection device for transport. In other embodiments, the base portion and / or support portion may be removed from the rest of the device. In one embodiment, the base can be removed from the sample collection device and the container can be transported with the base. Alternatively, the base can be removed from the sample collection device to provide access to the container, and the container is removed and sent from the device. Removal of the base includes some disassembly of the sample collection device to detach the base. This is to prevent accidental disengagement, such as, but not limited to, detents, disengaging latches or other locking mechanisms, and other aggressive actions such as disengaging the base. Can be accomplished by: Optionally, some embodiments may allow removal of the container without removal of the base, but by means such as an opening on the base, an access port or an openable cover. Allows access to the container.

  In some embodiments, the channel and / or container is one of features such as separation members, coatings, anticoagulants, beads, or any other feature described elsewhere herein. May include more than one. In one example, the sample introduced into the sample collection device can be whole blood. Two channels and respective containers can be provided. In this non-limiting example, each of the channels has a coating such as, but not limited to, an anticoagulant that covers the channel. Such anticoagulant coatings may perform one or more of the following functions. First, the anticoagulant prevents whole blood from clotting inside the channel during the sample collection process. Depending on the amount of whole blood to be collected, clotting can prematurely occlude the channel before a sufficient amount of blood is brought into the channel. Another function is to introduce an anticoagulant into the whole blood sample. By having the anticoagulant in the channel, this process starts earlier in the collection process compared to some embodiments having anticoagulant only in the container 446a or 446b. it can. This early introduction of the anticoagulant can have a whole blood sample having a portion that is not covered by the anticoagulant, such as, but not limited to, the inner surface of a needle coupled to the channel 422a or 422b. It can also be beneficial when guided along a path. Optionally, some embodiments may include a surfactant that may be used to modify the contact angle (wetting) of the surface.

  In some embodiments, the inner surface of the channel and / or other surfaces along the fluid path, such as, but not limited to, the sample inlet into the interior of a sample collection container may be surfactant and / or Or it can be coated with an anticoagulant solution. The surfactant provides a wettable surface to the hydrophobic layer of the fluidic device and facilitates filling of the metering channel with a liquid sample, eg, blood. The anticoagulant solution helps prevent clotting when the sample, eg, blood, is provided to the fluidic device. Exemplary surfactants that can be used include, but are not limited to, Tween, TWEEN® 20, Thesit®, sodium deoxycholate, Triton, Triton® X-100, Pluronic and / or interfaces. Other non-hemolytic detergents that provide the proper wettability characteristics of the active agent are included. EDTA and heparin are non-limiting anticoagulants that can be used. In one non-limiting example, the embodiment solution comprises 2% Tween, 25 mg / mLEDTA in 50% methanol / 50% water, which solution is then air dried. The methanol / water mixture provides a means to dissolve EDTA and Tween and also quickly dries on the plastic surface. This solution ensures a uniform thin film, such as pipetting, spraying, printing, or wicking, on the surface to be coated, on the surface of the channel or other surface along the fluid flow path Can be applied using these techniques.

  It should be understood that any of the embodiments herein with a coating in the channel can extend along the entire path of the channel. Optionally, the coating covers most but not all of the channel. Optionally, some embodiments allow the coating material from one channel to be in contact with the target sample fluid at the same time, and thus through all channels to the nearby channel, with a connecting fluid path. In order to minimize the risk of cross-contamination that transfers, the channel is not covered in the region closest to the entrance opening.

Although embodiments herein are shown as having two separate channels in the sample collection device, some embodiments may use more than two separate channels. I want you to understand. Optionally, some embodiments may use less than two completely separate channels. Some embodiments may use only one separate channel. Optionally, some embodiments may use an inverted Y-shaped channel that starts as a single channel and then branches into two or more channels. Any of these concepts may be adapted for use with other embodiments described herein.

Collection equipment with self-supporting collection channel

  5A-5B provide another example of a sample collection device 500 provided by the embodiments described herein. The sample collection device may include a collection device body 520, a support 530, and a base 540. In some cases, a cap may optionally be provided. The collection device body may include one or more collection channels 522a, 522b defined by a collection tube and capable of receiving a sample. The base may include one or more optical instruments 542a, 542b that may provide a visual indication of whether the sample has reached one or more containers housed within the base. The support can have one or more optical instruments 532a, 532b that can provide a visual indication of whether the sample has reached or passed through a portion of the channel.

  The collection device body 520 of the sample collection device includes at least a portion of one or more tubes having channels 522a, 522b therein. Optionally, the instrument collection body 520 may also define channels that connect with channels 522a, 522b defined by the tubes. In some embodiments, a portion of the channel may extend beyond the collection device body. The channel may extend beyond one end of the collection device body or beyond two ends.

  The collection device body 520 may be coupled to a support 530. The collection device body may include one or more channel portions therein. The collection device body may be permanently fixed to the support or may be removable with respect to the support. In some cases, the collection device body and the support may be formed as a single integrated piece. Alternatively, the collection device body and support can be formed as separate pieces.

  During operation of the device, the collection device body 520 and the support 530 can move relative to each other. In some cases, a portion of the body 520 can be inserted into the support 530 and / or a portion of the support can be inserted into the body. The body may have the ability to move relative to the support. In some cases, the sample collection device may have a longitudinal axis that extends along the length of the sample collection device. The body and / or support can move relative to each other in the direction of the longitudinal axis. The body and / or support may move a limited distance relative to each other. The body and / or support can move coaxially without rotational movement. Alternatively, rotational movement can be provided.

  The collection device body 520 may be formed of an optically transmissive material. For example, the collection device body may be formed of a transparent or translucent material. Alternatively, the body may be formed from an opaque material. The support 530 may be formed of an optically opaque, translucent, or transparent material. The support may or may not have the same optical properties as the collection device body. The support may be formed from a material different from the collection device body or from the same material as the collection device body. There may be variations and alternatives to the embodiments described herein, and any single embodiment should not be construed to encompass the complete invention.

The collection device body, support, and / or base may have any shape or size. In some embodiments, the collection device body support and / or base is a circle, ellipse, triangle, square (eg, square, rectangle, trapezoid), pentagon, hexagon, octagon, or any It may have other cross-sectional shapes. The cross-sectional shape may remain the same along the length or may vary. In some cases, the collection device body, support, and / or base is about 10 cm ² , 7 cm ² , 5 cm ² , 4 cm ² , 3 cm ² , 2.5 cm ² , 2 cm ² , 1.5 cm ² , 1 cm ^2. , 0.8 cm ² , 0.5 cm ² , 0.3 cm ² , or 0.1 cm ² or less. The cross-sectional area may remain the same along the length or may vary. The cross-sectional shape may be the same for the body, support, and base, or may vary. In some cases, the collection device body, support, and / or base is about 10 cm2, 7 cm2, 5 cm2, 4 cm2, 3 cm2, 2.5 cm2, 2 cm2, 1.5 cm2, 1 cm2, 0.8 cm2, 0.5 cm2. It may have a cross-sectional area of 0.3 cm2, or 0.1 cm2. The cross-sectional area can vary along the length or can remain the same. The cross-sectional size may be the same for the body, support, and base, or may vary. The collection device body, support, and / or base is about 20 cm, 15 cm, 12 cm, 10 cm, 9 cm, 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3 cm, 2 cm, 1 cm, 0.5 cm, or 0.1 cm or less. Can have a length of The collection device body may have a length that is greater than or shorter than a support or base, or may have a length equal to the support or base.

  The channel 522a and 522b may be supported by the device body 520 and / or the support 530. In some cases, the length of the tube or the entire channel therein may be included in the combination of the instrument body and the support. Alternatively, as seen in FIG. 5, the channel may extend beyond the instrument body and / or support. In some cases, the channel may extend beyond one end of the instrument body / support combination, or both ends. In some cases, a portion of the channel can be in the device body and a portion of the channel can be in the support. The position of the channel may be fixed by the device body and / or the support. In some cases, the channel can be fixed to the device body and / or does not move relative to the device body. The channel may move relative to the support. In some cases, multiple channels may be provided. At least a portion of the channels are substantially parallel to each other. The channels can be parallel to each other and / or parallel to a longitudinal axis that extends along the length of the sample collection device. Alternatively, no part of the channel need be parallel to each other. In some cases, at least a portion of the channels are not parallel to each other. The channel may be slightly curved. Optionally, they can be super struggling but are aligned to get closer as they approach the sample collection point. The tubes that define the channels 522a and 522b are sufficient to provide a detectable change in the sample that has reached a desired fill level in a transparent, permeable, or at least one other channel. It should be understood that it can be formed from a material. Optionally, the detectable change can be used to detect when both channels have reached at least the desired fill level.

  A base 540 may be provided in the sample collection device. The base may be coupled to the support 530. In some cases, a portion 540 of the base can be inserted into the support 530 and / or a portion of the support can be inserted into the base. The base may be fixed to the support or may be movable relative to the support. The base may be provided at the end of the support opposite to the end of the support coupled to the body. The base may be formed as a separate piece from the support. The base is separable from the support. Alternatively, the base can be fixed to the support and / or can be formed as a single piece with the support.

  Base 540 may house one or more containers therein. The container can be in fluid communication with the channel and / or can be brought into fluid communication with the channel. The end of the channel can be in the container or can be provided in the container. The base may include one or more optical instruments 542a, 542b that may provide a visual indication of whether the sample has reached one or more containers housed within the base. In some embodiments, the optical meter may be an optical window that allows a user to view the interior of the base. The optical window may be formed from a transparent and / or translucent material. Alternatively, the optical window may be an opening that has no material in it. The optical window may allow direct viewing of the container in the base. The container in the base may be formed from a transparent and / or translucent material that allows a user to see if a sample has reached the base container. For example, if blood reaches the container via the channel, the container may indicate the blood therein. In other embodiments, the optical meter may include other characteristics that indicate that the container has been filled. For example, one or more sensors can be provided in the base or container that can determine whether a sufficient amount of sample has been loaded into the container. The one or more sensors may provide a signal to an optical meter on the base of whether the sample has been provided to the container and / or a certain amount of sample has been provided to the container. For example, the optical meter may provide a display, including but not limited to, an indication that the container is fully filled, LCD display, light display (eg, LED display), plasma screen display, etc. Can be included. In an alternative embodiment, an optical meter need not be provided, but is not limited to when the container is filled, such as a sound meter or a temperature controlled meter, or other device. Alternative equipment can be provided that can be displayed by a detectable signal, such as that sensed by the user.

  The support has one or more optical instruments 532a, 532b that can provide a visual indication of whether the sample has reached or passed through a portion of the channel contained within the support. obtain. In some embodiments, the optical meter may be an optical window that allows a user to view the interior of the support. The optical window may be formed from a transparent and / or translucent material. Alternatively, the optical window may be an opening that has no material in it. The optical window may allow direct viewing of the channel in the support. The channel may be formed from a transparent and / or translucent material that allows a user to see if a sample has reached a portion of the channel that is under the optical window. In other embodiments, the optical meter may include other features, such as sensors described elsewhere herein, that may indicate whether the sample has passed through a portion of the channel.

  With reference to FIGS. 6A-6B, additional views of a sample collection device 500 in accordance with embodiments described herein are provided.

  In some embodiments, the portion of the tube that includes the channels 522a, 522b may extend beyond the collection device body 520. The portion of the extending channel includes a portion of the channel configured to receive a sample from a subject. In one example, the channel may have first ends 523a, 523b, which may be sample receiving ends of the channel.

  The channel can optionally be defined by a rigid material. Alternatively, the channel may be defined by a flexible material or may have a flexible component. The channel may or may not be designed to bend or bend. The channels may or may not be substantially parallel to each other. In some cases, the first end of the channel can be separated by some distance in the relaxed state. During operation of the device, the first ends of the channels may remain separated from each other by the distance. Alternatively, the first ends of the channels can be brought closer together. For example, the first ends of the channels can be pressed together. Each open end of the channel can receive a sample separately. The samples can be received sequentially. The sample can be from the same subject. Alternatively, the channel may have the ability to receive the same sample simultaneously.

  The channels 522a, 522b may include one or more features or characteristics referred to elsewhere in this specification. At least a portion of the channels may be parallel to each other. Alternatively, the channels can be at an angle relative to each other. In some embodiments, the channel may have a first end, which may be a sample receiving end 526 of the sample collection device. The first end of the channel may be an open end capable of receiving a sample. In some embodiments, each end of the channel may be provided to a sample receiving end of the sample collection device. One, two, or more channels may have a first end at the sample receiving end of the sample collection device.

  In some embodiments, the device body 520 is movable relative to the support 530. A portion of the device body may be insertable into the support or vice versa. In one embodiment, the device body may include a lip 527 and an internal portion 529. The edge may have a larger cross-sectional area than the inner portion. The internal portion may have the ability to be inserted into the support. The lip can act as a stop to prevent the support from being inserted into the entire body. The edge can rest on the shoulder of the support.

  7A-7B show a partial cutaway view of an example of a sample collection device 700 provided by the embodiments described herein. Prior to bringing the channels 722a, 722b into fluid communication with one or more containers 746a, 746b housed in the instrument base 740, the sample collection instrument is in an extended state. The sample collection device may include a body 720, a support 730, and a base 740. The body and / or support may support and / or include at least a portion of one, two or more channels. The base may support and / or contain one, two or more containers. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed to encompass the complete invention.

  In one embodiment, the body 720 and / or the support 730 may support one or more channels 722a, 722b of the sample collection device. In one example, two channels are provided, but the description of the two-channel embodiment is not limited to any number of channels, such as, but not limited to, 1, 3, 4, 5, 6, or more channels. Applicable to channels. The first end of each channel may be open. The channel can open to the outside air. If the first end of the channel contacts a fluid such as blood, the fluid can be drawn into the channel. Blood is drawn by capillary action, or any other technique described elsewhere herein. The fluid may travel along the length of the channel to the respective second end of the channel. The channels can be fluidly separated from each other. For example, fluid can enter the first channel 722a via the first end 723a, pass through the length of the channel, and exit from the first channel at the second end. Similarly, fluid can enter the second channel 722b via the first end 723b, pass through the length of the channel, and exit the second channel at the second end. The first and second channels may be fluidly separated so that fluid from the first channel does not pass through the second channel and vice versa. In some embodiments, the fluid may travel to the channel second end without first exiting.

  The channels 722a, 722b may have a parallel configuration. For example, the first ends 723a, 723b of the channel can be separated by approximately the same distance as between the second ends of the channel. The first ends of the channels may or may not touch each other.

  The support 730 may have one or more optical measuring instruments such as optical windows 732a, 732b. The optical window may be disposed over the channels 722a, 722b. In some cases, the optical window may be disposed over a portion of the channel. A single window may provide a view to a single channel or multiple channels. In one embodiment, the same number of optical windows as the container can be provided. Each optical window may correspond to a respective channel. Both the optical window and the channel allow the user to see from the outside of the sample collection device whether the sample has reached the container and / or has passed through the lower part of the channel; It can be formed of an optically transparent material. Such a determination is useful in determining when to compress the sample collection device.

  A base 740 may be coupled to the sample collection instrument support 730. The base may or may not be in direct contact with the support. During use of the device, the base can be secured to the support. In some cases, the base can move relative to the support. A portion of the base can be inserted into a portion of the support and / or vice versa. In some embodiments, the base can slide out of the support in a longitudinal direction relative to the support. In some cases, the base can slide coaxially with the support without rotating. In some cases, the base can rotate without moving relative to the support.

  The base 740 may have the ability to support one or more containers 746a, 746b. The base may have a housing that at least partially surrounds one or more containers. In some cases, the container can be completely enclosed when the base engages the support 730. The height of the base may extend beyond the height of the container. Alternatively, the height of the base may extend to about the height of the container or less. The base may have one or more indentations, protrusions, grooves, or shaped features to receive the container. The base may be formed to have a shape that is complementary to the shape of the container. For example, the base may have one or more tube-shaped indentations into which a tube-shaped container can fit snugly. The container may be friction fitted into the base. The container may be maintained in an upright position relative to the base. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed to encompass the complete invention.

    As many containers as the number of channels may be provided. For example, N channels may be provided, followed by N containers, where N is a positive integer (eg, 1, 2, 3, 4, 5, 6, 7, 8 Or more). Each channel corresponds to a respective container. In one example, the sample collection device may have a first container and a second container simultaneously with the first channel and the second channel, respectively. The first channel 722a is in communication with the first container 746a or can be configured to be brought into communication and the second channel 722b is in communication with the second container 746b. It can be configured to be in a state or brought into communication.

  In some embodiments, each container may have a body 749a, 749b and a cap 748a, 748b. The container may have any of the features or characteristics described elsewhere in this specification.

  Base 740 may have one or more optical measuring instruments such as optical windows 742a, 742b. The optical window may be disposed over the containers 746a, 746b. In some cases, the optical window may be disposed in the container body. A single window may provide a view to a single container or multiple containers. In one embodiment, the same number of optical windows as the container can be provided. Each optical window may correspond to a respective container. Both the optical window and the container may be formed of an optically transmissive material that allows a user to see from the outside of the sample collection device whether a sample has reached the container. Such a visual assessment may be useful to determine when the sample has reached the container and when the base is removed from the sample collection device.

  One or more engagement assemblies may be provided. The engagement assembly may include a channel holder 750 and / or a component that exerts a force, such as a spring 752 or a stretchable material. In one embodiment, the holder 750 can continue to secure the adapter channel 754 to the support. As described elsewhere herein, the adapter channel 454 can be formed integrally with the collection channel, or can be a stand-alone piece, a portion of the collection channel, or a portion of the container. It can be a separate element that can be part. In one embodiment, the holder 750 may prevent the adapter channel 754 from sliding relative to the support. The holder 750 may optionally provide a support on which a component that exerts a force, such as a spring, rests.

  In one embodiment, the engagement assemblies each include a spring 752 that can exert a force so that the body 720 can be in an extended state when the spring is in its natural state. obtain. A space may be provided between the containers 746a, 746b and the engagement assembly when the body is in the extended state. When the body 440 is in the extended state, the interior portion 729 of the body can be exposed and / or not covered by the support 730. In some cases, the second end 722a, 722b of the channel may or may not contact the cap of the container when the body is in its extended state. The second end of the channel may be in place when not in fluid communication with the interior of the container. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed to encompass the complete invention.

  The sample collection device can include any number of engagement assemblies. For example, as many engagement assemblies as the number of channels may be provided. Each channel may have an engagement assembly. For example, if a first channel and a second channel are provided, a first engagement assembly can be provided for the first channel, and for the second channel A second engagement assembly may be provided. The same number of engagement assemblies and containers can be provided.

  8A-8B provide an example of a sample collection device 800 having channels 822a, 822b that are in fluid communication with the interior of the containers 846a, 846b within the device. The sample collection device can include a body 820, a support 830, and a base 840. The body and / or support can support and / or include at least a portion of one, two, or more channels. The channel may extend beyond the end of the body. The base may support and / or contain one, two or more containers.

  In one embodiment, the body 820 and / or the support 830 can support one or more channels 822a, 822b in the sample collection device. For example, a first channel and a second channel can be provided. Each of the channels may have a first end 823a, 823b that may be provided at a sample receiving end 426 of the instrument that may extend beyond the body. The first end of each channel may be open. The channel can open to the outside air. The channel can be rigid or flexible. In some embodiments, the channels may have a length that allows them to curve and begin to contact each other. If the first end of the channel contacts a fluid such as blood, the fluid can be drawn into the channel. Each channel end can be separately contacted with fluid drawn into the respective channel. This includes bending the sample collection device at an angle so that only one opening into the channel can be in contact with the sample fluid at any one time. Alternatively, all channels can be brought into contact with the same sample at the same time, and this sample is drawn into each channel simultaneously. Alternatively, multiple, if not all, channels can be contacted with the same sample at the same time, and the sample is drawn into each channel simultaneously. The fluid may be withdrawn by capillary action or any other technique described elsewhere herein. The fluid may travel along the length of the channel to the respective second end of the channel. In some embodiments, the fluid may reach the second end of the channel by capillary action or any other technique described elsewhere herein. In other embodiments, the fluid need not reach the second end of the channel. The channels can be fluidly separated from each other.

  In some embodiments, if the channel is not in fluid communication with the interior of the container 846a, 846b, the fluid may pass through to the second end of the channel without exiting. For example, the fluid can be drawn into the channel by capillary action, causing the fluid to flow to or near the channel without causing the fluid to exit the channel.

During use of the device, the body 820 can move relative to the support 830. In some embodiments, the base may slide longitudinally with respect to the support. In one embodiment, the base is compressed (i) a portion that extends when the channel is not in fluid communication with the interior of the container, and (ii) is compressed when in fluid communication with the interior of the container. Can have a part. The sample collection device can be provided in an initially stretched state, as shown in FIG. After the sample has been collected and flowed through the length of the channel, the user pushes the base as shown in FIG. 8 to provide the sample collection device with its compressed state be able to.
In some cases, the internal portion of the body is exposed when the body is in an extended state. When the main body is in a compressed state, an internal portion of the main body can be covered with the support. The edge of the body can contact the support. Once the base is pushed in, it can remain naturally pushed in, or it can spring back to its extended state once the pressing force is removed. In some cases, the body can be withdrawn in an extended state or fully withdrawn to provide access to the container therein. Optionally, in some assemblies, removal of the body does not provide access to the container.

  A base 840 may be coupled to the sample collection instrument support 830. The base 840 may be capable of supporting one or more containers 846a, 846b. The base may have a housing that at least partially surrounds one or more containers. In some cases, the container can be completely enclosed when the base engages the support 830. The base may have one or more indentations, protrusions, grooves, or shaped features to receive the container. The base may be formed to have a shape that is complementary to the shape of the container. The container may be maintained in an upright position relative to the base.

  As many containers as the number of channels may be provided. Each channel corresponds to a respective container. In one example, the sample collection device may have a first container and a second container simultaneously with the first channel and the second channel, respectively. The first channel 822a is in communication with the first container 846a or can be configured to be brought into communication and the second channel 822b is in communication with the second container 846b. It can be configured to be in a state or brought into communication. The first channel may not be in fluid communication with the first container initially, and the second channel may not be in fluid communication with the second container initially. When the body is pushed against the support, the first and second channels can be brought into fluid communication with the interior of the first and second containers, respectively. The first and second channels can be brought into fluid communication with the first and second containers, respectively, when the body is pushed against the support. The first and second channels may be brought into fluid communication simultaneously with the first and second containers, respectively. Alternatively, they need not be brought into fluid communication at the same time. The timing of the fluid communication may depend on the height of the container and / or the length of the channel. The timing of the fluid communication may depend on the relative distance between the second end of the channel and the container.

  In some embodiments, each container may have a body 849a, 849b and a cap 848a, 848b. The container body may have a tubular shape. In some cases, the container body may have a cylindrical portion. The bottom of the container can be flat, tapered, rounded, or any combination thereof. The container may include an open end and a closed end. The open end may be the uppermost end of the container at the end of the container closer to one or more channels. The closed end may be the bottom end of the container at the end of the container that is further from one or more channels. The closed end can be the bottom end of the container, which can be at the end farther from one or more channels of the container. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed to encompass the complete invention.

  The support 830 may have one or more optical measuring instruments such as optical windows 832a, 832b. The optical window may be disposed over the channels 822a, 822b. The optical window may be disposed on a portion of the channel. The optical window may provide an indication of whether a sample has entered the container. The optical window may indicate how much sample has entered the container and / or passed through the portion of the channel indicated by the optical window. This can be useful for the user to assess whether enough sample has flowed to push the body into the sample collection device. In some cases, it may be desirable for the sample to reach the rain that brings the channel into fluid communication with the container, at or near the second end of the channel. In some cases, it may be desirable for the sample to reach a particular portion of the channel prior to pushing the body into the channel to provide fluid communication with the container. A particular portion of the channel may be under the optical window.

  Base 840 may have one or more optical instruments such as optical windows 842a, 842b. The optical window may be disposed over the containers 846a, 846b. In some cases, the optical window may be disposed in the container body. The optical window may provide an indication of whether a sample has entered the container. The optical window may indicate how much sample has filled the container. This can be useful for assessing whether a sufficient amount of sample has filled the container. In some cases, it may be desirable for a certain amount of sample to enter the container before removing the container from fluid communication with the channel. Before removing the base of the instrument and thereby starting to remove the container from fluid communication with the channel, it is desirable to have a predetermined volume of sample in the container.

  The container and / or the channel may have characteristics or features such as those described elsewhere herein. In some cases, the second end of the channel penetrates the cap of the container, thereby providing the channel in fluid communication with the container. In some cases, the channel can be withdrawn from the container, and the cap of the container can form a liquid tight seal so that the channel is out of fluid communication with the container. Enables a liquid-tight environment in the container when done.

  One or more engagement assemblies may be provided. The engagement assembly may include a channel holder and / or a component that exerts a force, such as a spring or stretchable material. The holder can keep the channel secured to the support. The holder may prevent the channel from sliding relative to the support. The holder may optionally provide a support on which a component that exerts a force, such as a spring, rests.

  In one embodiment, the engagement assembly can include a spring that can exert a force because the body can be in an extended state when the spring is in its natural state. A space may be provided between the containers 846a, 846b and the bottom of the sample body 820 when the body is in the extended state. The second end of the channel may be in place when not in fluid communication with the interior of the container.

  When the body is press fit, the spring 852 can be compressed (see also FIGS. 9A-9C). The second end of the channel may pass through the cap of the container. The second end of the channel can enter the interior of the container. In some cases, force may be provided to drive the fluid from the channel into the container. For example, a pressure differential can be created between the first and second ends of the channel. A positive pressure can be provided at the first ends 823a, 823b of the channels and / or a negative pressure can be provided at the second ends of the channels. The positive pressure can be positive with respect to the second end of the channel and / or outside air. The negative pressure may be negative with respect to the channel first end and / or ambient air. In one example, the containers 846a and 846b may have a vacuum therein. As the second end of the channel penetrates the container, the negative pressure in the container draws the sample into the container. In an alternative embodiment, the sample can be driven by capillary forces, gravity, or any other motive force to enter the container. Optionally, there may be a single or multiple force combination to fill the container with fluid.

  In some cases, different types of motive forces can be used to withdraw the sample into the channel and to move the sample from the channel into the container. For example, capillary forces can pull the sample into the channel, and pressure differences can drive the sample from the channel into the container. Any combination of motive forces can be used to draw a sample into the channel and the container.

  Some time has passed since the sample was introduced into the channel to travel along the length of the channel. A user can introduce a sample into the sample collection device and wait for the sample to travel the length of the channel. One or more optical measuring instruments may be provided along the length of the channel that indicates whether the sample has reached a desired fill level, such as an end of the channel. In another embodiment, the user may wait for a predetermined time before pushing in the body. The user determines that the sample has moved a sufficient length of the channel and / or the body is pushed in after a sufficient time has elapsed since the sample was introduced. The body has a flat surface to facilitate pressing by the user. In some cases, the flat surface has a cross-sectional area that may be sufficient for a user's finger to push down the body. After the body is pushed in, the channel is brought into fluid communication with the container, and a sample can flow from the channel into the container. An optical meter can be provided so that the user can know when the container is filled.

  As soon as the containers are filled, they can be transported to the desired location using the systems and methods described elsewhere herein. As previously described, the entire sample collection device can be transported. In one embodiment, the base portion may be removed from the rest of the device. In one embodiment, the base can be removed from the sample collection device and the container can be transported with the base. Alternatively, to provide access to the container, the base can be removed from the sample collection device and the container can be removed from the device and transported.

  With reference to FIGS. 9A-9C, an example of a sample collection device 900 and will be described. In one non-limiting example, the device can have a body 920, a support 930, and a base 940. The body 920, support 930, and base 940 can move relative to each other. In some cases, the various components of the device may be movable between different stages of use. Examples of stages of use include when the device is in an expanded state, in a compressed state, and in a separated state.

  FIG. 9A shows an example of the device 900 in an expanded state. The body 920 may extend relative to the support. Channels 922a, 922b configured for transporting samples can be fixed relative to the body. A first end of the channel may extend out of the body and / or the rest of the sample collection device. The second end of the channel can be in and / or encompassed by a portion of the sample collection device. The channel may be fluidly separated from the respective container housed by the base 940. The support 930 may be disposed between the main body and the base. The support may at least partially include a portion of the channel. In some cases, the support may include a second end of the channel.

  When in the extended state, the device may have an extended length. The instrument length may be from the bottom of the base to the channel first end. Alternatively, the length of the instrument can be measured from the bottom of the base to the top of the body.

  As seen in FIG. 9A, the instrument 900 may be in an expanded state when the sample is introduced into the instrument. For example, the sample can be contacted by at least the first end of the channel. The sample may be drawn into the channel by capillary action or any other technique or motive force described herein. In order to extract a sample into the instrument, the instrument 900, which can act alone or in combination, can remain stretched while the sample traverses the channel. The sample can fill the entire length of the channel, a portion of the length of the channel, or at least a minimum portion to satisfy a desired sample acquisition volume.

  FIG. 9B shows an example of the device 900 in a compressed state. The body 920 can be compressed against the support. The channels 922a and 922b may be fixed to the body. The channel may be in fluid communication with the respective container. When the device is brought into a compressed state, the first channel can be brought into fluid communication with the interior of the first container, and the second channel is in fluid communication with the interior of the second container. Can be brought.

  As a non-limiting example, a user can push the body 920 against the support 930 (or vice versa) to bring the device into a compressed state. The relative movement between the parts may include only one of those movements. Optionally, the motion may include only one of them. In this embodiment, the body 920 is last with respect to the support 930 so that the internal portion of the body is not exposed and / or the lip of the body can contact the support. Can be pushed up. Any stop mechanism that can be engaged when the device is fully compressed can be used. Alternatively, it can be pushed only on the body part. For example, a portion of the inner portion of the body can be exposed. The support may be disposed between the body and the base. The support may at least partially include a portion of the channel. In some cases, the second end of the channel may extend beyond the support of the device.

  It should be appreciated that the device 900 may have a compressed length when in a compressed state. The length of the device 900 may be from the bottom of the base to the channel first end. Alternatively, the length of the instrument can be measured from the bottom of the base to the top of the body. The compressed length of the device may be less than the extended length of the device. In some embodiments, the compressed length of the device is at least about 0.1 cm, 0.5 cm, 1.0 cm, 1.5 cm, 2.0 cm, 2 than the stretched length of the device. 5 cm, 3.0 cm, 3.5 cm, 4.0 cm, or 5.0 cm may be less. The compressed length of the device is about 50%, 60%, 70%, 75%, 80%, 85%, 90%, 95%, 97% or 99% of the stretched length of the device It may be.

  The device 900 can be provided with one or more engagement assemblies. The engagement assembly may include a channel holder 950 and / or a component that exerts a force, such as a spring 952 or a stretchable material. The holder 950 can continue to secure the adapter channel 954 to the support. As described elsewhere herein, the adapter channel 954 can be integrally formed with the collection channel, or can be a stand-alone piece, a portion of the collection channel, or of the container. It can be a separate element that can be part. In one embodiment, the holder 950 may prevent the adapter channel 954 from sliding relative to the support. The holder 950 may optionally provide a support on which a component that exerts a force, such as a spring, rests. When the device is in a compressed state, a component that exerts a force, such as the spring, may be in a compressed state. The spring may exert a force on the body of the device when the device is in a compressed state.

  The instrument may be in a compressed state when the sample is moved from the channel to the respective container. In some embodiments, the movement is caused by a pressure differential between the channel and the interior of the container when they are brought into fluid communication. For example, the second end of the channel may be brought into fluid communication with the interior of the container. The container may have a vacuum and / or negative pressure therein. When the channel is brought into fluid communication with a vacuum vessel, the sample can be drawn into the vessel. While the sample is transferred to the container, the instrument can remain in a compressed state. The sample may fill the entire container or a portion of the container. The entire sample from the channel (and / or an amount greater than 90%, 95%, 97%, 98%, 99%, 99.5% or 99.9% of the sample) is transferred to the container. obtain. Alternatively, only a portion of the sample from the channel can be transferred to the container.

  With reference to FIG. 9C, an embodiment of the device 900 in a detached state will be described. The base 940 can be separated from the rest of the device 900. The body 920 can be stretched or compressed against the support 930. In one embodiment, the extended state can be a natural state so that the main body can return to the extended state unless a force is exerted on the main body by a user. The channels 922a and 922b may be fixed to the body.

  When the device 900 is in a separated state, the base 940 can be separated from the support 930 of the device. The channels 922a, 922b can be removed from fluid communication with the respective containers 946a, 946b. When the device 900 is brought into a detached state, a first channel can be brought into fluid communication with the interior of the first container, and the second channel is coupled with the interior of the second container. It can be brought into fluid communication. This can occur sequentially or simultaneously. When the channel is removed from the container, the container can be sealed to prevent unwanted material from entering the container. In some embodiments, after removing the channel, the container may become liquid tight. Optionally, the container may become airtight after removing the channel.

  A user may separate the base 940 from the support 930 to bring it into a separate state for the device to remove the container therein. In embodiments, the base may be separated from the support or vice versa. Separating the base from the support can expose the containers 946a, 946b supported by the base. The container is held in the base by press fitting or other methods. The containers 946a, 946b can be removed from the base. As a non-limiting example, removing the containers 946a, 946b allows it to be placed in other containers with adjusted temperature and humidity for transport to an analytical facility. Optionally, prior to being sent for processing at an analytical facility, the containers 946a, 946b may be removed to allow pre-processing such as but not limited to centrifugation. Alternatively, the containers 946a, 946b can stay with the base.

  10A-10B provide additional views of the sample collection device 1000 in a separated state. The base 1040 may be separated (partially or completely) from the device support 1030 and / or the body 1020 when in the separated state. This allows removal of the containers 1046a and 1046b through the end of the base 1040 that is not exposed to the outside when the device 1000 is not in a separated state.

  When the device is in a separated state, the one or more channels 1022a, 1022b are fluidly separated from the one or more containers 1046a, 1046b housed in the base 1040. The containers can be fluidly sealed from their environment. The containers can be moved through the collection channel therein to reach a minimum fill level and then contain substantially completely deposited sample in each container. The base 1040 may include one or more optical measuring instruments 1046a, 1046b. The optical meter shows a portion of the container therein so as not to move the instrument 1000 to a separate state until the minimum fill level is reached in the container. As a non-limiting example, the container may have an optically transmissive material that allows a user to view a sample in the container from outside the base.

In some embodiments, the base 1040 can include at least a portion of the container. The base may have a hollow interior and a wall surrounding the hollow interior. The base may have one or more shaped features that support the container. The container may be provided within the hollow interior. The wall can surround the container. The base may have an open top through which the container is exposed. The container may or may not be removed through this open top.

Collection equipment with multiple collection channels

  With reference to FIGS. 11A-11F, further embodiments described herein will be described. This embodiment provides a bodily fluid sample collection device 1100 that may be pooled or otherwise formed on a body surface such as, but not limited to, subject skin or other target area, used for fluid sample collection. To do. This embodiment shows an instrument body defining at least two collection channels having different volumes therein, but it should be understood that instruments with fewer or greater numbers of collection channels are not excluded. . Embodiments in which the same collection volume is used for one or more of the channels are not excluded. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed to encompass the complete invention.

  FIG. 11A shows a perspective view of one embodiment of a bodily fluid sample collection device 1100 having a distal end 1102 configured to engage a fluid sample on a surface. In this embodiment, the distal end 1102 may have a shape for better engagement with a drop or bodily fluid pool or formed sample on the surface. Some embodiments, in addition to the desired shape, to facilitate fluid flow toward one or more openings 1104 and 1106 on the distal end 1102 that guide the channel into the device 1100. A surface treatment such as, but not limited to, chemical treatment, texturing, surface features, or coating may also be present at the distal end 1102.

As seen in FIG. 11A, this embodiment of the sample collection device 1100 has two openings 1104 and for receiving sample fluid. It should be understood that some embodiments may have more than two openings at the distal end. Some embodiments may have only one opening at the distal end. Optionally, some embodiments may have additional openings along a side or other surface that exits the distal end 1102 of the device 1100. The openings 1104 and 1106 can have any cross-sectional shape. In some non-limiting examples, the opening has a circular, elliptical, triangular, quadrangular (eg, square, rectangular, trapezoidal), pentagonal, hexagonal, octagonal, or any other cross-sectional shape. obtain. The cross-sectional shape can remain the same or can vary along the length of the collection device body. In some cases, the opening is about ^{2mm 2, 1.5mm 2, 1mm 2} , 0.8mm 2, 0.5mm 2, may have a 0.3 mm ² or 0.1 mm ² or less of the cross-sectional area, . Some embodiments have the opening with the same shape. Others can use different shapes for one or more openings.

  The sample filling portion 1120, which can be the body of the sample collection device 1100, allows a user to see if a sample has entered a sample collection channel (see FIG. 11B) within the sample filling portion 1120. Can be formed of transparent and / or translucent materials. In some embodiments, the entire sample fill portion 1120 is transparent or translucent. Alternatively, some embodiments may select only the entire area above the channel or the channel or sample filling portion 1120 to allow the user to visualize the filling of the sample into the sample collection device 1100. Only the area made can be transparent or translucent. Optionally, the sample fill portion is formed of an opaque material but has openings or windows for visualization of the fill level therein. The device 1100 may further include one or more visualization windows 1112 and 1114 that allow a user to see if a desired fill level has been reached. This visualization window may be formed of a transparent and / or translucent material. Alternatively, the visualization window may be an opening that does not have any material in it. An additional visualization window can also be used to determine if all of the fluid in the collection channel has been emptied and entered the containers 1146a and 1146b (see FIG. 11B).

  FIG. 11A shows the fill level in the containers 1146a and 1146b to show that some embodiments of the support 1130 have been moved in the base 1140 to a position for receiving sample fluid. It is also shown that it may have optical windows 1132 and 1134 arranged therefor. Optionally, the windows 1132 and 1134 can be cutouts that act as guides to the base snap feature to determine “start” and “end” during activation. It should be understood that the base can be configured to hold one or more sample containers. By way of example and not limitation, the entire base 1140 can be removed from the sample collection device before or after sample filling. The base 1140 can be used as a holder to hold the sample container therein during shipping, and in such embodiments, the base 1140 and the sample container can be a shipping tray or for shipping. Can be loaded into a holder. Alternatively, some embodiments may remove the sample container from the base 1140 and then transport the container without the base 1140 holding it.

  FIG. 11B shows a cross-sectional view along section line BB of the embodiment shown in FIG. 11C. FIG. 11B shows the channels 1126 and 1128 in the portion 1120. The sample fill portion 1120 may be formed from two or more pieces that combine to define the portion 1120. The channel can be defined within one piece and then has another piece that coincides with the first piece for defining the opposite or top wall of the channel. it can. For manufacturing, one piece is allowed to have a molded or otherwise formed channel in the body, and the opposite piece acts as a cover for the channel. It can also combine or include portions of the channel. The channels 1126 and 1128 may be formed only in the portion 1120 or may extend into a support 1130 having features that couple with the container held in a base or carrier 1140. Some embodiments may integrally form portions 1120 and 1130 together. Support 1130 may also be configured to hold fluidly connected to said channels 1126 and 1128 having respective containers 1146a and 1146b.

  Although these embodiments herein have been described by using two channels and two containers, it should be understood that other numbers of channels and containers are not excluded. Some embodiments may have more channels than containers, with some channels connecting to the same container. Some embodiments may have more containers than channels, where multiple containers are operably coupled to the same channel.

  As seen in FIG. 11B, the channels 1126 and 1128 may be different sizes. This allows different fluid volumes to be collected in each channel before being moved to the containers 1146a and 1146b. Optionally, some embodiments may have channels 1126 and 1128 formed to contain the same volume of fluid. In some embodiments, the openings near the distal end 1102 are closer together than those at the proximal end, which can be arranged further apart for entry into the containers 1146a and 1146b. The fluid path of the channels 1126 and 1128 is shaped and / or angled so that There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed to encompass the complete invention.

  FIG. 11B also illustrates that some embodiments may use needles for adapter channels 1150 and 1152 in the body 1130 that communicate with the channels 1126 and 1128. Each of the needles has a channel that allows fluid to pass therethrough from the collection channels 1126 and 1128 to the end of the needle. As seen in FIG. 11B, the containers 1146 a and 1146 b in the base 1140 can slide relative to the support 1130 as indicated by arrows 1156. Relative movement between the support 1130 and the base 1140 can close the spacing 1160. Closing the spacing 1160 brings the adapter channel 1150 into the cap 1148a of the container 1146a until fluid communication is formed between the interior of the container 1146a and the collection channel 1126. At that point, the driving force in the configuration moves the fluid in the channel 1126 into the container 1146a.

  By way of example and not limitation, any combination of motive forces can be used to withdraw a sample into the container. Some embodiments may use a vacuum pull in the container 1146a to withdraw a sample into the container. A pushing force from external pressure can be used to move fluid into the container. Some embodiments may use both. It may depend on capillaries and / or gravity. In some embodiments, the motive force used to withdraw the sample into the channel is different from the motive force used to withdraw the sample into the container. In some alternative embodiments, the motive force is the same at each stage. In some embodiments, the motive forces are applied sequentially or at a defined time. As a non-limiting example, the motive force for withdrawing the sample into the container is not applied until at least one channel reaches a minimum fill level. Optionally, the motive force for withdrawing the sample into the container is not applied until the two channels each reach a minimum fill level. Optionally, the motive force for withdrawing the sample into the container is not applied until all channels each reach a minimum fill level. In some embodiments, the motive forces are applied simultaneously. This enumerated feature may be applied to any embodiment herein.

  Referring to FIG. 11E, an enlarged cross-sectional view of the device 1100 is shown. In this embodiment, the support 1130 is above the adapter channels 1150 and 1152 and is sufficient to prevent a user from inserting a finger within the interval 1160 and penetrating the finger with one of the needles. It is shown having a lip portion 1136 shaped to stretch in the correct amount.

  Additionally, as shown in FIGS. 11B and 11E, this embodiment has at least two channels in the sample collection device 1100. This allows each of the channels 1128 and 1126 to introduce a different substance into the sample, respectively. As a non-limiting example, if the sample is whole blood, one channel can introduce heparin into the blood while another channel introduces ethylenediaminetetraacetic acid (EDTA). These anticoagulants not only prevent premature clotting while the channel is filled, but also introduce anticoagulants into the whole blood in preparation for transport to the containers 1146a and 1146b. Optionally, the channel can also be plasma coated instead of or in combination with the anticoagulant. This plasma coating can reduce the flow resistance as a body fluid sample enters the channel. Such a coating, along with any other coating used in the channel, can be coated with a pattern such as, but not limited to, strips, rings, or other patterns.

  Optionally, a sufficient amount of anticoagulant is each provided so that a desired level of anticoagulant can be included in the sample fluid after the sample fluid has passed through the channel only once. In the channel. In conventional blood vials, the blood sample contains no anticoagulant until it enters the vial, and once in the vial, a technician is allowed to allow mixing of the anticoagulant in the vial. Typically, the vial is repeated, tilted, shaken and / or agitated. In this embodiment, the sample fluid has an anticoagulant prior to entering the sample container and does so without having to repeatedly tilt or agitate the sample collection device. In the embodiments herein, a single pass provides sufficient time and a sufficient concentration of an additive such as an anticoagulant into the sample fluid. In one embodiment, the EDTA channel has a volume of 54 μL coated with 200 mg / mL EDTA; the heparin channel has a volume of about 22 μL coated with 250 units / mL heparin. In another embodiment, the EDTA channel has a volume of 70 μL coated with 300 mg / mL EDTA; the channel of heparin has a volume of about 30 μL coated with 250 units / mL heparin. As a non-limiting example, a channel with a volume of 50-70 μL can be coated with EDTA in the range of about 200-300 mg / mL EDTA. Optionally, a channel with a volume of 70-100 μL can be coated with EDTA in the range of about 300-450 mg / mLEDTA. Optionally, channels with a volume of 20-30 μL can be coated with heparin in the range of 250 units / mL heparin. As an example, the material can be solution coated on the surface of the target in less than an hour and then dried overnight. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed to encompass the complete invention.

  With reference to FIG. 11G, a further embodiment will be described. In the embodiment of FIG. 11G, instead of having one opening 1204 for each of the channels at the distal end 1202 of the sample collection device 1200, the sample collection device 1200 includes two or more channels. Are merged into a single channel. The embodiment of FIG. 11G shows that there is a common channel portion before this common channel branches into multiple separate channels. As discussed in FIG. 11I below, optionally reduces sample withdrawal from one channel to another and / or sample withdrawal from the channel into the sample container during filling. Thus, there may be a backflow prevention portion, such as, but not limited to, vents along separate channels.

  As seen in FIG. 11H, the use of this common flow path can result in a reduced number of openings external to the sample collection device 1200 that aligns the openings 1204 to engage a bodily fluid sample. . This also increases the capillary force for drawing a bodily fluid sample into the sample collection device 1200 by having more capillaries that draw the same channel where the bodily fluid sample enters the collection device.

  Referring to FIG. 11I, a cross-sectional view of selected components of the sample collection device will be described. FIG. 11I shows that the sample collection device may have two channels 1182 and 1184 having a common portion 1186 that leads toward an inlet opening on the device. In some embodiments, this common portion 1186 may be a continuation with respect to the size, shape, and / or orientation of one of the channels 1182 or 1184. Optionally, this common portion 1186 is in the same size, shape, and / or orientation as said channel 1182, 1184, or any other channel that may be in fluid communication with this common portion 1186. None of them. FIG. 11I shows that in one non-limiting example, there can be a step at the junction 1188 between the channels 1182 and 1184. This junction 1188 can be configured to ensure flow into the channels such that both of the two channels are completely filled. In one embodiment, the junction 1188 has a larger size than the channel 1182 exiting the junction 1188. Other sizes are not excluded, but the larger sized joint portion 1188 has sufficient flow, but in this embodiment the channel has a smaller diameter and reduced volume compared to the channel 1184. 1182 can be guaranteed to enter. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed to encompass the complete invention.

  FIG. 11I may also have vents 1190 and 1192 that can be used to prevent cross-flow between the channels, especially when a sample is being moved into the sample container. Show. In one embodiment, the vents 1190 and 1192 may be open at all times. In another embodiment, the vents 1190 and 1192 can only open when selected, such as but not limited to, after the channels 1182 and 1184 are filled or substantially filled. Some embodiments may use a dissolvable material that plugs the vents 1190 and 1192 until they contact the sample fluid. Optionally, some embodiments may use a slidable cover that only opens at one or more of the vents 1190 and 1192 when selected by a user. In one embodiment, movement of the sample container that moves to enter fluid communication with the channel may also open one or more vents 1190 and 1192 to reduce the risk of crossflow between the channels. Thus, this cover is connected to the sample container. Optionally, other crossflow prevention mechanisms such as valves, gates, or plugs can also be used to prevent fluid from moving between channels 1190 and 1192.

  FIG. 11I also shows that there may be a leak prevention device 1194 disposed between the adapters 1150 and 1152. In this embodiment, the leak prevention device 1194 is a frit that allows the adapter to deliver fluid into the sample container from a first position that prevents leakage of the sample from the adapters 1150 and 1152. It can be slidably moved to an allowable second position. In one non-limiting example, the leakage prevention device 1194 slides when engaged by the sample container or a housing that holds the sample container. In this non-limiting example, the movement of the sample container or its housing indicates that the operation of those elements also causes the operation of the leak prevention device 1194.

  Referring now to FIG. 11J, yet another embodiment of the sample collection device 1160 is described. This embodiment of the sample collection device 1160 shows that the device 1160 has a sample entry location 1204 that leads to a plurality of channels 1162 and 1164 in the device 1160. Although FIG. 11J shows that the channels 1162 and 1164 can have different shapes and / or sizes, some embodiments can be configured to have the same volume and / or shape. The sample entrance location 1204 may be on the surface of the instrument 1160, or optionally it may be on a tip, nozzle, stub, or other protrusion extending from the body of the instrument 1160. I want you to understand. This protrusion can be coplanar with and parallel to the instrument, or optionally it can be arranged at an angle so that the axis of the protrusion intersects the plane of the instruments1160 of the instrument 1160. .

  FIG. 11J further illustrates that in some embodiments there may be sample flow features 1166 and 1168 that either pull the sample in the desired direction or otherwise preferentially direct. In some embodiments, the features 1166 and 1168 are guides that act to reduce the dimension of the channel by at least one axis, such as but not limited to width or height, and thus reduced dimensions. Increases capillary action throughout the region. In one non-limiting example, these flow features 1166 and 1168 can assist fluid flow through the channel region located near the anti-cross flow feature 1170 while the sample enters the channel. In one embodiment, the flow features 1166 and 1168 are sized to preferentially improve inward flow when the flow is first withdrawn by capillary action. In one scenario, the outward flow is not based on capillary forces, but on vacuum pulling forces (such as from adjacent channels), and in this embodiment, these flow features 1166 and 1168 are non-capillary flow In such a vacuum, it is not configured to provide assistance. Thus, some but not all of the flow features 1166 and 1168 are configured to assist under at least one type of flow condition, but not certain other flow conditions. Optionally, some embodiments may use other techniques alone or without limitation, such as, but not limited to, shaped features, hydrophobic materials, or other techniques to push / pull the sample to the desired location. Can be used in combination.

  FIG. 11J illustrates that in one or more of the embodiments herein, the cone can be held in a channel and the sample is funnel-like to minimize the amount of sample not collected. It also shows that there may be angled sidewall features 1167 (not shown) that reduce the cross-sectional area of the channel in shape or otherwise. FIG. 11J also shows that there may be a positioning feature 1169 (not shown) to facilitate joining parts together in a defined location and orientation during manufacture.

  FIG. 11K shows a side view of the sample collection device 1160 of this embodiment. The side view of the instrument 1160 includes, but is not limited to, an outlet for minimizing unwanted cross flow of the sample between the channels 1162 and 1164, once in each channel, once the desired fill level has been reached. There are certain examples of one or more anti-crossflow features 1170 such as. The anti-crossflow features 1170 and 1172 can prevent crossflow by disrupting the fluid path created by the outlet. The cross flow problem most commonly occurs when the container 1140 in the holder is engaged and provides additional motive force to pull the sample from the channel into the container. This “pulling” effect can pull a sample from one channel to an adjacent channel for some reason. To minimize cross flow, the force associated with drawing a sample from a channel into the container is drawn from the outlet rather than from the fluid in the adjacent channel, thus minimizing unwanted sample mixing. .

  FIG. 11K also shows that in some embodiments herein, there may be common portions 1130 and 1140 that may be adapted for use with different sample fill portions 1120. Different capillary fillings Filled portions using different types of capture techniques can be used, such as venous blood collection of the subject, samples from arterial blood collection, or samples collected from internal locations or target sites.

  Referring to FIG. 11L, one embodiment of the sample flow features 1166 and 1168 is shown. This cross-sectional view of a sample collection portion with channels 1162 and 1164 and the sample flow features 1166 and 1168 near a common entrance path 1165 is desirable in an embodiment near where the sample enters the channel. It shows that. FIG. 11L may show that for different volume channels, it may be desirable to locate the inlet 1165 near the channel 1164 with a larger volume, as seen at the asymmetric location of the inlet 1165. Show. In some embodiments, it is also shown that the location of the sample flow features 1166 and 1168 may be selected to control the fill rate, fill volume, etc. into the sample collection device 1160. It should be understood that one or more of the described features can be adapted for use in other embodiments herein.

  Referring to FIG. 11M, channels 1162 and 1164 with sample anti-crossflow characteristics are shown. In one embodiment, the anti-crossflow characteristics of the sample are outlets 1170 and 1172 disposed on at least one surface of channels 1162 and 1164. In one non-limiting example, in the instrument, these sample anti-crossflow features are located near any sample flow features 1166 and 1168. In one embodiment, these anti-crossflow features are configured to prevent flow between channels. These anti-crossflow features are said to be excessive when the channels that can be located near the maximum fill location of each channel are at or near their maximum sample capacity. Filled samples are arranged to prevent samples being processed in one channel from entering another channel and causing the samples in the two channels to mix undesirably. The

  FIG. 11N shows a perspective view of the sample collection device with sample fill indicators 1112 and 1114. In one embodiment, these indicators 1112 and 1114 are openings or transparent portions of the instrument 1160 that allow observation of at least a portion of the channel 1162 or 1164. When the sample is visible in at least one indicator 1112 and 1114, it then signals the user to take another action, such as but not limited to engaging the sample container in the holder 1140. I will provide a. In some embodiments, there is only one sample fill indicator that substitutes for a full fill indication of samples in more than one channel. In some embodiments, the activity of engaging the sample container is performed only when indicated by indicators 1112 and 1114. In some embodiments, the activity of engaging the sample container is performed only when displayed by only one of the indicators.

  Referring to FIGS. 11O, 11P, and 11Q, cross sections at various locations along one embodiment of the device 1160 in FIG. 11J are shown. FIG. 11W shows a cross section illustrating the sample flow features 1166 and 1168. The anti-crossflow features 1170 and 1172 are also shown. Engagement features 1174 are also provided to allow the pieces to be coupled together to form the device 1160.

  FIG. 11P shows that adapter channels 1150 and 1152 are positioned to extend into or at least in fluid communication with the sample channels 1162 and 1164. Optionally, some embodiments may have multiple lumen adapter channels 1150 or 1152. Optionally, some embodiments can have multiple adapter channels per sample channel, and such additional channels are parallel to each other, angled, or wrap around ( Wrapped, or otherwise oriented relative.

FIG. 11Q illustrates that, in some embodiments, the container holder 1140 can be shaped asymmetrically (on a cross-sectional plane), or otherwise, in the instrument 1160, the holder 1140 can be Shaped to allow it to be accepted in only one orientation. This is particularly desirable when it is desired to direct the sample from a particular channel to a selected container. If the holder 1140 can be inserted in various orientations, the sample from one channel can result in incorrect containers. Optionally, other features such as sucha alignment features, slots, visual cues, texture cues, and / or the like can be used to facilitate the sample container being oriented appropriately for the instrument.

Integrated tissue penetrating member

  With reference to FIG. 11R, a further embodiment of the sample collection device will be described. This sample collection device 1210 includes features similar to those shown in FIG. 11G, except that it further includes a tissue penetrating member attached to the sample collection device 1210. An actuation mechanism 1214 such as, but not limited to, a spring actuation device can be used to fire the tissue penetrating member. FIG. 11Z shows that the actuating mechanism 1214 is in a quiescent state and that it is a spring that can be compressed to fire the tissue penetrating member 1212 toward the target tissue. This tissue penetrating member 1212 can be housed in a housing 1216 (shown in dotted lines). In one embodiment, the housing 1216 not only allows the tissue penetrating member 1212 to exit the housing, but can also be peeled off, which also maintains the sterility of the tissue penetrating member 1212 prior to its use. Including a portion that can be opened, opened, or otherwise opened. In some embodiments, the portion is a foil, cap, polymer layer, and the like. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed to encompass the complete invention.

  In one embodiment, the path of the tissue penetrating member 1212 is in both a “normal” (ie, forward direction of the tissue penetrating member) and a “normal” (ie, perpendicular to the main motion vector) trajectory. Can be controlled along the way. Some embodiments do not have a hard stop (hard s top) or sudden stop (bang s top) at the deepest point of penetration (ie, the return point), which is the main cause of spontaneous pain. Also good. Some embodiments may use cushions, cam paths, or other mechanisms other than hard stops to prevent the pain associated with sudden stop shock waves. Such shock waves can activate the nerve even if direct contact is avoided, even if the tissue penetrating member successfully avoids hitting the nerve near the damaged site. Because it is harmful. Optionally, some embodiments may allow the tissue penetrating member to follow a non-jitter path to prevent rough wound channels (residual pain). In some embodiments, this may be achieved with tighter accuracy in the guide path used with the tissue penetrating member, or the pin associated with the tissue penetrating member. This can be a path that does not excite when penetrating tissue. Optionally, the tissue penetrating member may be a path that does not provide excitement both when outside the tissue and when it is inside the tissue. It can reduce the “wobble” of the tissue penetrating member that can cause residual pain, long lasting wounds, and scarring.

  Some embodiments may have a controlled outward speed to prevent slow and delayed wound closure and subsequent bleeding. As a non-limiting example, the controlled outward speed of the tissue penetrating member can be controlled by a mechanical mechanism such as, but not limited to, a cam or higher friction material.

  Some embodiments may also include an anti-bounce mechanism to prevent unintentional re-penetration associated with an uncontrolled tissue penetrating member that recoils into the tissue after forming the initial wound. . Some embodiments herein include the tissue penetrating member or attachment thereof to prevent re-entry into tissue as soon as the tissue penetrating member is retracted or retracted a desired distance. It may have a “parking” mechanism or a lockout mechanism that engages an object.

  The lancet stops in its skin at its maximum depth, the abruptness of returning to the starting point before it begins to move outward, and the inherent problem with this design. When the lancet is at the deepest penetration point, the maximum amount of force is applied to the skin. This drive mechanism simply bounces the end of the device so that the ball bounces off the floor. The lancet suddenly stops at the end of its inward movement and sends a shock wave into the skin, causing many pain receptors near the lancet to be excited even if not hit directly . This greatly amplifies spontaneous pain.

  As mentioned, instead of a simple penetrating tissue penetrating member, some embodiments may use mechanical cam actuation. Devices with a cam-actuated design can minimize the “hard stop” of the tissue penetrating member. The cam mechanism is usually driven by a spring and generally provides a better guided actuation. The trajectory of the tissue penetrating member is strictly controlled by a guided path of the tissue penetrating member holder via a pin mounted on a cam. The cam mechanism allows a predetermined speed profile with gentle return for the outward trajectory of the tissue penetrating member and well-defined speed control. When this mechanism reaches the end of motion, it can also effectively avoid the lancet from bouncing into the skin. In addition, the mechanical vibration (or fluctuation / stagger) of the path in both directions of the lancet is reduced when launched into the air. Some embodiments in the specification also have any mechanical wander of the drive mechanism (e.g., to prevent transmission of such drive mechanism wobble to the tissue due to its "forced motion profile"). (Due to uneven or coarse cam slots) can also be minimized.

  Optionally, some embodiments may use electronic actuation with an electronically controlled drive mechanism. This technique uses a miniaturized electronic motor (eg, voice coil, solenoid) coupled to a highly accurate position sensor to accurately place the tissue penetrating member on the skin with controlled motion and speed. Move it in or out of the skin. In order to follow a rapid intrusion, return without stimulation, and relatively slowly and smoothly, the instrument decelerates the tissue penetrating member to a precisely predetermined depth. This makes it possible to avoid early wound sutures and long-term wounds. This device controls the force required to penetrate the lancet through the skin while the tissue penetrating member is advanced. An advantage of tightly controlling the actuation “profile” of the tissue penetrating member is a reproducible and painless puncture that produces a sufficient and consistent blood sample for testing.

  With respect to generating a puncture site for drawing a blood sample, it is desirable to select an appropriate puncture site on one of the patient's fingers (ringing or middle finger) of the non-dominant hand. The puncture site can be on the side of the fingertip. In one non-limiting example, it is desirable to apply a hand warming strip to a patient's selected finger for 15 seconds. Optionally, the patient's finger can be warmed for 10-60 seconds. In other cases it can be warmed longer. Warming increases blood flow to the target site. In order to prepare the target site, it is desirable to ensure that the selected puncture site is wiped by wiping off the tip of the side of the selected finger or the surface of the patient with alcohol or a similar cleaning agent. In some embodiments, it is desirable to wait until the skin is completely dry. Typically, it is not wiped with gauze to expedite drying or air is rubbed against the fingertips.

  After the puncture hole is formed, the hand is held downwards below the patient's waist to allow blood to flow. Lightly massage the finger from the base of the fingertip until a drop of blood is formed. Carefully fill the blood collection device by touching the tip of the device with a drop of blood on the finger. Make sure the device is fully filled. As soon as the blood collection device is filled, press the bleeding area of the finger against the gauze pad on the table. The blood sample is moved into the collection container. Put the bandage on your finger. The container with the sample is placed in a shipping box in the refrigerator. Discard all supplies in a biohazardous medical needle container. All supplies are disposable.

  If the first puncture does not provide enough blood, place the blood collection device carefully on the surface of the table to ensure that the device is level. Place a bandage on the punctured finger. Select an appropriate puncture site for different fingers on the same hand of the patient. If the ring finger is punctured first, a new puncture site is selected on the middle finger, or vice versa. The hand warming strip is applied to the patient's selected finger for 60 seconds. Optionally, the patient's finger can be warmed for 30-90 seconds. This increases the blood flow to the finger. These techniques for blood collection using a sample collection device, such as any herein, are clinical in facilities and / or standards certified by the Clinical Laboratory Improvement Amenity (CLIA). Allows sufficient sample collection of capillary blood for use in testing.

  With reference to FIG. 11S, yet another embodiment of a sample collection device 1220 is described. In this embodiment, the tissue penetrating member 1222 can be attached at an angle to the sample collection device 1220. This angled configuration allows a wound to be created where the tissue penetrating member is aligned with the sample acquisition openings 1103 and 1105. Although a standard spring activated actuator 1224 is shown as a drive mechanism for the tissue penetrating member 1222, a cam and / or electrical drive system may be used instead of or in combination with the spring starter. It should also be understood that it can be used. If the drive mechanism 1224 is a spring, the spring can be compressed to move the tissue penetrating member 1222 to a starting position and then released to penetrate into the target tissue. FIG. 11S shows the tissue penetrating member 1222 in the rest position. This figure shows a spring for the drive mechanism 1224, but other drive mechanisms suitable for use to fire a tissue penetrating member to create a healing wound on the subject are not excluded. Please understand that. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed to encompass the complete invention.

  A housing 1226 similar to that described for the housing 1216 may be formed around the tissue penetrating member 1222. While FIG. 11S shows two tissue penetrating members 1222 attached to the sample collection device, it should be understood that devices with more or fewer tissue penetrating members are not excluded. For example, some embodiments may have only one tissue penetrating member 1222 attached to the sample collection device 1220. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed to encompass the complete invention.

  With reference to FIG. 11T, another embodiment of a sample collection device 1230 will be described. In this embodiment, the tissue penetrating member 1232 is housed within the sample collection device 1230 and it is actually coaxially aligned with the central axis of the sample collection device, as seen in FIG. 11T. . In this position, the tissue penetrating member 1232 extends outward from the sample collection device 1230 at a location near where the openings 1103 and 1105 are located on the sample collection device 1230. Of course, devices with more or fewer openings are not excluded, and the embodiment of FIG. 11T is exemplary and non-limiting. FIG. 11T illustrates that in one embodiment of the sample collection device, a fire button 1234 can be attached to the sample collection device 1230. Optionally, some embodiments can have a shaped tip 1236 that functions as an activation button, and when the tissue is compressed against the tip 1236 at a specific depth and / or a specific pressure, The tissue penetrating member is activated.

  Upon firing, the tissue penetrating member 1232 moves as indicated by arrow 1233. In some embodiments, the tissue penetrating member 1232 is fully contained within the sample collection device 1230 prior to actuation. Some embodiments provide visual measurements on the device 1230 to help guide the user where the tissue penetrating member 1232 exits the device and roughly where a wound is formed. A vessel 1235 may be included.

  In this non-limiting example, the entire device 1230 is in a bag or package that can only be opened before the device 1230 is used. In this manner, the tissue penetrating member and the collection device are maintained in a sterile state before use. This external sterile bag or package applies to any of the other embodiments herein. FIG. 11T also shows a shaped tip 1236 (shown in dotted lines) that can be integrally formed or separately attached to the sample collection device 1230. This shaped tip 1236 may provide aspiration that draws sample fluid into the sample collection device 1230. Optionally, the shaped tip 1236 target tissue is stretched and / or shaped tip to apply pressure to increase production of sample fluid from the wound formed by the tissue penetrating member 1232. Can be used to force it to go inside. It should be understood that any embodiment herein may be adapted to have a shaped tip 1236. Optionally, the shaped tip may have a selected hydrophobic region for directing sample fluid to one or more collection regions on the tip. Optionally, the shaped tip can have a selected hydrophilic region for directing sample fluid to one or more collection regions on the tip.

  With reference to FIG. 11U, yet another embodiment of a sample collection device will be described. This embodiment is similar to that of FIG. 11T except that instead of a single tissue penetrating member such as a lancet, the embodiment of FIG. 11U uses multiple tissue penetrating members 1242. In one embodiment, these tissue penetrating members are reduced diameter microneedles 1242 compared to conventional lancets. Multiple microneedles 1242 can be actuated simultaneously for instrument 1240 and create multiple wound sites on the tissue. The spacing of the microneedles 1242 can result in more capillary loops being punctured, and more channels are available for blood to reach the tissue surface. This allows for a more “square” penetration profile compared to a lancet with a pointed tip and a tapered profile. This allows the microneedles 1242 to engage more capillary loops over a larger area without going too deep into deeper tissue layers where there are more nerve terminals. be able to.

  With reference to FIGS. 11V and 11W, a further embodiment of the sample collection device will be described. In the embodiments shown in these figures, the sample collection device 1100 is angled attached to a dedicated wound creation device 1250 having a tissue penetrating member 1252 configured to extend forward from the wound creation device 1250. Can be. Optionally, the sample collection device 1100, which may be configured to have a shaped tip 1236 (with or without an opening for receiving the tissue penetrating member 1252), is a wound creation device 1250. Can be detachably attached. Optionally, the sample collection device 1100 can be mounted flat to the device 1250. Optionally, there may be a shaped cutout on device 1250 to hold the sample collection device 1100 by press fitting. It should be understood that other techniques for removably attaching the sample collection device 1100 are not excluded. This decoupling of the collection device and the wound creation device allows the use of a wound creation device 1250 that can generate a more sophisticated, reusable, controlled and reduced pain wound creation experience.

  FIG. 11W shows that the sample collection device 1100 can be below horizontal to become neutral with respect to the gravitational effect on the sample collection. Other attachment configurations of the device 1100 to the wound creation device 1250 are not excluded.

  With reference to FIGS. 11X-11Z, further embodiments of various sample collection devices are described. FIG. 11X shows a sample collection device in which a shaped tip 1236 can be used with the device 1240. This shaped tip 1236 is similar to that previously described. A vacuum source 1270 can be used to draw a bodily fluid sample into the device 1240. The vacuum source 1270 may be coupled to the body of the instrument 1240 and / or the shaped tip 1236. It should be understood that any embodiment described in the present disclosure may be adapted for use with sample acquisition assisting equipment, such as but not limited to a vacuum source 1270.

  FIG. 11Y shows yet another embodiment of a sample collection device. This embodiment uses a pipette system having a tip 1280 for collecting sample fluid. The tip can include a tissue penetrating member 1282 attached coaxially. Optionally, a tissue penetrating member 1284 is shown for creating a wound at the target site, attached to the side or angled. The pipette system with the tip 1280 applies a vacuum to draw sample fluid from the subject. Optionally, shaped tip 1236 can be used with tip 1280 to assist in stretching or remodeling skin at the target site.

FIG. 11Z shows that some embodiments can use a diaphragm 1291 coupled to an actuation mechanism to create a vacuum to withdraw a blood sample. This connection allows the diaphragm to create a vacuum on one return stroke of the tissue penetrating member 1292 from the target site. In one embodiment, the tissue penetrating member 1292 is a microneedle. Actuation of the tissue penetrating member, indicated by arrow 1294, transmits the tissue penetrating member 1292 and generates a vacuum in the return path due to the movement of the diaphragm coupled to the operation of the tissue penetrating member 1292. One or more containers 1296 may be coupled to hold fluid collected by the device 1290. Some embodiments have only one container 1296. Some embodiments may have a set of containers 1296. Some embodiments may have multiple sets of containers 1296. Some embodiments may be mounted on the exterior of device 1290. Some embodiments may be mounted on the inside of the instrument 1290. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed to encompass the complete invention.
Vertical spill restriction

  FIG. 11E also shows more clearly that there is a sleeve 1156 around the adapters 1150 and 1152. Although shown only in FIGS. 11A-11F, it is understood that a sleeve with or without a vent can be configured for use with any of the embodiments contemplated herein. I want. As seen in the embodiment of FIG. 11E, the channel is defined by a needle. These sleeves 1156 prevent premature outflow of fluid samples from the adapter channels 1150 and 1152 before the containers 1146a and 1146b engage the needle. Since a low volume of sample fluid is required, premature outflow prevention reduces fluid loss as fluid moves from the channel to the vessel. In one embodiment, the sleeve 1156 may minimize fluid loss by providing a sleeve that is liquid tight but not air tight. If the sleeve is airtight, it can prevent the capillary action of the channel from working properly. Optionally, some embodiments may place a vent near the base remote from the tip of the needle so that the sleeve can accommodate the sample at a location remote from the vent.

  FIG. 11F shows that in an exemplary embodiment, the sleeve 1156 is configured to have a sleeve 1158 extending therethrough. This provides an improved embodiment over conventional sleeves that typically fit loosely on the needle. Because of the loose fit, in conventional sleeves, the sleeve space is in the tip and in the side wall space between the needle and the sleeve, in which fluid samples can accumulate. A sleeve of this design can prevent a greater loss of fluid by limiting the loss to a defined amount compared to a sleeveless needle that can continuously lose fluid, but along the tip and sidewalls. The fluid that accumulates in the sleeve region is still lost and not collected by the container 1146a or 1146b. The sleeve 1156 provides, but is not limited to, a needle, probe, tube, channel, or to facilitate engagement of the sleeve with the device that provides fluid communication with the channels 1126 and 1128. Narrowed regions 1176, such as other adapter channels 1150 may be included. It should be understood that some embodiments of the device shown in FIG. 11 may not have a sleeve 1156, but instead use a frit 1194 or the like. Optionally, some embodiments may not have items that restrict any flow.

  In the embodiment of FIG. 11F, the sleeve 1158 is dimensioned based on calculations that will sufficiently withstand the fluid pressure associated with the flow from the capillary action of the channel in the sample fill portion 1120. This force not only allows the sleeve 1158 to be there to allow air to vent from the channel, but also causes the containers 1146a and 1146b to be pushed into engagement with the adapter channels 1150 and 1152. Until then, fluid is prevented from exiting the sleeve. Because of the venting effect produced by the sleeve 1158, the sidewalls and other areas of the sleeve can be engaged much more closely with the needle than in a conventional sleeve. The space between the needle and the sleeve can be reduced, thus minimizing the amount of fluid lost due to the loose fit compared to a non-vented sleeve with a much larger spacing. Additionally, the sleeve 1158 has sufficient resistance as soon as fluid reaches the opening so that there is minimal fluid loss whatever the spacing between the sleeve and the needle tip. And can be dimensioned so that outflow from the channel or needle is also stopped.

  The calculation for sizing the opening is as shown in FIG. The hope is that the forces should be balanced so that there is sufficient leakage prevention associated with the hydrophobic material defining the vents to prevent the flow of sample fluid outside the sleeve. is there. In FIG. 12, the side wall of the sleeve 1156 can be in direct contact with the needle, or in some embodiments, can be spaced along the side wall with the sleeve. In one embodiment, the sleeve 1156 includes a hydrophobic material such as, but not limited to, a thermoplastic elastomer (TPE), butyl rubber, silicone, or other hydrophobic material. In one embodiment, the thickness of the sleeve also determines the length of the side wall of the opening or the vent 1180 in the sleeve 1156.

  The sleeve 1158 may be disposed at one or more locations along the sleeve 1156. Some may have as shown in FIG. Alternatively, some embodiments may have the sleeve 1158 on the side wall of the sleeve. Other places are not excluded. Optionally, the sleeve 1156 may have a plurality of openings through the sleeve, but fluid is prevented from exiting the sleeve, and the container 1146a or 1146b is engaged, and the channel and fluid It is configured such that the resistance from the opening is sufficient to prevent additional outflow from the channel until it is in communication.

  With respect to how the device 1100 is used to collect a sample, in one technique, the sample collection device 1100 is held in engagement with a target body fluid and a desired fill level is achieved. Until it is in place. During this time, the device 1100 can be held horizontally to minimize gravity, and if the device 1100 is held more vertically, it needs to overcome gravity. After reaching the fill level, the device 1100 can be disengaged with the fluid of interest and then disengaged with the containers 1146a and 1146b engaged to withdraw fluid into the container. Optionally, the device 1100 contacts the target fluid such that the filling also draws fluid in the channel and possibly some additional sample fluid remaining at the target site, and the container It can engage with the channel and remain in fluid communication. This ensures that sufficient body fluid is drawn into the container.

  After filling the containers 1146a and 1146b, they are prepared for shipping. Optionally, they are sent to pre-processing prior to shipping. Some embodiments of the containers 1146a and 1146b may be used for different samples of the centrifuged sample in the same container due to the selected density after pretreatment such as centrifugation. The container contains a dense material such that it becomes a part separated from the part.

  The container 1146a or 1146b may have a vacuum and / or negative pressure therein. When the channel is brought into fluid communication with a vacuum vessel, the sample can be drawn into the vessel. Optionally, the container may take the form of a test tube-like instrument that falls into the category as marketed under the “Vactainer” trademark from Becton-Dickinson Company, East Rutherford, NJ. While the sample is transferred to the container, the instrument may remain in a compressed state with the base 1140 closing the interval 1160. The sample may fill the entire container or a portion of the container. The entire sample from the channel (and / or an amount greater than 90%, 95%, 97%, 98%, 99%, 99.5% or 99.9% of the sample) is transferred to the container. obtain. Alternatively, only a portion of the sample from the channel can be transferred to the container.

  In one embodiment described herein, the two-stage filling of the sample collection device 1100 with sample fluid includes i) a collection channel that has been treated with a sufficient amount to prevent premature clotting. Allows a metered collection of the sample fluid to ensure that it is in, and then ii) an efficient manner of transferring a high percentage of the sample fluid into the container. This low loss filling of the container from the prefill channel to meter the minimum fluid volume of the sample into the container 1146 offers several advantages, especially when dealing with the collection of small volumes of sample fluid. Prefilling the channel to the desired level ensures that there is sufficient volume in the container to perform the desired test of the sample fluid.

  In another embodiment described herein, the entire instrument, including the sample loading portion 1120, support 1130, and base 1140, is completely transparent to allow visualization of components therein. Translucent. Optionally, only one of the sample loading portion 1120, support 1130, and base 1140 is completely transparent or translucent. Optionally, only selected portions of sample fill portion 1120, support 1130, or base 1140 are transparent or translucent. As a result, the user can more accurately determine when various procedures should be performed based on the progress of sample fluid filling and engagement of the sample container with the channel at the sample filling portion 1120. Bubbles in the collection channel are visible during filling, and if a bubble is seen, the user can locate the sample collection device 1100 in order to minimize air drawn into the channel. It can be adjusted to better engage the fluid. This allows the user to know when to separate or disengage a piece such as the base or container holder 1140 when filling is complete.

Other methods prevent outward sample flow from the adapter channels 1150 and 1152 when the instrument is held at a non-horizontal angle, such as, but not limited to, a vertically downward manner. It should be understood that can be used for In one embodiment, a frit 1194 can be used with a needle with a central hole, which can be used as the adapter channels 1150 and 1152. The frit can be in the sample collection device body or on the collection container. In some embodiments, the frit comprises a material such as but not limited to PTFE. Optionally, some embodiments may use tape / adhesive on the needles that function as the adapter channels 1150 and 1152. In one embodiment, the tape / adhesive may be used to cover the needle opening to prevent premature release of the sample. Optionally, some embodiments may have adapter channels 1150 and 1152 having hydrophobic surfaces to prevent controlled outflow from the adapter channel opening leading to the sample container. In some embodiments, the adapter channels 1150 and 1152 are needles having a hydrophobic material only on the inner surface near the outlet. Optionally, the hydrophobic material is only on the outer surface of the needle near the outlet. Optionally, the hydrophobic material is on the inner and outer surfaces of the needle. Optionally, another way to prevent downward flow increases the surface area by changing the cross-sectional area of the capillary. As a non-limiting example, some embodiments may introduce a tooth or finger-like structure within the capillary to increase the cross-sectional area of the capillary. Optionally, some embodiments may include fins that are oriented towards the fluid flow and / or opposite the flow to increase the cross-sectional area of the capillary. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed to encompass the complete invention.

Position of one sample collector for multiple channels

  With reference to FIGS. 13A-13B, yet another embodiment described herein will be described. FIG. 13A illustrates, but is not limited to, a sample fill portion 1320 having a single collection location 1322, such as a collection well, where two channels 1324 and 1326 meet to withdraw fluid from a single collection location 1322. The figure looked down on from is shown. Optionally, some embodiments branch into channels 1324 and 1326 after only a single channel is exiting the collection location 1322 and then a single common channel exiting the collection location 1322 A Y-branch channel configuration may be used. Members that provide fluid communication with the channels 1324 and 1326 include, but are not limited to, needles, probes, tubes, channels, hollow elongated members, or other structures, etc. at one end of the sample fill portion 1320. Can be linked.

  FIG. 13B is a side cross-sectional view showing a collection location 1322 in fluid communication with a channel 1326 that then fluidly connects to an adapter channel 1352 such as, but not limited to, a fluid communication member. In some embodiments, the fluid communication member has sufficient rigidity and sufficiently penetrates the tip into the septum, cap, or other structure of the container. Some may have the adapter channel 1352, 1150, etc. in a non-hollow structure so as not to leave an unsealed hole in the septum, cap, or other structure of the container.

  As seen in FIG. 13B, sample fluid is applied or dropped into the collection location 1322 as indicated by drop D. Optionally, some may be applied directly to or in direct contact with the collection location 1322 to apply the sample fluid. Although the embodiments herein show the use of only a single collection location 1322, it should be understood that other embodiments are envisioned where multiple channels are coupled to a common sample collection point. As a non-limiting example, an embodiment of a collection device may have two collection locations 1322 each with its own channel that exits from its respective collection location. Some embodiments may combine the common collection point channel shown in FIGS. 13A-B with a separate channel as shown in FIGS. Other combinations of common collection location structures and other structures with separate channels are not excluded.

  FIG. 13B also shows that this embodiment may include one or more tissue penetrating members 1327 configured to extend outwardly from the collection location 1322. In one embodiment, this allows the user to place a target tissue and a wound creation location for fluid sample acquisition on the collection location 1322 simultaneously. Optionally, a puller 1323 can be positioned to fire the tissue penetrating member. Optionally, this puller is placed in the interface of the device with the tissue to allow firing of the device when the target tissue is in contact and / or sufficient pressure or contact is in place. Incorporated into. The overlap of these two locations allows a simplified protocol for the user to follow for successful sample collection. The tissue penetrating member 1327 may be actuated by one or more actuation techniques such as, but not limited to, spring actuation, spring / cam actuation, electronic actuation, or a combination of the foregoing or single. For improved sample acquisition, other support methods such as, but not limited to, vacuum sources, tissue expansion devices, tissue expansion hardware, etc. can be used alone or in combination with any of the foregoing. I want you to understand.

  With reference to FIG. 13C, a further embodiment of the sample collection device will be described. This embodiment shows a cartridge 1400 with a sample collection device 1402 integrated therein. There are one or more sample openings 1325 to which samples collected at location 1322 can then be accessed, such as collection location 1322, and but not limited to pipette tip handling (not shown). 1329. The sample from the drop D moves along the path 1326 towards the openings 1325 and 1329 as indicated by the arrows and into the respective openings 1325 and 1329; And some of the paths 1324 and / or 1326 are withdrawn into the pipette P. As indicated by the arrow beside the pipette P, the pipette P can be moved in at least one axis to allow the sample fluid to be transported to the desired location. In this embodiment, the cartridge 1400 may have a plurality of holding containers 1410 for reagents, washing solutions, mixing areas, incubation areas, and the like. Optionally, some embodiments of the cartridge 1400 do not include any holding containers, or optionally have only one or two types of holding containers. Optionally, in some embodiments, the holding container may be a pipette tip. Optionally, in some embodiments, the holding container can be a pipette tip that has been treated to contain reagents on the tip surface (typically the inner surface of the tip but other surfaces). Is not excluded). Optionally, some embodiments of the cartridge 1400 include only the sample collection device 1402 without the tissue penetrating member, or vice versa.

  Referring to FIG. 13D, a side cross-sectional view of the embodiment of FIG. 13C is shown. Optionally, a tissue penetrating member 1327 may be included at location 1322 for use in creating a wound for the sample fluid to be collected.

  FIG. 14 shows that the sample filling portion 1320 can be combined with supports 1330 and 1340 to form the sample collection device 1300. There may be a visualization window 1312 to see if the sample fluid has reached the desired fill level. Components that exert a force, such as a spring 1356 or a stretchable material, may be included. The channel holder may keep the channel fixed to the support. In one embodiment, the holder may prevent the channel from sliding relative to the support. It may use press fit, mechanical fasteners, adhesives, or other attachment techniques to connect to the channel. The holder may optionally provide a support on which a component that exerts a force, such as a spring, may rest.

  In one example, the engagement assembly can include a spring 1356 that can exert a force so that the base 1340 can be in an extended state when in its natural state. Space may be provided between the containers 1346a, 1346b and the engagement assembly when the base is in the extended state. In some cases, the second end of the channel may or may not contact the cap of the container when the base 1340 is in the extended state. The second ends 325a, 325b of the fluid communication member 1352 may be in proper positions when not in fluid communication with the interior of the container.

  Joining the support 1330 and the base 1340 when the member 1352 passes through the cap into the container and thus withdraws sample fluid into the containers 1346a and 1346b, the channels 1324 and 1326 Provides fluid communication 1346a and 1346b with the vessel.

  Said container 1346a or 1346b may have a vacuum and / or negative pressure therein. When the channel is brought into fluid communication with a vacuum vessel, the sample can be drawn into the vessel. While the sample is transferred to the container, the instrument can remain in compression with the positioned base 1340 so that the container can be in fluid communication with the channels 1326 and 1328. The sample may fill the entire container or a portion of the container. The entire sample from the channel (and / or an amount greater than 90%, 95%, 97%, 98%, 99%, 99.5% or 99.9% of the sample) is transferred to the container. obtain. Alternatively, only a portion of the sample from the channel can be transferred to the container.

  As seen in FIG. 15, in one embodiment described herein, the two-stage filling of sample fluid into the sample collection device 1300 includes i) a sufficient amount to prevent premature clotting. A metered collection of the sample fluid to ensure that it is in a treated collection channel, and then ii) an efficient manner of transferring a high percentage of the sample fluid into the container to enable. This low loss filling of the container from the prefill channel to meter the minimum fluid volume of the sample into the container 1346 offers several advantages, especially when dealing with the collection of small volumes of sample fluid. Prefilling the channel to the desired level ensures that there is sufficient volume in the container to perform the desired test of the sample fluid.

  With reference to FIGS. 16 and 17, further embodiments will be described. FIG. 16 shows a blood collection device 1300 having a secondary collection region 1324 around the collection location 1322. The secondary collection region 1324 can be used to direct any overflowed, spilled, or misdirected fluid sample to the collection location 1322.

  FIG. 17 further illustrates that the containers 1346a and 1346b may have identifiers associated with the containers 1346a and 1346b, respectively. FIG. 17 illustrates, in one non-limiting example, the identifiers 1600 and 1602 barcodes (eg, 1-D, 2-D, or 3-D), quick response (QR) codes, images, shapes , Language, number, alphanumeric string, color, or any combination thereof, or at least one of any type of visual identifier. Others may use identifiers that are not visible spectra. Can use RFID tags, RF identifiers, IR emitting tags, or other markers that do not rely on identification by signals sent through the visible spectrum.

  Identifiers 1600 and 1602 may be used to identify samples and / or types of samples in the sample collection device. There may be one or more identifiers per container. Some may also use an identifier on the container holder. The identifier may identify the sample collection device, one or more individual containers within the device, or a component of the device. In some cases, the sample collection device, a portion of the sample collection device, and / or the container may be transported. In one example, the sample collection device, a portion of the sample collection device, may be transported via a delivery service, or any other service described elsewhere herein. The sample can be delivered to perform one or more tests on the sample.

  The identity of the sample and / or the identity of the individual who provided the sample can be tracked. The person's accompanying information (eg, name, contact information, social security number, date of birth, insurance information, billing information, medical history) and other information about who provided the sample may be included. In some cases, the type of sample (eg, whole blood, plasma, urine, etc.) can be tracked. The type of reagent that the sample should encounter (eg, anticoagulant, label, etc.) can be tracked. Additional information about the sample collection, date and / or time of collection, the circumstances when the sample was collected, the type of examination to be performed on the sample, insurance information, medical record information, or any other Types of information can be considered.

  The identifier helps keep track of such information. The identifier is associated with such information. Such information may be stored off-board of the sample collection device, on-board of the sample collection device, or any combination thereof. In some cases, the information may be stored on one or more external devices, such as a server, computer, database, or any other device with a storage device. In some cases, the information can be stored on a cloud computing infrastructure. One or more resources that store the information may be distributed on the cloud. In some cases, a peer-to-peer infrastructure may be provided. The information can be stored in the identifier itself, or can be associated with the identifier elsewhere, or any combination thereof.

  The identifier may provide a unique identification or a high possibility of providing a unique identification. In some cases, the identifier may include a visible component. The identifier is optically detectable. In some cases, the identifier may be identifiable using visible light. The identifier 1600 and 1602 barcode (eg, 1-D, 2-D, or 3-D), quick response (QR) code, image, shape, language, number, alphanumeric string, color, or It can be any combination thereof or at least one of any type of visual identifier.

  In other embodiments, the identifier may be optically detectable by any other type of radiation. For example, the identifier can be detected via infrared, ultraviolet, or any other type of wavelength in the electromagnetic spectrum. The identifier may utilize luminescence, such as fluorescence, chemiluminescence, bioluminescence, or any other type of optical luminescence. In some cases, the identifier may be a wireless transmitter and / or a receiver. The identifier may be a radio frequency identification (RFID) tag. The identifier may be any type of wireless transmitter and / or receiver. The identifier may transmit one or more electrical signals. In some cases, GPS or other location related signals may be utilized by the identifier.

  The identifier may include an audio component or an acoustic component. The identifier may generate a sound that can be identified to uniquely identify the identified component.

  The identifier may be detected via an optical detection device. For example, a barcode scanner may have the ability to read the identifier. In another example, a camera (eg, a static or video image) or other image capture device may have the ability to capture the image of the identifier and analyze the image to determine the identification.

  16 and 17 show examples of identifiers provided for use with the sample collection device 1300 according to embodiments described herein. In one example, the sample collection device may have a base 1340 that supports and / or includes one or more containers 1346a, 1346b. A sample may be provided to the sample collection device. The sample may be provided to the sample collection device via an inlet 1322. The sample may travel to one or more containers 1346a, 1346b within the instrument.

  One or more identifiers 1600, 1602 may be provided on the sample collection device. In some embodiments, an identifier is located at the base 1340 of the sample collection device. The identifier may be located on the bottom surface of the base, the side of the base, or any other part of the base. In one embodiment, the base may have a flat bottom surface. The identifier may be on a flat bottom surface of the base. One or more indentations may be provided in the base. The identifier may be placed inside the notch. The indentation may be on the bottom or side of the base. In some embodiments, the base may include one or more protrusions. The identifier may be on the protrusion. In some cases, the identifier may be provided on the outer surface of the base. The identifier may alternatively be located on the inner surface of the base. The identifier may be detected from outside the sample collection device.

  In some embodiments, the identifier may be provided on the containers 1346a, 1346. The identifier may be on the outer surface of the container or on the inner surface of the container. The identifier may be detected from outside the container. In some embodiments, the identifier may be provided on the bottom surface of the container.

  In one embodiment, the base may include an optically transmissive portion. The optically transmissive portion may be on the bottom or side of the base. For example, a transparent or translucent window can be provided. In another example, the optically transmissive portion is a hole that does not require a window. The optically transmissive portion allows a portion inside the base to be visualized. The identifier may be provided on an optically transparent portion of the outer surface of the base, an inner surface of the base, but may be visualized through the optically transparent portion, or external to the container Or it can be provided on the inner surface, but can be visualized through the optically transparent portion. In some cases, the identifier can be provided on the interior surface of the container, but the container can be optically modified so that the identifier can be viewed through the container and / or an optically transmissive portion. It can be permeable.

  The identifier may be a QR code or other optical identifier that can be optically visualized from outside the sample collection device. The QR code can be visualized through an optical window or a hole in the bottom of the base of the sample collection device. The QR code may be provided on a base of the sample collection device or a portion of the container that is visible through the base. An image capture device such as a camera or scanner can be provided external to the sample collection device and can have the ability to read the QR code.

  Single or multiple QR codes, or other identifiers may be provided on the sample collection device. In some cases, each container may have at least one associated identifier, such as a QR code. In one example, at least one window per container can be provided in the base and each window allows a user to view a QR code or other identifier. For example, two containers 1346a, 1346b can be housed within the base 1340, each having an associated identifier 1600, 1602 identifiable from outside the sample collection device.

  The base 1340 may be separated from the support 1330 or other part of the sample collection device. The identifier may be separated from the rest of the sample collection device along the base.

  In some embodiments, the identifier may be provided on a container housed in the base. Separating the base from the remainder of the sample collection device can cause the container to be separated from the remainder of the sample collection device. The container can remain in the base or can be removed from the base. The identifier can remain with the container when the container is removed from the base. Alternatively, the identifier can remain in the base when the container is removed. In some cases, both the base and the container can have an identifier so that the container and the base can be tracked separately and / or can be adapted even if separated.

  In some cases, any number of containers may be provided in the sample collection device. The sample container may be capable of receiving a sample from a subject. Each sample container may have a unique identifier. The unique identifier may be associated with any information regarding the sample, subject, device, or component of the device.

  In some cases, each identifier for each container may be unique. In other embodiments, the identifier on the container need not be unique, but can be unique with respect to the device, the subject, or the sample type.

  The sample collection device can receive a sample from the subject. The subject can directly contact the sample collection device or provide a sample to the device. The sample may travel through the instrument to one or more containers within the instrument. In some cases, the sample may be processed before reaching the container. One or more coatings or substances may be provided in the sample collection unit and / or channel that can carry the sample to the container. Alternatively, the sample is not provided with processing before reaching the container. In some embodiments, the sample may or may not be processed in the container. In some cases, the sample may be provided with a plurality of different types of processing before or when the sample reaches the container. The processes can be provided in a preselected order. For example, the first treatment desired first may be provided upstream of the second treatment. In some cases, the sample is not processed at any point.

  In some embodiments, the may be a blood sample. The first container can receive whole blood and the second container can receive blood plasma. An anticoagulant may be provided along the fluid path and / or in the container

  Once the sample is provided in the container and the container is sealed, the container can be sent to another location for sample analysis. The another location can be a clinical laboratory. The separate location may be a facility remote to the sample collection site. The entire sample collection device can be sent to the separate location. One or more identifiers can be provided on the sample collection device and it can be useful for identifying the sample collection device and / or the container therein. Alternatively, the base 1340 can be removed from the sample collection device and sent to the separate location with the container therein. One or more identifiers can be provided on the base and it can be useful for identifying the base and / or the container therein. In some cases, a container can be removed from the base and sent to the separate location. One or more identifiers can be provided on each container and it can be useful for identification of said containers.

  The identifier can be read by any suitable technique. As a non-limiting example, in some cases, the identifier can be read using an optical detector such as an image capture device or a barcode scanner. In one example, the image capture device may capture an image of a QR code. Information related to the container may be tracked. For example, when the container arrives at a location, the identifier can be scanned and a record of the arrival of the container can be maintained. The progress and / or the position of the container can be updated actively and / or passively. In some cases, the identifier may need to be intentionally scanned to determine the position of the container. In another example, the identifier actively emits a signal that can be picked up by a signal reader. For example, as the identifier moves through a building, the signal reader can track the location to the identifier.

  In some cases, reading the identifier allows a user to access additional information associated with the identifier. For example, the user may capture an image of the identifier using a device. The device or another device may display information about the sample, subject, device, component of the device, or any other information described elsewhere herein. Information about the tests to be performed and / or test results may be included. A user may perform a subsequent examination or activity on the sample based on information associated with the identifier. For example, the user can direct the container to an appropriate location for inspection. In some cases, the container can be directed to the appropriate location and / or suitable for being performed in an automated fashion without requiring human intervention on the contents in the container. Sample processing (eg, sample pretreatment, assay, detection, analysis).

Information regarding sample processing is collected and associated with the identifier. For example, if the container has an identifier and sample processing is performed on the contents of the container, one or more signals generated in response to the sample processing can be stored, and / or It can be associated with the identifier. Such updates can be done in an automated manner without the need for human intervention. Alternatively, the user can begin saving the information or can manually enter the information. Thus, medical records about the subject can be aggregated in an automated manner. The identifier may be useful for indexing and / or accessing information about the subject.

Sample container

  18A-18B illustrate one non-limiting example of a sample container 1800 that can be used with a sample collection device according to embodiments described herein. In some cases, the container may be supported by the sample collection device. The container can be contained or enclosed by a portion of the sample collection device. In one example, the sample collection device may have a first configuration in which the container is completely closed. A second configuration may be provided in which the sample collection device is opened and at least a portion of the container is exposed. In some embodiments, the container can be supported and / or at least partially enclosed by the base of the sample collection device. The base can be separated from the rest of the sample collection device, thereby providing access to the container therein.

  In the case of bodily fluid collection, the sample fluid is a US Provisional Patent Application No. 61 / 697,797 filed September 6, 2012, both of which are incorporated herein by reference in their entirety for all purposes. And a sample collection device such as those described in US Provisional Patent Application No. 61 / 798,873, filed March 15, 2013, can be used to collect blood from a patient. As a non-limiting example of a blood sample, some embodiments may collect the blood sample via collection of capillary blood from the subject. This can be done by means of a wound, penetration site, or other access site to capillary blood from the subject. Optionally, blood can also be collected by venipuncture or other vascular puncture to obtain a blood sample for filling into the sample container. For example, the blood can be collected by a device configured to collect a small volume of blood by venipuncture. Such devices include, for example, a container having a small internal volume and a hollow needle that is fluidly coupled or capable of being fluidly coupled. The container having a small internal volume is, for example, 5 mL, 4 mL, 3 mL, 2 mL, 1 mL, 750 μL, 500 μL, 400 μL, 300 μL, 200 μL, 100 μL, 90 μL, 80 μL, 70 μL, 60 μL, 50 μL, 40 μL, 30 μL, 20 μL, It has a volume of 10 μL, or 5 μL or less. Other types and techniques of equipment for collecting bodily fluids are not excluded.

  Various methods including, but not limited to, fingertip puncture, puncture, injection, pumping, wiping, pipetting, venous blood collection, venipuncture, and / or other techniques described elsewhere herein The body fluid is removed from the subject and provided to the device. In some embodiments, the sample may also be collected from the subject's breath. The bodily fluid may be provided using a bodily fluid collector. Body fluid collectors include lancets, capillaries, tubes, pipettes, syringes, needles, microneedles, pumps, or any other collector described elsewhere herein. In some embodiments, the sample may be a tissue sample provided from the subject. The sample can be removed from the subject or discarded by the subject.

  In one embodiment, the lancet punctures the subject's skin and the sample is withdrawn using, for example, gravity, capillary action, suction, pressure differential or vacuum force. The lancet, or any other bodily fluid collector, may be part of the device, part of the device cartridge, part of the system, or stand-alone component. If necessary, the lancet or any other body fluid collector may be a variety of mechanical, electrical, electromechanical, or any other well-known activation mechanism or any combination of such methods. Can be activated.

  In one example, a subject's finger (other part of the subject's body) may be punctured to produce fluid. The body fluid may be collected using capillaries, pipettes, wipes, drops, or any other mechanism known in the art. The capillary or pipette may be separate from or part of the instrument and / or cartridge of the instrument that is inserted into or attached to the instrument and / or the instrument. In another embodiment where an active mechanism is not required, the subject can simply provide bodily fluids to the device and / or cartridge, such as in the case of a saliva sample.

  Body fluid is removed from the subject and provided to the device by a variety of methods including, but not limited to, fingertip puncture, piercing, injection, pumping, wiping, and / or pipetting. The body fluid may be collected by intravenous or non-venous methods. The body fluid may be collected using a body fluid collector. Body fluid collectors include lancets, capillaries, tubes, pipettes, venous blood draws, or any other collector described elsewhere herein. In one embodiment, the lancet punctures the skin and the sample is withdrawn using, for example, gravity, capillary action, suction, or vacuum force. The lancet may be a part of the instrument, a part of the cartridge of the instrument, a part of the system, or a stand-alone component. If necessary, the lancet or any other body fluid collector may be a variety of mechanical, electrical, electromechanical, or any other well-known activation mechanism or any combination of such methods. Can be activated. In one example, a subject's finger (other part of the subject's body) may be punctured to produce fluid. Examples of other parts of the subject's body include, but are not limited to, the subject's hand, wrist, arm, torso, leg, foot, ear, or neck. The bodily fluid may be collected using a capillary tube, pipette, or any other mechanism known in the art. The capillary or pipette may be separate from the instrument and / or cartridge, or may be part of the instrument and / or cartridge or container. In another embodiment where no active mechanism is required, the subject may simply provide bodily fluids to the device and / or cartridge, as occurs with a saliva sample. The collected fluid may be placed in the instrument. The body fluid collector may be attached to the device, removably attached to the device, or provided separately from the device.

  A sample obtained from the subject can be stored in the sample container 1800. In one embodiment described herein, the sample container 1800 includes a body 1810 and a cap 1820. In some cases, at least a portion of the sample container body may be formed from a transparent or translucent material. The sample container body allows the sample provided in the sample container body to be visible when viewed from outside the sample container. The sample container body may be optically transmissive. The sample container body may be formed from a material that allows electromagnetic radiation to pass through. In some cases, the sample container body may be formed of a material that allows selected wavelengths of electromagnetic radiation to pass therethrough while not allowing other selected electromagnetic radiation to pass through. In some cases, part or all of the body can be formed of a material that is opaque between selected wavelengths of electromagnetic radiation, such as the wavelength of visible light. Optionally, some portions of the sample container body are shaped to provide a specific optical path length. Optionally, some parts of the sample container body provide a flat surface (external and / or internal) or other structure to allow analysis of the sample while in the sample container Shaped for.

  In one embodiment, an open end and a closed end can be provided on the sample container body 1810. The open end, which can be at an end configured to engage a cap, can be the top end 1812 of the sample container 1800. The closed end may be the bottom end 1814 of the sample container, which may be at the end of the container opposite the cap. In an alternative embodiment, the bottom end can also be an open end that can be closed with the floor. In some embodiments, the cross-sectional area and / or top shape and the bottom end may be substantially the same. Alternatively, the cross-sectional area of the top end can be larger than the cross-sectional area of the bottom end, or vice versa. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed to encompass the complete invention.

  In one embodiment, the sample container body can have an inner surface and an outer surface. The surface of the sample container body may be smooth, rough, textured, faceted, shiny, dull, include grooves, include ridges, or may include any other feature. The surface of the sample container body can be treated to provide the desired optical properties. The inner and outer surfaces can have the same properties or can be different. For example, the outer surface can be smooth while the inner surface can be rough.

  Optionally, the sample container body may have a tubular shape. In some cases, the sample container body may have a cylindrical portion. Alternatively, the sample container may include an ellipse, triangle, square (eg, square, rectangle, trapezoid, parallelogram), pentagon, hexagon, heptagon, octagon, or any other shape It may have other cross-sectional shapes. The shape of the cross section of the sample container may or may not have a convex and / or concave shape. The cross-sectional shape of the sample container can be the same or can vary along the length of the sample container. The sample container may have a prismatic shape along the length of the body. The prism may have a cross-sectional shape such as those described herein.

  Optionally, the bottom 1814 of the sample container can be flat, tapered, rounded, or any combination thereof. In some cases, the sample container may have a hemispherical bottom. In other embodiments, the sample container may have a rounded bottom with a flat portion. The sample container itself may or may not be able to stand on a flat surface.

  In one embodiment, the sample container 1800 can be sized to contain a small volume of fluid sample. In some embodiments, the sample container is about 5 ml, 4 ml, 3 ml, 2 ml, 1.5 mL, 1 mL, 900 μL, 800 μL, 700 μL, 600 μL, 500 μL, 400 μL, 300 μL, 250 μL, 200 μL, 150 μL, 100 μL, 80 μL. 50 μL, 30 μL, 25 μL, 20 μL, 10 μL, 7 μL, 5 μL, 3 μL, 2 μL, 1 μL, 750 nL, 500 nL, 250 nL, 200 nL, 150 nL, 100 nL, 50 nL, 10 nL, 5 nL, 1 nL, 500 pL, 300 pL, 100 pL, 50 pL, 10 pL It can be configured to accommodate as much as 5 pL, or 1 pL. As a non-limiting example, the sample container may have an information storage unit thereon, as discussed in FIGS. 1F and 1G. In one non-limiting example, in order to hold the sample fluid in a liquid state during movement, the sample vessel 100 can absorb a small volume of sample fluid by capillary action, a mesh, a solid matrix, etc. Can be held without using. This means that the sample fluid does not lose the sample or its integrity due to the liquid being absorbed from the sample container by the substance or other substance that is substantially absorbed by the capillary action in the liquid state. Allows to be removed.

  Optionally, the sample container 1800 can be configured to contain only a few drops of blood, a drop of blood, or less than a drop of blood. For example, the sample container may have an internal volume that is less than the amount of fluid sample that it is configured to contain. Having a small container can advantageously allow storage and / or transport of multiple sample containers in a small volume. This may reduce resources for storing and / or transporting the sample container. For example, less storage space is required. Additionally, less cost and / or fuel can be used for transporting the sample container. More sample containers can be transported with the same work load.

  In some embodiments, the sample container 1800 may have a short length. For example, the length of the sample container is 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3.5 cm, 3 cm, 2.5 cm, 2 cm, 1.7 cm, 1.5 cm, 1.3 cm, 1.1 cm, 1 cm, 0.9 cm, 0.8 cm, 0.7 cm, 0.6 cm, 0.5 cm, 0.4 cm, 0.3 cm, 0.2 cm, 0.1 cm, 700 μm, 500 m, 300 μm, 100 μm, 70 μm, 50 μm, 30 μm, It can be on the order of 10 μm, 7 μm, 5 μm, 30 μm, or 1 μm. In some cases, the maximum dimension of the sample container (eg, length, width, or diameter) is 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3.5 cm, 3 cm, 2.5 cm, 2 cm, 1. 7 cm, 1.5 cm, 1.3 cm, 1.1 cm, 1 cm, 0.9 cm, 0.8 cm, 0.7 cm, 0.6 cm, 0.5 cm, 0.4 cm, 0.3 cm, 0.2 cm,. It may be on the order of 1 cm, 700 μm, 500 m, 300 μm, 100 μm, 70 μm, 50 μm, 30 μm, 10 μm, 7 μm, 5 μm, 30 μm, or 1 μm.

The sample container 1800 may have a cross-sectional area. The cross-sectional area is about 8 cm ² , 7 cm ² , 6 cm ² , 5 cm ² , 4 cm ² , 3.5 cm ² , 3 cm ² , 2.5 cm ² , 2 cm ² , 1.5 cm ² , 1 cm ² , 0.9 cm ² , ^{0.8cm 2, 0.7cm 2, 0.6cm 2} , 0.5cm 2, 0.4cm 2, 0.3cm 2, 0.2cm 2, 0.1cm 2, 0.07cm 2, 0.05cm 2, It may be on the order of 0.03 cm ² , 0.02 cm ² , 0.01 cm ² , 0.5 cm ² , 0.3 cm ² , or 0.1 cm ² . The cross-sectional area can be the same or can vary along the length of the container.

  The sample container 1800 may have any thickness. The thickness can be the same or can vary along the length of the sample container. In some cases, the thickness can be selected and / or varied to provide the desired optical properties. In some cases, the thickness is 5 mm, 3 mm, 2 mm, 1 mm, 700 μm, 500 μm, 300 μm, 200 μm, 150 μm, 100 μm, 70 μm, 50 μm, 30 μm, 10 μm, 7 μm, 5 μm, 3 μm, 1 μm, 700 nm, 500 nm, It can be on the order of 300 nm or 100 nm.

  In one embodiment, the sample container 1800 may have a shape that contributes to allow centrifugation of a small volume of blood sample. This allows the collected sample in the sample container to be transported directly towards the centrifuge without having to move the sample fluid further to another sample container used in the centrifuge. To.

  Optionally, the sample container can include a cap 1820. The cap may be configured to fit over the open end of the sample container. The cap may block the open end of the sample container. The cap may fluidly seal the sample container. The cap may form a liquid tight seal with the sample container body. For example, the cap can be gas and / or liquid impervious. Alternatively, the cap may allow certain gases and / or liquids to pass through. In some cases, the cap is gas permeable while liquid impermeable. The cap may be impermeable to the sample. For example, the cap can be impermeable to whole blood, serum or plasma.

  The cap may be configured to engage the container body in any manner. For example, the cap can be press-fitted into the container body. A friction fit or interference fit allows the cap to remain in the body. In other examples, locking mechanisms such as sliding mechanisms, clamps, fasteners, or other techniques may be provided. In some cases, the cap and / or the sample container body can be threaded to allow threaded engagement. In other examples, adhesive, welding, soldering, or brazing can be utilized to connect the cap to the sample container body. The cap may be removably coupled to the sample container body. Alternatively, the cap can be permanently secured to the sample container body.

  In some cases, a portion of the cap may fit into a portion of the sample container body. The cap may form a stop with the sample container body. In some cases, a portion of the sample container body can fit into a portion of the cap. The plug may include a lip or shelf that can protrude over a portion of the sample container body. The lip or shelf may prevent the cap from sliding into the sample container body. In some cases, a portion of the cap can lie over the top and / or sides of the sample container body. Optionally, some embodiments may include additional portions, such as a cap holder, in the container assembly. In one embodiment, the purpose of the cap holder is to maintain a tight seal between the cap and sample container. In one embodiment, the cap holder engages an accessory, lip, indent, or other accessory location on the outside of the sample container to hold the cap in place. . Optionally, some embodiments may combine the functions of the cap and the cap holder into one component.

  In some embodiments, the sample container body may be formed of a rigid material. For example, the sample container body may be formed of a polymer such as polypropylene, polystyrene, or acrylic. In alternative embodiments, the sample container body may be semi-rigid or flexible. The sample container body may be formed from a single integrated piece. Alternatively, multiple pieces can be used. The plurality of pieces may be formed of the same material or different materials.

  Optionally, the sample container cap may be formed from an elastomeric material, or any other material described elsewhere herein. In some cases, the cap may be formed from rubber, polymer, or any other material that may be flexible and / or compressible. Alternatively, the cap can be semi-rigid or rigid. The sample container cap may be formed from a friction material. The sample container cap may form a liquid tight seal when engaged with the sample container body. The inner body of the sample container can be fluidly separated from the outside air. In some cases, at least one of the cap and / or a portion of the sample container body that contacts the cap may be formed of a high friction and / or compressible material.

  In one embodiment, the cap 1820 is in an open end of the sample container that is automatically sealed and can be penetrated by a needle and / or cannula to maintain a vacuum and / or a closed atmosphere in the sample container. May be a hermetic closure during the sealing engagement. In some embodiments, the interior of the sample container is simply a partial vacuum rather than a full vacuum. Excessive vacuum can damage blood components formed in the sample fluid. As a non-limiting example, the partial vacuum is in the range of about 50-60% of full vacuum. Optionally, the partial vacuum does not exceed about 60% of the full vacuum. Optionally, the partial vacuum does not exceed about 50% of the full vacuum. Optionally, the partial vacuum does not exceed about 40% of the full vacuum. By way of non-limiting example, the partial vacuum is about 10% to about 90% of full vacuum, or about 20% to about 70%, or about 30% to about 60% of full vacuum. By way of non-limiting example, the partial vacuum is about 10% to about 60% o of full vacuum, or about 20% to about 50%, or about 30% to about 50% of full vacuum. . In this way, a reduced amount of force is exerted on the body fluid sample to minimize problems with sample integrity. Optionally, after transport of the sample, the atmosphere is at atmospheric pressure. Optionally, after transport of the sample, the atmosphere is some partial vacuum. Optionally, only one of the plurality of sample containers is in partial vacuum while the other is at a higher vacuum level or full vacuum.

  In some embodiments, the cap 1820 can be a closure device having one end in the sample container and another end outside the sample container, the inner end being the sample container. A surface in continuous sealing contact with the end, the interior of the end having an annular sleeve extending from the surface toward the closed end, the annular sleeve penetrating the wall of the annular sleeve And having a first notch extending and parallel to the sample container. In one embodiment, the closure has a recessed ring formed around a first notch inside the end, and the recessed ring is associated with the hump of a tubular sample container. Match.

  Optionally, the sample container cap can be formed from a single integrated piece. Alternatively, multiple pieces can be used. The plurality of pieces may be formed of the same material or different materials. The material of the cap can be the same as or different from the material of the sample container body. In one embodiment, the sample container body may be formed from an optically transmissive material, while the cap is formed from an opaque material.

  Optionally, the cap 1820 can be removably engaged with the body. A portion of the cap can be inserted into the body. The cap may include a lip that may rest on the top of the body. This edge is not inserted into the body. In this non-limiting embodiment, the lip may prevent the cap that prevents it from being fully inserted into the body. The lip may form a continuous flange around the cap. In some cases, a portion of the lip can overlap or lie over a portion of the body. A portion of the body may be insertable into a portion of the cap.

  Optionally, a portion of the cap insertable into the body may have a rounded bottom. Alternatively, the bottom of the container may have a flat, tapered, curved, curved or any shape. The container may include an open end and a closed end. The cap may be formed because it can be easily inserted into the body.

  In some cases, a depression may be provided at the top of the cap. The depression may be associated with the portion of the cap that is inserted into the body. In some cases, a hollow or depression may be provided in the cap. The depression may have the ability to accept a portion of a channel that can be used to deliver a sample to the container. The depression may help guide the channel to a desired portion of the cap. In one example, the channel may be positioned within the recess prior to providing fluid communication within the channel and the sample container.

  The channel and cap can be pressed together so that the channel penetrates the cap and enters the interior of the container, thereby providing fluid communication to the interior of the channel and the sample container. In some cases, the cap may have a cut for the channel to pass therethrough. Alternatively, the channel can penetrate an unobstructed cap material. The channel can be withdrawn from the sample container, thereby removing the channel and sample container from fluid communication. The cap may have the ability to reseal when the channel is removed. For example, the cap may be formed from a self-healing material. In some cases, the cap may have a cut that closes when the channel is removed, thereby forming a fluid tight seal.

  In some embodiments, the body may have one or more flanges or other surface features. Examples of surface features may include flanges, ridges, protrusions, grooves, ridges, threads, holes, facets, or any other surface features. The flange and / or other surface features can surround the body. The flange and / or surface features may be located on or near the top of the body. The flange and / or other surface features are: half from the top, one third from the top, one quarter from the top, one fifth from the top, one sixth from the top, eight from the top Or a tenth from the top. The surface features can be useful for the support of the sample container inside a sample collection device. The surface feature may be useful for removing the sample container from the sample collection device and / or for placing the sample container in the sample collection device. The flange and / or other surface features may or may not engage the cap.

  Optionally, the cap may have any dimension with respect to the sample container body. In some cases, the cap and / or body may have a similar cross-sectional area. The cap may have the same or substantially similar cross-sectional area and / or shape as the top of the body. In some cases, the cap may have a length that is less than the body. For example, the cap may be less than 60%, 50%, 40%, 30%, 25%, 20%, 15%, 10%, 7%, 5%, 3% or 1% of the length of the body. Can have

  With reference to FIGS. 18C-18E, a further embodiment of the sample container 1800 may include a cap holder 1830 that fits over the cap to hold the cap in place. As a non-limiting example, the cap holder 1830 also includes an opening in the cap holder 1830 that allows a member, such as an adapter, to slide therethrough and penetrate the cap 1820. obtain. FIG. 18C shows the part in the enlarged view.

  FIG. 18D shows a cross-sectional view illustrating an embodiment in which the sample container body 1810 has a cap 1820 covered by a cap holder 1830. As seen in FIG. 18D, the cap holder 1830 has a locking feature 1832 for securely securing the cap holder 1830 to the sample container body 1810 and / or the cap 1820. In one embodiment, the locking feature 1832 includes an internal ridge that engages one or more ridges 1812 and 1814 on the sample container body 1810. FIG. 18E shows a side view of the cap holder 1830 connected to the container body 1810.

  In some cases, the surface (internal and / or external) of the sample container can be coated and / or treated with a substance. For example, the internal surface of the sample container can be coated with fixatives, antibodies, optical coatings, anticoagulants, sample additives and / or preservatives. These may be the same as or different from any material that coats the channel. In one non-limiting example, the coating may be, but is not limited to, polytetrafluoroethylene, poly-xylene, polysorbate surfactant (eg, polysorbate 20) or other that treats the surface to reduce surface tension. It can be a substance.

  In embodiments, the sample container is a blood coagulation activator (eg, thrombin, silica particles, glass particles), a glycolytic inhibitor (eg, sodium fluoride), or a gel that facilitates separation of blood cells from plasma. Can be included. In an example, the sample container may contain polyanetole sodium sulfate (SPS), acidic citrate dextrose additive, perchloric acid, or sodium citrate. Some embodiments may include at least one substance of each of the above classes. It should also be understood that optionally other additives or materials, especially additives that do not interfere with each other with respect to functionality, are not excluded.

  Optionally, the coating is applied over the entire internal surface of the sample container. Optionally, some embodiments may apply the coating as a pattern that covers the berries of selected areas of the sample container. Some embodiments may cover the upper interior region of the sample container. Optionally, some may cover only the lower interior region of the sample container. Optionally, some may cover the interior region of the sample container with strips, lanes, or other geometric patterns. Optionally, some embodiments may also coat the surface of the cap, plug, or cover used with the sample container. Some embodiments have a surface to be coated that allows the sample to enter the sample container to provide smooth transport as the sample moves away from the entrance region and toward the destination site.

  Optionally, the coating may be a liquid or dry coating. Some embodiments may have at least one dry coating and at least one liquid coating. In some cases, one or more reagents may be coated on the internal surface of the sample container and dried. The coating may alternatively be provided in a moist environment or may be a gel. Some embodiments may include a separating gel in the sample container to separate selected portions of the sample from other portions of the sample. Some embodiments may include serum separating gels or plasma separating gels such as, but not limited to, polyester based separation gels available from Becton Dickinson.

  Optionally, one or more solid substrates can be provided in the sample container. For example, one or more beads or particles can be provided in the sample container. The beads and / or particles can be coated with reagents or any other material described herein. The beads and / or particles may have the ability to dissolve in the presence of the sample. The beads and / or particles can be formed by one or more reagents, or can be useful for processing the sample. Reagents can be provided in the sample container in gaseous form. The sample container can be sealed. The sample container may be before the sample is introduced into the sample container, after the sample is introduced into the sample container, and / or while the sample is introduced into the sample container. You can stay sealed. In one embodiment, the sample container may have a smooth surface and / or a round bottom. This helps to minimize stress on the blood sample, especially during centrifugation. Of course, in alternative embodiments, other shaped bottoms of the sample containers are not excluded.

  In an embodiment, the bodily fluid sample in the sealed sample container can retain gas dissolved in the bodily fluid sample, so that the sample stored in the sealed sample container is freshly drawn from the subject's body. Samples, or samples freshly prepared from different samples (eg, plasma freshly prepared from whole blood) can have similar or identical dissolved gas composition. In embodiments, the body fluid sample in the sealed sample container is at least 99%, 98%, 95%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, or 20% Dissolved gas for 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours, 48 hours, or 72 hours Can hold over. In such embodiments, typically the period starts from the time the sample was deposited in the sample container or the time the sample container was sealed. In order to facilitate the storage of gas dissolved in the body fluid sample, the sample is placed in a sealed sample container at a selected temperature, eg, 20 ° C., 15 ° C., 10 ° C., 4 ° C., or 0 It can be stored at freezing temperatures below ℃. Other temperatures for sample storage are not excluded.

  Similarly, in embodiments, the body fluid sample in the sealed sample container can retain the analyte in the body fluid sample, so the sample stored in the sealed sample container has been freshly extracted from the subject's body. A sample of body fluid or freshly prepared from a different sample (eg, plasma freshly prepared from whole blood) can have a similar or identical analyte composition. In embodiments, the body fluid sample in the sealed sample container is at least 99%, 98%, 95%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, or 20% Specimens are held for a period of 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours, 48 hours, or 72 hours obtain. In such embodiments, typically the period starts from the time the sample was deposited in the sample container or the time the sample container was sealed. In order to facilitate the storage of gas dissolved in the body fluid sample, the sample is placed in a sealed sample container at a selected temperature, eg, 20 ° C., 15 ° C., 10 ° C., 4 ° C., or 0 It can be stored at freezing temperatures below ℃. Other temperatures for sample storage are not excluded. Optionally, the sample container can be centrifuged after the sample is introduced into the container. For example, the sample container may be 30 seconds, 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes after introducing the sample into the container. Centrifuge for 2 hours, 4 hours, 8 hours, 24 hours, 2 days, 3 days, 4 days, 5 days, 7 days, or 10 days. Centrifugation of the sample container containing the sample facilitates separation of blood cells from plasma, for example, in the case of whole blood samples, producing plasma and pelleted cells. In some cases, centrifuging a sample increases the stability of one or more analytes in blood or plasma.

  FIG. 18F further illustrates that each of the sample containers can have at least one information storage unit associated with the sample container. Optionally, some embodiments provide a single information store that carries information about multiple sample containers, especially (but not exclusively) when all of the sample containers contain samples from the same subject. You can have a unit. Such an information storage unit may be on a carrier holding a plurality of sample containers instead of on the sample container itself.

  FIG. 18F shows a view of one lower side of the sample container from one non-limiting example as viewed from the bottom up, wherein the information storage unit 1860 includes: barcodes (eg, 1-D, 2- D, or 3-D), quick response (QR) code, image, shape, word, number, alphanumeric string, color, or any combination thereof, or any type of visual information storage unit at least There may be one. Others may use information storage units that are not in the visible spectrum. Others may use RFID tags, RF information storage units, IR emitting tags, or other markers that do not rely on identification by signals sent over the visible spectrum. Of course, the information storage unit 1860 can also be positioned at the top of the sample container. FIG. 18G optionally shows that an information storage unit can also be included on the side of the sample container. This may be an addition to or an alternative to the information storage unit 1860 located on the top or bottom surface.

  In one non-limiting example, the information storage unit 1860 can be used to identify a sample and / or sample type within the sample collection device. Optionally, there may be one or more information storage units per sample container. The information storage unit can also be used on the sample container holder. The information storage unit may identify the sample collection device, one or more individual sample containers within the device, or a component of the device. In some cases, the sample collection device, a portion of the sample collection device, and / or the sample container may be transported. In one example, the sample collection device or a portion of the sample collection device may be transported by a delivery service, or any other service described elsewhere herein. The sample container may be delivered such that one or more tests can be performed on the sample.

  Optionally, the identification of the sample and / or the identity of the individual who provided the sample can be tracked. Non-limiting examples include information associated with an individual (eg, name, contact information, social security number, date of birth, insurance information, billing information, medical history) and other information about who provided the sample. May be included. In some cases, the type of sample (eg, whole blood, plasma, urine, etc.) can be tracked. Optionally, the type of reagent that the sample is expected to encounter (eg, anticoagulant, label, etc.) can also be tracked. Date and / or time of collection, situation in which the sample was collected, type of test to be performed on the sample, settings for the test, test protocol, insurance information, medical record information, or any other type of information Additional information about the sample collection, such as

  In at least one or more embodiments described herein, the information storage unit may assist in tracking such information. The information storage unit can be related to such information. Such information may be stored external to the sample collection device, onboard the sample collection device, or any combination thereof. In some cases, the information may be stored on one or more external devices, such as a server, computer, database, or any other device having memory. In some cases, the information may be stored on a cloud computing infrastructure. One or more resources that store the information are distributed on the cloud, via the Internet from a remote server, wirelessly to a remote computer processor, and so on. In some cases, a peer-to-peer infrastructure may be provided. The information can be stored in the information storage unit itself, or can be associated with an information storage unit at another location, or stored in any combination thereof.

  Optionally, the information storage unit may provide a unique identification or may provide a high possibility of providing a unique identification. In some cases, the information storage unit may have visible components. The information storage unit may be optically detectable. In some cases, the information storage unit may be identifiable using visible light. In some embodiments, the information storage unit is a bar code (eg, 1-D, 2-D, or 3-D), quick response (QR) code, image, shape, word, number, alphanumeric character. It may be a string, color, or any combination thereof, or any type of visual information storage unit.

  In other embodiments, the information storage unit is optically detectable by any other type of radiation. For example, the information storage unit can be detected by infrared, ultraviolet or any other type of wavelength in the electronic spectrum. The information storage unit may use luminescence such as fluorescence, chemiluminescence, bioluminescence, or any other type of optical radiation. In some cases, the information storage unit may be a radio transmitter and / or a receiver. The information storage unit may be a radio frequency identification (RFID) tag. The information storage unit may be any type of wireless transmitter and / or receiver. The information storage unit may transmit one or more electrical signals. In some cases, GPS or other location related signals may be utilized by the information storage unit.

  Optionally, the information storage unit may be and / or include an audio component or an acoustic component. The information storage unit may generate a sound that is recognizable to uniquely identify the identified component.

  Optionally, the information storage unit may be detectable via an optical detection device. For example, a barcode scanner may have the ability to read the information storage unit. In another embodiment, the ability of a camera (eg, for still or video images) or other image capture device to capture the image of the information storage unit and analyze the image to determine identification Can have.

  Optionally, the information storage unit can be on a holder of the sample container. One or more identifications may be provided in the holder. The information storage unit may be disposed in the indentation. The indentation may be on the bottom or side surface of the holder. In some embodiments, the holder may include one or more protrusions. The information storage unit may be disposed on the protrusion. In some cases, the information storage unit may be provided on the outer surface of the holder. The information storage unit may alternatively be provided on the inner surface of the holder. The information storage unit may be detected from outside the sample collection device.

  In some embodiments, the information storage unit may be on the outer surface of the sample container or the inner surface of the sample container. The information storage unit can be detected from the outside of the sample container. In some embodiments, the information storage unit may be provided on the bottom surface of the sample container.

  In one non-limiting example, the holder can include an optically transmissive portion. The optically transmissive portion may be on the bottom of the holder or on the side of the holder. For example, a transparent or translucent window can be provided. In another embodiment, the optically transmissive portion may be a hole that does not require a window. The optically transmissive portion allows an internal portion of the holder to be visible. The information storage unit is on an optically transmissive portion of the outer surface of the holder, on an inner surface of the holder, but on a portion that is visible through the optically transmissive portion, or the sample It can be provided on the exterior or interior surface of the container but on the part that is visible through the optically transparent part. In some cases, the information storage unit may be provided on an internal surface of the sample container, but because the sample container is optically transmissive, the information storage unit may include the sample container and / or Or it is visible through an optically transparent part.

  Optionally, the information storage unit is a QR code, barcode, or other optical information storage unit that is optically visible, such as but not limited to, visible from outside the sample collection device. obtain. The QR code is visible through an optical window, hole or the like at the bottom of the holder of the sample collection device. The QR code may be provided on the sample collection device holder or on a portion of the sample container that is visible through the holder. An image capture device, such as a camera or scanner, can be provided outside the sample container or transport container and can have the ability to read the QR code.

  In some embodiments, single or multiple QR codes or other information storage units may be provided on the sample collection device. In some cases, each sample container can have at least one information storage unit, such as a QR code associated therewith. In one example, for each sample container, at least one window can be provided in the holder, and each window allows a user to view a QR code or other information storage unit. For example, two sample containers can be stored in a holder, each of which has an associated information storage unit that can be recognized from the outside of the holder.

  In some embodiments, the information storage unit may be provided in a sample container housed by the holder. Separating the holder from the rest of the sample collection device causes the sample container to be separated from the rest of the sample collection device. The sample container may remain in the holder or may be removed from the holder. Even when the holder is removed, the information storage unit may remain with the sample container. Alternatively, the information storage unit can remain with the holder even if the sample container is removed. In some cases, both the holder and the sample container can have an information storage unit so that the sample container and holder can be tracked separately and / or match when separated. Can do.

  In some cases, any number of sample containers can be provided in the sample collection device. Some embodiments can instantly connect all of these sample containers with the sample collection device. Optionally, the sample containers can be connected sequentially or in other non-simultaneous manner. The sample container may have the ability to receive a sample received from a subject. Each sample container may optionally have a unique information storage unit. The unique information storage unit can be associated with any information regarding the sample, subject, device, or component of the device.

  In some cases, each information storage unit for each sample container may be unique or may contain unique information. In other embodiments, the information storage unit on the sample container need not be unique. Optionally, some embodiments may have unique information for the device, the subject, and / or the type of sample. In some embodiments, the information on the information storage unit can be used to associate several sample containers with the same subject or the same information.

  In some embodiments, in a collection appointment, the information storage unit is attached to or otherwise associated with the sample container or group of sample containers (physical or non-physical such as a database pointer or linkage) Attached). When accompanied by a group, the attachment may be based on everything from the same user or other factors described herein. Optionally, some embodiments may have an information storage unit already on the sample container or group of sample containers. In one non-limiting example, the information storage unit then provides identifier information associated with the subject at or near the time of sample collection. In this embodiment, the information on the information storage unit remains the same, but is then connected to the subject. In another embodiment, the information on the information storage unit is modified to include information about the subject. Optionally, some embodiments can have both, some information is changed and some is not changed (but then related to other information about the subject or collection event such as date and time) Can be attached).

  With reference to FIGS. 19A-19C, various embodiments of a sample collection instrument tip will be described. FIG. 19A shows a view of the tip of the sample collection device with openings 1103 and 1105 for the respective channels. In this embodiment, the openings 1103 and 1105 are disposed very close to each other with a partition wall 1910 between the openings 1103 and 1105. In one non-limiting example, the thickness of the partition wall 1910 is set to a minimum thickness that can be reliably formed through the manufacturing process used to form the sample collection device. In one embodiment, the wall thickness should be about 1-10 mm. In some embodiments, instead of being side-by-side, the openings 1103 and 1105 can be in a top-to-bottom configuration, a diagonal configuration, or other configuration where the two openings are very close to each other.

  Referring to FIG. 19B, this embodiment shows the openings 1910 and 1912 configured coaxially with respect to each other. This coaxial configuration of openings 1910 and 1912 allows for greater overlap between the two openings.

Referring to FIG. 19C, this embodiment is similar to that of FIG. 19B, except that these openings 1920 and 1922 are circular instead of square-shaped openings. Any of a variety of different shapes, including but not limited to circular, elliptical, triangular, quadrangular (eg, square, rectangular, trapezoidal), pentagonal, hexagonal, octagonal, or any other cross-sectional shape, It should be understood that it can be used. Of course, it should be understood that different shapes can be used for each opening and that the collection device need not have the same cross-sectional shape for all openings. Some embodiments may have one cross-sectional shape for the opening, but have a different cross-sectional shape for the channel downstream from the opening.

Single channel sample collection instrument

  Referring to FIGS. 20A-20B, the embodiments herein are typically described as a sample collection device having two separate channels, although some embodiments are described as a single inlet channel. It should be understood that 2010 can be used. This single inlet channel 2010 may or may not be coated. Suitable coatings include, but are not limited to, anticoagulants, plasma, or other materials.

  FIG. 20A shows that in this sample collection device 2000 embodiment, a tissue penetrating member 2112 can be coaxially mounted within the single entrance pathway 2010. This allows wounds in the target tissue to be formed in a manner that aligns with the single entrance pathway 2010. The tissue penetrating member 2012 is not limited, but is activated by pulling iron, activated by contact between the instrument tip and the target tissue, or when the instrument is pressed against the target tissue with sufficient pressure. Can be activated by one of a variety of techniques, such as by After actuation, the tissue penetrating member 2012 can remain in the single entrance pathway 2010. Optionally, the tissue penetrating member 2012 can be retracted out of the single entrance pathway 2010.

  The sample fluid entering the sample collection device 2000 may branch from the single inlet path 2010 into two or more separate paths 2014 and 2016. This allows the sample fluid to be divided into at least two parts from a sample collected from a single contact point. The two parts are optionally held in two separate holding chambers 2018 and 2020. Each of these chambers may have one or more adapter channels 2022 and 2024, such as, but not limited to, containers 1146a and 1146b, for transferring the sample fluid to the container. It should be understood that the holding chambers 2018 and 2020 and / or the containers 1146a and 1146b contain an anticoagulant therein for preparing the sample fluid for processing.

  Referring to FIG. 20B, this embodiment is such that the tissue penetrating member 2012 in the single entrance passage 2010 remains in whole or in part in the single entrance passage 2010 after actuation. It is shown that it is configured. It should be understood that embodiments may use penetrating members that are not hollow or are hollow with a lumen therein.

  With reference to FIG. 21, yet another embodiment of the sample collection device 2030 will be described. This embodiment shows a reduced length single entrance passageway 2032 with a tissue penetrating member 2012 configured to extend outwardly from the passageway 2032. After actuation, the tissue penetrating member 2012 can be in the pathway 2032 or, optionally, can be retracted so that it is not in the pathway 2032. The sample fluid entering the sample collection device 2030 may branch from the single inlet path 2032 into two or more separate paths 2034 and 2036. This allows the sample fluid to be divided into at least two parts from a sample collected from a single contact point. This embodiment shows that the pathways 2034 and 2036 remain in a capillary channel configuration and do not expand into a chamber, such as in the embodiment of FIGS. 20A-20B. The embodiments herein provide one or more filling measuring instruments for the collection path and / or the container on the instrument so that a user can know when a sufficient filling level has been reached. It should be understood that

  Due to the small sample volume collected by containers such as, but not limited to, containers 1146a and 1146b, a "pull" from a reduced pressure, such as but not limited to a vacuum pressure in said container, can cause the sample fluid to It should be understood that the collected blood vessels or other lumens are minimally transferred or not transferred into the subject's body in a manner that collapses or deleteriously alters its morphology. For example, pediatric and gynecological patients typically have higher vacuum forces associated with drawing larger sample volumes into conventional containers when conventional large volume vacuum containers are used. Has small and / or weak veins that can collapse. At least one embodiment of the device does not have this problem because it does not apply a vacuum (suction) force to the vein. In one embodiment, the amount of vacuum force draws about 120 μL of sample fluid into the container 1146a. Optionally, the amount of vacuum force draws about 100 μL of sample fluid into the container 1146a. Optionally, the amount of vacuum force draws about 80 μL of sample fluid into the container 1146a. Optionally, the amount of vacuum force draws about 60 μL of sample fluid into the container 1146a. Optionally, the amount of vacuum force draws about 40 μL of sample fluid into the container 1146a. Optionally, the amount of vacuum force draws about 20 μL of sample fluid into the container 1146a. In one embodiment, this type of withdrawal can be done without the use of a syringe and is primarily based on some pulling force from the container and some force from the fluid leaving the subject. Optionally, a shaped path through the device to withdraw the sample that has reached the interior of the device reduces the force transferred from the containers 1146a and 1146b to the subject's blood vessel or other body lumen. Can help. Some embodiments have less than about three-quarters in the small volume containers listed above to prevent collapse of blood vessels in the subject that minimizes and prevents hemolysis of the sample. Vacuum can be used. Some embodiments use less than about half the vacuum in the small volume containers listed above to prevent collapse of blood vessels in the subject that minimizes and prevents hemolysis of the sample. obtain. Some embodiments provide about one-quarter or less in the above-listed small volume containers to prevent collapse of blood vessels in the subject that minimizes and prevents hemolysis of the sample. Vacuum can be used. The vacuum in this specification is a complete vacuum with respect to atmospheric pressure.

  In one embodiment, it should be understood that the chamber cross-sectional area in the device is greater than the diameter of the cross-section of the flexible tubing used to withdraw fluid from the needle and / or subject. This further assists in reducing force transfer to the subject. Drawing a vacuum from the container draws the liquid sample in the instrument most quickly, rather than directly the sample in the needle closer to the subject. The longer path, buffered by the larger volume chamber in the collection device, weakens the pull on the subject's blood vessels. Additionally, the initial peak force pull is significantly less in small volume containers than in larger volume containers that are also under vacuum. The duration of the “pull” is also longer in order to allow a larger amount of sample to enter the container. At smaller volumes, a significant portion of the sample to be collected is already in the instrument, and the portion that is withdrawn from the subject that was not already on the instrument before starting to draw the sample is Less than.

  With reference to FIG. 22, yet another embodiment of the sample collection device will be described. This embodiment shows a collection device 2100 having a connector 2102 such as, but not limited to, a Luer connector that allows for coupling with various sample acquisition devices such as tissue penetrating members, needles, and the like. While some luer connectors can use press fit to engage other connectors, some embodiments of the connector 2102 can include threads to facilitate engagement. FIG. 22 illustrates that in this current embodiment, a winged needle 2104 is connected to a fluid connection, such as, but not limited to, a flexible tube that leads to a connector 2108 to connect the sample acquisition feature to the sample collection device 2100. It shows that it connects with the path | route 2106. FIG. The flexible tubing 2106 allows the needle portion 2104 to be located remotely from the sample collection device 2100 but still operably fluidly coupled to the sample collection device 2100. This allows for greater flexibility with respect to positioning the needle 2104 without moving the sample collection device 2100 to obtain sample fluid. Optionally, some embodiments may couple the tissue penetrating member directly to the device 2100 without using flexible tubing.

  At least some or all of the above embodiments can have a filling indicator, such as, but not limited to, a viewing window or opening, shown when there is a sample inside the collection device, and therefore Indicates that it is acceptable to engage the sample container. Optionally, embodiments without a filling indicator are not excluded. Some embodiments optionally include one or more vents, such as but not limited to ports, to allow air to escape when the channel in the collection device is filled with sample. Can have. In most embodiments, the filled sample container is separated from the sample collection device after reaching a desired fill level. Optionally, an additional sample container can be engaged with the sample collection device to collect additional volumes of bodily fluid samples. Optionally, the internal condition of the sample container is one having a vacuum that is configured for the container to draw only a predetermined amount of sample fluid.

  FIG. 23 shows an exploded view of one embodiment of the sample collection device 2100. In this non-limiting example, the portion 1130 can be configured to hold a portion having a container holder 1140 and a sampling instrument holder 2160. The instrument 2100 includes adapter channels 2022 and 2024 to minimize sample loss through the open end before the container in holder 1140 is engaged to withdraw the sample in any container therein. A leak prevention device 2162 that can engage the open end can be included. In the current embodiment, the leakage prevention device 2162 is configured to cover and move over at least two adapter channels 2022 and 2024. This embodiment of the leakage prevention device 2162 is movable so as not to cover the openings on the adapter channels 2022 and 2024 while allowing the adapter channels 2022 and 2024 to engage the container in the holder 1140. So that it is dimensioned.

  With reference to FIGS. 24 and 25, one embodiment of a sampling instrument holder 2160 is shown in more detail. FIG. 24 shows the sampling device holder 2160 as an assembled unit. FIG. 25 shows an exploded view of a sampling instrument holder 2160 having a first portion 2164 and a second portion 2166. FIG. The adapter channels 2022 and 2024 are also shown as removable from the second portion 2166. Although this embodiment of the sampling instrument holder 2160 is shown as two separate parts, it will be understood that several alternative embodiments may configure the sample instrument holder 2160 as a single unified unit. I want to be. Optionally, some embodiments can be calibrated to have more than two parts assembled together to form the holder 2160. Optionally, some embodiments may form separated portions along the longitudinal axis 2165 or other axis of the holder 2160 instead of along the horizontal axis of the holder 2160, which is shown in FIG. Shown as separation.

  With reference to FIGS. 26-28, various cross-sectional views of embodiments of the sample instrument holder 2160 and the instrument 2100 are shown. FIG. 26 shows a cross-sectional view of portions 2164 and 2166. FIG. While not being bound to a particular theory, the use of separate portions 2164 and 2166 can be selected to simplify the manufacture of various internal channels and chambers in the holder 2160, among others. For example, at least one wall 2167 of the chamber can be formed in the first portion 2164, while the complementary wall 2168 of the chamber can be formed in the second portion 2166. FIG. 27 shows an end view from the top to the bottom of the portion 2166 where the wall 2168 can be seen from the end view.

  With reference to FIG. 28, a cross-sectional view of the assembled device 2100 will be described. FIG. 28 shows that the sample entering the instrument through the connector 2102 enters the common chamber 2170 before being directed to the adapter channels 2022 and 2024. From the adapter channels 2022 and 2024 in the direction of the holder 1140 in the direction indicated by arrow 2172 operably fluidly connects the containers 1146a and 1146b to the adapter channels 2022 and 2024, and the sample is Move from channel into container. In this embodiment, because the containers 1146a and 1146b have sufficient space 2174 to allow movement through the adapter channels 2022 and 2024 through the caps of the containers 1146a and 1146b, the adapter channels 2022 and 2024 can be in fluid communication with the interior of the containers 1146a and 1146b. In this figure, only two container and adapter channel sets are shown, but other configurations with more or fewer sets of container and adapter channels are possible with the instrument as shown in FIG. It should be understood that it can be configured for use.

Modular sample collection device

  Referring to FIGS. 29A-29C, the embodiments herein describe a sample collection device that typically has an adapter channel for connecting the sample collection channel to the container, It should be understood that embodiments without such a configuration are not excluded.

  As a non-limiting example of FIG. 29A, as previously suggested, some embodiments herein may not have a separate adapter channel. As used herein, the collection channel 2422 may be directly connected to the container 2446 by means of relative movement between one or both of those elements, indicated by the arrow 2449.

  As a non-limiting example of FIG. 29B, one or more adapter channels 2454 may initially be separate elements that are not in direct fluid communication with either the collection channel 2422 or the container 2446. . As used herein, to create a fluid path from the collection channel through the one or more adapter channels into the container, the collection channel 2422 is referred to as the collection channel, the adapter channel 2454. Or connected to the container 2446 by means of relative movement between one or more of the containers 2446 (sequentially or simultaneously).

  As a non-limiting example of FIG. 29C, one or more adapter channels 2454 may be elements that initially communicate with the container 2446. The adapter channel 2454 may not be in direct communication with the interior of the container. As used herein, in order to create a fluid path from the collection channel through the one or more adapter channels into the container, the collection channel 2400 includes one or more of those elements ( It can be connected to the container by means of relative movement (sequentially or simultaneously). Some embodiments may have a septum, sleeve, vented sleeve, or cover 2455 on the end of the collection channel that is engaged with the adapter channel. Initially, the adapter channel 2454 may not be in fluid communication with the interior, but engagement of the various elements may also move the adapter channel 2454 to the interior 2446 of the container. Some embodiments herein may have more than one adapter channel, and some embodiments may use an adapter channel with pointed ends at both ends of the channel. There may be variations or alternatives to the embodiments described herein, and no single embodiment should be construed to encompass the complete invention.

It should be understood that any of the embodiments herein may be modified to include the features listed in the description for FIGS. 29A-29C.
Sample processing

  In this embodiment, the sample containers 1540 in their holders 1542 (or optionally removed from their holders 1542) after the bodily fluid sample has entered the interior of the sample containers 1540 are the transport containers 1500. Filled in. In this embodiment, there can be one or more slots sized for the sample container holder 1542 or a slot for the sample container in a transport container 1500. As a non-limiting example, they can hold the sample containers in an array configuration and oriented vertically or in some other predetermined orientation. It should be understood that some embodiments of the sample containers 1540 are configured to hold different amounts of sample in each container. As a non-limiting example, this may be based on the amount of vacuum force in each of the sample containers, the amount of sample collected in the sample collection channel of the collection device, and / or other factors. Controlled. Optionally, different pretreatments such as but not limited to different anticoagulants can also be present in the sample container.

  As seen in FIG. 30, the sample container 1540 collects a sample at a first location, such as but not limited to a sample collection site. As a non-limiting example, the bodily fluid sample is then transported in the transport container 1500 to a second location, such as but not limited to a receiving site such as an analysis site. The method of transport may be a courier, mail, or other shipping technique. In many embodiments, the transport may be performed by having a further container holding the transport container therein. In one embodiment, the sample collection site may be point of care. Optionally, the sample collection site is a point of service. Optionally, the sample collection site is remote from the sample analysis site.

  While this embodiment of FIG. 30 illustrates the collection of a body fluid sample from the surface of the subject, other alternative embodiments include the subject, such as by venipuncture, to fill the sample container 1540. Collection techniques may be used to collect samples from other regions. Such other collection techniques are not excluded for use in place of or in conjunction with surface collection. Surface collection can be performed on the external surface of the subject. Optionally, some embodiments may collect from an accessible surface within the subject. The presence of bodily fluid sample B on these surfaces occurs either naturally or through the creation of a wound, or by other techniques to make the bodily fluid surface accessible.

  Referring to FIG. 31, a further embodiment described herein for collecting samples pooled on the subject's surface, whereas bodily fluid samples may be collected from within the subject, will be described. . This embodiment of FIG. 31 shows a collection device 1550 with a hypodermic needle 1552 configured to collect a body fluid sample, such as but not limited to venous blood. In one embodiment, the fluid sample fills the chamber 1554 in the device 1550 when the sample containers 1540 can be engaged to withdraw the samples into the respective containers. Optionally, some embodiments do not have a chamber 1554, but instead a very small empty space, path, other than a channel, used to direct a sample from the needle 1552 to the sample container 1540. Or have a tube. For body fluid samples such as blood, the pressure in the blood container is such that the blood sample can fill the chamber 1554 without much assistance if there is any assistance from the collection device. Is. Such embodiments may optionally have one or more vents, such as, but not limited to, ports that allow air to escape when a channel in the collection device is filled with sample. . Optionally, some embodiments may directly replace the needle connection, similar to that shown in FIG. 44, where the needle is rigidly or substantially rigidly connected to the collection device instead of the tubing connection. There may be a needle connected to the collection device 1550. Some embodiments may have a removable connection, a releasable connection, a luer connection, a screw connection, or other needle connection technique developed in the future.

At least some or all of the embodiments indicate, but are not limited to, indicating that a sample is present in the collection device and thus indicating that engaging the sample container 1540 is acceptable. It may have a filling indicator such as a viewing window or opening. Optionally, embodiments that do not have a fill indicator are not excluded. The filled sample container 1540 can be removed from the sample collection device after the desired fill level is reached. Optionally, an additional sample container 1540 can be connected to the sample collection device 1550 (or 1530) to collect additional volumes of bodily fluid samples.
Point of Service System Referring to Figure 32, it should be understood that the process described herein can be performed using automated techniques. The automated process can be used in an integrated, automated system. In some embodiments, this may be a single instrument having multiple functional components therein and surrounded by a common housing. Processing techniques and methods for the sedimentation means can be preset. Optionally, it is both in the manner described in US patent applications 13 / 355,458 and 13 / 244,947, both of which are hereby incorporated by reference in their entirety. It can be based on protocols or operating procedures that can be changed dynamically as desired.
Point-of-service system

  Referring to FIG. 32, it should be understood that the processes described herein may be performed using automated techniques. The automated process can be used in an integrated, automated system. In some embodiments, this may be in a single device that includes multiple functional components therein and is surrounded by a common housing. The processing technique and method of the settling means can be preset. Optionally, both, optionally, in the manner described in US patent application Ser. Nos. 13 / 355,458 and 13 / 244,947, which are hereby incorporated by reference in their entirety for all purposes. It can be based on protocols or procedures that can be changed dynamically.

  In one non-limiting example shown in FIG. 32, an integrated device 2500 can be provided having a programmable processor 2502 that can be used to control multiple components of the device. For example, in one embodiment, the processor 2502 may control a single or multiple pipette system 2504 that may move in the XY and Z directions, as indicated by arrows 2506 and 2508. The same or different processors may control other components 2512, 2514, or 2516 in the device. In one embodiment, one of the components 2512, 2514, or 2516 includes a centrifuge.

  As seen in FIG. 32, control by the processor 2502 allows the pipette system 2504 to obtain a blood sample from the cartridge 2510 and move the sample to one of the components 2512, 2514, or 2516. Make it possible to do. Such movement may dispense the sample into a removable container in the cartridge 2510 and then transport the removable container to one of the components s2512, 2514, or 2516. Including. Optionally, the blood sample is dispensed directly into a container already attached to one of the components 2512, 2514, or 2516. In one non-limiting example, one of these components s2512, 2514, or 2516 is a centrifuge with an imaging configuration that allows both illumination and visualization of the sample in the container. Can be a machine. Other components 2512, 2514, or 2516 perform other analysis, assay, or detection functions.

All of the foregoing can be integrated into a single housing 2520 and can be configured for mounting on a tabletop or a small floor space footprint. In one embodiment, a system mounted on a small footprint floor occupies a floor area of about 4 m ² or less. In one embodiment, a system mounted on a small footprint floor occupies a floor area of about 3 m ² or less. In one embodiment, a system mounted on a small footprint floor occupies a floor area of about 2 m ² or less. In one embodiment, a system mounted on a small footprint floor occupies a floor area of about 1 m ² or less. In some embodiments, the footprint of the device is about ^{4m 2, 3m 2, 2.5m 2} , 2m 2, 1.5m 2, 1m 2, 0.75m 2, 0.5m 2, 0.3m ² , 0.2 m ² , 0.1 m ² , 0.08 m ² , 0.05 m ² , 0.03 m ² , 100 cm ² , 80 cm ² , 70 cm ² , 60 cm ² , 50 cm ² , 40 cm ² , 30 cm ² , 20 cm ² , 15 cm ² , or 10 cm ² . It can be: Some suitable systems suitable for setting point-of-service are described in U.S. Patent Application Nos. 13 / 355,458 and 13/244, which are incorporated herein in their entirety for all purposes. 947. This embodiment may be configured for use with any of the modules or systems described in those patent applications.

  With reference to FIGS. 33-37, further embodiments of sample collection devices will be described. As seen in FIGS. 33 and 34, at least one embodiment increases the cross-sectional area of the channel and then increases the flow rate to provide a capillary channel region and then a lower flow resistance. A sample collection region 2600 is shown having a low flow resistance region 2610. In at least one embodiment, this lower flow resistance region 2610 is still a capillary channel but has a lower flow resistance. Optionally other embodiments may increase the size of the location through which the sample flows, but it is not under capillary action. The increased channel size can also be used to store samples therein. As a non-limiting example, this preservation is primary during collection, or from collection site to refrigeration, from collection site to receiving site, transport from other location to location, or for other purposes. Can be of a longer duration. One embodiment may be configured to have caps on both ends of the instrument so that the sample is contained therein without having to move to containers 1146a and 1146b.

  Since the joint between regions 2600 and 2610 can be arranged to intersect the midline 2620, this can also reduce the amount of binding material to bond the elements together. It should be understood that this embodiment may have channels 2612 and 2614 configured to accommodate the same or substantially the same volume in the same cross-sectional size and / or in the channel. Optionally, the channels 2612 and 2614 can be configured to hold different volumes. The same is true when the channel continues to enter region 2610. Optionally, some embodiments may be the same in region 2600, while when in region 2610, may have different sizes, or vice versa. Other size configurations are not excluded. Here, the channel is shown in a straight line, but some embodiments of any of the embodiments disclosed herein may have a curved or other non-linear portion of the channel. Please understand that you get.

  Other parts are similar to those already described herein with respect to the containers 1146a and 1146b, adapter channels, frits, holder 130, etc. Aspiration by capillary action of both channels at the contact (both filling times <6 seconds) is improved (step is removed) and blood easily enters the channel and passes without the need to tilt the contact area . The part may be formed of PMMA, PET, PETG or the like. In this embodiment, this provides a 7.5 times faster filling than a capillary channel of one cross-sectional size, as the increase in channel size in region 2610 allows easier flow into this region. obtain.

As seen in the equation below, the flow resistance decreases in region 2610 based on the fourth power of the channel size change:

  It should be understood that as soon as a desired amount of sample enters the channel, some embodiments may be configured to be manipulated to move the sample into a storage container. As a non-limiting example, the movement of this sample can be via tensile force, pushing force, or both. In one embodiment, the tensile force has a container having a vacuum therein, a suction device, or other movable surface that can increase volume and withdraw a sample therein or active. Can be provided by a container having a positive vacuum force. In one embodiment, the pushing force may be pressure from air or other gas, or other fluid population supplied from behind the bolus. In embodiments, to push gas forward, compressed gas, pressure from a cap with a seal around the device that bypasses the collection device, a syringe connected to one end and applying gas pressure, or others The power of is demonstrated. The force provided can be different from the motive force for collecting the sample in the channel. Optionally, some embodiments may use different motive forces per channel. Optionally, different motive forces may be used in zone 2600 for zone 2610.

  Although the above teachings have been described and illustrated with reference to specific embodiments thereof, those skilled in the art will recognize that various adaptations, changes, procedures, and protocols, without departing from the spirit and scope of the present invention, It will be understood that modifications, substitutions, deletions or additions may be made. For example, with any of the above embodiments, the fluid sample can be whole blood, diluted blood, interstitial fluid, sample collected directly from a patient, sample on a surface, sample after some pre-treatment, etc. I want you to understand. One skilled in the art will appreciate that alternative embodiments may have one or more containers that can be sequentially operatively coupled to the needle or the opening of the channel to draw fluid into the container. Will do. Optionally, some embodiments may have a container configured to be operably coupled to the channel simultaneously. Some embodiments all use a single instrument to bring the target sample fluid to the tissue surface, and then collect the sample fluid, a puncture device or other wound making device and sample collection device And can be integrated. By way of a non-limiting example, the wound site created can be on the same side as the collection opening along the edge of the instrument, at the end of the sample collection device near the sample collection channel opening. To have a penetrating tip exiting from the side, a tissue penetrating member that is actuated by a spring, mechanically actuated, and / or electromechanically actuated can be attached. Optionally, the integrated device can have a collection opening on one surface and a tissue penetrating element along another surface of the device. In any of the embodiments disclosed herein, the first opening of the collection channel can have any rounded shape configured to not easily puncture human skin. .

  Additionally, the use of a heating pad on the finger or other target tissue increases blood flow to the target area and thus increases the rate at which sufficient blood or other body fluid is drawn from the subject. Let The heating is used to bring about 40C-50C to the target tissue. Optionally, the heat brings the target tissue to a temperature range of about 44-47C.

  Furthermore, those skilled in the art will recognize that any of the embodiments described herein can be applied to the collection of sample fluids from humans, animals, or other subjects. Some embodiments described herein may also be suitable for collection of non-biological fluid sumps. Some embodiments may use a container that is not removable from the carrier. Some direct the fluid sample after measurement at the sample collection portion to a cartridge that is placed by the second motive force and then in an analyte or other analytical instrument. Optionally, many embodiments show the container in the carrier, but it should be understood that embodiments in which the container is not covered or mounted in the carrier are not excluded. Some embodiments may have a container that is separate from the device and is brought into fluid communication only when the channel reaches a minimum fill level. For example, the containers can be held in different locations and are brought into communication by a technician only when there is a sufficient amount of blood or sample fluid in the sample collection device. At that time, the container can be brought into fluid communication with one or more of the channels of the sample collection device simultaneously or sequentially.

Additionally, concentrations, amounts, and other numerical data are provided herein in a range format. Such range formats are merely used for convenience and shortness, and do not include only the numerical values explicitly listed as the limits of said ranges, but all individual numerical values, or ranges thereof. It is to be understood that the sub-ranges included in each are included as if each numerical value and sub-range were explicitly listed. For example, for example, particle size ranges from about 1 nm to about 200 nm are not only explicitly presented ranges of about 1 nm and about 200 nm, but also individual sizes such as 2 nm, 3 nm, 4 nm, and 10 nm to 50 nm, It should be construed to include sub-ranges such as 20 nm to 100 nm.
Shipping container

  With reference to FIGS. 38A-38B, an exploded perspective view of a non-limiting example of a shipping container 3200 provided in accordance with the embodiments described herein is shown. It should be understood that the shipping container 3200 may be configured to have any other one or more features described in other parts of the shipping container herein. As a non-limiting example, the shipping container 3200 may be useful for transporting one or more sample containers therein. In some embodiments, the shipping container 3200 is thermally limited to minimize undesired thermal decomposition of the sample during transport to another location, such as but not limited to an analytical facility. Provides a controlled internal area. It should be understood that the shipping container may be placed in one or more other containers during shipping.

  In one embodiment, the sample container may be provided from a sample collection device that has collected the bodily fluid sample. As a non-limiting example, the sample container may contain a sample in liquid form therein. In most embodiments, the liquid form may include embodiments that are suspensions.

As a non-limiting example, the shipping container 3200 can have any dimensions. In some cases, the transport container 3200 is about 1 m ³ , 0.5 m ³ , 0.1 m ³ , 0.05 m ³ , 0.01 m ³ , 1000 cm ³ , 500 cm ³ , 300 cm ³ , 200 cm ³ , 150 cm ³ , 100 cm ³ , 70 cm ³ , 50 cm ³ , 30 cm ³ , 20 cm ³ , 15 cm ³ , 10 cm ³ , 7 cm ³ , 5 cm ³ , 3 cm ³ , 2 cm ³ , 1.5 cm ³ , 1 cm ³ , 700 mm ³ , 500 mm ³ , 300 mm ³ , It may have a total volume of 100 mm ³ , 50 mm ³ , 30 mm ³ , 10 mm ³ , 5 mm ³ , or 1 mm ³ or less. The installation area and / or the maximum cross-sectional area of the transport container is about 1 m ² , 0.5 m ² , 0.1 m ² , 0.05 m ² , 100 cm ² , 70 cm ² , 50 cm ² , 30 cm ² , 20 cm ² , 15 cm ² , It can be 10 cm ² , 7 cm ² , 5 cm ² , 3 cm ² , 2 cm ² , 1.5 cm ² , 1 cm ² , 70 mm ² , 50 mm ² , 30 mm ² , 10 mm ² , 5 mm ² , or 1 mm ² or less. In some cases, the transport container is about 1 m, 75 cm, 50 cm, 30 cm, 25 cm, 20 cm, 15 cm, 12 cm, 10 cm, 9 cm, 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3 cm, 2 cm, 1 cm, 0.7 cm. , 0.5 cm, 0.3 cm, or 1 mm or less (eg, height, width, length, diagonal, or circumference). In some cases, the maximum dimensions of the transport container are about 1 m, 75 cm, 50 cm, 30 cm, 25 cm, 20 cm, 15 cm, 12 cm, 10 cm, 9 cm, 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3 cm, 2 cm, 1 cm , 0.7 cm, 0.5 cm, 0.3 cm, or 1 mm.

  Optionally, the shipping container can be lightweight. In some embodiments, the transport container is about 10 kg, 5, kg, 4 kg, 3 kg, 2 kg, 1.5 kg, 1 kg, 0.7 kg, with or without the sample container having a sample therein. 0.5 kg, 0.3 kg, 100 g, 70 g, 70 g, 30 g, 20 g, 15 g, 10 g, 7 g, 5 g, 3 g, 2 g, 1 g, 500 mg, 300 mg, 200 mg, 100 mg, 70 mg, 50 mg, 30 mg, 10 mg, 5 mg, Or the weight is 1 mg or less.

  As seen in FIGS. 38A and 38B, one embodiment of the shipping container includes a top cover 3210, a housing for thermal conditioning equipment 3220, one or more insertion trays 3230a, 3230b, and a bottom plate for the shipping container. 3240.

  In one embodiment, the top cover 3210 has a substantially flat shape, but other shapes are not excluded. The top cover 3210 covers a thermal conditioning device such as, but not limited to, a heater or cooler included in the shipping container. The top cover may or may not have the same footprint as the housing for the thermal adjustment device 3220. A cooler, heater, or other thermal conditioning device 3220 may be provided in the transport container 3200. Optionally, the device 3220 can be an active or passive unit. The thermal conditioning device may keep the sample container in the transport container 3200 at a desired temperature or below a predetermined threshold temperature. Optionally, the thermal conditioning device can be any temperature control unit known in the art. Optionally, the thermal conditioning device may have the ability to heat and / or cool. Optionally, the thermal conditioning device may be a thermoelectric cooler. Optionally, the thermal conditioning device is encased between a top cover and a housing for the cooler.

  Optionally, the top cover and the housing may or may not form an airtight seal. The top cover and / or housing is formed from a material having a desired thermal conductivity. For example, the housing 3220 can have a selectable thermal conductivity. In one embodiment, the temperature may be substantially uniform everywhere because it may include a phase change material (PCM) embedded in the housing box material. PCM maintains a very good temperature profile. It is desirable that the sample is not supercooled by contact with ice or the like that causes a temperature drop to −5 ° C. The PCM can be configured to control to a temperature range above freezing. As a non-limiting example, heat transfer can be in the range of about 100 to 250 W / m / K (Watts / meter / Kelvin). Optionally, each sample container is abutted with the PCM. Some embodiments may have a PCM in each layer. The PCM material may be flow molded into the transport container material. Optionally, there may be a chamber for PCM material. Optionally, the steps in the tray can be filled with PCM. The PCM may provide a passive thermal control technique.

  Optionally, the PCM can be incorporated into an injection molding material. In such embodiments, the entire container can be a cooling medium. This can prevent leakage of PCM from the chamber in the transport container. The shipping container size can also shrink when the PCM is integrated directly into the shipping container material. The energy density is larger because the storage capacity per mass is increased. Mixing PCM material and plastic can be configured to have both strength and cooling. As a non-limiting example, for rigidity, 30% of the material is PCM and the rest is plastic. By way of non-limiting example, 20% to 40% of the material can be PCM, while the rest can be other materials such as, but not limited to, plastic for mechanical rigidity. Some embodiments may use an outer surface that is hollow molded with PCM or other material. The interior is not essential for aesthetic appeal and can be formed by different techniques. Optionally, casting or other bass molding processes can also be used instead of or in conjunction with injection molding of the PCM integrated transport container material. Embedded PCM can also be included in the tray. Some embodiments could be much more thermally conductive trays to achieve a more uniform and uniform cooling profile. Optionally, the PCM material is contained in a chamber inside the shipping container housing, and the wall of the chamber can be thinner than the wall thickness of other regions of the shipping box housing.

  In one embodiment, the transport container 3200 moves each of the trays 3230a and 3230b configured to be easily readable by any information storage unit of the sample container without removing the sample container from the trays 3230a and 3230b. Can have. In one embodiment, the holder has an opening in the bottom that allows the bottom information storage unit to be visualized while the sample container is stationary in the trays 3230a and 3230b.

  FIG. 39 shows a plurality of views of the transport container 3200. In some cases, the sample container holder in the tray 3230a or 3230b is not limited to any information storage unit, such as a bar code or other information storage unit, but the sample container can be removed from below or from the transport container 3200. Indicates having an open bottom so that it can be read from other orientations that do not remove. Optionally, only certain portions of the shipping container 3200, such as but not limited to layers, trays, etc., can be removed to obtain the desired information. Optionally, a barcode or other information storage unit may be accessed through one or more openings in the tray. That allows barcode scanning of very small shipping containers. Optionally, the rows of sample containers can be scanned individually or the entire tray can be scanned simultaneously. Optionally, the user can see all of the sample container holders. Optionally, the computer vision system can also scan to see if a step such as centrifugation has been completed. This can be done at either end of the shipping process. The computer vision system can visualize the sample container and determine whether the sample therein is in a form that has completed a desired step. If it detects an error, the system notifies the user or the system of the problem and / or re-performs steps that have not been taken and / or taken improperly. Optionally, the holder has a closed end, and the information can be on the side or other surface of the shipping container 3200.

  In some embodiments, the shape of the holder can be designed to follow the contour of the sample container 3134 therein to increase surface area contact and improve the sample container thermal control. Optionally, thermal control of the sample container can occur through thermal transfer with the tray and / or the PCM, but not in direct contact with the PCM. Optionally, some sample containers 3134 could also be in direct contact with the container and / or the PCM. The openings for the sample container and / or the holder can be in a linear row, in a honeycomb pattern, or in another pattern.

  40A and 40B, a fully assembled shipping container 3200 is shown. FIG. 40B shows a plurality of sample containers 3134 such as those associated with the sample collection device. All of the sample containers 3134 can be from samples associated with one subject, and an information storage unit associated with the tray 3230 can be used to provide information about this group of samples. . Optionally, each individual sample container may still have an information storage unit that is the same as or different from that of the tray 3230a. Some embodiments may insert sample containers from multiple subjects into the same tray 3230a. Optionally, some can only partially fill each tray. Each opening in the tray can be filled, but not all sample containers have samples in them (ie some are inserted to provide a uniform thermal profile) Can be an empty sample container). These stackable trays 3230a may have closure devices that use elements that connect the trays to each other, such as but not limited to magnets, mechanical latches, or other connection mechanisms. In some embodiments, a magnet can be used to engage the tray holding the sample container to allow easy opening during automated filling and removal. Optionally, the user cannot remove the tray from the shipping container. Optionally, the user cannot remove the tray from the shipping container without using a tool to release the tray. Some embodiments have a locking mechanism (magnetic or other technique). In this way, the patient service center can put the sample in, but not take it out. Optionally, some embodiments may have a selected shaped opening to prevent errors, and may misplace the sample containers and / or their holders. Can not.

  In one embodiment, the filling and / or removal may be performed in a temperature-controlled room or chamber to maintain the sample in the desired temperature range. In one embodiment, it is desirable to have a temperature range of about 1 ° C to 10 ° C. Optionally, it is desirable to have a temperature range of about 2 ° C to 8 ° C. Optionally, it is desirable to have a temperature range of about 4 ° C to 5 ° C. Optionally, the materials of the trays 230a and 230b can be used to provide a thermally controlled atmosphere for the sample containers. In some cases, convection can be used to control the thermal profile inside the shipping container 200.

  FIG. 40B also shows that in this particular embodiment, there may be an O-ring or other sealing groove 3232 that provides a tight connection between the layers of the shipping container. The system may also include a closure mechanism 3234 such as, but not limited to, a magnetic closure device to maintain the stackable insertion tray in the desired position. It should be understood that some embodiments may have a through hole 3236 for wiring a sensor to detect conditions experienced by the stackable insertion tray during shipping.

FIG. 40C shows various perspective views of the embodiment of FIGS. 40A and 40B when various components such as the stackable tray and lid are combined together to form the shipping container 3200. FIG. Indicates. As seen in FIG. 40C, the transport container may be contained in multiple layers of sample containers or trays with sample containers. Optionally, some embodiments may have only a single layer of sample containers. Some embodiments may use active cooling or thermal control in one or more layers of the shipping container 3200. As a non-limiting example, one embodiment may have a thermoelectric cooler on the top layer. Optionally, some embodiments may use a combination of active and passive theoretical control. As a non-limiting example, an embodiment may have a thermal mass such as, but not limited to, a phase change material (PCM) that is already at the desired temperature. An active thermal control unit may be included to keep the PCM in the desired temperature range. Optionally, some embodiments may use only a thermal mass such as but not limited to PCM to maintain the temperature in the desired range.

Transport container with removable tray

  Referring now to FIG. 41, yet another embodiment of the transport container will be described. FIG. 41 shows a transport container 3300 having a thermally controlled interior 3302 containing a tray 3304 that can hold a plurality of sample containers 3306 in any configuration, each of which is a large sample of that sample. The portions are held in a free-flowing, unabsorbed form, and there are about 1 ml or less of sample fluid in each container. Optionally, there are about 2 ml or less of sample fluid in each container. Optionally, there are about 3 ml or less of sample fluid in each container. In one non-limiting example, the containers are arranged such that there are at least two containers in each transport container having sample fluid from the same subject, and in the matrix, at least the first sample is The first anticoagulant and the second sample contain the second anticoagulant.

  FIG. 41 shows that the sample container 3306 is held in an array configuration, but other predetermined configurations are not excluded. Some may be placed in a rocking or other holding mechanism that allows one or two degrees of freedom in motion, connected by the sample container hinge. Some embodiments may place the sample container in an instrument having a first configuration during filling. And then take a second configuration to hold the sample container during transport. Some embodiments have a second property, such as the sample container having a first material property during filling, and then, but not limited to, curing the sample container during transport. It can be placed in the material.

  In some embodiments, the sample container is in a holder 3310 and the tray 3304 is an opening and / or cavity sized to fit into the holder 3310 rather than the sample container. Is defined. As a non-limiting example, the holder 3310 can be used to physically hold an associated container 3306 together while in the tray 3304. Some embodiments have the holder 3310 in direct contact with the tray 3304 so that the container is protected from direct contact with the tray 3304. In one non-limiting example, the tray may hold at least 100 containers, or optionally 50 holders each having at least two containers.

  Still referring to FIG. 41, this embodiment of the shipping container 3300 may have a number of holding mechanisms 3320 for holding the tray 3306, including but not limited to clips, magnetic regions, and the like. The holding mechanism 3320 may be configured to hold the tray 3304 in a releasable manner when desired. Optionally, the holding mechanism 3320 can be configured to hold the tray 3304 in an unreleasable manner. In the embodiment shown in FIG. 41, the retaining mechanism 3320 is shown as a magnetic and / or metal member in the tray 3304 that is attracted to a metal and / or magnetic member in the transport container 3300. ing. When the shipping container 3300 arrives at a processing facility, the tray 3304 can be configured to be removed from the shipping container 3300. This can be done through the use of one or more techniques such as, but not limited to, a strong magnet that engages magnetic and / or metallic members in the tray 3304. Some embodiments may use grips, hooks, or other mechanical mechanisms to remove the tray 3304 from the shipping container 3300. Some embodiments may use a combination of techniques to remove the tray 3304. Some embodiments choose to remove the container 3306 and / or the holder 3310 while the tray 3304 is in the transport container 3300. Some techniques may perform more than one of the aforementioned techniques.

  It should also be understood that the shipping container 3300 itself can be a cooling device including, but not limited to, a thermal control material such as ice, PCM. Other embodiments may integrate a thermal control material directly into the material forming the transport container 3300. As can be seen in FIG. 41, some embodiments of the shipping container 3300 include a substantially empty container in which one or more of the thermal control materials are housed or integrated. Space 3324.

  Still referring to FIG. 41, the transport container 3300 may be connected to the cover and / or cover, or other for ease of illustration, for attachment of a cover to other layers of the transport container 3300. The layers are not shown in FIG. It should be understood that some embodiments use only a single layer, but multiple layer embodiments are not excluded.

  With reference to FIG. 42, an exploded perspective view of yet another embodiment of the shipping container 3400 is described. The embodiment of FIG. 42 is designed to hold a tray 3402 within the shipping container interior 3404. The exploded perspective view shows a plurality of containers 3406 in a holder 3410 in a tray 3402. The tray 3402 may be configured to have some or all of the retention mechanisms 3420 in the tray 3402 similar to the retention mechanism 3320. It will be appreciated that the tray 3402 may have one or more notches, protrusions, or features to allow the tray 3402 to be inserted into a limited number of predetermined orientations. I want. Some embodiments may be configured to allow only one orientation of the tray in the container. Some embodiments may be configured to allow only two possible orientations of the tray within the container.

  FIG. 42 illustrates that in one embodiment, the shipping container 3400 can be formed from two separate pieces 3430 and 3432. Optionally, some embodiments may be formed from more than two pieces. Optionally, some embodiments may be a single piece. The pieces 3430 and 3432 can have openings that are filled with plugs 3434 and 3436. The interior 3438 of the shipping container 3400 may hold a thermal control material such as, but not limited to ice, phase change material. Other embodiments may integrate the thermal control material directly into the material used for the shipping container 3400.

  In one example, the interior 3433 of the piece 3432 can be filled with a thermal control material such as but not limited to PCM. Optionally, one embodiment could use an active thermal control material such as but not limited to a thermoelectric cooler to cool the interior.

  Referring to FIG. 43, still another embodiment of the transport container 3500 will be described. FIG. 43 shows that the shipping container 3500 can include a lid 3502 to cover the features therein and / or the sample container. In some embodiments, the lid 3502 can include a thermally insulating material. Optionally, the lid 3502 may include a thermal control unit that assists in maintaining the interior of the shipping container 3500 at a desired temperature range. Optionally, some embodiments may be a thermally conductive material useful to keep the interior of the shipping container 3500 within a desired temperature range via heat transfer from an external thermal control source. Can be configured. As a non-limiting example, the thermal control source can be a cooling source, a heating source, a thermoelectric heat exchanger, or other thermal control device. It should also be understood that a similar thermal control source, such as but not limited to PCM, or active cooling equipment can be included in the empty space 3514 below the layer 3516.

The features 3512 of the holders 3310, 3410 to hold, or other shaped holders for the container can be in a piece separated from the shipping container, or they can be inside the shipping container It should be understood that they can be integrally formed. Optionally, the feature 3512 can be part of such trays of trays 3302 and 3402, as shown in FIGS. Such a tray may be fixed to the transport container 3500 or may be removable. A retaining mechanism 3520 can also be integrated into the tray to allow it to be held in place during transport.

Sample collection and transportation

  In embodiments, provided herein are systems and methods for collecting or transporting small volumes of bodily fluid samples.

  In an embodiment, a sample container containing a small volume of bodily fluid sample may be transported. The sample and sample container may have any respective characteristics described elsewhere herein. In embodiments, the sample container is 5 ml, 3 ml, 4 ml, 2 ml, 1.5 ml, 1 ml, 750 μl, 500 μl, 400 μl, 300 μl, 200 μl, 150 μl, 100 μl, 75 μl, 50 μl, 40 μl, 30 μl, 20 μl, 10 μl, or 5 μl. The following body fluid samples may be included. In embodiments, the sample container is 5 ml, 3 ml, 4 ml, 2 ml, 1.5 ml, 1 ml, 750 μl, 500 μl, 400 μl, 300 μl, 200 μl, 150 μl, 100 μl, 75 μl, 50 μl, 40 μl, 30 μl, 20 μl, 10 μl, or 5 μl. It may have the following internal volume: In embodiments, the sample container is 5 ml, 4 ml, 3 ml, 2 ml, 1.5 ml, 1 ml, 750 μl, 500 μl, 400 μl, 300 μl, 200 μl, 150 μl, 100 μl, 75 μl, 50 μl, 40 μl, 30 μl, 20 μl, 10 μl, or 5 μl. And having at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95%, 98%, 99%, or 100% A body fluid sample that may fill the internal volume of the container may be included. In embodiments, the sample container can be sealed, for example, with a cap, lid, or membrane. Any of the container internal dimensions or sample dimensions described herein may be applied to the sealed sample container internal dimensions, or sample dimensions therein, respectively. In embodiments, the sealed sample containers are 5 ml, 4 ml, 3 ml, 2 ml, 1.5 ml, 1 ml, 750 μl, 500 μl, 400 μl, 300 μl, 200 μl, 150 μl, 100 μl, 75 μl, 50 μl, 40 μl, 30 μl, 20 μl, 10 μl Or an internal volume of 5 μl or less, and it is 2 ml, 1.5 ml, 1 ml, 750 μl, 500 μl, 400 μl, 300 μl, 200 μl, 150 μl, 100 μl, 75 μl, 50 μl, 40 μl, 30 μl, 20 μl, 10 μl, 5 μl, At least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90, so that 4 μl, 3 μl, 2 μl, or 1 μl of air is present inside the sealed container. %, 95%, 98%, 99%, or 100% internal content of the container You can have a body fluid sample that fills the product. Thus, for example, a sealed sample container can have an internal volume of 300 μl or less, and it is at least as small as 30 μl of air in the internal volume of the sealed container so that air is present in the internal volume of the sealed container. A body fluid sample that fills 90% may be included. In another example, the sealed sample container can have an internal volume of 500 μl or less, and it is said that the internal volume of the container is such that 100 μl of air is present in the internal volume of the sealed container. A body fluid sample satisfying at least 80% of In another embodiment, the sealed sample container can have an internal volume of 150 μl or less, and it is said that the internal volume of the container is such that 3 μl of air is present in the internal volume of the sealed container. A body fluid sample satisfying at least 98% of

  In embodiments, the sample container containing the sample may also contain an anticoagulant. The anticoagulant can be dissolved in the sample or otherwise present in the container (eg, dried on one or more internal surfaces of the container or the bottom of the container Present in solid form). The sample container containing the sample can have a “total anticoagulant content”, wherein the total anticoagulant content is the total amount of anticoagulant present in the internal volume of the container. And an anticoagulant (if present) dissolved in the sample at the same time as an anticoagulant (if present) in the container that is not dissolved in the sample. In an embodiment, the sample container containing the sample has a total anticoagulant content of less than 1 ml of sample and less than 3 mg EDTA total anticoagulant content, less than 750 μl sample and less than 2.3 mg EDTA. A total anticoagulant content of less than 500 μl sample and less than 1.5 mg EDTA and less than 400 μl sample and less than 1.2 mg EDTA The total anticoagulant content of less than 300 μl of sample and less than 0.9 mg EDTA, and less than 200 μl of sample and less than 0.6 mg of EDTA total anticoagulant content Can have a total anticoagulant content of less than 150 μl of sample and EDTA of less than 0.4 mg, Can have a total anticoagulant content of less than 0 μl sample and less than 0.3 mg EDTA, can have a total anticoagulant content of less than 75 μl sample and less than 0.23 mg EDTA, Can have a total anticoagulant content of less than 50 μl sample and less than 0.15 mg EDTA, have a total anticoagulant content of less than 40 μl sample and less than 0.12 mg EDTA, Can have a total anticoagulant content of less than 30 μl and EDTA less than 0.09 mg, can have a total anticoagulant content of less than 20 μl and EDTA less than 0.06 mg; Can have a total anticoagulant content of less than 10 μl sample and less than 0.03 mg EDTA, or less than 5 μl sample All anticoagulant content of EDTA less than 0.015mg and may have. In an embodiment, the sample container containing the sample can contain less than 1 ml of sample and have a total anticoagulant content of less than 2 mg EDTA, contain less than 750 μl of sample and less than 1.5 mg EDTA. Can have a total anticoagulant content, contain less than 500 μl of sample and have a total anticoagulant content of EDTA of less than 1.0 mg, contain less than 400 μl of sample and 0.8 mg Can have a total anticoagulant content of less than EDTA, can contain less than 300 μl of sample, and can have a total anticoagulant content of less than 0.6 mg EDTA, including less than 200 μl of sample And a total anticoagulant content of EDTA of less than 0.4 mg, including less than 150 μl of sample and 0.3 mg Can have a total EDTA anticoagulant content of less than 100 μl and can have a total anticoagulant content of less than 0.2 mg EDTA and includes less than 75 μl of sample And can have a total anticoagulant content of EDTA of less than 0.15 mg, can contain less than 50 μl of sample and can have a total anticoagulant content of EDTA of less than 0.1 mg, less than 40 μl And may have a total anticoagulant content of EDTA of less than 0.08 mg, a sample of less than 30 μl and a total anticoagulant content of EDTA of less than 0.06 mg Can contain less than 20 μl of sample and have a total anticoagulant content of less than 0.04 mg EDTA, contain less than 10 μl of sample and It can have a total anticoagulant content of EDTA less than 0.02 mg, or it can have a total anticoagulant content of less than 5 μl of sample and EDTA less than 0.01 mg. In embodiments, the sample container containing the sample can have a total anticoagulant content of heparin of less than 1 ml of sample and less than 30 United States Pharmacopeia (USP) units, less than 750 μl of sample and less than 23 USP units. Can have a total anticoagulant content of heparin, can have a sample less than 500 μl and a total anticoagulant content of heparin of less than 15 USP units, and can have a total anticoagulant content of less than 400 μl and heparin of less than 12 USP units Can have a total anticoagulant content, can have a sample less than 300 μl and a total anticoagulant content of heparin of less than 9 USP units, and can have a total anticoagulant content of less than 200 μl and less than 6 USP units of heparin Can have a clot content, less than 150 μl sample and 4.5 USP single Can have a total anticoagulant content of heparin of less than 100 μl and a total anticoagulant content of heparin of less than 3 USP units, a sample of less than 750 μl and 2.3 USP units Can have a total anticoagulant content of less than 50 μl, and can have a total anticoagulant content of less than 50 μl and less than 1.5 USP units of heparin, less than 40 μl and Can have a total anticoagulant content of heparin of less than 2 USP units, can have a sample of less than 30 μl and a total anticoagulant content of heparin of less than 0.9 USP units, and can have a sample of less than 20 μl and Can have a total anticoagulant content of heparin of less than 0.6 USP units, less than 10 μl of sample and 0.3 USP single It can have a total anticoagulant content of heparin less than about 5, or it can have a total anticoagulant content of heparin of less than 5 μl of sample and less than 0.15 USP units. In an embodiment, the sample container containing the sample contains less than 1 ml of sample and can have a total anticoagulant content of 15 USP units of heparin, contains less than 750 μl of sample, and 11 USP units of heparin. Can have a total anticoagulant content, includes less than 500 μl of sample, and can have a total anticoagulant content of heparin of 7.5 USP units, includes a sample of less than 400 μl, and 6 USP Can have a total anticoagulant content of units of heparin, contains less than 300 μl of sample, and can have a total anticoagulant content of 4,5 USP units of heparin, and samples less than 200 μl And can have a total anticoagulant content of 3 USP units of heparin, including less than 150 μl of sample And can have a total anticoagulant content of heparin of 2,3 USP units, contain less than 100 μl of sample, and have a total anticoagulant content of heparin of 1.5 USP units, 75 μl Less than and can have a total anticoagulant content of heparin of 1.2 USP units, a sample of less than 50 μl, and a total anticoagulant content of heparin of 0.75 USP units Can have a total anticoagulant content of heparin of 0.6 USP units and can contain less than 40 μl of heparin and can contain less than 30 μl of heparin and 0.45 USP units of heparin Have a clot content, contain less than 20 μl of sample, and have a total anticoagulant content of heparin of 0.3 USP units Can contain less than 10 μl of sample and have a total anticoagulant content of heparin of 0.15 USP units, or contain less than 5 μl of sample and 0.08 USP units of heparin total anticoagulant Can have blood content.

  In an embodiment, a sample container containing two or more samples from a single subject can be obtained or transported. When two or more sample containers containing a sample from a single subject are obtained or transported, the two or more sample containers contain or do not contain samples from other subjects In can be stored or transported. In embodiments, at least 2, 3, 4, 5, 6, 7, 8, 9, or 10 sample containers containing samples from a single subject can be obtained or transported. In embodiments, fewer than 2, 3, 4, 5, 6, 7, 8, 9, or 10 sample containers containing samples from a single subject can be obtained or transported. In embodiments, at least 2, 3, 4, 5, 6, 7, 8, or 9 sample containers and 3, 4, 5, 6, 7, 8, 9, or 10 containing samples from a single subject. Less than one sample container can be obtained or transported. In embodiments comprising two or more sample containers, including samples from a single subject, the samples in each sample container may be obtained from the subject at the same time or at different times. In some embodiments including two or more sample containers, including samples from the same subject, the samples in each sample container may be from the same location or source site as the subject. . For example, two sample containers containing whole blood from the same subject can be obtained, and both sample containers contain whole blood from the same fingertip puncture. In other embodiments including two or more sample containers, including samples from the same subject, the samples in each sample container may be from a different location / source site than the subject. For example, two sample containers containing whole blood from the same subject can be obtained, the sample containers containing whole blood from a first fingertip puncture site (eg, above the first finger), and The second sample container contains whole blood from a second fingertip puncture site (eg, above the second finger). In embodiments that include two or more sample containers, including samples from the same subject, the two or more sample containers may include different types of anticoagulants or other blood additives. For example, the first sample container can contain whole blood containing EDTA, and the second sample container can contain whole blood containing heparin, the plurality of samples being from the same subject. is there. In another example, the first and second sample containers EDTA can contain whole blood, and the third sample container can contain whole blood containing heparin, the plurality of samples being It can be from the same subject. In another example, the first sample container can contain whole blood containing EDTA, the second sample container can contain whole blood containing heparin, and the third sample container can contain sodium citrate. Whole blood can be included, and the plurality of samples can be from the same subject. In embodiments that include two or more sample containers, including samples from the same subject, the two or more sample containers may include different types of samples from the subject. For example, a first sample container can contain whole blood and a second sample container can contain plasma from the same subject. In another example, the first sample container can contain whole blood and the second sample container can contain urine from the same subject. In another example, the first and second sample containers can contain whole blood, and the third sample container can contain saliva from the same subject.

  In the systems and methods provided herein, a total volume of bodily fluid sample can be obtained from a subject. The total volume of the bodily fluid sample is moved into a single sample container or moved into two or more sample containers. For example, a total volume of 500 microliters of bodily fluid sample can be obtained from a subject, and it can be transferred into a single sample container, said single sample container having a maximum of 600 microliters Has an internal volume. In another example, a total volume of 500 microliters of bodily fluid sample can be obtained from the subject and it can be transferred into two sample containers, each sample container containing 300 microliters Has maximum internal volume. In another example, a total volume of 500 microliters of bodily fluid sample can be obtained from the subject, and it can be transferred into two sample containers, one sample container containing 400 microliters Having an internal volume, one sample container has a maximum internal volume of 100 microliters. In the systems and methods provided herein, 5 mL, 4 mL, 3 mL, 2 mL, 1.5 mL, 1 mL, 750 μL, 500 μL, 400 μL, 300 μL, 200 μL, 150 μL, 100 μL, 75 μL, 50 μL, 40 μL, 30 μL, 20 μL, A total volume of bodily fluid sample of 10 μL, 5 μL, or 1 μL or less can be obtained from the subject. The total volume of bodily fluid sample from the subject is 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more sample containers, as described elsewhere herein. Can be divided between. When the total volume of the body fluid sample from the subject is divided into two or more sample containers, the portion of the total volume of the body fluid sample in several different or all sample containers may be different anticoagulant. Agents or other additives can be included. For example, a total volume of 500 microliters of bodily fluid sample can be obtained from a subject and it can be transferred into two sample containers, where one sample container contains 250 of said bodily fluid sample containing EDTA. One sample container contains 250 microliters of said bodily fluid sample containing heparin. Typically, as used herein, the total volume of a bodily fluid sample refers to a single type of bodily fluid sample-such as whole blood or urine or saliva.

  In an embodiment, the sample container containing whole blood is centrifuged before being stored or shipped so that the whole blood is separated into plasma and pelleted cells in the sample container before being shipped. To be separated. In other embodiments, the sample container containing whole blood is not centrifuged before being stored or shipped.

  In some embodiments of the systems and methods provided herein, the bodily fluid sample is dried after being collected and before shipping. In embodiments, the dried sample can be reconstituted into a liquid form at a later time, such as during analysis or processing of the sample.

  In some embodiments of the systems and methods provided herein, the sample container can be transported from a first location to a second location. The first location can be the location where the sample is collected from the subject, and the second location can be the location where one or more steps are performed to process or analyze the sample. The sample and sample container may have any of the respective characteristics described elsewhere herein. For example, the sample may be in a liquid, unmatrixed, in a form that is not absorbed by the capillary. The sample container may be transported in a transport container as described herein or in other structures. For example, in some optional embodiments, the sample container may be transported in a bag, sachet, envelope, box, capsule, or other structure. In an embodiment, the first location and the second location may be in the same room, building, campus, or collection of buildings. In embodiments, the first location and the second location are at least at least 1 meter, 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 kilometer, 5 kilometers, 10 kilometers, 15 kilometers, 20 kilometers, It can be 30 kilometers, 50 kilometers, 100 kilometers, or 500 kilometers away. In embodiments, the first location and the second location are 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 kilometer, 5 kilometers, 10 kilometers, 15 kilometers, 20 kilometers, 30 kilometers, 50 kilometers. , 100 kilometers, 500 kilometers, or 1000 kilometers away. In embodiments, the first location and the second location are at least at least 1 meter, 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 kilometer, 5 kilometers, 10 kilometers, 15 kilometers, 20 kilometers, 30 kilometers, 50 kilometers, 100 kilometers, or 500 kilometers, and 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 kilometer, 5 kilometers, 10 kilometers, 15 kilometers, 20 kilometers, 30 kilometers, 50 kilometers, It can be less than 100 kilometers, 500 kilometers, or 1000 kilometers away. In embodiments where the first location is where the sample is taken from the subject, the sample container is 48 hours, 36 hours, 24 hours of the sample collection from the subject from the first location to the second location. It can be transported within hours, 12 hours, 8 hours, 6 hours, 4 hours, 3 hours, 2 hours, 1 hour, 45 minutes, 30 minutes, 15 minutes, 10 minutes, 5 minutes, 1 minute, or 30 seconds.

  As used herein, a “sample receiving site” is a place where a transported sample can be received, and one or more steps are performed on the sample. For example, a sample arriving at a sample receiving site can be processed, analyzed, or handled at the sample receiving site, for example, as part of a test or test of the sample. The sample can be transported, for example, in any container or instrument described herein. In an embodiment, the sample receiving site may include one or more sample processing equipment used to process or analyze the sample. Sample processing equipment is described, for example, in US patent application Ser. No. 13 / 244,947 or any other document filed on September 26, 2011, cited and incorporated elsewhere herein. It can be like that. During the transport of the sample from the sample collection site to the sample receiving site, the sample can pass anywhere. In an embodiment, the first location may be a sample collection site and the second location may be a sample receiving site.

  With reference to FIG. 44, one embodiment of body fluid sample collection and transport will be described. FIG. 44 shows a body fluid sample B on the skin surface of the subject. In the non-limiting example of FIG. 44, the bodily fluid sample B can be collected by one of various devices. By way of non-limiting example, the collection device 3530 is not limited to, but is incorporated by reference, US Provisional Patent Application No. 61 / filed on September 6, 2012, which is incorporated herein in its entirety for all purposes. 697,797. In this embodiment, the body fluid sample B is collected by one or more capillary channels and then directed into the sample container 3540. As a non-limiting example, at least one of the sample containers 3540 can have an interior that is initially under a partial vacuum that is used to withdraw a bodily fluid sample into the sample container 3540. Some embodiments may simultaneously draw samples from the sample collection device into the sample container 3540 and from the same or different collection channels in the sample collection device. Optionally, some embodiments may draw a sample into the sample container at the same time.

  In this embodiment, after the bodily fluid sample enters the sample container 3540, the sample containers 3540 in the holders 3542 (or optionally removed from the holders 3542) are transferred to the transport container. The container 3500 is filled. In this embodiment, there may be one or more slots sized for the sample container holder 3542 or a slot for the sample container in the transport container 3500. As a non-limiting example, they may hold the sample containers in a vertically oriented array configuration or in some other predetermined orientation. It should be understood that some embodiments of the sample containers 3540 are configured to hold different amounts of sample in each of the containers. As a non-limiting example, this may be controlled based on the amount of vacuum force in the sample container, the amount of sample collected in the sample collection channel of the collection device, and / or other factors. it can. Optionally, different pretreatments such as but not limited to different anticoagulants may be present in the sample container.

  As seen in FIG. 44, the sample container 3540 collects samples at a first location, such as but not limited to a sample collection site. As a non-limiting example, the bodily fluid sample is then transported in the transport container 3500 to a second location, such as but not limited to a receiving site, such as but not limited to a receiving site. The method of transport may be a courier, mail, or other shipping technique. In many embodiments, the transport may be performed by having a further container holding the transport container therein. In one embodiment, the sample collection site may be point of care. Optionally, the sample collection site is a point of service. Optionally, the sample collection site is remote from the sample analysis site.

  This embodiment of FIG. 44 illustrates the collection of a body fluid sample from the surface of the subject, but other alternative embodiments include the subject, such as by venipuncture, to fill the sample container 3540. Collection techniques may be used to collect samples from other regions. Such other collection techniques are not excluded for use in place of or in conjunction with surface collection. Surface collection can be performed on the external surface of the subject. Optionally, some embodiments may collect from an accessible surface within the subject. The presence of bodily fluid sample B on these surfaces occurs either naturally or through the creation of a wound, or by other techniques to make the bodily fluid surface accessible.

  With reference to FIG. 45, yet another embodiment described herein for collecting samples pooled on the subject's surface, whereas bodily fluid samples may be collected from within the subject, will be described. . This embodiment of FIG. 31 shows a collection device 3550 with a hypodermic needle 3552 configured to collect a body fluid sample, such as but not limited to venous blood. In one embodiment, the body fluid sample fills the chamber 3554 in the device 3550 when the sample containers 3540 can be engaged to withdraw the samples into the respective containers. Optionally, some embodiments do not have a chamber 3554, but instead a very small empty space, path, other than a channel, used to direct a sample from the needle 3552 to the sample container 3540. Or have a tube. For body fluid samples such as blood, the pressure in the blood container is such that the blood sample can fill the chamber 3554 without much assistance if there is any assistance from the collection device. Is. Such embodiments may optionally have one or more vents, such as, but not limited to, ports that allow air to escape when a channel in the collection device is filled with sample. .

  At least some or all of the above embodiments can have a filling indicator, such as, but not limited to, a viewing window or opening, shown when there is a sample inside the collection device, and therefore Indicates that it is acceptable to engage the sample container. Optionally, embodiments without a filling indicator are not excluded. Some of the filled sample containers can be removed from the sample collection device after reaching the desired fill level. Optionally, an additional sample container 3540 can be engaged with the sample collection device 3550 (or 530) to collect additional volumes of bodily fluid samples.

FIG. 46 shows a further embodiment of the sample collection device 3570. This embodiment described herein has a tissue penetrating portion 3572 such as, but not limited to, a hypodermic needle with a handling portion 3574. The handling portion 3574 may facilitate the tissue penetrating portion 3572 to more accurately enter the prior patient at the desired addition and location. In this embodiment, the sample collection container 3540 is in a carrier 3576 that is not in direct physical contact with the tissue penetrating portion 3572. A fluid connection path 3578, such as but not limited to a flexible tube, can be used to connect the tissue penetrating portion 3572 with the sample collection container 3540. Some embodiments can be configured to slide the sample container 3540 so that it is in fluid communication only with the tissue penetrating portion 3572 under user control. At least some or all of the above embodiments can have a filling indicator, such as, but not limited to, a viewing window or opening, shown when there is a sample inside the collection device, and therefore It is acceptable to engage the sample container 3540. Optionally, embodiments without a filling indicator are not excluded. Some embodiments optionally include one or more vents, such as but not limited to ports, to allow air to escape when the channel in the collection device is filled with sample. Can have. In most embodiments, the filled sample container 3540 is separated from the sample collection device after reaching a desired fill level. Optionally, an additional sample container 3540 can be engaged with the sample collection device 3570 to collect additional volumes of bodily fluid samples. Optionally, the internal condition of the sample container is one having a vacuum that is configured for the container to draw only a predetermined amount of sample fluid.
Sample processing

  Referring to FIG. 47, a system diagram of the shipping container 3500 with its contents removed by the removal assembly 3600 after arrival at the destination is shown. In one embodiment, after the lid 3502 is positioned in the open position, the sample container in the container 3500 can be removed therefrom. By way of non-limiting example, the removal can occur by removing the entire tray of sample containers, removing the holder of multiple sample containers from the tray, and / or removing the sample containers individually. Some embodiments include a robot for removing a sample container from the transport container 3500 that can move vertically as indicated by arrow 3604 and / or horizontally along gantry 3608 as indicated by arrow 3606. Controlled structure 3602 may be used. A programmable process 3610 may be used to control the position of the structure 3602 that is used to manipulate the sample container. In one embodiment, the structure 3602 includes a magnet for engaging the retention mechanism to remove the tray from the structure 3602. Other embodiments using robotic arms and / or other types of programmable operations can be configured for use herein and are not excluded.

  In an embodiment, the sample may be removed from the sample container when the sample container containing the sample arrives at a location for processing or analysis of the sample. Before the sample is removed from the sample container, the sample container can be processed (eg, shaken, rotated, mixed, or centrifuged). The sample can be aspirated (eg, by a fluid handling system or pipette), poured, or mechanical force (eg, forcing the sample from the container by reducing the size of the interior region of the sample container) Can be removed from the sample container by any suitable mechanism. In an embodiment, when the sample is removed from the sample container, only a sparse sample or no sample remains in the container (eg, as a mechanical / moving loss). For example, after removing a sample from the container, 50 μl, 40 μl, 30 μl, 20 μl, 15 μl, 10 μl, 5 μl, 4 μl, 3 μl, 2 μl, 1 μl or less, or 0 μl of sample may remain in the sample container.

  As a non-limiting example, the sample in the sample container is then U.S. Patent Application 13/30, filed September 26, 2011, which is incorporated herein by reference in its entirety for all purposes. It can be processed using a system such as that described in US Pat. The analysis system is a CLIA as described in US patent application Ser. No. 13 / 244,947, filed Sep. 26, 2011, which is hereby incorporated by reference in its entirety for all purposes. It can be configured in a compliant manner. In an embodiment, a sample transported by the system or method provided herein arrives at a location for processing or analysis and is divided into two or more smaller portions, and various assays for the sample. Can be accomplished. For example, in embodiments, at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, 30, 40, or 50 assays are provided by the system or method provided herein. It can be performed on the transported sample. The assay may include the use of different types of assays (eg, protein, nucleic acid, or cell assays) and one or more detection methods (eg, based on cytometry, luminescence, or spectrometer). In an embodiment, two or more sample containers containing a sample from a single subject can be transported, wherein the two or more sample containers are at least two different anticoagulants mixed with the sample. (For example, one sample container contains EDTA-sample and one sample container contains heparin-sample). The sample from the EDTA-sample container is then used for one or more assays that are heparin sensitive or EDTA insensitive. Similarly, the sample from the heparin-sample container is then used for one or more assays that are EDTA sensitive or heparin insensitive. In embodiments, a sample transported by the systems and methods provided herein can be divided into two or more smaller portions upon arrival at the destination, and 1, 2, 3, 4 Analyzed by 5, 6, 7, 8, 9, 10 or more different sample analyzers.

  49-51, at least any two of the tests in the list (FIGS. 49-51) can be performed using samples prepared or transported from a subject by the system or method provided herein. It should be understood that this can be accomplished. For example, at least two tests on the list can be performed using a bodily fluid sample from a subject, and the total volume of the bodily fluid sample used to perform the test is less than 300 microliters. And the total body fluid sample volume from the subject is transported in liquid form in a sample container having an internal volume of 400 microliters or less. In another embodiment, at least two tests on the list can be performed using a bodily fluid sample from a subject, and the total volume of the bodily fluid sample used to perform the test is 300 The total volume of the bodily fluid sample from the subject is transported in liquid form in the first sample container and the second sample container, each container having an interior of 200 microliters or less The first sample container includes a body fluid sample mixed with a first anticoagulant, and the second sample container includes a body fluid sample mixed with a second anticoagulant. including. In embodiments, the list of at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 50, or 60 (FIGS. 49-51) are 5 mL, 4 mL, 3 mL, 2 mL, 1.5 mL, 1 mL, 750 μL, 500 μL, 400 μL, 300 μL, 200 μL, 150 μL, 100 μL, 75 μL, 50 μL, 40 μL, 30 μL, 20 μL, 10 μL, It can be performed using a body fluid sample from a subject with a total volume of less than 5 μL or 1 μL. The total volume of the bodily fluid sample can be stored and transported in a single sample container from the collection site to the analysis or processing location, or it can be 2, 3, 4, 5, 6, 7, 8, 9 Can be divided into 10, 11, 12, 13, 14, 15, 20, 25, or more sample containers. When the total volume of the bodily fluid sample from a single subject is divided into two or more sample containers, some of the sample containers, or sample portions within each, may have different anticoagulants or other Additives can be included. In one embodiment, a total volume of less than 300 microliters of a body fluid sample from a subject can be used to perform two or more of the tests, and at least one portion of the less than 300 microliter sample Is mixed with a first anticoagulant and a second portion of the sample of less than 300 microliters is mixed with a second anticoagulant different from the first. Optionally, each portion of the less than 300 microliter sample can be in its own sample container. Optionally, more than one of the tests can be performed and all of the less than 300 microliter samples are transported in a single container and contain a single anticoagulant. Optionally, at least any three tests in the list can be performed with a total volume of less than 300 microliters of blood from the subject for all tests. Optionally, at least any five tests in the list can be performed using a total volume of less than 300 microliters of blood from the subject for all tests. Optionally, at least any seven tests in the list can be performed with a total volume of less than 300 microliters of blood from the subject for all tests. Optionally, at least any 10 tests in the list can be performed using a total volume of less than 300 microliters of blood from the subject for all tests. Optionally, at least any 15 tests in the list can be performed using a total volume of less than 300 microliters of blood from the subject for all tests. Optionally, at least any 20 tests in the list can be performed using a total volume of less than 300 microliters of blood from the subject for all tests. As for any of the above, in at least some embodiments, at least one portion comprises a first anticoagulant and the second portion is different from the first. Contains two anticoagulants.

Referring to FIG. 52, yet another embodiment for body fluid sample collection is shown. FIG. 52 shows the body fluid sample B on the subject being collected by the collection device 3710. As seen in FIG. 52, the collection device 3710 may include a collection portion 3712, such as but not limited to a capillary tube or other collection structure. The collection portion 3712 draws fluid therein and ultimately directs it toward the internal cavity 3714 of the instrument 3710. After the collection portion 3712 has collected the desired amount, the entire instrument 3710 can be oriented as shown in FIG. 52 so that gravity can then pull the sample into the cavity 3714. After all of the sample B has been transferred to the cavity 3714, the collection portion 3712 can be removed from the instrument 3710. In one embodiment, the cap and the collection portion 3712 are removed and replaced with a closed cap 3718. In one non-limiting example, the cap 3718 may be free of any openings on it. Optionally, some can have a septum or other closable opening in the cap, and the collection portion 3712 can be removed without having to replace the cap with a new one of a different shape.

Modular sample collection device

  53A-53C, the embodiments herein are typically described as having a sample collection device having an adapter portion 3750 to connect the sample collection portion 3740 to the sample storage container 3760. However, it should be understood that embodiments without such a configuration are not excluded.

  As a non-limiting example in FIG. 53A, one or more adapter portions 3750 are discrete elements that are not initially in direct fluid communication with either the collection portion 3740 or the sample storage container 3760. As used herein, the collection portion 3740 includes a collection portion, the adapter portion 3750 in the vessel 3760 to create a fluid path from the collection channel through the one or more adapter channels into the vessel. Or by means of relative movement between one or more of said containers 3760 (sequentially or simultaneously).

  As a non-limiting example in FIG. 53B, some embodiments do not have a separate, isolated adapter portion 3750, as previously suggested in some embodiments herein. As used herein, the collection portion 3740 may be directly connected to the container 3760 by means of relative movement between one or both of those elements, as indicated by the arrow 3770. As can be seen in FIG. 53B, there can be a fluid flow feature 3780 with relative relative movement between one or both of those elements as indicated by arrow 3782. In one non-limiting example, the fluid flow feature 3780 can be a cap that engages one end of the collection portion 3740 to facilitate fluid flow into the container 3760. Optionally, the fluid flow feature 3780 can be a cap having a front surface shaped to engage the collection portion 3740. Optionally, the fluid flow feature 3780 can be an aspirator, bar, and / or other device that facilitates flow toward the sample storage container 3760. Optionally, the fluid flow feature 3780 does not fully engage until the sample collection portion 3740 is ready to engage the container 3760. Optionally, some embodiments may be configured such that the flow from the collection portion 3740 to the sample storage container 3760 is performed without using the fluid flow feature 3780, but instead is limited. Not based on a different motive force such as vacuum, vacuum suction, or blowing force supplied from the appropriate end of the collection portion 3740.

  As a non-limiting example of FIG. 53C, one or more embodiments may use the collection portion 3740 as a storage container. Some embodiments can simply be capped at both ends with caps 3790 and 3792 once the desired fill level is achieved. As seen in FIG. 53C, the caps 3790 and 3792 can retain fluid therein even when the portion 3740 is in a vertical orientation.

  There may be variations and alternatives to the embodiments described herein, and any single embodiment should not be construed as encompassing the entire invention. For example, there may be more than one capillary tube within the collection portion 3740. Optionally, they can each be formed as a separate tube or channel. Optionally, some may have a common initial portion, but have separate outlet ports such as but not limited to a Y-shape. It should be understood that any embodiment herein may be modified to include the features listed in the description above for FIGS. 53A-53C.

  Referring to FIG. 54, after the sample container 3800 has arrived at the desired processing destination, the sample in the container 3800 can be appropriately prepared. In one embodiment, the container 3800 is similar to that of the container 3710. As seen in FIG. 54, the sample may be processed to aliquot into processing equipment such as, but not limited to, the inlet of cartridge 3802 and another inlet of another cartridge 3804. Can do. In one embodiment, both of the cartridges 3802 provide samples, including but not limited to Comprehensive Metabolic Panel (ALB, ALP, ALT, AST, BUN, Ca, Cl-, CRE, GLU, K + , Na +, TBIL, tCO2, TP), Basic Metabolic Panel (BUN, Ca, CRE, eGFR, GLU, Cl-, K +, Na +, tCO2) Lipid panel (CHOL, HDL, CHOL / HDL, LDL, TRIG, VLDL, nHDLc); Lipid Panel Plus (tCHOL, HDL, CHO / HDL ratio, LDL, TRIG, VLDL, GLU, ALT, AST, nHDLc); liver panel plastic (ALB, ALP, ALT, AST, AMY, TBIL, TP, GGT); electrolyte panel (Cl-, K +, Na +, tCO2); general chemistry (ALB, ALP, ALT, AMY, AST, BUN, Ca, CRE, eGFR, GGT, GLU, TBIL, TP, UA); general chemistry 6 (ALT, AST, CRE, eGFR, GLU, BUN, GGT); kidney function panel (ALB, BUN, Ca, CRE, eGFR, GLU, Cl-) , K +, Na +, tCO2PHOS); Metlyte (Cl−, K +, Na +, tCO2, BUN, CK, CRE, eGFR, GLU); kidney function (BUN, CRE, eGFR; liver function panel (ALB, ALP, ALT, AST, DBIL, TBIL, TP); basal metabolism (BUN, Ca, CRE, eGF) , GLU, Cl-, K +, Na +, tCO2, Mg, LDH); MetLyte Plus CRP (Cl-, K +, Na +, tCO2, BUN, CK, CRE, eGFR, GLU, CRP); BioChemistryPanelPlus (ALB, ALP, ALT) , AMY, AST, BUN, Ca, CRE, eGFR, CRP, GGT, GLU, TP, UA); Metrac (ALB, BUN, Ca, Cl-, CRE, GLU, K +, LAC, Mg, Na + , Phos, tCO2), etc. Microfluidic discs that are processed for blood chemistry testing, etc. Other fluid handling technologies developed in the future are also suitable for use in at least one embodiment herein. It should be understood that in some embodiments, the sun Can deliver the fluid to a generic chemical microfluidic / centrifugal cartridge 3802 (and / or 3804) using tubing that carries the fluid to a destination location, such as but not limited to a fluid receiving port on the cartridge. Can be done. At least one or more other cartridges, such as, but not limited to, an open fluid motion type cartridge as described in the application incorporated herein by reference also improve the type of available testing. Can be used for Although at least two destination cartridges are shown, it should be understood that embodiments having more than two are not excluded (as shown by the additional cartridges shown in dotted lines). Fluid transport may be performed by means of pipettes, fluid tubing, microfluidics, or other fluid handling techniques that may be developed in the future.

  Referring to FIG. 55A, it should be understood that some embodiments may use a sample handling system with a pipette or the like to extract the sample from the container 3800 in a tubeless manner. Although a pipette is described in this embodiment, it should be understood that other fluid handling techniques developed in the future may be adapted for use in at least one of the embodiments herein. FIG. 55A shows that an automated system can be used to equalize the sample. It should be understood that in some embodiments, there may be sample dilution to increase the liquid volume of the sample before, during, or after an equal portion. This is beneficial for a variety of purposes. FIG. 55A also illustrates that in some embodiments, the sample can be delivered to a generic chemical microfluidic / centrifuge cartridge 3802 (and / or 3804). At least one or more other cartridges, such as, but not limited to, open fluid motion type cartridges as described in the above application incorporated herein by reference, also include Can be used to improve the type of available testing. Although at least two destination cartridges are shown, it should be understood that embodiments having more than two are not excluded (as shown by the additional cartridges shown in dotted lines). Fluid transport may be performed by means of pipettes, fluid tubing, microfluidics, or other fluid handling techniques that may be developed in the future. Some embodiments can use the same technique to move a sample to the cartridge or other destination location, or optionally, to move the sample, in some cases One or more combinations of techniques may be used. By way of example and not limitation, in addition to using the cartridge 3802, testing is not limited, but increases ELISA, nucleic acid amplification, microscopy, spectrophotometry, electrochemistry and / or analysis of the types described above. Using other detection techniques, such as other detection techniques. It should be appreciated that optionally two or more cartridges 3802 and / or individual unit cartridges 3806 may be used herein in the system for equalization from the container 3800.

  With reference to FIG. 55B, a further embodiment is shown in which container 3800 is shown as having sample fluid. In one example, the sample fluid therein may be “neat” or undiluted. Optionally, in some embodiments, the sample is pretreated at the collection site and / or the receiving site to dilute the sample and / or provide specific chemicals in the sample. Can be configured to be. As seen in FIG. 55B, the fluid handling system may use pipette 3602 to equalize the sample from container 3800 to one or more other containers 3810, 3812, and / or 3814. As a non-limiting example, these containers 3810, 3812, or 3814 can be the same container as that of container 3800. Optionally, they can be different types of containers. Based on the barcode or other information about the sample, the processor is programmed to determine at least a desired sample dilution for the sample, and at least a desired number of aliquots. In this non-limiting example, the aliquots are transported to one sample processing unit 3820, 3822, and 3824, respectively. These can all be the same type of processing unit, each of which is a different type from each other, or some can be the same and some can be different. In at least one non-limiting example, the sample processing unit can be a single sample processor or a batch processor that can handle multiple samples simultaneously.

  FIG. 55C shows a further embodiment where, at the collection site, the sample is collected and then transported to the second site, while the sample remains in liquid form. FIG. 55C shows that multiple containers with samples can be collected from a single wound on the subject. This allows the subject to provide multiple samples that can be treated with different types of chemicals in each of the containers. FIG. 55C shows a courier delivering a shipping container that may contain a sample from a single subject or multiple samples from multiple subjects to a site. While humans are shown, it should be understood that robotic transport, drones, or other transport techniques, systems, or equipment developed in the future are not excluded (but not limited to the “virtual” of the sample Including shipping version). In this non-limiting example, the receiving site may fill one or more containers 1504 from the transport container into a cartridge having reagent units and / or assay units that can be moved independently. The cartridge can be filled into one or more processing modules 701-707. These units can be the same module. Optionally, at least one of the modules is different from the others. Similar to FIG. 55B, some embodiments may dilute the sample from the container 1504 prior to filling the container 1504 or other container containing the sample and / or pre-diluted sample into the cartridge. And / or a processor 3830 (based on vessel ID or other accompanying information) that may adjust equalization. In at least one embodiment herein, each of the modules may receive at least one cartridge and at least one sample container. Optionally, more than one sample container can be placed in each cartridge. Optionally, the sample container may contain different types of samples, so that the cartridge may have more than one type of sample filled therein. Optionally, some embodiments may have a module having at least one receiving area for the cartridge and at least one receiving area for the sample.

  Optionally, some embodiments can have only one place to receive the cartridge, which can then contain at least one sample. In this way, the user reduces the risk of having to fill a separate item in the module. Once filled, at least one embodiment herein is configured so that no user intervention is required once the sample is inserted into the module. This non-limiting example can be used to minimize errors associated with human factors once the sample is processed in the module.

  It should be understood that some embodiments can handle multiple samples simultaneously using a centrifuge or other force that causes a drop to a settled level inside the sample vessel. In one non-limiting example, this can be accomplished by means of tray centrifugation, such as, but not limited to, a 384 well plate centrifuge.

  FIG. 55C shows a system 700 according to an embodiment of the invention having multiple modules 701-706 and a hemocytometer station 707. The plurality of modules include a first module 701, a second module 702, a third module 703, a fourth module 704, a fifth module 705, and a sixth module 706.

  The hemocytometer station 707 is operatively connected to each of the plurality of modules 701-706 by means of a sample handling system 708. The sample handling system 708 may include a pipette, such as a positive displacement, exhaust or suction type pipette as described herein.

  The hemocytometer station 707 includes a hemocytometer as described above and in other embodiments of the present invention for performing a hemocytometer on a sample. The hemocytometer station 707 performs a blood cell count of a sample, while one or more of the modules 701-706 perform other preparation and / or other sample assay procedures. In some cases, the blood cell counting station 707 performs a blood cell calculation of the sample in one or more of the modules 701-706 after the sample has undergone sample preparation.

  The system 700 includes a support structure 709 having a plurality of bays (or attachment stages). The plurality of bays are for docking the modules 701 to 706 to the support structure 709. The support structure 709 is a rack as illustrated.

  Each module is securely attached to the rack 709 with the aid of the mounting member. In one embodiment, the attachment member is clamped to either the module or the bay by a hook. In such a case, the hook is configured to slide into a receptacle in either the module or the bay. In another embodiment, the attachment member includes a fastener such as a screw fastener. In another embodiment, the attachment member is formed of a magnetic material. In such cases, the module and bay may include a magnetic material of opposite polarity to provide an attractive force for securely attaching the module to the bay. In another embodiment, the attachment member includes one or more tracks or rails in the bay. In such a case, the module includes one or more structures for coupling with the one or more tracks or rails, thereby securely attaching the module to the rack 709.

  An example of a structure that allows a module to be coupled to a rack includes one or more pins. In some cases, the module receives the force directly from the rack. In some cases, the module may be a power source such as a lithium ion or battery powered by a fuel cell that powers the device internally. In one embodiment, the module is configured to couple with the rack with rail assistance and power for the module comes directly from the rail. In another embodiment, the module is coupled to the rack with the aid of mounting members (rails, pins, hooks, fasteners), but power to the module is inductive (ie, inductive coupling), etc. As such, it is supplied wirelessly. In some embodiments, coupling the module to the rack does not require pins. For example, individual electrical communication can be provided between the module and a rack or other support. In some cases, wireless communication with the support of ZigBee communication or other communication protocols or protocols developed in the future can be used.

  Each module may be removable from the rack 709. In some cases, one module can be replaced with a similar or different module or the like. In one embodiment, the module can be removed by sliding the module out of the rack 709. In another embodiment, a module can be removed from the rack 709 by twisting or rotating the module so that the module mounting members disengage from the rack 709. Removing a module from the rack 709 can terminate any electrical connectivity between the module and the rack 709.

  In one embodiment, the module is attached to the rack by sliding the module into the bay. In another embodiment, the module is attached to the rack 709 by twisting or rotating the module such that a mounting member of the module engages the rack 709. Attaching the module to the rack 709 can establish an electrical connection between the module and the rack. The electrical connection provides a communication bus to provide power from the module to the module or the rack or the equipment and / or between the module and one or more other modules or the controller of the system 700. It can be for providing.

  Each bay of the rack may or may not be occupied. As shown, all bays of the rack 709 are occupied by modules. In some cases, however, one or more of the bays of the rack 709 are not occupied by modules. In one embodiment, the first module 701 is removed from the rack. The system 700 may operate without the removed module in such a case.

  In some cases, a bay may be configured to accept a subset of the types of modules configured for use by the system 700. For example, a bay agglutination assay may be configured to accept a module that is not capable of performing a hemocytometer assay. In such cases, the module may be “specialized” for aggregation. Aggregation can be measured by various methods. Measuring the time-dependent change in turbidity of the sample is one method. This can be accomplished by illuminating the sample with light and measuring the reflected light at 90 degrees with an optical sensor such as a photodiode or camera. Over time, the measured light increases as more light is scattered by the sample. Measuring the time-dependent change in transmittance is another example. In the latter case, this is accomplished by illuminating the sample in a container and measuring the light passing through the sample with an optical sensor such as a photodiode or camera. As the sample aggregates over time, the measured light decreases or increases (eg, the aggregated material remains in suspension or settles out of suspension). In other cases, the bay is for the system 700 to accept all types of modules that are configured for use from the detection station to the supporting electrical system. Configured.

  Each of the modules may be configured to function (or perform) independently of the other modules. In one embodiment, the first module 701 is configured to perform independently of the second 702, third 703, fourth 704, fifth 705 and sixth 706 modules. obtain. In other cases, the module is configured to perform with one or more other modules. In such cases, the module may allow parallel processing of one or more samples. In one embodiment, the second module 702 examines the same or different samples while the first module 701 prepares the sample. Allows minimization or elimination of downtime between the modules.

  The support structure (or rack) 709 may have a wagon type configuration. In some cases, the various dimensions of the rack are standardized. In one embodiment, the spacing between the modules 701-706 is at least about 0.5 inch, or 1 inch, or 2 inches, or 3 inches, or 4 inches, or 5 inches, or 6 inches, or 7 inches. , Or 8 inches, or 9 inches, or 10 inches, or 11 inches, or a multiple of 12 inches.

  The rack 709 may indicate the weight of one or more of the modules 701-706. Additionally, the rack 709 is selected such that the module 701 (topmost) can be attached to the rack 709 without creating a moment arm that can cause the rack 709 to rotate or collapse. With a vacuum center. In some cases, the center of the rack 709 vacuum is disposed between the vertical midpoint of the rack and the base of the rack, and the vertical midpoint is 50% from the base of the rack 709 and the top of the rack. It is in. In one embodiment, the center of the rack 709 vacuum, measured along a vertical axis away from the base of the rack 709, is at least about 0.1 of the height of the rack measured from the base of the rack 709. %, Or 1%, or 10%, or 20%, or 30%, or 40%, or 50%, or 60%, or 70%, or 80%, or 90%, or 100% .

  A rack may have multiple bays (or mounting stations) configured to receive one or more modules. In one embodiment, the rack 709 may have six mounting stations that allow each of the modules 701-706 to be attached to the rack. In some cases, the bay is on the same side of the rack. In other cases, the bays alternate on both sides of the rack.

  In some embodiments, the system 700 includes an electrical connectivity component for electrically connecting the modules 701-706 to each other. The electrical connectivity component may be a bus, such as a system bus. In some cases, the electrical connectivity component also allows the modules 701-706 to communicate with each other and / or the controller of the system 700.

  In some embodiments, the system 700 includes a controller (not shown) for facilitating sample processing with the assistance of one or more of the modules 701-706. In one embodiment, the controller facilitates parallel processing of the sample in the modules 701-706. In one embodiment, the controller provides the sample handling system 708 with the samples in the first module 701 and commands the second module 702 to simultaneously perform the different assays of the samples. In another embodiment, the controller provides the sample handling system 708 with a sample in the modules 701-706 and delivers the sample (such as a finite volume portion of the sample) to the blood cell. Since the command is also provided to the calculation station 707, the blood cell count and one or more other sample preparation procedures and / or assays are performed in parallel on the sothat sample. In such a manner, the system minimizes the downtime between the modules 701-706 and the hemocytometer station 707 if not eliminated.

  Each individual module of the plurality of modules may include a sample handling system for providing samples to and removing samples from various processing and assay modules of the individual modules. In addition, each module may include various sample processing and / or assay modules in addition to other components that facilitate sample processing and / or assay with the assistance of the module. The sample handling system for each module may be separate from the sample handling system 708 of the system 700. That is, the sample handling system 708 moves samples to or from the modules 701-706, whereas the sample handling system of each module has various functions within each module. Samples are moved to and from the correct sample processing and / or assay module.

  In the illustrated embodiment of FIG. 55C, the sixth module 706 includes a sample handling system 710 that includes a suction-type pipette 711 and a positive displacement pipette 712. The sixth module 706 includes a centrifuge 713, a spectrometer 714, a nucleic acid assay (such as a polymerase chain reaction (PCR) assay) station 715 and a PMT 716. An example of the spectrometer 714 is shown in FIG. 55C (see below). The sixth module 706 further includes a cartridge 717 for holding a plurality of chips for facilitating transfer of samples to or from the processing or assay module of the sixth module.

  In one embodiment, the suction type pipette 711 is one or more, or two or more, or three or more, or four or more, or five or more, or six or more, or seven or more, or eight or more. Or 9 or more, 10 or more, 15 or more, 20 or more, 30 or more, 40 or more, or 50 or more heads. In one embodiment, the suction type pipette 711 is an eight head pipette having eight heads. The suction type pipette 711 may be as described in other embodiments of the present invention.

  In some embodiments, the positive displacement pipette 712 is about 20%, 15%, 12%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2% It has a coefficient of variation of 1%, 0.5%, 0.3%, or 0.1% or less or less. The coefficient of variation is determined according to σ / μ, where “σ” is the standard deviation and “μ” is the average over sample measurements.

  In one embodiment, all modules are identical to each other. In another embodiment, at least some of the modules are different from each other. In one embodiment, the first, second, third, fourth, fifth, and sixth modules 701-706 include positive displacement and aspiration type pipettes and nucleic acid assays and spectrometers. Including various tests. In another example, at least one of the modules 701-706 may have an assay and / or sample preparation station that is different from the other modules. In one example, the first module 701 includes an agglutination assay but does not include a nucleic acid amplification assay, and the second module 702 includes a nucleic acid assay but not an agglutination assay. The module may not include any tests.

  In the illustrated example of FIG. 55C, the modules 701-706 include the same assay and sample preparation (or manipulation) station. However, in other embodiments, each module includes any number and combination of assay and processing stations described herein.

  The modules can be stacked vertically or horizontally relative to each other. Two modules are oriented vertically with respect to each other if they are oriented along a plane that is parallel, substantially parallel, or substantially parallel to the gravitational acceleration vector. Two modules are oriented horizontally with respect to each other if they are oriented along a plane that is orthogonal, substantially orthogonal, substantially orthogonal to the gravitational acceleration vector.

  In one embodiment, the modules are stacked vertically, ie one module is stacked on top of another module. In the illustrated example of FIG. 55C, the rack 709 is oriented so that the modules 701-706 are arranged vertically in relation to each other. In other cases, however, the modules are oriented so that they are arranged horizontally in relation to each other. In such a case, the rack 709 can be oriented so that the modules 701-706 can be on the same side horizontally.

  Yet another embodiment of a system 730 is shown having multiple modules 701-704. In this embodiment, the modules 701-704 can be moved in and / or between modules to move elements such as, but not limited to, sample containers, chips, cuvettes, etc. FIG. 5 shows a horizontal configuration attached to a support structure 732 in which the transport device 734 can be moved along the Z axis. As a non-limiting example, the modules 701-704 are horizontal to each other if they are oriented along a plane that is orthogonal, substantially orthogonal, substantially orthogonal to the gravitational acceleration vector. Oriented.

  It should be understood that all of the modules 701-704 can be the same module as each other as in the previous embodiment of FIG. 55C. In another embodiment, at least some of the modules are different from each other. In one embodiment, the first, second, third, and / or fourth modules 701-704 are by one or more other modules that can occupy the location of the module to be replaced. Can be replaced. The other modules optionally include, but are not limited to, one of the modules 701-704, one or more blood cell counting modules 707, a communication module, a storage module, a sample preparation module, a slide preparation module, a tissue preparation module. Provide different functionality, such as replacing For example, one of the modules 701-704 is different, such as but not limited to providing a thermally controlled storage chamber for incubation, storage during testing, and / or storage after testing. It can be replaced by one or more modules that provide a hardware configuration. Optionally, the module replaces one or more of the modules 701-704, including but not limited to additional telecommunications devices, additional imaging or user interface devices for the system 730. Functionality unrelated to calibration, such as but not limited to additional power sources such as batteries, fuel cells, etc. can be provided. Optionally, the module that replaces one or more of the modules 701-704 may provide additional disposable items and / or reagent or fluid storage. Although some embodiments show only four modules attached to the support structure, it should be understood that other embodiments having fewer or more modules are not excluded from the horizontal mounting configuration. In particular, it should be understood that in scenarios where one or more types of modules consume more power than other modules, the configuration can be made without all the bays or slots occupied by the modules. In such a configuration, otherwise power directed to an empty bay can be used by the module taking more power than others.

  It should be understood that all of the modules 701-706 can be the same module as each other as in the previous embodiment of FIG. 55C. In another embodiment, at least some of the modules are different from each other. In one embodiment, the first, second, third, and / or fourth modules 701-706 are by one or more other modules that can occupy the location of the module to be replaced. Can be replaced. The other modules optionally include, but are not limited to, one of the modules 701-704, one or more blood cell counting modules 707, a communication module, a storage module, a sample preparation module, a slide preparation module, a tissue preparation module. Provide different functionality, such as replacing

  While some embodiments show that only six modules are attached to the support structure, other embodiments having fewer or more modules are not excluded from the horizontal and vertical mounting configurations. I want you to understand. In particular, it should be understood that in scenarios where one or more types of modules consume more power than other modules, the configuration can be made without all the bays or slots occupied by the modules. In such a configuration, otherwise power directed to an empty bay can be used by the module taking more power than others.

  Some embodiments may provide a system with multiple modules 701, 702, 703, 704, 706, and 707. Such embodiments provide, without limitation, a thermally controlled storage chamber for incubation with one or more modules, storage during testing, and / or storage after testing, etc. You can have additional modules with different hardware configurations. Optionally, the module replaces one or more of the modules 701-704, including but not limited to additional telecommunications devices, additional imaging or user interface devices for the system 730. Functionality unrelated to calibration, such as but not limited to additional power sources such as batteries, fuel cells, etc. can be provided. Optionally, the module that replaces one or more of the modules 701-704 may provide additional disposable items and / or reagent or fluid storage.

  While FIG. 55C shows that only seven modules are attached to the support structure, it should be understood that other embodiments having fewer or more modules are not excluded from this attachment configuration. In particular, it should be understood that in scenarios where one or more types of modules consume more power than other modules, the configuration can be made without all the bays or slots occupied by the modules. In such a configuration, otherwise power directed to an empty bay can be used by the module taking more power than others.

  In some embodiments, the modules 701-706 may include each other and / or the controller of the system 700 and electronic circuitry and components to facilitate communication between the module and / or the controller. It is in communication by means of a communication bus (“bus”). The communication bus includes a subsystem that transfers data between the modules and / or the controllers of the system 700. The bus provides the various components of the system 700 with communication with the central processing unit (CPU), memory (eg, internal memory, system cache) and storage location (eg, hard disk) of the system 700.

  The communication bus may include multiple electrical connections, or parallel electrical wiring with parallel electrical wiring having any physical arrangement that provides logical functionality, as a parallel electrical bus. The communication bus can include both parallel and bit series connections and is wired in either a branch (ie, electrical parallel) or daisy chain topology or connected by a switched bus . In one embodiment, the communication bus may be a first generation bus, a second generation bus, or a third generation bus. The communication bus allows communication with each of the modules and other modules and / or the control device. In some cases, the communication bus allows communication between multiple systems, such as, or the same as, the system 700.

  The system 700 may include one or more serial buses, parallel buses, or self-healing buses. The bus may include a master scheduler that controls data traffic, such as traffic to and from modules (eg, modules 701-706), controllers, and / or other systems. The bus may include an external bus that connects external devices and systems to a main system board (eg, a mother board), and an internal bus that connects internal components of the system to the system board. The internal bus connects internal components to one or more central processing units (CPUs) and internal memory.

  In some embodiments, the communication bus may be a wireless bus. The communication bus can be FireWire (IEEE 1394), USB (1.0, 2.0, 3.0, or others), Thunderbolt, or other protocol (current or future developed).

In some embodiments, the system 700 includes a media bus, a computer automated measurement and control (CAMAC) bus, an industry standard architecture (ISA) bus, a USB bus, a firewire, a thunderbolt, and an extended ISA (EISA). Bus, Low Pin Count Bus, M Bus, Micro Channel Bus, Multi Bus, Neubus or IEEE 1196, OPTi Local Bus, Peripheral Component Interconnect (PCI) Bus, Parallel Advanced Technology Attachment (ATA) Bus, Q-Bus, S-100 Bus (Or IEEE 696), S bus (or IEEE 1496), SS-50 bus, STE bus, STD bus (for STD-80 [8-bit] and STD32 [16- / 32-bit]), user Nibus, VESA local bus, VME bus, PC / 104 bus, PC / 104 Plus bus, PC / 104 Express bus, PCI-104 bus, PCIe-104 bus, 1-wire bus, Hyper Transport bus, Inter-Integrated Circuit (I ² C) bus, PCI Express (or PCIe) bus, serial ATA (SATA) bus, serial peripheral interface bus, UNI / O bus, SM bus, 2-wire or 3-wire interface, self-healing elastic It includes one or more buses selected from the group consisting of interface buses and variations and / or combinations thereof.

  In some cases, the system 700 includes a serial peripheral interface that connects between one or more microprocessors of the system 700 and peripheral components or I / O components (eg, modules 701-706). (SPI). The SPI may be 2 or more, or 3 or more, or 4 or more, or 5 or more, or 6 or more, or 7 or more, or 8 or more, or 9 or more. Or more than 10, or more than 50, or more than 100 I / O component compatible SPIs can be used to attach to a microprocessor or multiple microprocessors. In other examples, the system 700 includes RS-485 or other standards.

  In one embodiment, an SPI is provided having an SPI bridge with a parallel and / or series topology. Such a bridge allows the selection of one of many SPI components on the SPII / O bus without the proliferation of chip selection. This is accomplished by applying appropriate control signals to enable daisy chaining of the devices, or chip selection for the devices on the SPI bus, as described below. However, it maintains a parallel data path so that there is no daisy chaining of data to be moved between the SPI component and the microprocessor.

  In some embodiments, an SPI bridge component is provided between the microprocessor and the plurality of SPII / O components connected by a parallel and / or serial (or serial) topology. The SPI bridge component enables parallel SPI using (CSL /) serial (daisy chain) local chip select connections to MISO and MOSI lines and other slaves. In one embodiment, the SPI bridge component provided herein also solves any problems associated with multiple chip selection for multiple slaves. In another embodiment, the SPI bridge component provided herein provides 4, 8, 16, 32, 64 or more individual chip selections for four SPI enabled devices (CS1 / -CS4 /). Support. In another embodiment, the SPI bridge component provided herein allows for four cascading of external address line settings (ADR0-ADR1). In some cases, the SPI bridge components provided herein provide the ability to control up to 8, 16, 32, 64, or more general purpose output bits for control or data. The SPI bridge component provided herein allows for control of up to 8, 16, 32, 64, or more general purpose input bits for control or data, and in some cases, and the master Can be used for device identification and / or diagnostic communication to the master.

  One embodiment may use an SPI bridge arrangement with a master and a parallel serial SPI slave bridge according to an embodiment of the present invention. Multiple slave device cascading, virtual daisy chaining of device chips to keep module-to-module signal counts at acceptable levels, support for module identification and diagnostics, and slaves controlled by embedded SPI In order to allow for the addition of various system characteristics, including essential and non-essential system characteristics, such as communication to non-SPI components on the module, while maintaining compatibility with components, the SPI bus is , Local chip selection to the SPI bridge (CSL /), module selection (MOD_SEL), and selection data (DIN_SEL) can be increased by adding to the SPI bridge. FIG. 41B shows an example of an SPI bridge according to an embodiment of the present invention. The SPI bridge includes internal SPI control logic, control registers (8 bits as shown), and various input and output pins.

  Each slave bridge is connected to a master (also “SPI master” and “master bridge” herein) in a parallel series configuration. The MOSI pins of the respective slave bridges are connected to the MOSI pins of the master bridge, and the MOSI pins of the slave bridges are connected to each other. Similarly, the MISO pin of each slave bridge is connected to the MISO pin of the master bridge, and the slave bridge MISO pins are connected to each other.

  Each slave bridge may be a module (eg, one of the modules 701-706 of FIG. 7) or a component within the module. In one embodiment, the first slave bridge is the first module 701, the second slave bridge is the second module 702, and so on. In another embodiment, the first slave bridge is a component of a module.

  At least one non-limiting example may use a modular component diagram with interconnected module pins and master and slave bridges in accordance with embodiments of the present invention. A slave bridge may be connected to a master bridge according to an embodiment of the invention. The MISO pin of each slave bridge is electrically connected to the MOSI pin of the master bridge. The MISO pin of each slave bridge may be in electrical communication with the MOSI pin of the master bridge. The DOUT_SEL pin (left) of the first slave bridge is in electrical communication with the DOUT_SEL pin of the second slave. The DOUT_SEL pin of the first slave bridge is in electrical communication with the DIN_SEL (right) of the second slave. An additional slave bridge can be connected as the second slave by electrically connecting each additional slave bridge DIN_SEL pin to the DOUT_SEL pin of the previous slave bridge. In such a manner, the slave bridges are connected in a parallel series configuration.

  In some embodiments, a clock pulse directed to the connected SPI-bridge captures the state of the DIN_SEL bit shifted into the bridge at the assertion of the module select line (MOD_SEL). The number of DIN_SEL bits corresponds to the number of modules connected together on a parallel serial SPI link. In one embodiment, if two modules are connected in a parallel series configuration (eg, RS486), the number of DIN_SEL is equal to two.

  In one embodiment, an SPI-Bridge that latches “1” during the module selection sequence becomes a “selected module” set that receives an 8-bit control word during the subsequent element selection sequence. Each SPI-bridge can access up to four chained SPI slave devices. Additionally, in addition, each SPI-bridge may have an 8-bit GP receive port and an 8-bit GP transmit port. The “element selection” sequence allows the “selected module” SPI-bridge control to allow subsequent transactions with a particular SPI device, or to read or write data via the SPI-bridge GPIO port. Write an 8-bit word to the register.

  In one embodiment, element selection can occur by clocking the local chip select line (CSL /) assertion and then the first byte of a data word transferred to the control register by the first MOSI. In some cases, the format of the control register is CS4CS3CS2CS1AD1AD0RWN. In another embodiment, the second byte is for sending or receiving data. The cycle is complete when CSL / is deasserted.

  In the SPI transaction, following the element selection sequence, a subsequent SPI slave data transaction is started. The SPICS / (which may be referred to as SS /) is directed to one of four possible bridged devices for the true state of any of the CS4, CS3, CS2 or CS1. Jumper bits AD0, AD1 allow up to four SPI-bridges on the module to be compared with AD0, AD1 of the control register.

  One embodiment shows a device having a plurality of modules mounted on the SPI link of the communication bus of the device according to one embodiment described in the present invention. Three modules are shown: module 1, module 2 and module 3. Each module includes one or more for electrically connecting various components of the module to the SPI link, including a master controller (including one or more CPUs) in electrical communication with the SPI link. Including SPI bridges. Module 1 includes a plurality of SPI slaves in electrical communication with each of SPI bridge 00, SPI bridge 01, SPI bridge 10 and SPI bridge 11. In addition, each module includes a receive data controller, a transmit data controller, and a module ID jumper.

  In other embodiments, the modules 701-706 are configured to communicate with each other and / or one or more controllers of the system 700 with the assistance of a wireless communication bus (or interface). In one embodiment, the modules 701-706 communicate with each other with the assistance of a wireless communication interface. In another embodiment, with the assistance of a wireless communication bus, one or more of the modules 701-706 communicate with the controller 700 of the system. In some cases, communication between modules 701-706 and / or one or more control devices of the system is performed only by means of a wireless communication bus. This may advantageously eliminate the need for the air interface in the partition to accept the modules 701-706. In other cases, the system 700 includes a wired interface that operates in conjunction with the wireless interface of the system 700.

  The system 700 has a single rack as shown, but systems such as the system 700 may have multiple racks. In some embodiments, the system is at most 1, or 2, or 3, or 4, or 5, or 6, or 7, or 8, or 9, or 10, or 20, or 30, or 40 , Or 50, or 100, or 1000, or 10,000 racks. In one embodiment, the system has a plurality of racks arranged in side-by-side configurations.

  In some embodiments, a sample is provided to a system having one or more modules, such as the system 700 of FIG. 55C. The user provides the sample to the sample collection module of the system. In one embodiment, the sample collection module comprises a lancet, needle, microneedle, venous blood collection, scalpel, cup, wipe, wash, bucket, sputum, kit, osmotic matrix, or any other herein. Including one or more of any other sample collection mechanisms or methods described in the section. The system then directs the sample from the sample collection module to one or more processing modules (eg, modules 701-706) for sample preparation, assay, and / or detection. In one embodiment, the sample is directed from the collection module to the one or more processing modules with the assistance of a sample handling system such as a pipette. The sample is then processed in the one or more modules. In some cases, the sample is assayed in the one or more modules and then passes through one or more detection routes.

  In some embodiments, following processing in the one or more modules, the system communicates its results to a user or system (eg, a server) that communicates with the system. Other systems or users can then access the results to aid in the treatment or diagnosis of the subject.

  In one embodiment, the system is for two-way communication with other systems such as similar or similar systems (eg, a rack described in the context of FIG. 55C), or other computer systems including servers. Composed.

  The equipment and methods provided herein can advantageously reduce the energy or carbon dioxide emissions of a point-of-service system by allowing parallel processing. In some cases, in some situations, a system such as system 700 of FIG. 55C may have a maximum of 10%, 15%, 20%, 25%, 30%, 35 of other point of service systems %, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or 99% carbon dioxide emissions.

  In some embodiments, a method is provided for detecting an analyte. In one embodiment, the processing routine includes detecting the presence or absence of an analyte. Processing routines are facilitated with the assistance of the systems and equipment provided herein. In some cases, the analyte is a biological process, a physiological process, an environmental condition, a sample condition, one or more autoimmune diseases, obesity, hypertension, diabetes, neurological and / or muscle degenerative diseases, heart disease, endocrine Associated with a disease, such as a disease, or stage of disease.

  In some cases, one instrument processes one sample at a time. However, the system provided herein is configured for the processing of multiplexed samples. In one embodiment, one device processes multiple samples at once or in duplicates. In one example, the user provides a sample to a device with multiple modules, such as the system 700 of FIG. 55C. The instrument then processes the sample with the assistance of one or more modules of the instrument. In another example, a user provides multiple samples to an instrument with multiple modules. The instrument then processes the sample at the same time by processing the first sample of the first module while processing the second sample of the second module with the assistance of a plurality of modules.

  The system may process the same or different types of samples. In one embodiment, the system processes one or more portions of the same sample simultaneously. This is useful when different assays and / or detection protocols for the same sample are desired. In another embodiment, the system processes different types of samples simultaneously. In one example, the system processes blood and urine samples simultaneously, either in different modules of the system or in a single module with a processing station for processing blood and urine samples.

  In some embodiments, a method of processing a sample with the assistance of a point-of-service system, such as system 700 of FIG. 55C, accepts inspection criteria or parameters, and the order of inspection based on the criteria. Or including determining a schedule. The inspection criteria are accepted from a user, a system communicating with a point of service system, or a server. The inspection criteria can be selected based on desired or predetermined effects such as time, cost, component usage, steps and energy minimization. The point-of-service system processes the samples according to the inspection order or schedule. In some cases, a feedback loop (coupled with a sensor) allows the point of service system to monitor the progress of sample processing and the maintenance or modification of inspection instructions or schedules. In one example, if the system detects that processing takes longer than the predetermined time described in the schedule, it can speed up the processing of the system or perform parallel processing, such as sample processing in another module of the system. adjust. The feedback loop allows real time or pseudo real time (eg, cached) monitoring. In some cases, the feedback loop may include another test and / or test, or subsequent tests, tests, preparation steps and / or other processes that should be initiated after detection or detection of one or more parameters. It can provide permission for reflex testing that can cause. Such subsequent tests, assays, preparation steps, and / or other processes can be automatically initiated without human intervention. Optionally, a reflex test is performed in response to the test result. That is, as a non-limiting example, when a reflex test is ordered, the cartridge is pre-filled with reagents for Assay A and Assay B. Test A is a preliminary test, and test B is the reflex test. If the result of the calibration A meets the predetermined criteria for initiating the reflection test, then calibration B is then performed on the same sample in the instrument. The instrument protocol is planned to configure the possibility to perform the reflection test. Some or all protocol steps of assay B may be performed before the results of assay A are complete. For example, sample preparation can be completed in advance on the instrument. A reflex test can also be performed on a second sample from the patient. In some embodiments, the instruments and systems provided herein can include components for multiple different assays and assay types to be reflex tested with the same instrument. In some embodiments, multiple clinically important tests can be performed as part of a reflex test protocol on a single instrument provided herein, according to known systems and methods. Performing the same test requires two or more separate instruments. Thus, the systems and equipment provided herein allow for reflex testing that is faster and requires less sample than, for example, known systems and methods. In addition, in some embodiments, there is no need to know in advance which reflected inspection is performed relative to the reflection inspection by the instrument provided herein.

  In some embodiments, the point-of-service system may adhere to predetermined inspection instructions or schedules based on initial parameters and / or desired effects. In other embodiments, the schedule and / or inspection instructions may be modified on the fly. The schedule and / or inspection instructions may include one or more detected conditions, one or more additional processes to be driven, one or more processes to be stopped, one or more processes to be corrected, one Modification of usage of these resources / components, one or more detected errors or alarm conditions, unavailability of one or more resources and / or components, subsequent input provided by one or more users Or it can be modified based on samples, external data, or any other reason.

  In some embodiments, one or more additional samples may be provided to the device after one or more initial samples are provided to the device. The additional sample can be from the same subject or from different subjects. The additional sample may be the same type of sample as the initial sample or may be a different type of sample (eg, blood, tissue). The additional sample may be provided prior to, simultaneously and / or subsequent to processing one or more initial samples on the instrument. To contrast with each other and / or the initial sample, the same and / or different tests or desired criteria can be provided for additional samples. The additional sample may be processed sequentially and / or in parallel with the initial sample. The additional sample may use the same or different components as the one or more initial samples. The additional samples may or may not be required depending on the detection status of one or more of the initial samples.

  In some embodiments, the system receives a sample with the assistance of a sample collection module, such as a lancet, scalpel, or liquid collection container. The system then loads or accesses a protocol from a plurality of possible processing routines to execute one or more processing routines. In one example, the system loads a centrifugation protocol and a hemocytometer protocol. In some embodiments, the protocol may be loaded from a device external to the sample processing device. As an alternative, the protocol may already be in the same sample processing equipment. The protocol may be created based on one or more requirement criteria and / or processing routines. In one embodiment, creating a protocol may include creating a list of one or more subtasks for each input process. In some embodiments, individual subtasks are performed by a single component of one or more devices. Creating a protocol may also include creating a list order, creating one or more resource timings and / or allocations.

  In one embodiment, the protocol provides processing details or specifications specific to the sample or components within the sample. For example, the centrifugation protocol can include a rotation speed suitable for a given sample density, and processing time, depending on the density of the sample from other materials that may be present with the desired components of the sample. Allows separation.

  Protocols are retrieved from other systems, such as databases, included in the system, such as a protocol repository within the system, or in communication with the system. In one embodiment, one or more processing protocols of the system are in one-way communication with a database server that provides protocols to the system upon request from the system. In another embodiment, the system allows a user-specific processing routine to be uploaded to the database server for future use by the user or other users who may use the user-specific processing routine. In a two-way communication state with the database server.

  Referring to FIGS. 56A and 56B, the transport container 4000 is configured to receive a plurality of bodily fluid samples from a plurality of subjects such as a patient therein. In some embodiments, there are multiple sample containers from each subject. Optionally, at least two samples from the same subject are subjected to different chemical pretreatments such as, but not limited to, different anticoagulants in each container. Optionally, some embodiments may use a container having two or more separate chambers, each chamber holding a portion of the fluid sample separate from the fluid sample in another chamber. Configured to do. Some embodiments may include samples from a subject in a single chamber container and / or multiple chamber containers.

  As seen in FIGS. 56A and 56B, various views of one embodiment of the shipping container 4000 are shown, with the lid 4010 in a recess above the bottom of the shipping container 4000, as seen in FIG. 57A. The container 4000 is stackable to have at least one mesa portion 4012 sized for mating. The shipping container 4000 may have any of the features described herein for other embodiments of the shipping containers described herein.

  FIG. 57B shows that there may be a tray 4030 fixed in and / or from the shipping container 4000 in the shipping container 4000. In one embodiment, the tray 4030 is by a fixed device such as, but not limited to, a magnetic or metallic portion 4032 that aligns with a metal or magnetic portion of the housing of the shipping container 4000 to form a magnetic connection. Held in the right place. In some embodiments, the length to width aspect ratio is in the range of about 128: 86 to 127: 85. Optionally, the length to width aspect ratio is in the range of about 130: 90 to 120: 80. Optionally, the length of the tray is in the range of about 130 mm to 120 mm, and the width is in the range of about 90 mm to 80 mm. In some embodiments, the height or thickness of the tray is in the range of about 14-20 mm. The aspect ratio and / or size is configured to hold a tray sized to fit into a slot, concave surface, or other holder on the plate centrifuge. Thus, the entire tray 4030 can be centrifuged therein to prepare multiple samples.

  As seen in FIGS. 57B and 58B, the tray 4030 has a plurality of slots 4034 that are sized to hold at least one of the sample storage containers. At least one portion 4040 of the slot 4034 has a first shape and at least a second portion 4042 has a second shape different from the first shape, the shape being It can be locked by being inserted into the slot 4034 only in the desired orientation. As can be seen in FIG. 58B, one end is semi-circular while the other end is shaped asymmetrically. Since the tray 4030 is also shaped to have a cutout 4036 or other shape, the tray 4030 can be inserted into the shipping container 4000 in only one orientation. It should also be understood that because the tray 4030 can be held in the tray, the user cannot remove the container 4000 with a finger without a tool or other tray extraction device. This minimizes the risk of user interference. The tray 4030 is retained in the transport container 4000 even when the transport container 4000 is upside down and can resist the pulling of the earth's gravity.

  FIGS. 59A and 59B illustrate yet another embodiment in which a plurality of slots 4100 are in the tray 4102. The tray has a different aspect ratio (close to a square) and has a plurality of shaped slots in the tray to hold the sample container.

  In at least one embodiment described herein, the treatment optionally includes an initial separation process of components formed from liquid components, starting with formed components such as but not limited to red blood cells. At some point after the separation step, such as a second or subsequent separation, plasma is not extruded at all or minimally through the separation gel between the formed layer and the liquid component layer. Sample collection locations such as, but not limited to, remote sites that are different from retail sites such as analysis sites, patient service centers (PSCs), or pharmacies to allow only plasma to be extruded. Complete or substantially complete plasma separation of the sample.

  In one embodiment, the time interval between the first separation step and the subsequent separation step is at least about 1 hour. Optionally, the time interval is at least about 2 hours. Optionally, the time interval is at least about 3 hours. Optionally, the time interval is at least about 4 hours. Optionally, the time interval is at least about 5 hours. Optionally, the time interval is at least about 6 hours. Optionally, the time interval is at least about 7 hours. Optionally, the time interval is at least about 8 hours. Optionally, the time interval is at least about 9 hours. Optionally, the time interval is at least about 10 hours. Optionally, the time interval is at least about 11 hours. Optionally, the time interval is at least about 12 hours. Optionally, the time interval is at least about 13 hours. Optionally, the time interval is at least about 14 hours. Optionally, the time interval is at least about 15 hours. Optionally, the time interval is at least about 16 hours. Optionally, the time interval is at least about 17 hours. Optionally, the time interval is at least about 18 hours. Optionally, the time interval is at least about 19 hours. Optionally, the time interval is at least about 20 hours. Optionally, the time interval is at least about 21 hours. Optionally, the time interval is at least about 22 hours. Optionally, the time interval is at least about 23 hours. Optionally, the time interval is at least about 24 hours. Optionally, the time interval is at least about 28 hours. Optionally, the time interval is at least about 32 hours. Optionally, the time interval is at least about 362 hours. Optionally, the time interval is at least about 40 hours. Optionally, the time interval is at least about 44 hours. Optionally, the time interval is at least about 48 hours.

  In one embodiment, the time interval is at least, but not limited to, excess serum or plasma in contact with red blood cells after the initial separation, such subsequent separation step is excess serum or plasma, Sufficient time to allow it to be expressed from under the separation barrier, such as a gel barrier between most of the formed and liquid components in the sample.

In one embodiment, the first separation step includes centrifuging at at least about 3000 g. In one embodiment, the first separation step includes centrifuging at least about 3100 g. In one embodiment, the first separation step includes centrifuging at at least about 3200 g. In one embodiment, the first separation step includes centrifuging at at least about 3300 g. In one embodiment, the first separation step includes centrifuging at at least about 3400 g. In one embodiment, the first separation step includes centrifuging at at least about 3500 g. In one embodiment, the initial separation step includes centrifuging at least about 3550 g. In one embodiment, the initial separation step includes centrifuging at least about 3575 g. Optionally, the method includes an initial accelerated settling force, such as but not limited to a centrifugation step of at least about 3700 g. The method includes an initial accelerated settling force such as but not limited to a centrifugation step of at least about 3800 g. The method includes an initial accelerated settling force such as, but not limited to, a centrifugation step of at least about 3900 g. The method includes an initial accelerated settling force such as, but not limited to, a centrifugation step of at least about 3950 g. In some embodiments, the gravitational acceleration generated in the first centrifugation step herein may be less than 3100 g, 3200 g, 3300 g, 3400 g, 3500 g, 3600 g, 3700 g, 3800 g, 3900 g, or 3990 g. it can. In some embodiments, a minimum of about 3000 g, 3100 g, 3200 g, 3300 g, 3400 g, 3500 g, 3600 g, 3700 g, 3800 g, 3900 g, or 3950 g, and 3100 g, 3200 g, 3300 g, 3400 g, 3500 g, 3600 g, 3700 g, 3800 g It may have an acceleration selected from a range having a maximum of 3900 g, or 3990 g. In at least one embodiment, for any of the foregoing, the minimum acceleration may be at least 1400 g. In at least one embodiment, for any of the foregoing, the minimum acceleration may be at least 1500 g. In at least one embodiment, for any of the foregoing, the minimum acceleration may be at least 1600 g. In at least one embodiment, for any of the foregoing, the minimum acceleration may be at least 1700 g. In at least one embodiment, for any of the foregoing, the minimum acceleration may be at least 1800 g. In at least one embodiment, for any of the foregoing, the minimum acceleration may be at least 1900 g. In at least one embodiment, for any of the foregoing, the minimum acceleration may be at least 2000 g. For at least the above embodiments, “g” conforms to a gravitational acceleration of about 9.8 m / s ^{2 at} the Earth's sea level.

  Optionally, the sample is centrifuged for at least about 1 minute. Optionally, the sample is centrifuged for at least about 2 minutes. Optionally, the sample is centrifuged for at least about 3 minutes. Optionally, the sample is centrifuged for at least about 4 minutes. Optionally, the sample is centrifuged for at least about 5 minutes. Optionally, the sample is centrifuged for at least about 6 minutes. Optionally, the sample is centrifuged for at least about 7 minutes. Optionally, the sample is centrifuged for at least about 8 minutes. Optionally, the sample is centrifuged for at least about 9 minutes. Optionally, the sample is centrifuged for at least about 10 minutes. In some embodiments, the initial centrifugation step is 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 6 minutes, 7 minutes at the desired speed or speed range described in the paragraph above. , 8 min, 9 min or 10 min minimum and 2 min, 3 min, 4 min, 5 min, 6 min, 7 min, 8 min, 9 min, 10 min or 11 min max It can be done for a period of time selected from a range.

  Optionally, the first or first separation step for separating plasma from red blood cells occurs within 5 minutes after the sample is collected in the sample container. Optionally, the first or first separation step for separating plasma from red blood cells occurs within 10 minutes after the sample is collected in the sample container. Optionally, the first or first separation step for separating plasma from red blood cells occurs within 15 minutes after the sample is collected in the sample container. Optionally, the first or first separation step for separating plasma from red blood cells occurs within 20 minutes after the sample is collected in the sample container. Optionally, the first or first separation step for separating plasma from red blood cells occurs in less than 5 minutes after the sample is collected in the sample container. Optionally, the first or first separation step for separating plasma from red blood cells occurs in less than 10 minutes after the sample is collected in the sample container. Optionally, the first or first separation step for separating plasma from red blood cells occurs in less than 15 minutes after the sample is collected in the sample container. Optionally, the first or first separation step for separating plasma from red blood cells occurs in less than 20 minutes after the sample is collected in the sample container.

  Optionally, a secondary centrifugation step, such as but not limited to a centrifuge spin, is performed to keep the transported sample level with respect to the receiving location. In one embodiment, the gravitational acceleration of this secondary or subsequent centrifuge is less than about 43% of the gravitational acceleration of said first centrifuge. In one embodiment, the gravitational acceleration of this secondary or subsequent centrifuge is less than about 40% of the gravitational acceleration of said first centrifuge. In one embodiment, the gravitational acceleration of this secondary or subsequent centrifuge is less than about 30% of the gravitational acceleration of said first centrifuge. In one embodiment, the gravitational acceleration of this secondary or subsequent centrifuge is less than about 25% of the gravitational acceleration of said first centrifuge. In one embodiment, the gravitational acceleration of this secondary or subsequent centrifuge is less than about 20% of the gravitational acceleration of said first centrifuge. In one embodiment, the gravitational acceleration of this secondary or subsequent centrifuge is less than about 15% of the gravitational acceleration of said first centrifuge. In one embodiment, the gravitational acceleration of this secondary or subsequent centrifuge is less than about 12.5% of the gravitational acceleration of said first centrifuge. In one embodiment, the gravitational acceleration of this secondary or subsequent centrifuge is less than about 10% of the gravitational acceleration of said first centrifuge.

  In one embodiment, this secondary or subsequent spin is less than 1400 g. In one embodiment, this secondary or subsequent spin is less than 1300 g. In one embodiment, this secondary or subsequent spin is less than 1200 g. In one embodiment, this secondary or subsequent spin is less than 1100 g. In one embodiment, this secondary or subsequent spin is less than 1000 g. In one embodiment, this secondary or subsequent spin is less than 900 g. In one embodiment, this secondary or subsequent spin is less than 800 g. In one embodiment, this secondary or subsequent spin is less than 700 g. In one embodiment, this secondary or subsequent spin is less than 600 g. In one embodiment, this secondary or subsequent spin is less than 500 g. In one embodiment, this secondary or subsequent spin is less than 400 g. In one embodiment, this secondary or subsequent spin is less than 300 g. In one embodiment, this secondary or subsequent spin is less than 200 g. In one embodiment, this secondary or subsequent spin is less than 100 g. In at least one embodiment, for any of the foregoing, the minimum gravitational acceleration can be at least 10 g. In at least one embodiment, for any of the foregoing, the minimum gravitational acceleration can be at least 20 g. In at least one embodiment, for any of the foregoing, the minimum gravitational acceleration can be at least 30 g. In at least one embodiment, for any of the foregoing, the minimum gravitational acceleration can be at least 40 g. In at least one embodiment, for any of the foregoing, the minimum gravitational acceleration can be at least 50 g. As a non-limiting example, in one embodiment, the secondary spin is no greater than about 500 g, but is at least greater than 10 g. Optionally, in one embodiment, the secondary spin is about 500 g or less, but greater than at least 20 g. Optionally, in one embodiment, the secondary spin is no greater than about 500 g, but greater than at least 30 g. Optionally, in one embodiment, the secondary spin is about 500 g or less, but greater than at least 40 g. Optionally, in one embodiment, the secondary spin is no greater than about 500 g, but greater than at least 50 g. As a non-limiting example, in one embodiment, the secondary spin is not greater than about 400 g, but is at least greater than 10 g. Optionally, in one embodiment, the secondary spin is not greater than about 400 g, but greater than at least 20 g. Optionally, in one embodiment, the secondary spin is not greater than about 400 g, but greater than at least 30 g. Optionally, in one embodiment, the secondary spin is about 400 g or less, but greater than at least 40 g. Optionally, in one embodiment, the secondary spin is about 400 g or less, but greater than at least 40 g.

  As a non-limiting example, in one embodiment, the secondary spin is about 500 g or less, but sufficient to form a horizontal, substantially flat meniscus for the sample in the vessel. It exceeds the minimum. Too high gravitational acceleration can cause the rupture or leakage of internal cellular fluids or substances into the plasma of the sample, which can alter the results, so the upper bound is not formed during the second centrifugation. Selected blood components can be selected so as not to overcompress. The lower bound can be selected such that a horizontal, substantially flat meniscus can be formed on the sample in the vessel. In one embodiment, when processing a volume of about 10 to about 100 microliters, this substantially flat, non-angular surface can facilitate aspiration of the sample in an accurate and reproducible manner. In one embodiment, when processing volumes of about 20 to about 150 microliters, this substantially flat, non-angular surface can facilitate aspiration of the sample in an accurate and reproducible manner. In one embodiment, when processing volumes of about 30 to about 200 microliters, this substantially flat, non-angular surface can facilitate aspiration of the sample in an accurate and reproducible manner. A meniscus that is not flat or that is angled with respect to horizontal can cause problems for partial suction. Optionally, the meniscus may be on a plane substantially perpendicular to the longitudinal axis of the vessel (such as a horizontal plane perpendicular to the longitudinal axis of the vessel when the vessel retains a vertical orientation).

  Optionally, the time interval for the secondary centrifugation is approximately the same as the first centrifugation. Optionally, the time interval for the secondary centrifugation is less than the first centrifugation. Optionally, the time interval for the secondary centrifugation is about 50% of the first centrifugation. Optionally, the time interval for the secondary centrifugation is about 40% of the first centrifugation. Optionally, the time interval for the secondary centrifugation is about 30% of the first centrifugation. Optionally, the time interval for the secondary centrifugation is about 20% of the first centrifugation. Optionally, the time interval for the secondary centrifugation is about 5-50% of the first centrifugation. Optionally, the time interval for the secondary centrifugation is about 5-40% of the first centrifugation. Optionally, the time interval for the secondary centrifugation is about 5 to 33% of the first centrifugation. Optionally, the time interval for the secondary centrifugation is about 5-30% of the first centrifugation.

  Optionally, the gravitational acceleration of the secondary centrifuge is about 5% to about 30% of the first centrifuge and after the sample is transported from the first position to the second position Arise. Optionally, the gravitational acceleration of the secondary centrifuge is about 5% to about 35% of the first centrifuge and after the sample is transported from the first position to the second position Arise. Optionally, the gravitational acceleration of the secondary centrifuge is about 5% to about 40% of the first centrifuge and after the sample is transported from the first position to the second position Arise. Optionally, the gravitational acceleration of the secondary centrifuge is about 5% to about 50% of the first centrifuge, and after the sample is transported from the first position to the second position Arise.

  Optionally, the gravitational acceleration of the secondary centrifuge is about 5% to about 50% of the first centrifuge, and after the sample is transported from the first position to the second position Occurs and the secondary centrifugation does not exceed about 500 g. Optionally, the gravitational acceleration of the secondary centrifuge is about 5% to about 40% of the first centrifuge and after the sample is transported from the first position to the second position Occurs and the secondary centrifugation does not exceed about 500 g. Optionally, the gravitational acceleration of the secondary centrifuge is about 5% to about 30% of the first centrifuge and after the sample is transported from the first position to the second position Occurs and the secondary centrifugation does not exceed about 500 g. Optionally, the gravitational acceleration of the secondary centrifuge is about 5% to about 20% of the first centrifuge and after the sample is transported from the first position to the second position Occurs and the secondary centrifugation does not exceed about 500 g.

  Optionally, the gravitational acceleration of the secondary centrifuge is about 5% to about 50% of the first centrifuge, and after the sample is transported from the first position to the second position Occurs and the secondary centrifugation does not exceed about 400 g. Optionally, the gravitational acceleration of the secondary centrifuge is about 5% to about 40% of the first centrifuge and after the sample is transported from the first position to the second position Occurs and the secondary centrifugation does not exceed about 400 g. Optionally, the gravitational acceleration of the secondary centrifuge is about 5% to about 30% of the first centrifuge and after the sample is transported from the first position to the second position Occurs and the secondary centrifugation does not exceed about 400 g. Optionally, the gravitational acceleration of the secondary centrifuge is about 5% to about 20% of the first centrifuge and after the sample is transported from the first position to the second position Occurs and the secondary centrifugation does not exceed about 400 g.

  Secondary spin after sample transport can be used to keep the / plasma level horizontal, lowering the plasma adhering to the cap and side walls of the sample container (so sample loss is And) and move the fibrin clot out of the plasma. This ensures the optimal use of the sample (no loss), accurate imaging of the sample, and sample volume calculation, and efficient aspiration of the sample from the sample container.

  Optionally, in some embodiments, the non-centrifugation second step includes, but is not limited to, a shaker, tapper, to facilitate re-joining the sample on the cap with other sample portions in the container. , Inverters, other non-centrifugation mechanical methods can be used, or any single or combination of the above to move the sample from the cap or side wall of the sample vessel into the vessel Can be used.

  In an embodiment, the process provided herein comprises transporting a blood sample at a sample collection location, and then the blood sample from the sample collection location to an analysis site at a location different from the sample collection location. May be included. Similarly, the analysis site may receive blood samples collected at different sample collection locations. In such embodiments, the blood sample or a portion thereof may be centrifuged at the sample collection location and then again at the analysis site after arriving at the analysis site. In an embodiment, centrifugation of the blood sample at the sample collection site can facilitate separation of blood into i) plasma or serum and 2) formed components (eg, red blood cells). In an embodiment, a gel-like substance can be provided in the container for blood, so that during the centrifugation of the blood in the container, the gel layer from the components formed in the blood collector To separate the plasma or serum layer. In an embodiment, centrifugation of the blood sample at an analysis site may facilitate movement of the blood sample in the container toward the bottom of the container (eg, leaving the container cap or under a wall).

  In one embodiment, the time interval between centrifugation of the blood sample at the sample collection site and centrifugation at the analysis site is at least about 1 hour. Optionally, the time interval is at least about 2 hours. Optionally, the time interval is at least about 3 hours. Optionally, the time interval is at least about 4 hours. Optionally, the time interval is at least about 5 hours. Optionally, the time interval is at least about 6 hours. Optionally, the time interval is at least about 7 hours. Optionally, the time interval is at least about 8 hours. Optionally, the time interval is at least about 9 hours. Optionally, the time interval is at least about 10 hours. Optionally, the time interval is at least about 11 hours. Optionally, the time interval is at least about 12 hours. Optionally, the time interval is at least about 13 hours. Optionally, the time interval is at least about 14 hours. Optionally, the time interval is at least about 15 hours. Optionally, the time interval is at least about 16 hours. Optionally, the time interval is at least about 17 hours. Optionally, the time interval is at least about 18 hours. Optionally, the time interval is at least about 19 hours. Optionally, the time interval is at least about 20 hours. Optionally, the time interval is at least about 21 hours. Optionally, the time interval is at least about 22 hours. Optionally, the time interval is at least about 23 hours. Optionally, the time interval is at least about 24 hours. Optionally, the time interval is at least about 28 hours. Optionally, the time interval is at least about 32 hours. Optionally, the time interval is at least about 36 hours. Optionally, the time interval is at least about 40 hours. Optionally, the time interval is at least about 44 hours. Optionally, the time interval is at least about 48 hours.

  In one embodiment, centrifuging the blood sample at the sample collection site comprises centrifuging at least 3000 g. In one embodiment, centrifuging the blood sample at the sample collection site comprises centrifuging at least 3100 g. In one embodiment, centrifuging the blood sample at the sample collection site comprises centrifuging at least 3200 g. In one embodiment, centrifuging the blood sample at the sample collection site comprises centrifuging at least 3300 g. In one embodiment, centrifuging the blood sample at the sample collection site comprises centrifuging at least 3400 g. In one embodiment, centrifuging the blood sample at the sample collection site comprises centrifuging at least 3500 g. In one embodiment, centrifuging the blood sample at the sample collection site comprises centrifuging at at least 3550 g. In one embodiment, centrifuging the blood sample at the sample collection site comprises centrifuging at least 3575 g. In one embodiment, centrifuging the blood sample at the sample collection site comprises centrifuging at least 3700 g. In one embodiment, centrifuging the blood sample at the sample collection site comprises centrifuging at least 3800 g. In one embodiment, centrifuging the blood sample at the sample collection site comprises centrifuging at least 3900 g. In one embodiment, centrifuging the blood sample at the sample collection site comprises centrifuging at least 3950 g. Optionally, the sample is centrifuged for at least about 1 minute. Optionally, the sample is centrifuged for at least about 2 minutes. Optionally, the sample is centrifuged for at least about 3 minutes. Optionally, the sample is centrifuged for at least about 4 minutes. Optionally, the sample is centrifuged for at least about 5 minutes. Optionally, the sample is centrifuged for at least about 6 minutes. Optionally, the sample is centrifuged for at least about 7 minutes. Optionally, the sample is centrifuged for at least about 8 minutes. Optionally, the sample is centrifuged for at least about 9 minutes. Optionally, the sample is centrifuged for at least about 10 minutes.

  Optionally, the centrifugal acceleration of gravity at the analysis site is less than about 43% of the centrifugal acceleration of gravity at the sample collection site. Optionally, the centrifugal acceleration of gravity at the analysis site is less than about 40% of the centrifugal acceleration of gravity at the sample collection site. Optionally, the centrifugal acceleration of gravity at the analysis site is less than about 30% of the centrifugal acceleration of gravity at the sample collection site. Optionally, the gravity acceleration of the centrifuge at the analysis site is less than about 25% of the gravity acceleration of the centrifuge at the sample collection site. Optionally, the gravity acceleration of the centrifuge at the analysis site is less than about 20% of the gravity acceleration of the centrifuge at the sample collection site. Optionally, the centrifugal acceleration of gravity at the analysis site is less than about 15% of the centrifugal acceleration of gravity at the sample collection site. Optionally, the centrifugal acceleration of gravity at the analysis site is less than about 12.5% of the centrifugal acceleration of gravity at the sample collection site. Optionally, the gravity acceleration of centrifugation at the analysis site is less than about 10% of the gravity acceleration of centrifugation at the sample collection site.

  In one embodiment, the centrifugation at the analysis site is less than 1400 g. In one embodiment, the centrifugation at the analysis site is less than 1300 g. In one embodiment, the centrifugation at the analysis site is less than 1200 g. In one embodiment, the centrifugation at the analysis site is less than 1100 g. In one embodiment, the centrifugation at the analysis site is less than 1000 g. In one embodiment, the centrifugation at the analysis site is less than 900 g. In one embodiment, the centrifugation at the analysis site is less than 800 g. In one embodiment, the centrifugation at the analysis site is less than 700 g. In one embodiment, the centrifugation at the analysis site is less than 600 g. In one embodiment, the centrifugation at the analysis site is less than 500 g. In one embodiment, the centrifugation at the analysis site is less than 400 g. In one embodiment, the centrifugation at the analysis site is less than 300 g.

  Optionally, the time interval of centrifugation at the analysis site is about the same as the centrifugation at the sample collection site. Optionally, the time interval for centrifugation at the analysis site is shorter than the centrifugation at the sample collection site. Optionally, the time interval for centrifugation at the analysis site is less than 50% of the centrifugation at the sample collection site. Optionally, the time interval for centrifugation at the analysis site is less than 40% of the centrifugation at the sample collection site. Optionally, the time interval for centrifugation at the analysis site is less than 30% of the centrifugation at the sample collection site. Optionally, the time interval for centrifugation at the analysis site is less than 20% of the centrifugation at the sample collection site. In at least some embodiments, a health care provider (or their staff if appropriate) may be the sample collector, the recipient of the test results, and / or both. For example, in one embodiment, a health care professional such as but not limited to a dentist collects samples as part of a dental procedure or as a separate one. Optionally, some embodiments may have a sample from blood and / or saliva aspirated from the subject's dental procedures. The collected samples are processed at the dental office and / or shipped to a receiving location that receives a plurality of samples for processing.

  In embodiments, a bodily fluid sample used in the system, device, or method provided herein can be diluted. In embodiments, the bodily fluid sample may be diluted before it is transported from the first location to the second location. In embodiments, the bodily fluid sample may be diluted after it is transported from the first location to the second location. In embodiments, the bodily fluid sample can be diluted both before and after it is transported from the first location to the second location. In an embodiment, the bodily fluid sample is used after it has been transported from a first location to a second location and to perform one or more steps of a clinical test at the second location. Diluted before. The original samples are at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 50, 100, 200, 300, 400, 500, 1000, 5,000, 10,000, It can be diluted 50,000 or 100,000 times. As used herein, “n-fold dilution” refers to the ratio at which the original sample is diluted—for example, an original sample diluted 5 times is one-fifth of the original concentration after dilution. Contains the original sample (ie, the diluted sample contains 1/5 of the concentration of the sample in the original sample); similarly, the original sample diluted 500 times is Include an original sample at 1/500 of the original concentration. Thus, for example, if the original sample contains 5 mg / microliter of protein and it is diluted 2-fold, the diluted sample contains 2.5 mg / microliter of protein. The bodily fluid sample can be divided into any number of parts, and the various parts can be diluted to different degrees of dilution, so that the original bodily fluid sample is a multi-diluted sample. Can be processed to produce, each having a different degree of dilution. Thus, for example, an original body fluid sample can be divided into five parts, one part diluted 8 times, another part diluted 12 times, and another part diluted 3 times. , Another part is diluted 400 times, and another part is diluted 2,000 times. Sample dilution can be performed sequentially in a single step. For single-step dilution, a selected amount of sample can be mixed with a selected amount of diluent to achieve the desired dilution of the sample. For sequential dilution, two or more individual sequential dilutions of the sample can be performed to achieve the desired dilution of the sample. For example, a first dilution of the sample can be performed, and a portion of the first dilution can be used as the input material for the second dilution to produce a sample at a selected dilution level.

  For the dilutions described herein, “original sample” etc. refers to the sample used to initiate a given dilution process. Thus, an “original sample” is a sample obtained directly from a subject (eg, whole blood), while any other sample (eg, processed) used as a starting material for a given dilution procedure. Or a sample already diluted in a separate dilution procedure).

  In some embodiments, serial dilution of the sample can be accomplished as follows. A selected amount (eg, volume) of the original sample can be mixed with the selected amount of diluent to produce a first diluted sample. The first diluted sample (and any subsequent diluted sample) is: i) a sample dilution factor (eg the amount by which the original sample is diluted in the first diluted sample) and ii) the initial amount (Eg, the total amount of the first diluted sample present after the selected amount of the original sample and the selected amount of diluent have been mixed). For example, to produce a first diluted sample with a 5 times sample dilution factor (as compared to the original sample) and an initial volume of 50 microliters, 10 microliters of the original sample is 40 microliters of Can be mixed with a diluent. Next, a selected amount of the first diluted sample can be mixed with a selected amount of diluent to produce a second diluted sample. For example, to produce a second diluted sample having a 100-fold sample dilution factor (as compared to the original sample) and an initial volume of 100 microliters, the first diluted sample of 5 microliters is 95 May be mixed with microliters of diluent. For each of the above dilution steps, the original sample, diluted sample, and diluent can be stored or mixed therein in a fluidly separated container. Sequential dilution may continue in the preceding manner for as many steps as necessary until the selected sample dilution level / dilution factor is reached. In embodiments, the sample can be found in, for example, US patent application Ser. No. 13 / 769,820, filed Feb. 18, 2013, or any other document incorporated by reference elsewhere herein. Can be diluted as described.

  As used herein, those that can be used as reagents, or “diluents” are useful, for example, to increase sample volume, sample portion, or reconstituted after lyophilization, Or useful for the preparation of liquid formulations for adding solutions or substances to a sample for any other reason. In embodiments, the diluent can be buffered (eg, having a pH, or other desired pH close to or close to pH 7.4), and pharmaceutically acceptable (to humans). Safe and non-toxic). The diluent typically does not react or bind to the analyte in the sample. The water can be a diluent, as a saline solution, a buffered solution, a solution containing a surfactant, or any other solution. Exemplary diluents include sterile water, bacteriostatic water for injection (BWFI), pH buffered solution (eg, phosphate buffered saline), sterile saline solution, Ringer's solution or dextrose solution. . In embodiments, the diluent may comprise an aqueous solution of saline or buffer.

  In an embodiment, a system or method provided herein, for example, a body fluid sample or portion thereof collected, processed or transported from a subject is at least 2, 3, 4, 5, 6 , 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100, 200, 300, 400, 500, 1000, 5,000, 10,000 or more different parts Can be done. For splitting a sample into multiple parts, as provided herein, “original sample” or the like refers to a sample used to initiate a given splitting process. Thus, an “original sample” is a sample obtained directly from a subject (eg, whole blood), while any other sample (eg, processed) that was used as a starting material for a given splitting procedure. Or a sample already diluted in a separate splitting procedure). In an embodiment, an “original sample” can be subjected to both a sample division and dilution step; in such circumstances, reference to the “original sample” refers to a sample dilution / sample division procedure. Refers to the starting material used for the combination. When a sample is divided into different parts, the different parts may contain different amounts of the original sample. For example, if an original sample having a volume of 100 microliters is divided into 5 parts, one part can contain 50 microliters of the original sample and another part can contain 25 microliters of the original sample. Can contain a sample, another part can contain 15 microliters of the original sample, another part can contain 8 microliters of the original sample, and the last part can contain 2 microliters Original sample can be included. Similarly, when a sample undergoes both dilution and division into different parts, the different parts can have different degrees of dilution relative to the original sample. For example, when an original sample is divided into three parts, one part is diluted 5 times with respect to the original sample and another part is diluted 20 times with respect to the original sample. , And the third part can be diluted 200 times with respect to the original sample.

  Thus, in one embodiment, a body fluid sample can be collected from a subject at a first location (eg, a sample collection site). The bodily fluid sample initially collected from the subject is considered the “original sample”. An “original sample” can be, for example, a small amount of whole blood (eg, less than 400, 300, 200, or 100 microliters) from the subject. A little later or simultaneously with the collection of the “original sample” from the subject, the “original sample” can be divided into at least a first part and a second part, after which The first part is moved into a first container and the second part is moved into a second container. In embodiments, the first container can include a first anticoagulant (eg, EDTA) and the second container is a second anticoagulant (eg, heparin). The first and second containers may be transported from the first location to the second location by the system or method provided herein. In an embodiment, at the second location, the sample, or part thereof, in one or both of the containers is subjected to further processing or analysis steps. For example, the sample, or portion thereof, in one or both of the containers can be divided into additional portions, diluted, and / or used to perform one or more tests.

  In another example, the systems and methods provided herein route a bodily fluid sample in a container from a first location to a second location. The bodily fluid sample in the container may be the entire sample collected from the subject or a portion thereof. At the second location, at least some of the bodily fluid sample in the container can be removed from the container and used for sample splitting and / or dilution procedures. The sample that has been removed from the container and used in the sample splitting and / or dilution procedure may be considered the “original sample”. The original sample can be, for example, whole blood, plasma, serum, saliva, or urine, and can constitute the whole or a portion of the sample transported in the container. The original sample can be divided into any number of parts; the various parts can have different degrees of dilution relative to the original sample. For example, the original sample removed from the transported container is 400, 300, 250, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, It may have a volume of 9, 8, 7, 6, 5, 4, 3, 2, or 1 microliter or less. The original sample removed from the transported container is then at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100 , 200, 300, 400, 500, 1000, 5,000, 10,000 or more different parts. In an embodiment, the different parts may have different degrees of dilution relative to the original sample. For example, the different parts are at least a few, with the condition that the number of parts having different degrees of dilution relative to the original sample does not exceed the total number of parts prepared from the original sample. 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100, 200, 300, 400, 500, 1000, or 5,000 different dilutions Can have. The different portions are, for example, undiluted, at least 2-fold diluted, at least 3-fold diluted, at least 5-fold diluted, at least 10-fold diluted, at least 20-fold diluted, at least 50-fold diluted, at least 100 relative to the original sample Can have any type of dilution, including fold dilution, at least 500 fold dilution, at least 1000 fold dilution, at least 5000 fold dilution, at least 10,000 fold dilution, at least 50,000 fold dilution, or at least 100,000 fold dilution . In embodiments, one or more different parts of the original sample can be used for clinical testing. In an embodiment, one part of the original sample can be used for clinical testing. One part of the original sample used for the clinical test can be a diluted sample.

  In embodiments, the original sample can be a whole blood sample collected from a subject. The original sample can be obtained from a subject's finger. The original samples are 400, 300, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, It can have a volume of less than 3, 2, or 1 microliter. The original sample may be divided into a plurality of parts. Dividing the sample into multiple parts is a combination before, after, or before and after the sample is transported from the first location to the second location by the system or method provided herein. Can be performed. In an embodiment, the original sample is at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100, 200, 300, 400, 500. , 1000, 5,000, 10,000 or more different parts, and said different parts are at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15 , 20, 25, 30, 35, 40, 50, 100, 200, 300, 400, 500, 1000, 5,000, 10,000 different clinical tests. Different parts of the original sample may have a diluted original sample. In the embodiment, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0. The original sample of less than 3, 0.2, 0.1, 0.05, or 0.01 microliter is used for each clinical test.

  In embodiments, the original sample can be plasma or serum obtained from a whole blood sample obtained from a subject. The whole blood can be obtained from a subject's finger. The whole blood sample from which the plasma or serum is obtained is 400, 300, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7 , 6, 5, 4, 3, 2, or a volume of less than 1 microliter. The original samples of plasma or serum are 300, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, It may have a volume of less than 4, 3, 2, or 1 microliter. The original sample may be divided into a plurality of parts. Dividing the sample into multiple parts is a combination before, after, or before and after the sample is transported from the first location to the second location by the system or method provided herein. Can be performed. In an embodiment, the original sample is at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100, 200, 300, 400, 500. , 1000, 5,000, 10,000 or more different parts, and said different parts are at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15 , 20, 25, 30, 35, 40, 50, 100, 200, 300, 400, 500, 1000, 5,000, 10,000. Different parts of the original sample may have a diluted original sample.

  In the embodiment, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0. The equivalent of an original sample of less than 3, 0.2, 0.1, 0.05, or 0.01 microliter is used for clinical testing. For example, the original sample is whole blood, and the original sample is divided into a plurality of portions, and at least one of the portions includes a diluted sample that includes the original sample diluted 100-fold, and If 5 microliters of the diluted sample is used to perform a clinical test, 0.05 microliter equivalent of the original sample (eg, whole blood) is used for the test (5 microliters). x 1/100 dilution). In another example, the original sample can be whole blood. The whole blood can be processed to produce plasma [eg, by separating the liquid component of the blood from the solid component of the blood (eg, cells)]. A specific volume of plasma can be obtained from a specific volume of whole blood. -For example, the volume of plasma obtained from the volume of whole blood can be, for example, at least or about 30%, 40%, 50%, 60%, or 70% of the whole blood volume. Thus, for example, if the volume of the plasma from whole blood is 50%, 1 ml of plasma can be obtained from 2 ml of whole blood. The plasma from whole blood can be further diluted, and one or more diluted portions of the plasma can be used to perform one or more clinical tests. In another example, the original sample can be whole blood. The whole blood is processed to produce plasma, and the volume of plasma from the whole blood is 60% of the whole blood (eg, 100 microliters of whole blood yields 60 microliters of plasma). ). The plasma can be diluted 10-fold. Two microliters of the diluted plasma can be used to perform a clinical test. Thus, for that clinical test, the equivalent of about 0.33 microliters of the original sample (whole blood) is used to perform the test (2 microliters x 1/10 dilution x 100/60 whole blood / Plasma conversion). In another example, the original sample can be plasma, and the original sample is divided into a plurality of portions, and at least one of the portions includes the original sample diluted 50-fold. Since the diluted sample contains and 4 microliters of the diluted sample is used to perform a clinical test, the equivalent of 0.08 microliters of the original sample (eg, plasma) Used for inspection (4 microliters x 1/50 dilution).

  In embodiments, the original sample is at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100, 200, 300, 400, Divided into 500, 1000, 5,000, 10,000 or more parts, and different parts are at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, It can be used to perform 35, 40, 50, 100, 200, 300, 400, 500, 1000, 5,000, 10,000 different clinical tests. In some embodiments, a number of sample portions equal to at least the number of sample portions on which a clinical test is performed are prepared (eg, to perform 10 clinical tests with an original sample, the original Sample is divided into at least 10 parts and at least one part is used per test). In certain other embodiments, more than one clinical test can be performed with a single sample. For example, in embodiments, the optical properties of a sample can be measured (eg, cell count in a blood sample), and then the same sample can be used for the assay of an analyte in the blood. Thus, in some embodiments, more clinical tests can be performed with the original sample than the number of parts prepared from the same original sample (eg, 10 clinical tests are divided into 8 parts). Can be carried out from original samples).

  If the original sample is divided into multiple parts, and if the multiple parts are used to perform more than one clinical test, the clinical tests are the same type of clinical test or they are There can be different types of clinical tests. For example, if the original sample is divided into 10 parts and each of the 10 parts is used in a clinical test, the clinical test performed by each of the parts may be an immunoassay. In another embodiment, if the original sample is divided into 5 parts and each of the 5 parts is used for clinical testing, the clinical test performed by each of the parts is a test that also follows nucleic acid amplification. obtain.

  In other cases, if the original sample is divided into multiple parts, and if the multiple parts are used to perform more than one clinical test, at least two of the clinical tests are of different types Can be clinical laboratory tests. For example, if the original sample is divided into 5 parts, and each of the 5 parts is used for clinical testing, two of the parts can be used for an immunoassay (eg, ELISA), and Three of the parts can be used for tests based on nucleic acid amplification.

  A body fluid sample or portion thereof transported by the system or method provided herein is used for various types of clinical tests such as immunological assays, nucleic acid amplification assays, general chemical assays, or hemocytometer assays. Can be. In embodiments, a bodily fluid sample or portion thereof transported by the system or method provided herein is, for example, US patent application Ser. No. 13 / 769,820, filed Feb. 18, 2013. Or any other type of assay or clinical test as described elsewhere in this specification, or in any other document incorporated by reference.

  In some embodiments, a bodily fluid sample or portion thereof transported by the system or method provided herein can be used in an immunoassay. As used herein, “immunological assay” refers to any assay, including probing a sample with an antibody having affinity for the sample. Immunological assays can include, for example, enzyme immunoassay adsorption (ELISA) assays, and can include competitive and non-competitive based assays. As used herein, the term “antibody” refers to an immunoglobulin molecule and an immunologically active portion of an immunoglobulin molecule, ie, an antigen binding unit that specifically binds an antigen (“initiates an immune response”) ( “Abu” or plural “Abus”). Structurally, the simplest natural antibody (eg, IgG) contains four polypeptide chains, two heavy (H) chains and two light (L) chains interconnected by disulfide bonds. Immunoglobulins represent a large family of molecules including diverse molecules such as IgD, IgG, IgA, IgM, and IgE. The term “immunoglobulin molecule” includes, for example, hybrid antibodies, or converted antibodies, and fragments thereof. Antigen binding units can be broadly divided into “single chains” (“Sc”) and “non-single chains” (“Nsc”) based on molecular structure.

  Furthermore, terms such as “antibody” and “antigen-binding unit” include human, non-human (from spine or invertebrate), chimeric, humanized immunoglobulin molecules and fragments thereof. For a description of chimeric and humanized antibodies, see Clark et al., 2000 and references cited therein (Clark, (2000) Immunol. Today 21: 397-402). A chimeric antibody contains the variable regions of a non-human antibody, eg, VH and VL regions of rat or mouse origin are operably linked to the constant region of a human antibody (see US Pat. No. 4,816,567). I want to be) In an embodiment, an “immunological assay” provided herein is such that the analyte to be measured in the assay is an antibody, and the antibody is a molecule to which the antibody has affinity (eg, the antibody Also included are assays probed with antibody target molecules.

  In some embodiments, a body fluid sample or portion thereof transported by the system or method provided herein can be used in a nucleic acid amplification assay. As used herein, a “nucleic acid amplification assay” refers to one in which the copy number of a target nucleic acid can be increased. Nucleic acid amplification assays can include both isothermal and variable temperature amplification techniques, and can include techniques such as, for example, polymerase chain reaction (PCR) and loop-mediated isothermal amplification (LAMP). Typically, a nucleic acid amplification assay includes at least i) a nucleic acid polymerase, ii) a primer that can bind to a target spreading sequence, and iii) a free nucleic acid that can be incorporated into the synthesized nucleic acid by the polymerase. Amplification of the target nucleic acid can be detected by various methods such as measuring the fluorescence or turbidity of the reaction over time.

  In some embodiments, a body fluid sample or portion thereof transported by the system or method provided herein can be used in a general chemical assay. General chemical assays include, for example, basal metabolic assay panels [glucose, calcium, sodium (Na), potassium (K), chloride (Cl), CO2 (carbon dioxide, bicarbonate), creatinine, blood nitrogen urea (BUN) )], Electrolyte assay panel [sodium (Na), potassium (K), chloride (Cl), CO2 (carbon dioxide, bicarbonate)], Chem14 assay panel / integrated metabolism panel [glucose, calcium, albumin, total protein , Sodium (Na), potassium (K), chloride (Cl), CO2 (carbon dioxide, bicarbonate), creatinine, blood nitrogen urea (BUN), alkaline phosphatase (ALP), alanine aminotransferase (ALT / GPT), aspartate aminotransferase (AST / GOT), total bilirubi ], Lipid profile / lipid panel assay [LDL cholesterol, HDL cholesterol, total cholesterol, and triglycerides], liver panel / liver function assay [alkaline phosphatase (ALP), alanine aminotransferase (ALT / GPT), aspartate aminotransferase ( AST / GOT), total bilirubin, albumin, total protein, γ-glutamine transpeptidase (GGT), lactate dehydrogenase (LDH), prothrombin time (PT)], alkaline phosphatase (APase), hemoglobin, VLDL cholesterol, ethanol, Lipase, pH, zinc protoporphyrin, direct bilirubin, blood group (ABO, RHD), lead, phosphate, hemagglutination inhibition, magnesium, iron, iron intake, fecal occult Blood, and others are included individually or in any combination.

  In some examples of the general chemical assays provided herein, the level of an analyte in a sample is reacted with one or more reagents of the analyte of interest, resulting in a detectable change (eg, , Change in turbidity of the reaction, generation of luminescence in the reaction, change in color of the reaction, etc.). In some embodiments, the nature of the sample reacts with one or more reagents of the analyte of interest to produce a detectable change (eg, change in turbidity of the reaction, generation of luminescence in the reaction). , The color change of the reaction, etc.). Typically, as used herein, a “general chemistry” assay is a nucleic acid amplification, imaging of cells on a microscope platform, or in solution based on the use of labeled antibodies / binders. Does not include determination of specimen level. In some embodiments, a general chemical assay is performed with all reagents in a single container--i.e., All necessary reagents are added to the reaction container to perform the reaction, and the During the course of the assay, no material is removed from the reaction or reaction vessel (eg, there is no wash step; it is a “mix and read” reaction). The general chemical assay can be, for example, a colorimetric assay, an enzymatic assay, a spectroscopic assay, a turbidity assay, an agglutination assay, a coagulation assay, and / or other types of assays. Many general chemical assays can be analyzed (eg, by a spectrometer) by measuring the absorbance of light at one or more selected wavelengths according to the assay reaction. In some embodiments, a general chemical assay can be analyzed by measuring the turbidity of the reaction according to the assay reaction (eg, by a spectrometer). In some embodiments, a general chemical assay can be analyzed by measuring the chemiluminescence produced by the reaction (eg, with a PMT, photodiode, or other optical sensor). In some embodiments, a general chemical assay can be performed computationally based on experimental values determined for one or more other analytes in the same or related assay. In some embodiments, a general chemical assay can be analyzed by measuring the fluorescence of the reaction (eg, i) a light source at a specific wavelength (“excitation wavelength”); and ii) emitted at a specific wavelength Including a sensor configured to detect light ("radiation wavelength") or connected to them). In some embodiments, a general chemical assay can be analyzed by measuring agglutination of the reaction (eg, by measuring the turbidity of the reaction with a spectrometer, or by imaging the reaction with an optical sensor). By getting). In some embodiments, general chemical assays can be analyzed by imaging the reaction (eg, with a CCD or CMOS optical sensor) and then image analysis at one or more time points. Optionally, the analysis can include prothrombin time, activated partial thromboplastin time (APTT), both of which can be measured by methods such as, but not limited to, turbidimetry. In some embodiments, a general chemical assay can be analyzed by measuring the viscosity of the reaction (for example, by a spectrometer if the viscosity of the reaction changes the optical properties of the reaction). In some embodiments, a general chemical assay can be analyzed by measuring the formation of a complex between two non-antibody reagents (eg, metal ion versus chromophore; such a reaction can be measured with a spectrometer Or by colorimetric analysis using another instrument). In some embodiments, the general chemical assay can be analyzed by a cellular antigen assay method by an ELISA or non-cytometric method (eg, hemagglutination for a blood group that can be measured by the turbidity of the reaction). Test). In some embodiments, general chemical assays can be analyzed with the aid of electrochemical sensors (eg, for carbon dioxide or oxygen). Additional methods can also be used to analyze general chemical assays.

  In some embodiments, a spectrometer can be used to measure general chemical assays. In some embodiments, a general chemical assay can be measured at the end of the assay (“end point” assay), or it can be measured at two or more times during the course of the assay (“time course”). Or “dynamic” test).

  In some embodiments, a bodily fluid sample or portion thereof transported by the system or method provided herein can be used in a hemacytometric assay. A cytometric assay is typically used to optically, electrically, or acoustically measure individual cell properties. For purposes of this disclosure, a “cell” includes, but is not limited to, a vesicle (such as a liposome), a small group of cells, a viral particle, a bacterium, a protozoan, a crystal, a mass due to aggregation of lipids and / or proteins And samples generally sized the same as individual cells containing substances bound to small particles, such as beads, nanoparticles, or microspheres. Properties include, but are not limited to: size; shape; particle size; light scattering pattern (or optical refractive index ellipsoid); whether cell membrane is complete; concentration; morphology and not limited Protein content, protein modification, nucleic acid content, nucleic acid modification, organelle content, nuclear structure, nuclear content, internal cell structure, internal follicular content (including pH), ion concentration, and steroids or drugs The presence of small molecules such as; and the spatio-temporal distribution of intracellular contents such as cell surface (both cell membrane and cell wall) markers including proteins, lipids, carbohydrates, and modifications thereof. By using an appropriate dye, stain, or other labeling molecule, in pure form, conjugated to other molecules, immobilized in other molecules, or bound to nano- or micro-particles A hemacytometer can be used to determine the presence, amount, and / or modification of a particular protein, nucleic acid, lipid, carbohydrate, or other molecule. Colorimetric analysis can be, for example, by flow cytometry or by microscopy. Flow cytometry typically uses a mobile liquid medium that brings individual cells sequentially to an optical, electrical or acoustic detector. Microscopy typically uses optical or acoustic means to detect immobile cells, generally by recording at least one magnified image. In an embodiment, the hemacytometry assay may include obtaining an image of one or more cells in the sample. In embodiments, the sample can be provided on or in a microscope slide or cuvette that allows cells in the sample to settle in a desired orientation for imaging. For example, an image of a cell can be obtained with a camera based on CCD or CMOS.

  In some embodiments, the type of clinical test is categorized based on how the result of the test is detected. Detection of different types of clinical laboratory results can include, for example, i) luminescence detection; ii) fluorescence detection; iii) absorbance detection; iv) light scatter detection; and v) imaging. Each of these detection methods is described, for example, in US patent application Ser. No. 13 / 769,820, filed Feb. 18, 2013, which is hereby incorporated by reference in its entirety for all purposes. The Briefly, luminescence can be detected from a test that produces a measurable light signal. Such a reaction can be, for example, a chemiluminescent reaction. In order to detect the result of the luminescent reaction, a photodetector such as a PMT or a photodiode can be used to detect light from the assay unit that contains the luminescent reaction. Fluorescence can be detected by optical settings including, for example, a light source and a photodetector. The light source may emit light of a specific wavelength. An assay unit containing the test substance can be present in the optical path of the light source so that light of the specific wavelength (“excitation wavelength”) can reach the contents of the assay unit. The assay unit may include molecules of interest that, under at least some circumstances, absorb light of a particular wavelength from the light source and then emit light of a different wavelength. The photodetector may be configured to detect light emitted from the molecule of interest (“radiation wavelength”). The light source and / or photodetector may include a band pass filter to limit light of the wavelength from the light source from reaching the photodetector after the light source or before the photodetector. May be included. The light source can be, for example, a light bulb, a laser, or an LED, and the photodetector can be, for example, a PMT or a photodiode. Absorbance can be detected by optical settings including, for example, a light source and a photodetector. The light source and photodetector can be in line with each other, and the light can pass through the test material to reach the photodetector, and so that some light can be absorbed. An assay unit containing a test substance may be configured to be between the light source and the photodetector. Based on the result of the test, different amounts of light can be absorbed by the test substance. Similarly, transmission of light passing through the test substance can be determined. For an assay for determination of absorbance / transmittance, the wavelength of light emitted by the light source may be the same as the wavelength of light detected by the photodetector. The light source can be, for example, a light bulb, a laser, or an LED, and the photodetector can be, for example, a PMT or a photodiode. Light scattering can be detected by optical settings including, for example, a light source and a photodetector. The light source and the light detector can exist at a fixed angle to each other, and light can pass through the test substance to reach the assay unit to reach the light detector, and An assay unit containing the test substance under test can be configured to be in line with both the light source and the photodetector so that light in the assay unit can be scattered. Based on the result of the examination, different amounts of light can be scattered by the examination substance. The light source can be, for example, a light bulb, a laser, or an LED, and the photodetector can be, for example, a PMT or a photodiode. An image of the test substance can be acquired by a detector including, for example, an image sensor (eg, a CCD or CMOS sensor). Typically, the image sensor can be included in a camera. The test substance image can be analyzed, for example, by automated or manual image analysis to determine test results. The body fluid sample provided herein is based on a non-optical detection method. Can also be used in clinical tests to detect results (eg, measurement of conductivity, radioactivity, or temperature).

  In an embodiment, in order to perform an assay / test with a body fluid sample portion, the body fluid sample portion is moved into an assay unit for at least one step of the assay / test. The assay unit may have various form factors such as pipette tips, tubes, or microscope slides. Assay steps that can be performed in an assay unit include, for example, binding of an analyte in the sample to a binder (eg, an antibody to the analyte), amplification of a target nucleic acid in the sample by a nucleic acid amplification reaction, one to the sample. Sample coagulation based on the addition of these reagents, or a sample that takes the shape for optical analysis (eg, sediments on the surface of a microscope slide to facilitate obtaining one or more images of the cells) Cells). As used herein, the terms “assay” and “test” can be used interchangeably unless the context clearly indicates otherwise.

EXAMPLES The following examples are provided for illustrative purposes only and are not intended to limit the present disclosure in any manner.

  Example 1

  A whole blood sample was obtained from the subject. The whole blood sample was centrifuged in a container to separate the whole blood into pelleted cells and plasma supernatant. The centrifuged container was transferred to a glove box ventilated with argon. Plasma is aspirated from the centrifuged container and then aliquoted into individual sample container notes provided herein, each of the sample containers having an internal volume of less than 100 microliters. And less than 95 microliters of plasma was aliquoted into each sample container, and each of the sample containers was the same size and received the same volume of plasma. Each of the containers had a removable butyl rubber cap. The five sample containers are associated with each sample container labeled “0 hours”, “1 hour”, “2 hours”, “8 hours”, and “24 hours”, The sample in each container was assayed for bicarbonate. The results of the assay are provided in Table 1 of the tongue.

  As shown in Table 1, the bicarbonate in the sample was stable for at least 24 hours in the sample containers provided herein.

Example 2

  A whole blood sample was obtained from the subject. EDTA was mixed into the whole blood sample. 80 microliters of blood containing the EDTA is equally differentiated into each of the ten sample containers provided herein, each of the sample containers having an internal volume of less than 100 microliters and the same size. had. The sample containers were labeled for analysis as follows: real time: 1, 2, 3, 4, 5, and 7 days; before centrifugation: 1, 2, 4, and 7 days . Each container before “centrifugation” was centrifuged at the time the samples were equidifferentiated in the container to produce plasma and pelleted cells. Each of the “real time” containers was centrifuged on the respective day to produce plasma and pelleted cells. After the samples were equally differentiated into their respective sample containers, they were capped. For each container, on each day, plasma was removed from the container and assayed for blood nitrogen urea (BUN). The result of the BUN test is shown in the graph in FIG. As shown in the graph, among the samples in the sample containers provided herein, BUN was stable for at least 7 days in both whole blood and plasma samples.

Publications discussed or cited herein are provided solely for their disclosure prior to the filing date of the present application. Nothing in this specification should be construed as an admission that it is not eligible for prior publications for reasons of prior invention. Furthermore, the publication dates provided can be different from the actual publication dates that need to be individually confirmed. All publications mentioned in this specification are herein incorporated by reference to disclose and describe in which structure and / or method the publication is cited. The following applications are hereby incorporated by reference in their entirety for all purposes: US Provisional Application No. 61 / 435,250, filed Jan. 21, 2011 ("SYSTEMS AND METHODS FOR SAMPLE"). USE MAXIMIZATION "), and US Patent Application No. 2009/0088336 (" MODULAR POINT-OF-CARE DEVICES, SYSTEMS, AND USES THEREOF "). The following applications are hereby incorporated by reference in their entirety for all purposes: US Patent Application No. 2005/0100937, US Patent No. 8,380,541; filed on Feb. 18, 2013 U.S. Provisional Patent Application No. 61 / 766,113; U.S. Patent Application No. 13 / 769,798, filed February 18, 2013; U.S. Patent Application No. 13/769, filed February 18, 2013. US Patent Application No. 13 / 769,820 filed February 18, 2013; US Patent Application No. 13 / 244,947 filed September 26, 2011; September 2012 PCT / US2012 / 57155 filed on 25th; US patent application 13 / 244,946 filed on 26th September 2011; filed on 26th September 2011 National Patent Application No. 13 / 244,949; and US Provisional Patent Application No. 61 / 673,245 filed on September 26, 2011, the disclosures of these patents or patent applications are hereby incorporated by reference in their entirety. Are incorporated herein. Further, US Patent Application No. 62 / 195,287 filed on July 21, 2015, US Patent Application No. 62 / 011,023 filed June 11, 2014, July 30, 2014 U.S. Patent Application No. 14 / 447,099 filed, U.S. Patent Application No. 14 / 446,080 filed on July 29, 2014, and U.S. Patent Application filed on December 5, 2013 No. 14 / 098,177 is hereby incorporated by reference in its entirety for all purposes.
Embodiment

  In one embodiment described herein, a device is provided for collecting a bodily fluid sample from a subject, including: the bodily fluid sample into the device from a single end of the device that contacts the subject. At least two sample collection paths configured to withdraw, thereby separating the fluid sample into two separate samples; a plurality of sample containers for receiving the bodily fluid samples collected in the sample collection path; A second portion comprising: the sample container is operably engageable because of fluid communication with the sample collection path; and when fluid communication is established, the container is Provides a driving force for moving most of the two separate samples from the path to the vessel.

  In another embodiment described herein, an apparatus for collecting a bodily fluid sample is provided that is configured to withdraw a fluid sample therein via a first type of motive force. A first portion including at least one fluid collection location leading to at least two sample collection paths; a second portion including a plurality of sample containers for receiving bodily fluid samples collected from the sample collection path. Operatively engageable to be in fluid communication with the sample collection path, and when fluid communication is established, the container passes a majority of the two separate samples to the path. Providing a second motive force different from the first motive force for moving from the container to the container, and when at least one of the sample collection paths has reached a minimum fill level Includes a filling instrument for Shimesuru, and at least one of said sample container, at least one of said sample collection path can engage to be in fluid communication.

  In another embodiment described herein, an apparatus for collecting a bodily fluid sample is provided that includes: for drawing a fluid sample into a sample collection channel via a first type of motive force. A first portion comprising at least two sample collection channels, wherein one of the sample collection channels has an inner coating designed to mix with the fluid sample, and another The sample collection channel has a second inner coating that is chemically different from the inner coating; and is a second portion that includes a plurality of sample containers for receiving bodily fluid samples collected in the sample collection channel. The sample container is in fluid communication with the sample collection path and is operably engageable and fluid communication is When stood, the container provides a second motive force different from the first motive force for moving a majority of the two separate samples from the path to the container, the container , Arranged to prevent mixing of the fluid sample between the containers.

  In another embodiment described herein, an apparatus for collecting a bodily fluid sample is provided that includes: a first portion including a plurality of sample collection channels, wherein at least two of the channels are Configured to withdraw a fluid sample into each of the at least two sample collection channels simultaneously via a first type of motive force; a plurality of samples for receiving bodily fluid samples collected in the sample collection channel A second portion including a container, wherein the sample container is in a first state where the sample container is not in fluid communication with the sample collection channel, and the sample container is operated in fluid communication with the collection channel. Including a second state that is capable of engagement, and when fluid communication is established, To move to the container, the container provides a different second driving force from said first motive force.

  In another embodiment described herein, an apparatus for collecting a bodily fluid sample is provided that includes: (a) including a first opening and a second opening, and said first A collection channel configured to withdraw a bodily fluid sample by capillary action from an opening of the bodily toward the second opening; and (b) a sample container for receiving the bodily fluid sample, the container comprising: Engageable with the collection channel, having a vacuum interior therein and a cap configured to receive the channel; the second opening extends through the cap of the sample container And a portion of the collection channel configured to provide a fluid flow path between the collection channel and the sample container, and the sample container is Having an internal volume of less than 10 times the internal volume of said collection channel.

  In another embodiment described herein, an apparatus for collecting a bodily fluid sample is provided that includes: (a) including a first opening and a second opening, and said first A collection channel configured to withdraw a bodily fluid sample by capillary action from an opening of the bodily into the second opening; (b) a sample container for receiving the bodily fluid sample, the container being Is engageable with a collection channel, has a vacuum interior therein, and has a cap configured to receive the channel; and (c) a fluid flow path for the collection channel and the sample container An adapter channel configured to provide between, having a first opening and a second opening, wherein the first opening contacts the second opening of the collection channel Is configured in order, the second opening is configured to penetrate the cap of the sample container.

  In another embodiment described herein, an apparatus for collecting a bodily fluid sample is provided that includes: (a) a body including a collection channel, the collection channel comprising a first opening. And a second opening, and configured to withdraw a bodily fluid sample by capillary action from the first opening toward the second opening; (b) for receiving the bodily fluid sample A base including a sample container, the sample container being engageable with the collection channel, having a vacuum interior therein, and having a cap configured to receive the channel; and c) a support, wherein the sample collection device is configured to have a stretched state and a compressed state, wherein the stretched state of the device is at least one of the base portions than in the compressed state. The body and the base are coupled to opposite ends of the support and configured to be movable relative to each other so that a minute can be closer to the body, and the second of the collection channel An opening is configured to pass through the cap of the sample container, and in the extended state of the instrument, the second opening of the collection channel does not contact the interior of the sample container and the instrument is compressed In a state, the second opening of the collection channel extends through the cap of the container into the sample container, thereby providing fluid communication between the collection channel and the sample container.

  In another embodiment described herein, an apparatus for collecting a bodily fluid sample is provided that includes: (a) a body including a collection channel, the collection channel comprising a first opening. And a second opening, and configured to withdraw a bodily fluid sample by capillary action from the first opening toward the second opening; (b) for receiving the bodily fluid sample A base including a sample container, the sample container being engageable with the collection channel, having a vacuum interior therein, and having a cap configured to receive the channel; ) A support, and (d) an adapter channel having a first opening and a second opening, wherein the first opening is in contact with the second opening of the collection channel Structure And the second opening is configured to pass through the cap of the sample container, and the sample collection device is configured to have an extended state and a compressed state, wherein the extended state of the device is in a compressed state. Rather, the body and the base are coupled to opposite ends of the support and configured to be movable relative to each other so that at least a portion of the base can be closer to the body. In the extended state of the instrument, the adapter channel is not in contact with one or both of the collection channel and the interior of the sample container, and in the compressed state of the instrument, the first opening of the adapter channel. A portion is in contact with the second opening of the collection channel, and the second opening of the adapter channel , Through the cap of the container, the sample container and inside the elongation, thereby providing fluid communication between said collection channel and said sample container.

  In another embodiment described herein, an apparatus for collecting a bodily fluid sample is provided that includes: (a) a body including a collection channel, the collection channel comprising a first opening. And a second opening, and configured to withdraw a bodily fluid sample by capillary action from the first opening toward the second opening; (b) engage the body A base, the base supporting a sample container, the container being engageable with the collection channel, having a vacuum interior therein, and having a cap configured to receive the channel A second opening in the collection channel extends through the cap of the container and into the sample container, thereby providing fluid communication between the collection channel and the sample container; Constructed.

  In another embodiment described herein, an apparatus for collecting a bodily fluid sample is provided that includes: (a) a body including a collection channel, the collection channel comprising a first opening. And a second opening, and configured to withdraw a bodily fluid sample by capillary action from the first opening toward the second opening; (b) engage the body A base, the base supporting a sample container, the container being engageable with the collection channel, having a vacuum interior therein, and having a cap configured to receive the channel (C) an adapter channel having a first opening and a second opening, wherein the first opening is configured to contact a second opening of the collection channel; and Said second opening Configured to penetrate the cap of the sample container.

  It should be understood that one or more of the following features may be adapted for use with any of the embodiments described herein. As a non-limiting example, the body can include two collection channels. Optionally, the interior of the collection channel is coated with an anticoagulant. Optionally, the body is coated with a first collection channel and a second collection channel, and the interior of the first collection channel is a different anticoagulant than the interior of the second collection channel. . Optionally, the first anticoagulant is ethylenediaminetetraacetic acid (EDTA) and the second anticoagulant is different from EDTA. Optionally, the first anticoagulant is citrate and the second anticoagulant is different from citrate. Optionally, the first anticoagulant is heparin and the second anticoagulant is different from heparin. Optionally, one anticoagulant is heparin and the second anticoagulant is EDTA. Optionally, one anticoagulant is heparin and the second anticoagulant is citrate. Optionally, one anticoagulant is citrate and the second anticoagulant is EDTA. Optionally, the body is formed from an optically transmissive material. Optionally, the instrument includes the same number of sample containers as the collection channel. Optionally, the instrument includes the same number of adapter channels as collection channels. Optionally, the base includes an optical meter that provides a visual indication of whether the sample has reached a sample container in the base. Optionally, the base is a window through which a user can see a container within the base. Optionally, the support includes a spring, and the engagement assembly is such that the spring exerts a force so that the device can be in an extended state when in its natural state. Optionally, the second opening of the collection channel or the adapter channel is capped by a sleeve, the sleeve going through the capillary action from the first opening to the second opening. Does not prevent fluid movement. Optionally, the sleeve includes a vent. Optionally, each collection channel can hold a volume on the order of 500 μL. Optionally, each collection channel can hold a volume on the order of 200 μL. Optionally, each collection channel can hold a volume on the order of 100 μL. Optionally, each collection channel can hold a volume on the order of 70 μL. Optionally, each collection channel can hold a volume on the order of 500 μL. Optionally, each collection channel can hold a volume on the order of 30 μL. Optionally, the length of the circumference inside the cross section of the collection channel is about 16 mm. Optionally, the circumferential length inside the cross section of the collection channel is on the order of 8 mm. Optionally, the circumferential length inside the cross section of the collection channel is on the order of 4 mm. Optionally, the length of the inner circumference is the circumference. Optionally, the device includes first and second collection channels, and the first channel opening is adjacent to the second channel opening, and the opening is a single unit of blood. Configured to draw blood from one drop at the same time. Optionally, the opening of the first channel and the opening of the second channel have a center-to-center spacing of about 5 mm or less. Optionally, each sample container has an internal volume that is less than 20 times the internal volume of the collection channel that is engageable. Optionally, each sample container has an internal volume that is less than 10 times the internal volume of the collection channel that is engageable. Optionally, each sample container has an internal volume that is less than 10 times the internal volume of the collection channel that is engageable. Optionally, each sample container has an internal volume that is less than five times the internal volume of the collection channel that is engageable. Optionally, establishing fluid communication between the collection channel and the sample container results in movement of at least 90% of the bodily fluid sample in the collection channel into the sample container.

  It should be understood that one or more of the following features may be adapted for use with any of the embodiments described herein. Optionally, establishing fluid communication between the collection channel and the sample container results in movement of at least 90% of the bodily fluid sample in the collection channel into the sample container. Optionally, establishing fluid communication between the collection channel and the sample container results in movement of at least 98% of the bodily fluid sample in the collection channel into the sample container. Optionally, the establishment of fluid communication between the collection channel and the sample container results in the movement of the body fluid sample in the collection channel into the sample container, and as little as 10 μL of body fluid sample is contained in the collection channel. To remain. Optionally, establishment of fluid communication between the collection channel and the sample container results in movement of the bodily fluid sample in the collection channel into the sample container, with as little as 5 μL of bodily fluid sample being collected in the collection channel. To remain. Optionally, establishment of fluid communication between the collection channel and the sample container results in movement of the bodily fluid sample in the collection channel into the sample container, and as little as 2 μL of bodily fluid sample is collected in the collection channel. To remain.

  In another embodiment described herein, a method is provided comprising: drawing the sample into at least two collection channels of the sample collection device by means of a first type of motive force. Contacting one end of the sample collection device with the bodily fluid sample to divide the sample into at least two parts; confirm that a desired amount of sample fluid is in at least one of the collection channels After establishing fluid communication between the sample collection channel and the sample container, wherein the container is configured to move each of the bodily fluid sample portions into the respective container. Provides a second driving force different from

  In another embodiment described herein, a method is provided that includes: simultaneously withdrawing a fluid sample into each at least two sample collection channels via a first type of motive force. Using a configured sample collection device having at least two sample collection channels, metering a minimum amount of sample into at least two of said channels; a desired amount of sample fluid is collected in at least one of said collection channels Establishing fluid communication between the sample collection channel and the sample container after confirming that it is in a channel, the container moving each of the bodily fluid sample portions into the respective container And providing a second motive force different from the first motive force used for collecting.

  In another embodiment described herein, an instrument for collecting a bodily fluid sample is provided that includes: (a) an instrument including a collection channel, wherein the collection channel is a first opening. And from the first opening so that the bodily fluid sample can fill the collection channel through the second opening and from the first opening. Contacting the body fluid sample with a device configured to withdraw the body fluid sample by capillary action toward the second opening; (b) a fluid flow path between the collection channel and the interior of the sample container The sample container has an internal volume less than 10 times the internal volume of the collection channel, and a fluid flow path between the collection channel and the interior of the sample container The collection channel and the collection channel so that the establishment generates a negative pressure at a second opening of the collection channel and the fluidic sample can be moved from the collection channel into the sample container Before the fluid flow path between the interior of the sample container is established, there is a vacuum.

  In another embodiment described herein, an instrument for collecting a bodily fluid sample is provided that includes: (a) a second opening from a first opening of at least one of the collection channels in the instrument. Contacting the bodily fluid sample with any collection device described herein so that the bodily fluid sample can fill the collection channel via the opening of; and (b) the collection channel and the sample The collection is such that establishment of a fluid flow path within the container creates a negative pressure at a second opening of the collection channel and the fluidic sample is moved from the collection channel into the sample container. Establishing a fluid flow path between the channel and the interior of the sample container.

  It should be understood that one or more of the following features may be adapted for use with any of the embodiments described herein. Optionally, the collection channel and the sample container interior are not brought into fluid communication until the bodily fluid reaches the second opening of the collection channel. Optionally, the device includes two collection channels, and the collection channel and the sample container interior are not brought into fluid communication until the bodily fluid reaches the second opening of both collection channels. . Optionally, a second opening of the collection channel in the instrument is configured to penetrate a cap of the sample container, and a fluid between the second opening of the collection channel and the sample container The sex flow path provides relative movement between the second opening of the collection channel and the sample container such that the second opening of the collection channel penetrates the cap of the sample container. Established by Optionally, the device has an adapter channel for each collection channel of the device, the adapter channel having a first opening and a second opening, the first opening Is configured to contact a second opening of the collection channel, and the second opening is configured to contact a cap of the sample container, and between the collection channel and the sample container The fluidic flow path of the two or more such that the second opening of the adapter channel passes through the cap of the sample container: (a) the second opening of the collection channel; (b) the Established by providing an adapter channel, and (c) relative movement between the sample containers.

  In another embodiment described herein, an apparatus is provided for collecting a bodily fluid sample from a subject comprising: (a) an instrument comprising a first channel and a second channel, wherein the instrument comprises the subject. Each channel has an inflow opening configured for fluid communication with said body fluid, each channel having an inlet opening in each channel And each channel is configured to draw body fluid from the inflow opening toward the outflow opening via capillary action; (b) the first channel and Providing the first channel and the second channel to fluid communication with the first container and the second container, respectively, through the outflow opening of each of the second channels; and c) directing the body fluid in each of the first and second channels to each of the first and second containers with the aid of (i) or (ii) below (I) a negative pressure relative to an atmospheric pressure within the first container or the second container, wherein the body fluid passes through the first channel or the second channel. Sufficient to flow into the corresponding container, or (ii) a positive pressure relative to atmospheric pressure in the first channel or the second channel, wherein the positive pressure the body fluid is the first channel Or it is sufficient to flow through the second channel into the corresponding container.

  In another embodiment described herein, a method of manufacturing a sample collection device is provided that includes: fluid in each of at least two sample collection channels via a first type of motive force. Forming a portion of a sample collection device having at least two channels configured to withdraw a sample simultaneously; forming a sample container, wherein a body fluid sample is transferred from the channel into the container In order to provide a second motive force different from the first motive force used to collect the sample to do so, the container is configured for connection with the sample collection device.

  In another embodiment described herein, instructions are provided that are performed by a computer to perform a method including: a first type in each of at least two sample collection channels; Forming a portion of a sample collection device having at least two channels configured to draw a fluid sample simultaneously through the motive force of

  In another embodiment described herein, instructions are provided that are performed by a computer to perform a method including: forming a sample container from the channel into the container The container is configured for coupling with the sample collection device to provide a second motive force different from the first motive force used to collect the sample to move the body fluid sample to .

  In yet another embodiment described herein, a device for collecting a bodily fluid sample from a subject is provided comprising: From the single end of the device in contact with the subject, the bodily fluid sample is Means for drawing into the instrument and thereby dividing the fluid sample into two separate samples; means for moving the fluid sample into a plurality of sample containers, the container comprising the two separate samples Provides the motive force for movement from the path into the container.

  While the above is a complete description of the preferred embodiment of the present invention, it is possible to use various alternatives, modifications and equivalents. Accordingly, the scope of the present invention should not be determined with reference to the above description, but should be determined with reference to the appended claims, along with their full scope of equivalents. Any feature, whether preferred or not, can be combined with other features, whether preferred or not. Unless the claims are expressly stated using the phrase “means for,” the appended claims are not to be construed as including means plus functional limitations. As used throughout the description and the following claims, “a”, “an”, “the”, and “the”, as defined above, unless the context clearly indicates otherwise. It should be understood to include multiple meanings. Further, as used throughout the description and the following claims, the meaning of “in” unless otherwise expressly indicated by context is “in”. And “on (on)”. Finally, further, the meanings of “and” and “or” as used throughout the description and the following claims, unless otherwise clearly indicated in context, are conjunctions. And disjunctive conjunctions, and can be used interchangeably. Thus, unless the context clearly indicates otherwise, when the term “and (and)” or “or (or)” is used in a context, the usage of such a connection is “and / or (and / Or) "is not excluded. The following US patent applications are incorporated by reference into this application for all purposes: 61 / 733,886, filed Dec. 5, 2012, No. 61, filed Sep. 7, 2013. / 875,030 and 61 / 875,107 filed on September 8, 2013. This document contains material that is subject to copyright protection. For example, the drawings shown in this specification are all protected by copyright. Because they appear in the US Patent and Trademark Office patent file or record, copyright owners (patent applicants herein) are not opposed to reproductions of patent documents and disclosures, but otherwise All rights reserved. The following notes apply: Copyright 2013 Terranos

Claims (44)

A method for use with a bodily fluid sample from a subject, comprising:
Transporting a plurality of sample containers from a first location to a second location, wherein each of the sample containers comprises no more than about 500 μL but more than about 30 μL of a body fluid sample, each of the sample containers The internal volume is about 600 μL or less,
Subjecting the bodily fluid sample to a first accelerated settling force of at least about 1400 g or more to form a first processed sample;
Transporting a first processed sample from a first location to a second location; and a second processed sample at a second location that exceeds about 10 g but does not exceed about 500 g. Subject to accelerated settling forces. The method of claim 1, wherein the first treated sample comprises a first anticoagulant. The method of claim 1, wherein the first treated sample comprises a heparin-based anticoagulant. The method of claim 1, wherein the first processed sample comprises a plasma portion separated by a separation gel from a formed blood component portion. The method of claim 1, wherein the second treated sample does not drive the electrolyte separation gel through the formed blood component portion to the plasma portion. The method of claim 1, wherein the second processed sample does not drive a liquid separation gel from the formed blood component portion to the plasma portion. The method of claim 1, wherein the first accelerated settling force is provided via centrifugation. The method of claim 1, wherein the second accelerated settling force is provided via centrifugation. A plurality of samples are transported from a first location to a second location, each of the samples undergoes a first accelerated settling on an independent basis, and the plurality of samples are second accelerated. The method of claim 1 wherein the settling is simultaneously received as a group. A plurality of samples in a sample container are transported from a first location to a second location, undergoing a first accelerated sedimentation on an independent basis, and the plurality of samples undergo a second accelerated sedimentation, The method of claim 1, wherein the method is received simultaneously in a single tray as a group. A plurality of samples contained in each one of a plurality of sample containers are transported from a first location to a second location, each of the samples undergoing a first accelerated settling on an independent platform; The method of claim 1, wherein the plurality of samples undergo a second accelerated sedimentation simultaneously as a group in at least one centrifuge tray. 12. The method of claim 11, wherein the dead volume around the sample in each of the containers containing the sample is about 60 [mu] L or less. 12. The method of claim 11, wherein the dead volume around the sample in each of the containers containing the sample is about 50 [mu] L or less. 12. The method of claim 11, wherein the dead volume around the sample in each of the containers containing the sample is about 40 [mu] L or less. 12. The method of claim 11, wherein the dead volume around the sample in each of the containers containing the sample is about 30 [mu] L or less. 12. The method of claim 11, wherein the dead volume around the sample in each of the containers containing the sample is about 20 [mu] L or less. 12. The method of claim 11, wherein the dead volume around the sample in each of the containers containing the sample is about 10 [mu] L or less. 12. The method of claim 11, further comprising obtaining data from a sample container by scanning the plurality of sample container IDs simultaneously. The method of claim 18, wherein the scanning occurs while the container is in a transport frame. The method of claim 18, wherein the scanning includes scanning a lower surface of the shipping container. The method of claim 1, wherein at least some of the sample containers comprise a sample having a first anticoagulant and at least some of the sample containers comprise a second, different anticoagulant. Collecting capillary blood from a subject, wherein the blood is collected in a plurality of vessels, less than 500 microliters per vessel, but greater than at least about 10 microliters per vessel. Collecting capillary blood from a subject, wherein the blood is collected in a plurality of vessels, less than 400 microliters per vessel, but at least about 10 microliters per vessel. Collecting capillary blood from a subject, wherein the blood is collected in a plurality of vessels, less than 300 microliters per vessel, but greater than at least about 10 microliters per vessel. Collecting capillary blood from a subject, wherein the blood is collected in a plurality of vessels, less than 200 microliters per vessel, but greater than at least about 10 microliters per vessel. Collecting capillary blood from a subject, said blood being collected in a plurality of vessels, less than 100 microliters per vessel, but greater than at least about 10 microliters per vessel. Transporting a fluid sample in a liquid from a first location to a second location. Transporting a fluid sample in a liquid from a first location to a second location, wherein the sample is at least 1500 g at the first location and less than 400 g at the second location. Centrifuge above 10 g. Transporting a fluid sample in a liquid from a first location to a second location, wherein the sample is at least 1400 g at the first location and less than 500 g at the second location. Centrifuge above 10 g. Transporting a fluid sample in a liquid from a first location to a second location, wherein the sample is at least 1500 g at the first location and less than 400 g at the second location. Centrifuging, wherein the sample is about 50 to about 200 microliters. Transporting a fluid sample in a liquid from a first location to a second location, wherein the sample is at least 1500 g at the first location and less than 400 g at the second location. Centrifuging, wherein the sample is about 50 to about 300 microliters. Transporting a fluid sample in a liquid from a first location to a second location, wherein the sample is at least 1500 g at the first location and less than 400 g at the second location. Centrifuging, wherein the sample is from about 20 to about 180 microliters. Transporting a fluid sample in a liquid from a first location to a second location, wherein the sample is at least 1500 g at the first location and less than 400 g at the second location. Centrifuging, wherein the sample is about 20 to about 180 microliters and is in a vessel having a 5-30 microliter dead volume when filled with the sample. Equipment including transport containers. Transporting a fluid sample in a liquid from a first location to a second location, wherein the sample is at least 1400 g at the first location and less than 500 g at the second location; A method comprising centrifuging. Equipment including transport containers. Equipment including sample collection equipment. A system including a processor programmed to determine at least a desired sample dilution and at least a desired number of aliquots for a sample. A method comprising at least one technical feature from any of the above claims. A method comprising any two technical features from any of the above claims. An instrument comprising at least one technical feature from any of the above claims. A device comprising any two technical features from any of the above claims. A system comprising at least one technical feature from any of the above claims. A system comprising any two technical features from any of the above claims.