CN108968982B

CN108968982B - Device for detecting analyte in sample

Info

Publication number: CN108968982B
Application number: CN201810578554.8A
Authority: CN
Inventors: 洪亮; 周凯军
Original assignee: Hangzhou Biotest Biotech Co Ltd
Current assignee: Hangzhou Biotest Biotech Co Ltd
Priority date: 2018-06-07
Filing date: 2018-06-07
Publication date: 2024-08-02
Anticipated expiration: 2038-06-07
Also published as: CN108968982A

Abstract

The invention provides a detection device of an analyte in a sample, which comprises a solution reservoir, a puncture element and a detection channel; when the solution reservoir is positioned at the first position relative to the puncture element, a distance is reserved between the solution reservoir and the puncture element; when the solution reservoir is positioned at the second position relative to the puncturing element, the puncturing element opens the solution reservoir; the detection channel comprises a receiving part for receiving the solution and a testing part for placing the test strip, and the receiving part is communicated with the testing part; the piercing element is located at the receptacle. The device of the invention is used for taking blood and buffering solution, and the detection device is of an integrated structure, so that the collection and detection of blood samples can be completed in one step.

Description

Device for detecting analyte in sample

Technical Field

The present invention relates to a device for detecting an analyte in a sample, and in particular to a device for detecting an analyte in a blood sample.

Background

The following background is provided to aid the reader in understanding the invention and is not admitted to be prior art.

Blood has been a common sample in the field of testing because blood contains many biological indicators or analytes. In the POCT field, if it is necessary to detect an analyte in blood, it is generally necessary to collect the blood, for example, by puncturing a capillary on the skin with a lancet, collecting a blood sample with a blood collection tool, and then analyzing the blood sample. Generally, when an individual performs blood sample testing, a lancet, a blood collection tool, and a testing device are required, and a solution reagent for treating blood is usually carried. Generally, the tools are packaged together, which is not only unfavorable for packaging, but also causes trouble in use or damage to human body when in use.

There is a need for an improvement over conventional devices for testing blood samples that overcomes the above drawbacks and provides for greater convenience and convenience to the user.

Disclosure of Invention

In order to solve the problems in the prior art, the present invention provides a detection device for detecting an analyte in a fluid sample, particularly an analyte in a blood sample.

A device for detecting an analyte in a sample, comprising: the detection device comprises a solution reservoir, a puncture element and a detection channel; when the solution reservoir is positioned at the first position relative to the puncture element, a distance is reserved between the solution reservoir and the puncture element; when the solution reservoir is positioned at the second position relative to the puncture element, the puncture element opens the solution reservoir to release the solution; the detection channel comprises a liquid collecting part and a testing part, and the liquid collecting part is communicated with the testing part; the lancing element is positioned in the detection channel.

The liquid collecting part is used for collecting the solution released from the solution storage, and the testing part is used for placing a testing element (such as a test strip).

The solution reservoir is outside the detection channel, and when the solution reservoir is at the first position relative to the puncture element, the solution reservoir and the puncture element are not contacted with each other, and the solution is sealed in the solution reservoir; when the relative position of the solution reservoir and the puncturing element is the second position due to the external force, the puncturing element opens the solution reservoir, the solution enters the liquid collecting part, and the testing element (such as a test strip) absorbs the solution in the liquid collecting part, so that the detection result is displayed.

Puncture element

The piercing element is configured to open an opening of the solution reservoir to release the solution within the solution reservoir.

Preferably, the penetrating member faces the solution reservoir, and the penetrating member guide groove has a blade or tip.

The puncture part is used for opening the solution storage in a mode of puncturing the film, and the diversion trench is used for realizing solution release. Preferably, the tip surface is provided with a flow guide groove. The cross section of the diversion trench is semicircular, rectangular, V-shaped or L-shaped and the like; the number of the diversion trenches can be 1 or a plurality of diversion trenches. Preferably, the puncture part is conical.

Another scheme is as follows: preferably, the piercing element is formed by a plurality of sub-portions, all of which enclose a cylinder, with a gap between adjacent sub-portions, each sub-portion having a blade portion, the gap between the sub-portions being a channel. Or the puncture element is a cylinder or a cone, a channel with an open top is arranged in the puncture element, the puncture channel is provided with a liquid through hole or a liquid through groove which communicates the channel with the outside, and the opening of the channel is provided with a blade. The blade is used as a puncture part, and the channel, the liquid through hole or the liquid through groove are used as diversion trenches. When the blade of the piercing element contacts the membrane, the blade pierces the membrane and fluid enters the channel and reaches the fluid collection portion through the fluid passage or fluid reservoir.

Movable member

When the solution reservoir or the puncturing element is mounted on the movable member, the movable member displaces, so that the solution reservoir and the puncturing element relatively displace, thereby realizing the solution from sealing to releasing.

Preferably, the detection device includes a movable member capable of being displaced, the movable member including a pressing portion and a displacement portion, and the puncturing element or the solution reservoir is fixed to the movable member.

Preferably, the displacement part is a sleeve, and the detection device is provided with a guide post matched with the sleeve; the first end of the sleeve is fixed with the pressing part, and the second end of the sleeve is matched with the guide post. Initially, the cartridge is placed on the guide post and as the cartridge moves along the guide post, the solution reservoir and the lancing element are brought into proximity with each other.

Or the displacement part is a guide post, and the detection device is provided with a sleeve matched with the guide post; the first end of the guide post is fixed with the pressing part, and the second end of the guide post is matched with the sleeve. Initially, the guide post is placed on the sleeve and the guide post is moved along the sleeve to bring the solution reservoir and the lancing element into proximity with each other.

Preferably, the detection device is provided with a movable element window matched with the movable element, and the movable element is inserted into the movable element window.

Solution storage device

The solution reservoir is a device for storing a solution reagent. Preferably, the solution reservoir includes a cavity having an opening and a seal sealing the opening. Preferably, the seal is a film made of a material that is easily punctured and waterproof, such as a plastic film or the like. Preferably, the solution storage chamber is formed by enclosing a bottom plate and a side wall, the top of the solution storage chamber is opened, and the opening is sealed by a film.

Blood collector

Blood collectors are used to collect samples, such as blood samples.

Preferably, the test device is provided with a blood collector. Preferably, the hemostix has a tubular structure and includes a blood collection head, and a blood sample is collected by the blood collection head. Preferably, one end of the hemostix is connected with the blood sampling head, the other end of the hemostix is a blood sucking tube, and the blood sampling head is an air bag. Preferably, the detecting device has a mounting portion for detachably mounting the blood sampling device. Preferably, the mounting portion is a sleeve fixed to the detecting device, and one end of the sleeve is open. The hemostix is inserted into the sleeve from the opening. Or the mounting part is an elastic buckle fixed on the detection device, and the elastic buckle is provided with a bayonet for allowing the hemostix to enter. The hemostix is clamped into the elastic buckle from the opening.

Puncture device

A perforator is a device that is used to puncture skin or tissue to release blood. Lancing devices are commonly used lancing mechanisms, such as disposable safety lancets, and typically include a sharpened needle for lancing tissue for lancing. After the disposable safety blood taking needle is launched, the needle core is locked, so that the blood taking needle can be used once, and the safety of a user can be ensured.

Preferably, the test device has a lancet for receiving a lancing tissue, the lancet having an exposed end and the exposed end of the lancet comprises a lancet. The lancet is used to puncture tissue to release blood. As a preferable scheme, the puncture device comprises a body which is clamped with the detection device and a needle containing cavity which contains the needle, and the needle containing cavity is exposed out of the detection device.

Test element and test channel

Preferably, the detection device further comprises a test element. The presence or amount of an analyte in a blood sample can be detected by the test element. Preferably, the test element comprises a pipetting tip, a sample application area and a reagent test area, the pipetting tip being in communication with the collection portion of the test channel for pipetting the solution released from the solution reservoir. The sample loading area corresponds to a loading window on the shell, and the actual testing area corresponds to a display window.

Preferably, the detection channel is provided with a clamping groove element, and the test element is detachably arranged in the clamping groove element. Preferably, the lower plate has a cradle positioned within the test channel, and the test element is placed on the cradle. The bracket supports the test element to avoid the solution from soaking the test element.

Housing of detection device

The housing provides a receiving space for the lancing device, the solution reservoir and the detection channel.

Preferably, the test device has a housing having a solution reservoir, a lancing element, and a test element disposed therein, the lancing element, the solution reservoir, and the lancing element being integrated into the housing, one end of the lancing element being exposed. Preferably, the solution reservoir or the lancing element is mounted to the movable member, and the movable member, the solution reservoir and the lancing element are located in a first region of the housing, the first region having a space in which the movable member is displaced. Preferably, the test element comprises at least a liquid-absorbing region, a sample-adding region and a result-displaying region, the liquid-absorbing region of the test element is located in a first region, the part of the test element other than the liquid-absorbing region and the sample-adding region is located in a second region of the housing, and the second region has a mounting space required for the test element. The liquid collecting part of the detection channel is positioned in the first area, and the testing part of the detection channel is positioned in the second area. The solution reaches the liquid collecting part after being released, the test element absorbs the solution, the solution dissolves the sample through the sample adding area, and the sample reaches the reagent testing area through capillary action and reacts with the reagent to display the result.

The first region satisfies the running space of the movable member; the second region satisfies the installation space of the test element. The first area needs to meet the space requirement of the movable piece from the first position to the second position, and the second area only needs to be high enough to accommodate the test element and the bracket. The second area just accommodates the mounted test element, and the degrees of freedom of the test element are limited, so that the position of the test element is stable, and the detection accuracy is ensured. Preferably, the lower plate is a flat plate, and the first region and the second region of the upper plate are transited by an inclined plane.

Preferably, the piercer is located at an end of the housing. Preferably, the piercer is located in the first region. The puncture outfit is positioned at the end part, which is convenient for blood collection.

Preferably, the housing is provided with a movable member window, a display window for the detection result and a lancet window for allowing the lancet to be fitted. Preferably, the housing comprises an upper plate and a lower plate, the movable member window and the display window are arranged on the upper plate, and the detection channel is arranged on the lower plate; the puncturing element is arranged on the movable member, the solution reservoir is arranged on the lower plate, and the puncturing element is arranged on the lower plate when the solution reservoir is arranged on the movable member.

Preferably, the upper plate is provided with a sample loading window for loading samples, and the sample loading window is positioned between the movable piece window and the display window.

Preferably, the puncture device window is arranged on the upper plate, or the puncture device window is formed by splicing a notch of the upper plate and a notch of the lower plate.

Misoperation prevention cover

As the preferable scheme, the detection device comprises a shell, wherein a movable piece which is movably connected is arranged in the shell, and an anti-misoperation cover which covers the movable piece is arranged on the shell. Preferably, the movable member window is covered by an anti-misoperation cover, the anti-misoperation cover is provided with a flange, and the flange encloses the movable member window therein. The misoperation prevention cover is a protection measure for avoiding product failure caused by misoperation of the movable part. Preferably, the misoperation prevention cover is rotatably connected to the housing. Preferably, the misoperation preventing cover is connected with the shell through a rotating connecting piece, the rotating connecting piece comprises a connecting rod, one end of the connecting rod is connected with the misoperation preventing cover, and the other end of the connecting rod is connected with the shell. Preferably, the two sides of the shell are respectively provided with a connecting rod, one end of the connecting rod is fixed with the shell, the other end of the connecting rod is rotationally connected with the misoperation preventing cover, or one end of the connecting rod is rotationally connected with the shell, and the other end of the connecting rod is fixed with the misoperation preventing cover.

In another aspect, the invention provides a method of detecting an analyte in a blood sample, the method comprising: providing a test device comprising a test element, a solution reservoir, a piercing element operable to pierce the reservoir, wherein the solution reservoir has a first fixed position and a second position in the test device; allowing the solution reservoir to move from the first position to the second position; during movement, the lancing element is caused to lance the solution reservoir, thereby releasing the solution in the solution reservoir.

Advantageous effects

The device of the invention is used for taking blood and buffering solution, and the detection device is of an integrated structure, so that the collection and detection of blood samples can be completed in one step.

Drawings

Fig. 1 is a schematic perspective exploded view of a detection device according to an embodiment of the present invention.

Fig. 2 is a front view of the detecting device of fig. 1 according to the present invention.

Fig. 3 is an assembled cross-sectional view of the detection device of fig. 1 in accordance with the present invention.

Fig. 4 is a schematic perspective exploded view of a detecting device with a tamper-proof cover according to an embodiment of the present invention.

Fig. 5 is a schematic view illustrating a front view direction explosion structure of the detecting device with the anti-misoperation cover of fig. 4 according to the present invention.

Fig. 6 is an assembled cross-sectional view of the detection device with the anti-misoperation cover of fig. 4.

Fig. 7 is a schematic perspective exploded view of a detecting device having a lancing device according to an embodiment of the present invention.

Fig. 8 is a schematic view of an exploded front view of the device of fig. 7 with a lancing device according to the present invention.

FIG. 9 is an assembled cross-sectional view of the testing device of FIG. 7 with a lancing device according to the present invention.

Fig. 10 is a schematic perspective view of an upper plate according to an embodiment of the present invention.

Fig. 11 is a schematic perspective view of an anti-misoperation cover in an embodiment of the invention.

Fig. 12 is a schematic perspective view of a movable member according to an embodiment of the present invention.

Fig. 13 is a schematic perspective view of a lower plate according to an embodiment of the present invention.

FIG. 14 is a schematic perspective view of a lancing element according to one embodiment of the present invention.

FIG. 15 is a schematic view of a test element according to one embodiment of the invention.

Detailed Description

The structure to which the present invention relates or these terms of technology are further described below. These descriptions are merely illustrative of how the present invention may be implemented and are not intended to be in any way limiting.

Detection of

Detection indicates the assay or testing for the presence of a substance or material, such as, but not limited to, a chemical, an organic compound, an inorganic compound, a metabolic product, a drug or drug metabolite, an organic tissue or a metabolite of an organic tissue, a nucleic acid, a protein or a polymer. In addition, the detection indicates the amount of the test substance or material. Further, assays also refer to immunoassays, chemical assays, enzymatic assays, and the like.

Test element

A variety of test elements may be used in combination in the present invention. The test element includes a test element 80 that can take a variety of forms, such as an immunological or chemical test form, for detecting an analyte in a sample, such as a drug or related metabolite indicative of a physical condition. In some forms, the test element is a bibulous material having a loading zone, a reagent zone, and a detection result zone. The sample is applied to the application region and flows into the reagent region by capillary action. In the reagent zone, the sample dissolves and mixes with the reagent for detection of the analyte (if present in the sample). At this point the sample with the reagent continues to flow to the detection result zone. The additional reagent is immobilized in the detection result zone. These reagents immobilized in the detection result zone react and bind to the analyte (if present) or to the first reagent in the reagent zone. In a non-competitive assay format, a signal is generated if the analyte is present in the sample and no signal is generated if the analyte is not present. In the competitive assay format, a signal is generated if no analyte is present in the sample and no signal is generated if analyte is present. The invention is applicable to various analysis forms.

When the test element is a test element, it may be made of a water absorbent or non-water absorbent material, and one test element may use a variety of materials for fluid transfer. One material of the test element may be superimposed on another test element material, for example, filter paper superimposed on nitrocellulose. Or one region of the test element containing at least one material is located behind another region containing at least one different material. In this case, the liquid is circulated between the regions, which may or may not be superimposed on each other. The material on the test element may be fixed to a support such as a plastic liner or a hard surface to enhance the test element holding force.

In some embodiments where the analyte is detected by the signal producing system (e.g., where at least one enzyme specifically reacts with the analyte), at least one signal producing substance may be adsorbed to the detection result zone of the test element, as described above, as specifically adsorbed to the material of the test element. In addition, signal-generating substances present in the sample application zone, reagent zone, test result zone, or throughout the test element may be pre-treated on one or more materials of the test element in advance. This may be achieved by applying a solution of the signal generating substance to the surface of the application area or by immersing one or more materials of the test element in the signal solution. After the test element is added to the signal solution or immersed in the solution, the test element is dried. In addition, the above methods may be present in the sample application zone, reagent zone, test result zone, or signal generating substances throughout the test element may be pre-treated on one or more materials of the test element in advance. In addition, a signal substance present in the sample application region, reagent region or detection result region of the test element may be applied as a labeling reagent to one or more surfaces of the test element material.

As shown in FIG. 15, the test element 80 includes at least the following liquid absorbing zone 801, the sample application zone 802, and at least one detection result zone 803, which are arranged in this order. If the detection result zone 803 comprises a control zone 804, it is preferred that the control zone 804 is located after the analyte detection zone of the detection result zone 803. All of these regions, or a combination thereof, may be on a single strip containing one material. In addition, the zones are made of different materials and are connected together in the direction of liquid transfer. For example, the different regions may be in direct or indirect fluid communication. In this embodiment, the different zones may be connected end to end in the direction of liquid transfer, or superimposed on each other in the direction of liquid transfer, or by other materials, such as a connecting medium material (preferably a water-absorbent material such as filter paper, glass fiber or nitrocellulose). When a connecting material is used, the connecting material can allow a material including the end of each region to be in contact with the end, a material including the end of each region to be in contact with the end but not in fluid communication, or a material including the regions to be overlapped with each other (for example, but not limited to, overlapped from the beginning to the end) but not in fluid communication, to form fluid communication.

If the test element contains an adulterated detection control zone, this zone may be placed before or after the detection result zone. This may not be the case, if the detection result zone contains a control zone, the adulterated control zone is preferably placed before the control zone. In one embodiment of the invention, the test element is a control test element for adulteration analysis determination and/or control, and the adulteration control zone may be located before or after the control zone, preferably before the control zone.

Sample of

Samples that may be detected with the detection device of the present invention include biological fluids (e.g., case fluids or clinical samples). The liquid or fluid sample may be derived from solid or semi-solid samples, including fecal matter, biological tissue, and food samples. The solid or semi-solid sample may be converted to a liquid sample using any suitable method, such as mixing, mashing, macerating, incubating, dissolving, or digesting the solid sample with enzymatic digestion in a suitable solution (e.g., water, phosphate solution, or other buffer solution). "biological samples" include samples of animals, plants and food products, including for example urine, saliva, blood and its components, spinal fluid, vaginal secretions, sperm, feces, sweat, secretions, tissues, organs, tumors, cultures of tissues and organs, cell cultures and media derived from humans or animals. Preferably the biological sample is urine. Food samples include food processed materials, end products, meats, cheeses, wines, milks and drinking water. Plant samples include plants, plant tissues, plant cell cultures and media derived from any plant. An "environmental sample" is derived from the environment (e.g., a liquid sample from a lake or other body of water, a sewage sample, an earth sample, groundwater, seawater, and a waste liquid sample). The environmental sample may also include sewage or other wastewater. Any analyte may be detected using the present invention and a suitable detection element. The present invention is preferably used to detect an analyte in blood.

Analyte substance

Examples of analytes that can be used in the present invention include hapten materials, including drugs (e.g., drugs of abuse). "drug of abuse" (DOA) refers to the use of drugs (typically acting to paralyze nerves) in non-medical destinations. Abuse of these drugs can lead to physical and mental impairment, dependence, addiction and/or death. Examples of drug abuse include cocaine; amphetamine AMP (e.g., black americans, white amphetamine tablets, dextroamphetamine tablets, beans); methamphetamine MET (crank, methamphetamine, crystal, speed); barbiturate BAR (e.g., valium, roche Pharmaceuticals, nutley, new Jersey); sedatives (i.e. sleep aid drugs); lysergic acid diethylamide (LSD); inhibitors (downers, goofballs, barbs, blue devils, yellow jackets, hypnone); tricyclic antidepressants (TCAs, i.e., imipramine, amitriptyline, and doxepin); dimethyl dioxy methylaniline MDMA; phencyclidine (PCP); tetrahydrocannabinol (THC, pot, rope, hash, weed, etc.); opiates (i.e., morphine MOP or, opiates, cocaine COC; heroin, hydroxycodeinone); anxiolytics and sedative hypnotics, which are a class of drugs that are mainly used to relieve anxiety, stress, fear, stabilize mood, and have hypnotic sedative effects, including benzodiazepines BZO (benzodiazepines), atypical BZ, fused diazepines NB23C, benzoazepine, ligands of BZ receptors, ring-opened BZ, diphenylmethane derivatives, piperazine carboxylates, piperidine carboxylates, quinizolinones, thiazine and thiazole derivatives, other heterocycles, imidazole sedative/analgesic drugs (e.g., hydroxyhydrocodone OXY, methadone MTD), propylene glycol derivatives-carbamates, aliphatic compounds, anthracene derivatives, and the like. The detection device can also be used for detecting medical application and is easy to take excessive medicines, such as tricyclic antidepressants (promethazine or analogues), acetaminophen and the like. The medicines are decomposed into different small molecular substances after being absorbed by human bodies, and the small molecular substances exist in body fluids such as blood, urine, saliva, sweat and the like or part of body fluids exist in the small molecular substances.

Analytes to be detected with the present invention include, but are not limited to, creatinine, bilirubin, nitrite, proteins (non-specific), hormones (e.g., human chorionic gonadotropin, progesterone hormone, follicular stimulating hormone, etc.), blood, leukocytes, sugars, heavy metals or toxins, bacterial substances (e.g., proteins or carbohydrate substances directed against specific bacteria such as e.g., E.coli 0157: H7, staphylococci, salmonella, clostridium, campylobacter, L.unicytogenes, vibrio, or Cactus) and substances associated with physiological characteristics in urine samples such as pH and specific gravity. Any other clinical urine chemistry analysis can be tested using lateral flow testing in combination with the device of the present invention.

In some embodiments, as shown in FIGS. 1-3, a device for detecting an analyte in a sample includes a solution reservoir 101, a lancing element 50, and a detection channel. When the solution reservoir 101 is positioned in the first position relative to the lancing element 50, a distance is provided between the solution reservoir 101 and the lancing element 50; when solution reservoir 101 is in the second position relative to lancing element 50, lancing element 50 opens solution reservoir 101 to release solution; the detection channel comprises a liquid collecting part 402 and a testing part 405, and the liquid collecting part 402 is communicated with the testing part 405; lancing element 50 is positioned in the detection channel.

The liquid collecting portion 402 is used for collecting the solution released from the solution reservoir 101, and the test portion 405 is used for housing a test element (e.g., a test strip).

As shown in fig. 3, the solution reservoir 101 is outside the detection channel, and the solution is sealed within the solution reservoir 101 when the solution reservoir 101 is in the first position relative to the lancing element 50; when the relative position between the solution reservoir 101 and the puncturing element 50 is set to the second position by an external force, the solution reservoir 101 is opened, the solution enters the liquid collecting portion 402, the liquid absorbing region of the test element (e.g., test strip) absorbs the solution in the liquid collecting portion, and the detection result of the analyte is displayed in the detection result region.

Solution storage device

The solution reservoir 101 is a device for storing a solution reagent. In some embodiments, the solution reservoir includes a cavity having an opening and a seal sealing the opening. The seal is a film made of a material that is easily pierced and waterproof, such as a plastic film or the like.

In some embodiments, as shown in fig. 12, the solution reservoir is enclosed by a bottom plate and side walls 1011, the top of the chamber being open and the opening 1012 being sealed by a membrane. Or the containing cavity of the solution storage is surrounded by a bottom plate, side walls and a top plate, the top plate is provided with a liquid through hole or a liquid through groove, the liquid through hole or the liquid through groove is used as an opening of the containing cavity, and the opening is plugged and sealed by a plug.

Puncture element

In some embodiments, the lancing element includes a body, a lancing portion and a flow channel, the lancing portion facing the solution reservoir. The piercing portion is a blade or tip.

The puncture part is used for opening the solution storage device in a mode of puncturing the film, and the solution flows out along the diversion trench to realize solution release. In some embodiments, the piercing portion is a tip. The tip punctures the membrane, releasing the solution. The body is provided with a groove which is a diversion trench. The cross section of the diversion trench is semicircular, rectangular, V-shaped or L-shaped and the like; the number of the diversion trenches can be one or a plurality of diversion trenches. The puncture part is conical.

Or the piercing portion is a blade. The blade pierces the membrane releasing the solution. As shown in fig. 14, the penetrating member 50 is composed of a plurality of sub-portions 501, all of the sub-portions 501 are surrounded into a column, gaps are provided between adjacent sub-portions 501, and each sub-portion 501 has a blade portion. The blade of the sub-portion 501 serves as a piercing portion 502; the gap between the sub-portions 501 serves as a flow guide groove 503. Or the puncture element is a cylinder or a cone, a channel with an open top is arranged in the puncture element, the puncture channel is provided with a liquid through hole or a liquid through groove which communicates the channel with the outside, and the opening of the channel is provided with a blade. The blade is used as a puncture part, and the channel, the liquid through hole or the liquid through groove are used as diversion trenches. When the blade of the piercing element contacts the membrane, the blade pierces the membrane and fluid enters the channel and reaches the fluid collection portion through the fluid passage or fluid reservoir.

Movable member

In some embodiments, the detection device has a movable member capable of downward displacement, the movable member including a pressing portion and a displacement portion, the lancing element or the solution reservoir being fixed to the movable member. The detection device is provided with a movable piece window matched with the movable piece, and the movable piece is inserted into the movable piece window.

In some embodiments, as shown in fig. 1, 4, 7 and 12, the displacement portion is a sleeve 102, and the detection device has a guide post 404 that is matched with the sleeve 102; the first end of the sleeve 102 is fixed to the pressing portion 103, and the second end of the sleeve 102 is engaged with the guide post 404. Initially, the cartridge is placed on the guide post and as the cartridge moves along the guide post, the solution reservoir and the lancing element are brought into proximity with each other.

In some embodiments, the displacement part is a guide post, and the detection device is provided with a sleeve matched with the guide post; the first end of the guide post is fixed with the pressing part, and the second end of the guide post is matched with the sleeve. Initially, the guide post is placed on the sleeve and the guide post is moved along the sleeve to bring the solution reservoir and the lancing element into proximity with each other.

Blood collector

The blood collection device 30 is used to collect a sample, such as a blood sample.

In some embodiments, as shown in fig. 1 and 4, the testing device is provided with a blood collector 30, which is a tubular structure. The hemostix includes a blood collection head with which a blood sample is collected. Preferably, one end of the hemostix is connected with a blood collection head 301, the other end is a blood suction tube 302, and the blood collection head is an air bag. The detecting device has a mounting portion 203 for detachably mounting the blood collection device. The mounting portion 203 is a sleeve fixed to the detection device, and one end of the sleeve is opened. The hemostix is inserted into the sleeve from the opening. Or the mounting part is an elastic buckle fixed on the detection device, and the elastic buckle is provided with a bayonet for allowing the hemostix to enter. The hemostix is clamped into the elastic buckle from the opening.

Puncture device

The lancing device 70 is a device for lancing skin or tissue to release blood. Lancing devices are commonly used lancing mechanisms, such as disposable safety lancets, and typically include a sharpened needle for lancing tissue for lancing. After the disposable safety blood taking needle is launched, the needle core is locked, so that the blood taking needle can be used once, and the safety of a user can be ensured.

In some embodiments, as shown in FIG. 9, the test device has a receiving area for receiving the lancing tissue, the lancing device is mounted in the receiving area with one end of the lancing device exposed and the exposed end of the lancing device contains the lance. The lancet is used to puncture tissue to release blood.

In some embodiments, the lancing device includes a body that is snapped onto the testing device and a needle-receiving chamber that receives the needle, the needle-receiving chamber being exposed to the testing device.

Housing of detection device

In some preferred embodiments, as shown in fig. 7-9, the test device has a housing with a solution reservoir 101, lancing element 50, lancing element 70, and test element 80, wherein lancing element 70, solution reservoir 101, and lancing element 50 are integrated into the housing with one end of lancing element 70 exposed. Preferably, the solution reservoir 101 or the puncturing element 50 is mounted to the movable member 10, and the movable member 10, the solution reservoir 101 and the puncturing element 50 are located in a first region of the housing, the first region having a space for displacement of the movable member. Preferably, the test element 80 includes at least a liquid-absorbing region 801, a sample-applying region 802, and a detection result region 803, the liquid-absorbing region 801 of the test element 80 is located in a first region, and a portion of the test element 80 other than the liquid-absorbing region 801 and the sample-applying region 802 is located in a second region of the housing, the second region having a mounting space required for the test element 80. The liquid collecting portion 402 of the detection channel is located in the first area, and the test portion 405 of the detection channel is located in the second area. After the solution is released and reaches the liquid collecting part 402, the test element 80 absorbs the solution, the solution dissolves the sample through the sample adding area 802, and the sample reaches the detection result area 803 through capillary action and reacts with the reagent to display the result.

In some preferred embodiments, as shown in fig. 7-9, the lancing device 70 is located at the end of the housing. Preferably, the lancing device 70 is located in the first zone. The puncture outfit is positioned at the end part, which is convenient for blood collection. As shown in fig. 1 and 4, in some preferred embodiments, the housing is provided with a movable member window 201, a display window 202 for the detection result, and a lancet window 205 that allows the lancet to be loaded. The testing device has a housing in which the lancing element 50, the solution reservoir 101 and the testing channel are located, the housing being provided with a movable member window 201, a display window 202 for the test results and a lancet window 205 allowing the lancet to be installed. As shown in fig. 1 to 10 and 13, the housing includes an upper plate 20 and a lower plate 40, a movable member window 201 and a display window 202 are provided on the upper plate, and a detection passage is provided on the lower plate; when the puncture element 50 is provided in the movable element 10, the solution reservoir 101 is provided in the lower plate 40, and when the solution reservoir 101 is provided in the movable element 10, the puncture element 50 is provided in the lower plate 40.

As shown in fig. 10, in some embodiments, the upper plate is provided with a sample loading window 204 for sample loading, and the loading window 204 is located between the movable member window 201 and the display window 202.

In some embodiments, as shown in fig. 7, a piercer window 205 is provided in the upper plate 20, or the piercer window is made up of a notch in the upper plate and a notch in the lower plate.

Test element and test channel

In some embodiments, the detection device further comprises a test element. The presence or amount of an analyte in a blood sample can be detected by the test element. As shown in fig. 15, the test element includes a pipetting tip 801, a sample application area 802 and a detection result area 803, the pipetting tip 801 communicates with the liquid collection portion 402 of the detection channel and aspirates the solution released from the solution reservoir 101. The sample loading area 802 corresponds to the loading window 204 on the housing, and the detection result area 803 corresponds to the display window 202.

As shown in fig. 1 and 4, in some embodiments, the detection channel is provided with a slot member 403, and the test element 80 is removably mounted within the slot member 403. Preferably, the lower plate has a cradle 401 that is positioned within the test channel and the test element 80 is placed on the cradle 401. The carrier 401 holds the test element 80 up to avoid soaking the test element in solution.

As shown in fig. 6, in some embodiments, the movable member 10, the solution reservoir 101, and the lancing element 50 are located in a first region of a housing, the testing element 80 is located in a second region of the housing, the liquid collection portion 402 of the detection channel is located in the first region, and the testing portion 405 of the detection channel is located in the second region. After the solution is released and reaches the liquid collecting part 402, the test element 80 absorbs the solution, the solution dissolves the sample through the sample adding area 802, and the sample reaches the detection result area 803 through capillary action and reacts with the reagent to display the result.

The height of the first region is greater than the height of the second region. Height refers to the distance of lower plate 20 from upper plate 40. The height of the first zone needs to be sufficient for the space in which the movable element 10 operates, and the height of the second zone only needs to be able to accommodate the test element and the carrier. The second area is just high to hold the mounted test element 80, and the degrees of freedom of the test element 80 are limited, so that the test element 80 is stable in position and the accuracy of detection is ensured. Preferably, the lower plate is a flat plate, and the first region and the second region of the upper plate are transited by an inclined plane.

In some embodiments, as shown in fig. 7-9, the lancing device is located at the end of the housing. The perforator is located in the first area. The puncture outfit is positioned at the end part, which is convenient for blood collection.

Misoperation prevention cover

As shown in fig. 4-6 and 11, in some embodiments, the detection device further includes an anti-misoperation cover 60, the anti-misoperation cover 60 covering the movable member window 201. The misoperation prevention cover is a protection measure for avoiding product failure caused by misoperation of the movable part. Preferably, the misoperation prevention cover is rotatably connected to the housing. Preferably, the anti-misoperation cover 60 is connected with the shell through a rotating connecting piece, the rotating connecting piece comprises a connecting rod 601, one end of the connecting rod 601 is connected with the anti-misoperation cover 60, and the other end of the connecting rod is connected with the shell. Preferably, the two sides of the shell are respectively provided with a connecting rod, one end of the connecting rod is fixed with the shell, the other end of the connecting rod is rotationally connected with the misoperation preventing cover, or one end of the connecting rod is rotationally connected with the shell, and the other end of the connecting rod is fixed with the misoperation preventing cover.

In another aspect, the invention provides a method of detecting an analyte in a blood sample, the method comprising: providing a test device comprising a test element 80, a solution reservoir 101, a piercing element 50 capable of piercing the reservoir, wherein the solution reservoir 101 has a first position and a second position in the test device; allowing the solution reservoir 101 to move from the first position to the second position; during movement, the piercing element 50 is caused to pierce the solution reservoir 101, thereby releasing the solution in the solution reservoir 101.

At this time, after the sample application is finished, the holding device for holding the solution storage is sleeved on the channel structure, one end of the channel is aligned with one end of the solution holding cavity sealed by the film, the solution storage is pushed to move from the first position to the second position, the puncturing structure is inserted into the sealing openings on two sides of the solution holding cavity as the puncturing element is positioned on the channel, the puncturing structure is further inserted into the solution holding cavity along with the channel, the puncturing structure is further inserted into the channel, so that the solution is forced to enter the channel from the opening of the channel, and because the clamping groove element is close to the opening of the channel, the solution entering through the opening of the channel also enters the clamping groove and then flows into the sample application area, and the solution flowing into the application area flows through the sample application area corresponding to the sample application hole to process the sample positioned on the sample application area, so that the test or assay is finished.

The above method is directed to a blood sample, and when the blood sample is not a blood sample, the blood sample can be taken directly by using a blood collector without a puncture device, such as saliva, feces, etc., and the blood sample can be taken by using the blood collector as described above.

The invention shown and described herein may be practiced without any of the elements, limitations specifically disclosed herein. The terms and expressions which have been employed are used as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding any equivalents of the features shown and described or portions thereof, and it is recognized that various modifications are possible within the scope of the invention. It is therefore to be understood that while the present invention has been specifically disclosed by various embodiments and optional features, modification and variation of the concepts herein described may be resorted to by those skilled in the art, and that such modifications and variations are considered to be within the scope of this invention as defined by the appended claims.

The contents of the articles, patents, patent applications, and all other documents and electronically available information described or documented herein are incorporated by reference in their entirety to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference. Applicants reserve the right to incorporate any and all materials and information from any such articles, patents, patent applications, or other documents.

Claims

1. A device for detecting an analyte in a sample, characterized in that: the detection device comprises a solution reservoir, a puncture element and a detection channel; when the solution reservoir is positioned at the first position relative to the puncture element, a distance is reserved between the solution reservoir and the puncture element; when the solution reservoir is positioned at the second position relative to the puncturing element, the puncturing element opens the solution reservoir; the puncture element comprises a puncture part and a flow guiding part, the puncture element is composed of a plurality of sub-parts, all the sub-parts enclose a cylinder, gaps are reserved between adjacent sub-parts, and each sub-part is provided with a blade part; the blade part of the sub part is used as a puncture part; the gap between the sub-parts is used as a diversion trench; the detection channel comprises a liquid collecting part for receiving the solution, a test part for placing the test element and a bracket, and the liquid collecting part is communicated with the test part; the puncture element is positioned at the liquid collecting part; the test element comprises a liquid suction end, a sample adding area and a detection result area, and the liquid suction end is communicated with the liquid collecting part; the test element is placed on a carrier that holds the test element.

2. The device for detecting an analyte in a sample according to claim 1, wherein: the detection device has a movable member capable of displacement, the movable member includes a pressing portion and a displacement portion, and the puncturing element or the solution reservoir is fixed to the movable member.

3. The device for detecting an analyte in a sample according to claim 2, wherein: the displacement part is a sleeve, and the detection device is provided with a guide post matched with the sleeve; the first end of the sleeve is fixed with the pressing part, and the second end of the sleeve is matched with the guide post; or the displacement part is a guide post, and the detection device is provided with a sleeve matched with the guide post; the first end of the guide post is fixed with the pressing part, and the second end of the guide post is matched with the sleeve.

4. The device for detecting an analyte in a sample according to claim 1, wherein: the piercing portion of the piercing element is a blade or tip; the solution reservoir comprises a cavity for holding a solution reagent, the cavity being sealed by a membrane that is easily pierced, the piercing section being opposite the membrane; the puncture part releases the solution in a manner of puncturing the film.

5. The device for detecting an analyte in a sample according to claim 1, wherein: the detecting device is detachably provided with a hemostix.

6. The device for detecting an analyte in a sample according to claim 1, wherein: the detection device is provided with a puncture device for puncturing tissues; one end of the puncture outfit is exposed, and the exposed end of the puncture outfit contains a puncture needle.

7. The device for detecting an analyte in a sample according to claim 1, wherein: the detection device is provided with a shell, the movable piece, the solution reservoir and the puncture element are positioned in a first area of the shell, the test element is positioned in a second area of the shell, the liquid collecting part of the detection channel is positioned in the first area, and the test part of the detection channel is positioned in the second area.

8. The device for detecting an analyte in a sample according to claim 7, wherein: the first region satisfies the running space of the movable member; the second region satisfies the installation space of the test element.

9. The device for detecting an analyte in a sample according to claim 8, wherein: the first region having a movable member window into which the piercer fits; the second area has a display window of the detection result.

10. The device for detecting an analyte in a sample according to claim 2, wherein: the detection device comprises an misoperation prevention cover which shields the movable piece.