WO2025166356A1

WO2025166356A1 - Specimen collection containers and related transfer and/or enrichment systems and methods

Info

Publication number: WO2025166356A1
Application number: PCT/US2025/014333
Authority: WO
Inventors: Lorenzo D'AMICO; Faisal Khan; Justin HANENBERG
Original assignee: Fmrk Diagnostic Technologies Inc
Current assignee: Fmrk Diagnostic Technologies Inc
Priority date: 2024-02-01
Filing date: 2025-02-03
Publication date: 2025-08-07
Anticipated expiration: 2026-08-01

Abstract

Described are various embodiments of a container for sample collection and transfer of a fluid sample, a system for sample collection and preparation of a fluid sample, and systems and methods for sterilely enriching a fluid medical specimen for testing. In some embodiments, the container, system and/or method are configured to reduce contamination risk introduced by specimen handling and/or to allow for use by non-skilled technicians. Some embodiments of the container, system and/or method are suited for urine sample collection, enrichment and transfer for urinary tract infection analysis.

Description

SPECIMEN COLLECTION CONTAINERS AND RELATED TRANSFER AND/OR ENRICHMENT SYSTEMS AND METHODS

FIELD OF THE DISCLOSURE

[0001] The present disclosure relates to sample collection and transfer containers and enrichment systems, and in particular, to a container for sample collection and transfer of a fluid sample, a system for sample collection and preparation of a fluid sample, various systems for sterilely enriching a fluid medical specimen for testing and related methods.

BACKGROUND

[0002] Urinary tract infections (UTIs) occur when bacteria enter the urethra and infect the urinary tract. Although different parts of the urinary tract can be infected, UTIs typically affect the urethra (urethritis), bladder (cystitis) or kidneys (pyelonephritis). Untreated UTIs can lead to serious health problems, including permanent kidney damage, delivering low birth weight or premature infant (when UTI untreated during pregnancy), urethra narrowing and sepsis. Typical UTI diagnosis is based on a physical examination of the patient, together with symptom and patient history analysis.

[0003] The treatment of UTIs involves a healthcare practitioner prescribing antibiotics. Medicating patients with antibiotics carries the risk of various side effects, such as rash, dizziness, nausea, diarrhea, and yeast infections, as well as antibiotic-resistant infections. Since antibiotic resistance is itself on the rise, some antibiotic treatments may be ineffective. Recurrent UTIs, including two or more UTIs within six months or three or more within a year, are typically caused by reinfection of the same pathogen.

[0004] During diagnosis, a healthcare practitioner may request a urine sample to be collected in a specimen cup and may utilize a dipstick test to determine whether leucocytes are present in urine. Whilst leucocyte presence is correlated to UTI, this test cannot confirm whether the infection is bacterial and if so, the bacterial susceptibility thereof. Due to the cost and/or time delays, laboratory urine tests to confirm infection and/or identify pathogens are typically only ordered when a patient is experiencing recurrent UTIs. To confirm infection, urine samples are centrifuged and the sediment is microscopically analyzed by a technician for the presence of bacteria and/or white blood cells, amongst others, indicative of infection.

[0005] Urine cultures can be prepared with growth serum and provided microbial colony growth ensues up until visible identification by the naked eye, tested to detect and identify bacteria or yeast causing the UTI. Antibiotic sensitivity tests can also be carried out, to ensure effective antibiotic prescription. Conventional urine culturing typically takes 24 to 48 hours to determine antibiotic susceptibility. Although there have been recent developments which automate certain aspects of conventional urine culturing, this testing still requires expensive equipment and skilled labour, including the use of sterile technique.

[0006] Notably, other fluid medical specimens are also typically tested in a manner similar to urine, as described above, and can also benefit from new mechanisms for collecting, transferring, preparing and/or testing samples. Other fluid medical specimens may include semen, saliva or other bodily fluids.

[0007] This background information is provided to reveal information believed by the applicant to be of possible relevance. No admission is necessarily intended, nor should be constmed, that any of the preceding information constitutes prior art or forms part of the general common knowledge in the relevant art.

SUMMARY

[0008] The following presents a simplified summary of the general inventive concept(s) described herein to provide a basic understanding of some aspects of the disclosure. This summary is not an extensive overview of the disclosure. It is not intended to restrict key or critical elements of embodiments of the disclosure or to delineate their scope beyond that which is explicitly or implicitly described by the following description and claims.

[0009] A need exists for sample collection and transfer containers and systems, and/or sterile specimen enrichment systems and methods, that overcome some of the drawbacks of known techniques, or at least, provides a useful alternative thereto. Some aspects of this disclosure provide examples of such sample collection and transfer containers and systems, and/or sterile specimen enrichment systems and methods.

[0010] In one aspect, there is provided a system for sterilely enriching a fluid medical specimen for testing, the system comprising: a docking platform for docking a receptacle containing the fluid medical specimen; a receptacle accessing mechanism for sterilely accessing an internal chamber of the receptacle after docking; a pressure-driven transfer assembly for automatically and sterilely transferring at least a portion of the fluid medical specimen from the internal chamber of the receptacle to a specimen enrichment apparatus; the specimen enrichment apparatus for receiving at least a portion of the fluid medical specimen from the pressure-driven transfer assembly for enrichment, the specimen enrichment apparatus comprising an enriched specimen outlet fluidly connectable to a microfluidic test cartridge to sterilely output an enriched specimen thereto for testing.

[0011] In one embodiment, the receptacle accessing mechanism comprises a lid opener for opening a lid on the receptacle once docked. In one embodiment, the lid opener comprises a motor-driven lid engaging member shaped and dimensioned to releasably engage the lid for removal from the receptacle. In one embodiment, the motor-driven lid engaging member is connected to a motor and is configured to rotate so as to at least partially open and/or remove the lid from the receptacle.

[0012] In one embodiment, the pressure-driven transfer assembly comprises at least one conduit operatively connected to a pump for transferring at least a portion of the fluid medical specimen from the receptacle to the specimen enrichment apparatus.

[0013] In one embodiment, one end of at least one conduit is arranged for insertion into the receptacle.

[0014] In one embodiment, at least one conduit comprises a first conduit and a second conduit, the first conduit connected to the pump and arranged for insertion into the receptacle, and the second conduit arranged between the pump and the specimen enrichment apparatus. [0015] In one embodiment, the docking platform is linearly actuatable between a receptacle receiving zone, a specimen accessing zone and a specimen transfer zone. In one embodiment, the docking platform is powered by a motor.

[0016] In one embodiment, the docking platform comprises a docking formation for gripping a lower end of the receptacle.

[0017] In one embodiment, any one or combination of the receptacle accessing mechanism, the pressure-driven transfer assembly and the specimen enrichment apparatus are configured to be hands-free operable to ensure sterility of the fluid medical specimen.

[0018] In one embodiment, the receptacle accessing mechanism is reversibly operable as a receptacle closing mechanism.

[0019] In accordance with another aspect, there is provided a system for sterilely enriching a fluid medical specimen for testing, the system comprising a dock configured to dock a receptacle containing the fluid medical specimen, the receptacle having an actuatable specimen release mechanism for sterilely releasing at least a portion of the fluid medical specimen to a specimen release chamber of the receptacle; a fluid inlet arranged at the dock to be in sterile fluid communication with the specimen release chamber of the receptacle when docked; a specimen transfer conduit extending from the fluid inlet for sterilely transferring the fluid medical specimen from the specimen release chamber of the receptacle downstream; and a specimen enrichment apparatus for receiving at least a portion of the fluid medical specimen from the specimen transfer conduit for enrichment, the specimen enrichment apparatus comprising an enriched specimen outlet fluidly connectable to a microfluidic test cartridge to sterilely output an enriched specimen thereto for testing.

[0020] In one embodiment, the dock comprises a docking formation for securely docking the receptacle such that the fluid inlet is at least partially aligned with the chamber of the receptacle. [0021] In one embodiment, the actuatable specimen release mechanism comprises a mechanical valve, a pull tab, a slide tab, a push button, a stop cock, a plunger or a piercing member.

[0022] In one embodiment, the receptacle comprises a specimen collection chamber in juxtaposition with the specimen release chamber. In one embodiment, the specimen collection chamber and the specimen release chamber are fluidly separated by a septum.

[0023] In one embodiment, the fluid medical specimen flows in the specimen transfer conduit under a force of gravity or under a pressure differential.

[0024] In accordance with another aspect, there is provided a system for sterilely enriching a fluid medical specimen for testing, the system comprising: a dock configured to dock a receptacle containing the fluid medical specimen; a sterile specimen transfer mechanism operable in fluid communication with the receptacle once docked to sterilely access and transfer at least a portion of the fluid medical specimen under pressure from the receptacle to a specimen enrichment apparatus; and the specimen enrichment apparatus for receiving the at least a portion of the fluid medical specimen from the specimen transfer mechanism for enrichment prior to testing, the specimen enrichment apparatus comprising an enriched specimen outlet fluidly connectable to a microfluidic test cartridge to sterilely output an enriched specimen thereto for testing.

[0025] In one embodiment, the sterile specimen transfer mechanism comprises a conduit and the pressure comprises gravity pressure.

[0026] In one embodiment, the sterile specimen transfer mechanism comprises a pump and at least one conduit, and the pressure comprises any one or both of a positively applied pressure and a negatively applied pressure.

[0027] In one embodiment, any one or combination of the sterile specimen transfer mechanism and the specimen enrichment apparatus are configured to be hands-free operable to ensure sterility of the fluid medical specimen. [0028] In one embodiment, the system is configured to be automated such that the receptacle containing the fluid medical specimen and the microfluidic test cartridge arc respectively connected, and specimen enrichment and transfer to the microfluidic test cartridge is automated.

[0029] In one embodiment, the specimen enrichment apparatus comprises any one or combination of: an enrichment device, a fractionation device and a filtration device.

[0030] In one embodiment, the specimen enrichment apparatus comprises a foam fractionator.

[0031] In one embodiment, the system further comprises a digital controller which executes stored instructions to automate at least specimen transfer and enrichment within the system.

[0032] In one embodiment, the system further comprises a sample reservoir arranged upstream of the enriched specimen outlet to collect the enriched specimen from the specimen enrichment apparatus.

[0033] In one embodiment, the system is configured for sterilization between uses. In one embodiment, the system further comprises an ultraviolet light source arranged within the system for sterilization of one or more components between uses.

[0034] In accordance with another aspect, there is provided a method for sterilely enriching a fluid medical specimen for testing, the method comprising: docking a receptacle containing the fluid medical specimen to a dock; operating a sterile specimen transfer mechanism which is in fluid communication with the receptacle once docked, to sterilely access and transfer at least a portion of the fluid medical specimen under pressure from the receptacle to a specimen enrichment apparatus; and operating the specimen enrichment apparatus to enrich the at least a portion of the fluid medical specimen received from the specimen transfer mechanism, the specimen enrichment apparatus comprising an enriched specimen outlet fluidly connectable to a microfluidic test cartridge to sterilely output an enriched specimen thereto for testing. [0035] In one embodiment, the method further comprises, after docking, operating a receptacle accessing mechanism for stcrilcly accessing an internal chamber of the receptacle.

[0036] In one embodiment, operating the receptacle accessing mechanism comprises at least partially opening the receptacle. In one embodiment, operating the receptacle accessing mechanism comprises removing a lid from the receptacle. In one embodiment, operating the receptacle accessing mechanism comprises releasing the fluid medical specimen from the receptacle.

[0037] In one embodiment, docking comprises engaging a docking formation on the dock with a complementary docking formation on the receptacle.

[0038] In one embodiment, the sterile sample transfer mechanism comprises a pump and at least one conduit, and operating the sterile sample transfer mechanism comprises pumping at least a portion of the fluid medical specimen from the receptacle to the specimen enrichment apparatus.

[0039] In one embodiment, the sterile sample transfer mechanism comprises at least one conduit, and operating the sterile sample transfer mechanism comprises allowing at least a portion of the fluid medical specimen to flow under gravity pressure from the receptacle to the specimen enrichment apparatus.

[0040] In one embodiment, operating the specimen enrichment apparatus includes any one or combination of: filtering the portion of the fluid medical specimen; fractionating the portion of the fluid medical specimen; and enriching the portion of the fluid medical specimen.

[0041] In one embodiment, one or more steps of the method is automated or handsfree to ensure sterility of the enriched specimen.

[0042] In one embodiment, the system and/or method herein disclosed is configured for point-of-care sample enrichment and testing. [0043] In accordance with another aspect, there is provided a fluid sample collection and transfer container, comprising: a sample collection chamber having a sample inlet for receiving therethrough a fluid sample into the sample collection chamber; a sample transfer docking structure configured for engaging with a complementary docking station located on a sample preparation device, the sample transfer docking structure having a transfer outlet from which at least a portion of the fluid sample is transferable to the sample preparation device; and a septum arranged to fluidly separate the sample collection chamber and the sample transfer docking structure, the septum being configured to selectively permit transfer of at least a portion of the fluid sample thereacross.

[0044] In one embodiment, the container further comprises a fluid flow mechanism to selectively permit fluid transfer of at least a portion of the fluid sample across the septum.

[0045] In one embodiment, the sample collection chamber is located above the sample transfer docking structure such that fluid flow from the sample collection chamber across the septum to the transfer outlet is gravity-assisted.

[0046] In one embodiment, the septum comprises an impermeable membrane.

[0047] In one embodiment, the fluid flow mechanism is actuatable between a closed configuration and a fluid flow configuration.

[0048] In one embodiment, the fluid flow mechanism comprises a mechanical valve. In one embodiment, the mechanical valve comprises any one of a pull tab, a slide tab, a push button, a stop cock, or a plunger. In one embodiment, the fluid flow mechanism comprises a piercing member arranged to selectively pierce the septum to selectively permit fluid transfer of at least a portion if the fluid sample across the septum.

[0049] In one embodiment, the sample transfer docking structure comprises a sample transfer chamber configured to at least partially retain the fluid sample therein during sample transfer. [0050] In one embodiment, the sample transfer docking structure comprises a coupling formation configured to securely couple to a complementary coupling formation on the complementary docking station.

[0051] In one embodiment, the container further comprises a collection lid configured to permit access to the sample inlet for depositing the fluid sample in the sample collection chamber. In one embodiment, the collection lid comprises a vent having a releasable vent cover.

[0052] In one embodiment, the container further comprises a removable transfer lid configured to removably cover the transfer outlet to avoid contamination of the sample transfer docking structure.

[0053] In one embodiment, at least a portion of the fluid flow mechanism is integrated with or engageable with the complementary docking station of the sample preparation device.

[0054] In one embodiment, the fluid sample comprises a urine sample.

[0055] In one embodiment, the container is a single-use disposable.

[0056] In accordance with another aspect, there is provided a system for sample collection and preparation of a fluid sample, the system comprising: a fluid sample collection and transfer container as described in any of the above embodiments; and a sample preparation device with which the container is engageable, the sample preparation device comprising a complementary docking station configured to engage the sample transfer docking structure of the container; a preparation inlet formed in the complementary docking station, through which the fluid sample is receivable from the sample transfer docking structure; and a sample preparation assembly downstream of the preparation inlet for preparing the fluid sample for sample testing.

[0057] In one embodiment, the sample transfer docking structure comprises a coupling formation and wherein the complementary docking station comprises a complementary coupling formation, whereby the coupling formation and the complementary coupling formation, when engaged, dock the container to the sample preparation device for sample transfer. In one embodiment, the coupling formation and the complementary coupling formation are interlockable, clippable, or snap-fittable.

[0058] In one embodiment, the sample preparation device comprises a piercing member arranged to pierce the septum upon activation to allow the sample fluid to flow from the sample collection chamber to the sample preparation device.

[0059] In one embodiment, the sample preparation assembly comprises a filter assembly. In one embodiment, the filter assembly is configured to provide tangential flow filtration of the fluid sample. In one embodiment, the filter assembly comprises a filter; a circular filter conduit connectable to either end of the filter; at least one roller configurable to engage the circular filter conduit; and a peristaltic pump connectable to move the at least one roller when activated.

[0060] In one embodiment, the filter assembly comprises a hollow filter arranged within a filter housing.

[0061] In one embodiment, the filter assembly further comprises a permeate reservoir for receiving filter permeate after filtration. In one embodiment, the permeate reservoir comprises a permeate outlet and the sample preparation device further comprises a removable cap configured to seal the permeate outlet.

[0062] In one embodiment, the sample preparation device further comprises a connector tube arrangeable between the sample transfer docking structure and the preparation inlet of the sample preparation device.

[0063] In one embodiment, the connector tube comprises a piercing member arranged to pierce the septum upon activation to allow the sample fluid to flow from the sample collection chamber to the sample preparation device.

[0064] In one embodiment, the connector tube is a single-use disposable.

[0065] In one embodiment, the system further comprises a microfluidic test cartridge connectable in fluid communication with the sample preparation device. In one embodiment, the microfluidic test cartridge comprises: a test cartridge inlet configured to receive filter permeate from the sample preparation device; a fluid flow path from the test cartridge inlet to a test sample reservoir; and a plurality of fluid flow paths from the test sample reservoir to a plurality of test wells.

[0066] Other aspects, features and/or advantages will become more apparent upon reading of the following non-restrictive description of specific embodiments thereof, given by way of example only with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE FIGURES

[0067] Several embodiments of the present disclosure will be provided, by way of examples only, with reference to the appended drawings, wherein:

[0068] Figure 1 is a schematic diagram of a system for sample collection and preparation of a fluid sample, in accordance with one embodiment, assembled for fluid transfer of the fluid sample from a container, through a sample transfer connector tube, to a filter assembly;

[0069] Figure 2 is a schematic diagram of a container for sample collection and transfer of a fluid sample, in accordance with one embodiment;

[0070] Figure 3 is a schematic diagram of a sample transfer connector tube, in accordance with one embodiment;

[0071] Figure 4 is a schematic diagram of a filter assembly, in accordance with one embodiment;

[0072] Figure 5 is a schematic diagram of the filter assembly of Figure 4, connected to a microfluidic test cartridge, in accordance with one embodiment; and

[0073] Figure 6 is a schematic diagram of a system for sterilely enriching a fluid medical specimen for testing, in accordance with another embodiment of the disclosure. [0074] Elements in the several figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions of some of the elements in the figures may be emphasized relative to other elements for facilitating understanding of the various presently disclosed embodiments. Also, common, but well-understood elements that are useful or necessary in commercially feasible embodiments are often not depicted in order to facilitate a less obstructed view of these various embodiments of the present disclosure.

DETAILED DESCRIPTION

[0075] Various implementations and aspects of the specification will be described with reference to details discussed below. The following description and drawings are illustrative of the specification and are not to be construed as limiting the specification. Numerous specific details are described to provide a thorough understanding of various implementations of the present specification. However, in certain instances, well-known or conventional details are not described in order to provide a concise discussion of implementations of the present specification.

[0076] Various apparatuses and processes will be described below to provide examples of implementations of the system disclosed herein. No implementation described below limits any claimed implementation and any claimed implementations may cover processes or apparatuses that differ from those described below. The claimed implementations are not limited to apparatuses, systems or processes having all of the features of any one apparatus or process described below or to features common to multiple or all of the apparatuses, systems or processes described below. It is possible that an apparatus, system or process described below is not an implementation of any claimed subject matter.

[0077] Furthermore, numerous specific details are set forth in order to provide a thorough understanding of the implementations described herein. However, it will be understood by those skilled in the relevant arts that the implementations described herein may be practiced without these specific details. In other instances, well-known methods, procedures and components have not been described in detail so as not to obscure the implementations described herein. [0078] In this specification, elements may be described as “configured to” perform one or more functions or “configured for” such functions. In general, an element that is configured to perform or configured for performing a function is enabled to perform the function, or is suitable for performing the function, or is adapted to perform the function, or is operable to perform the function, or is otherwise capable of performing the function.

[0079] It is understood that for the purpose of this specification, language of “at least one of X, Y, and Z” and “one or more of X, Y and Z” may be construed as X only, Y only, Z only, or any combination of two or more items X, Y, and Z (e.g., XYZ, XY, YZ, ZZ, and the like). Similar logic may be applied for two or more items in any occurrence of “at least one ...” and “one or more...” language.

[0080] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs.

[0081] The following terms take the meanings explicitly associated herein, unless the context clearly dictates otherwise. The phrase “in one of the embodiments” or “in at least one of the various embodiments” as used herein does not necessarily refer to the same embodiment, though it may. Furthermore, the phrase “in another embodiment” or “in some embodiments” as used herein docs not necessarily refer to a different embodiment, although it may. Thus, as described below, various embodiments may be readily combined, without departing from the scope or spirit of the innovations disclosed herein.

[0082] In addition, as used herein, the term “or” is an inclusive “or” operator, and is equivalent to the term “and/or,” unless the context clearly dictates otherwise. The term “based on” is not exclusive and allows for being based on additional factors not described, unless the context clearly dictates otherwise. In addition, throughout the specification, the meaning of "a," "an," and "the" include plural references unless the context clearly dictates otherwise. The meaning of "in" includes "in" and "on."

[0083] The term “comprising” or “comprises” as used herein will be understood to mean that the list following is non-exhaustive and may or may not include any other additional suitable items, for example one or more further feature(s), component(s) and/or clcmcnt(s) as appropriate.

[0084] One limitation of conventional fluid testing is the need for sterile technique. Once a sample has been collected, the sample container is typically transported to a central laboratory for testing by a skilled technician trained in sterile technique and the particular testing required. This conventional fluid testing is both time-consuming and expensive.

[0085] In some embodiments, therefore, there is provided a sample collection container which is configured to allow for sterile transfer of the fluid sample (or “analyte”) to a sample testing device, a connector to the sample testing device, or the like. In some embodiments, there is provided a sample collection and transfer system which is configured to allow for sterile transfer from the sample collection container to the sample testing device. In some embodiments, the provision of the sample collection container and/or system so configured provides that the sample testing may be performed by technicians that need not be trained in sterile technique. Advantageously, in some embodiments, this may allow for testing to be conducted at the sampling site. For example, in the case of biological fluid samples taken at clinics or doctor’s offices, the biological fluid samples may be tested within the same building, eliminating the typical delays caused by transport of the sample and testing at a central laboratory. Notably, in the context of this disclosure, the term “sterile” may be used to refer to parts that are strictly sterile, as well as parts or processes that are intended to be kept sterile as far as possible during use, so as to avoid sample contamination, as the context will indicate. Put differently, the devices and systems described herein may be specifically configured for the transfer and preparation of a fluid sample with minimal risk of sample contamination prior to testing.

[0086] In some embodiments, the sample collection container and/or sample collection and transfer system are configured to provide a disposable, lightweight, single-use, sample collection and/or transfer apparatus.

[0087] In some embodiments, the sample collection container and/or sample collection and transfer system are configured to be used for urine testing, where sample collection and testing can be carried out at one site (e.g., in clinic), such that the overall time, expertise and expense of urine testing is reduced, particularly as compared to urine testing requiring sterile technique and cell culturing. Indeed, embodiments envisioned herein arc aimed at improving the timelines to assess the antibiotic susceptibility of UTIs, to at least ameliorate any unnecessary and/or frugal prescription of antibiotics. Other embodiments disclosed herein are intended for other fluid medical specimen testing, such as for semen testing or saliva testing.

[0088] Some embodiments are provided wherein a sample collection container, or specimen receptacle, is readily docked to a system for sample transfer and preparation prior to testing, typically diagnostic testing, wherein minimal or even zero specimen handling is necessary. Some embodiments, for example, provide for the opening of the specimen receptacle or otherwise accessing a specimen contained therein, so as to avoid the need for manual opening or accessing. Some embodiments provide for transferring at least a portion of the specimen contained within the receptacle to a specimen preparation and/or enrichment device or assembly, as the case may be, so as to avoid the need for manual transfer via pipette, syringe or similar manual transfer means. Yet further, some embodiments provide for transfer of a prepared sample (e.g., enriched specimen) directly to a testing device or cartridge, so as to avoid the need for manual transfer via pipette, syringe or similar- manual transfer means. It is to be appreciated that by the aforementioned embodiments reducing one or more handling steps, not only can an unskilled technician or layperson attend to the sample preparation, enrichment and/or transfer procedure, but they can do so with limited risk of specimen contamination. Indeed, in some of the forementioned embodiments, the sample collection container or specimen receptacle may be docked to the system in a closed and/or sealed configuration, and the system itself carries out sample transfer and preparation or enrichment within a sterile environment with limited or no further handling of the sample or specimen. Various embodiments provide various means of transferring the specimen within the system, including gravity-assisted transfers and pressure-assisted transfers, both positive and negative or vacuum, without limitation.

[0089] With reference to Figures 1 and 2, and in accordance with one exemplary embodiment, a container for sample collection and transfer of a fluid sample, or fluid sample collection and transfer container, generally referred to using the numeral 100, will now be described. The container 100 may also be referred to as a “specimen cup” or “collection cup” in some embodiments.

[0090] In this embodiment, the container 100 generally comprises a sample collection chamber 102 having a sample inlet 104 for receiving therethrough a fluid sample (shown in Figure 1) into the sample collection chamber 102, a sample transfer docking structure 106 configured for engaging with a complementary docking station located on a sample preparation device 200, the sample transfer docking structure 106 having a transfer outlet 108 (shown sealed) from which at least a portion of the fluid sample is transferable to the sample preparation device 200 (or indeed, any other sample processing device), and a septum 110 arranged to fluidly separate the sample collection chamber 102 and the sample transfer docking structure 106, the septum 110 being configured to selectively permit transfer of at least a portion of the fluid sample thereacross (i.e., across the septum 110).

[0091] In this embodiment, the container 100 further comprises a fluid flow mechanism 112 which is operable to selectively permit the fluid transfer of at least a portion of the fluid sample across the septum 110. In this embodiment, the fluid flow mechanism 112 is located proximate the septum 110 and when activated or actuated, enables at least a portion of the fluid sample to flow from the sample collection chamber 102 through the septum 1 10 to the transfer outlet 108 of the sample transfer docking structure 106.

[0092] In this embodiment, the sample transfer docking structure 106 is considered a sample transfer chamber, as shown in Figures 1 and 2. As such, in this embodiment, whilst the sample collection chamber 102 and the sample transfer docking structure 106 are sometimes described collectively as “chambers”, it is to be appreciated that each or both chambers 102, 106 need not be enclosed or sealed, although the chamber(s) may be, nor does the sample transfer docking structure 106 in fact need to define a chamber as such in certain embodiments. Indeed, in this embodiment, the sample transfer docking structure 106 is predominantly for securely docking or connecting the container 100 to the further componentry of the sample transfer system, as will be described later, and the chamber aspect thereof in this embodiment is an additional feature. In this embodiment, the chamber(s) 102, 106 are considered cavities or spaces within a body of the container 100, in which the fluid sample may be held or stored, temporarily or for some time.

[0093] In this embodiment, the sample collection chamber 102 and the sample transfer docking structure 106 are formed out of the body of the container 100. As shown in Figure 2, the sample collection chamber 102 is located opposed to the sample transfer docking structure 106, and more specifically, the sample collection chamber 102 is located above the sample transfer docking structure 106 such that the container 100 has a generally H- shaped cross-section in this embodiment. In use, this arrangement of the chambers 102, 106 provides that fluid flow from the sample collection chamber 102 through the septum 110 to the transfer outlet 108 of the sample transfer docking structure 106 is gravity- assisted. In this embodiment, as described further below, a collection lid 116 includes a vent 118 which further assists this gravity feed when in use.

[0094] In this embodiment, the container 100 has a generally cylindrical shape, having a cylindrical wall which, in this embodiment, is manufactured of plastic. Notably, plastic is suitable in this embodiment since it is not substantially reactive, corrosive, or the like, with the fluid sample collected. As shown in Figure 2, the sample inlet 104 is arranged on one end of the container 100 and the transfer outlet 108 is arranged on the other end of the container 100, in this embodiment. In this embodiment, the sample inlet 104 comprises a large circular aperture or opening on the one end (the top end) of the container 100 which is shaped and dimensioned for receiving therethrough the fluid sample. In this embodiment, the fluid sample (e.g., urine) is received directly from the source (e.g., patient) into the sample collection chamber 102.

[0095] In this embodiment, the transfer outlet 108 comprises a large circular aperture or opening on the other end (the bottom end) of the container 100 which is shaped and dimensioned for transferring therethrough the fluid sample to further componentry of the sample transfer and/or preparation system. In this embodiment, the relatively large transfer outlet 108 facilitates rapid transfer of at least a portion of the fluid sample. Notably, whilst the transfer outlet 108 is shown in this embodiment to generally match the shape of the sample inlet 104, having a circular shape of slightly narrower diameter, it is to be appreciated that the transfer outlet 108 may take on any shape and/or dimensions suited for allowing at least a portion of the fluid sample to flow therefrom. For example, the transfer outlet 108 may comprise a small aperture which matches that of conduit connected thereto.

[0096] As noted, in this embodiment the sample transfer docking structure 106 is configured for engaging with a complementary docking station located on a sample preparation device, which is described further below. In this context, the term “station” is to be interpreted broadly, such that the complementary docking station may take on a plurality of structures, formations, shapes and dimensions. For example, the sample transfer docking structure 106 may merely rest on the complementary docking station, otherwise may be received thereby, yet otherwise may be connected thereto, without limitation.

[0097] In this embodiment, the septum 110 forms a barrier between the sample collection chamber 102 and the sample transfer docking structure 106, such that transfer of the fluid sample from the former to the latter occurs only on-demand, when the fluid flow mechanism 112 is actuated, activated or engaged. The fluid sample collected thus remains in the sample collection chamber 102 until a technician is ready to perform sample transfer and/or preparation for testing. As such, a collected fluid sample may be transported in the sample collection chamber 102, if necessary, prior to sample transfer, preparation and/or testing occurring, provided the collection lid 116 is secured to the sample inlet 104.

[0098] In this embodiment, the septum 110 is positioned generally midway along the length of the container 100, such that the sample collection chamber 102 and the sample transfer docking structure 106 have similar capacities or volumes. In this embodiment, therefore, the majority if not all of the fluid sample collected is transferable to the sample transfer docking structure 106. Notably, the sample collection chamber 102 should be of a capacity or volume suitable for the testing to be carried out. For example, if 5mL of concentrated sample is required for downstream testing, the sample collection chamber 102 is shaped and dimensioned to ensure that sufficient sample is collected, allowing for system wastage and/or expected filtering volume reduction. [0099] In this embodiment, the septum 110 comprises a predominantly or substantially impermeable membrane. In particular, the septum 110 is impermeable to liquids. As such, as noted above, the fluid sample collected may be stored and/or transported in the sample collection chamber 102, above the septum 110, for some time, even a prolonged time, if necessary. In this embodiment, the septum 110 is manufactured of the same material as the container 100, plastic, and the septum 110 and chambers 102, 106 are of unitary construction in this embodiment. As such, the septum 110 is only openable upon activation or actuation of the fluid flow mechanism 112 in this embodiment.

[00100] In this embodiment, the fluid flow mechanism 112 is externally actuatable between a closed configuration, as shown in Figure 2, wherein the sample fluid is impeded from flowing between the chambers 102, 106, and a fluid flow configuration (or “open configuration”), as shown in Figure 1, wherein the sample fluid is allowed to flow between the chambers 102, 106, typically although not necessarily through an aperture through the septum 110. When the fluid sample is collected in the sample collection chamber 102, the fluid flow mechanism 112 is typically maintained in the closed configuration, as shown in Figure 2. As such, the fluid sample collects within the sample collection chamber 102. When the fluid sample is to be transferred to the sample transfer docking structure 106, the fluid flow mechanism 112 is manually actuated from the closed configuration to the fluid flow configuration, as shown in Figure 1 , such that at least a portion of the fluid sample flows from the sample collection chamber 102 to the sample transfer docking structure 106 through the fluid flow mechanism 112 and/or its aperture.

[00101] In this particular embodiment, the fluid flow mechanism 112 comprises a mechanical valve. More specifically, mechanical valve 112 comprises a mechanical, pull tab. In the closed configuration, shown in Figure 2, the pull tab 112 securely engages an opposed side of the aperture, covering the diameter of the aperture in the septum 210 to ensure that the fluid sample cannot egress into the sample transfer docking structure 106. In the fluid flow configuration, as shown in Figure 1, the pull tab 112 is pulled outwards, such that the aperture in the septum 210 is exposed or opened, and thus the fluid sample can egress into the sample transfer docking structure 106 under the force of gravity. Notably, various other fluid flow mechanism 112 are envisaged for other embodiments, including one-way valves and picrccablc members, as described later.

[00102] In this embodiment, the fluid flow mechanism 112 is configured so as to avoid accidental actuation and/or activation. For example, when in the closed configuration as shown in Figure 2, the pull-tab is located proximate, if not flush with, the external surface of the container 100. Such configuration may provide that the fluid flow mechanism 112 does not unnecessarily protrude, to avoid accidental transfer of the fluid sample when the sample transfer docking structure 106 is not docked or connected to the suited componentry. Indeed, it is to be appreciated that accidental transfer of the fluid sample when the sample transfer docking structure 106 is not docked or connected may result in leakage and/or wastage of the collected sample.

[00103] In this embodiment, the sample transfer docking structure 106 (or “sample transfer drain”, “sample transfer chamber”) is configured to sterilely dock or connect to a sample preparation device 200 by means of a complementary docking structure. More specifically, in this embodiment, the sample transfer docking structure 106 comprises a coupling formation 114 (or “coupling key”, “lock formation”) configured to securely couple to the complementary docking structure of the sample preparation device 200. As shown in Figure 2, the coupling formation 114 in this embodiment comprises an interlockable, snap-fittable, or clippable, coupling formation which is complementary to a similar formation on the complementary docking structure of the sample preparation device 200 (described later). In this embodiment, the coupling formation 114 is formed by a protuberance from an inner surface of the cylindrical wall of the sample transfer docking structure 106, as shown.

[00104] In this embodiment, the coupling formation 114 further facilitates the proper alignment of the sample transfer docking structure 106 with the connector tube 212, to allow fluid flow from the sample transfer docking structure 106 to the connector tube 212 in use. More specifically, in this embodiment, the coupling formation 114 facilitates the alignment between the transfer outlet 108 of the sample transfer docking structure 106 and the preparation inlet 204 of the complementary docking structure. In other embodiments, the coupling formation 114 may facilitate alignment between an aperture in the septum 1 10 and the preparation inlet 204 of the complementary docking structure (whether provided on a connector tube 212 or otherwise). In this embodiment, the proper alignment provided by the coupling formation 114 may further serve to provide a tight seal between the sample transfer docking structure 106 and the complementary docking structure (whether the connector tube 212 or otherwise), which in turn, may serve to minimize leakage or wastage upon the fluid sample being transferred between the sample transfer docking structure 106 and the complementary docking structure in use. Whilst several functional purposes of the coupling formation 114 are described here, it is to be appreciated that not any or all purposes need to be achieved for a workable embodiment and indeed, in some embodiments, a specific coupling formation 114 may be omitted entirely.

[00105] In this embodiment, as shown in Figure 2, the container 100 further comprises a collection lid 116, as mentioned, configured to removably cover the sample inlet 104 or put differently, configured to permit access to the sample inlet 104 for depositing the fluid sample in the sample collection chamber 102. In this embodiment, the collection lid 116 is a generally circular shape and includes container engaging formations (not shown) on an internal surface for securely connecting to the top end of the container 100, to cover the sample inlet 104. In this embodiment, the container engaging formations comprise male threaded formations configured to thread to female threaded formations formed on an external surface of the container 100. In use, the collection lid 116 is removed from the container 100 (a fresh, unused container), in this embodiment by unscrewing the collection lid 116, the fluid sample is inserted through the sample inlet 104 to the sample collection chamber 102 (e.g., by urination therein), and the collection lid 116 is reconnected to the container 100, in this embodiment by screwing the collection lid 116 back onto the container 100. Notably, when the collection lid 116 is attached or connected to the container 100, the sample collection chamber 102 is substantially sealed. As such, any fluid sample held within the sample collection chamber 102 is retained therein. In this embodiment, once closed with the collection lid 116, the container 100 is substantially leakproof when inverted or toppled over. [00106] In this embodiment, the collection lid 116 comprises a vent 118 (or “airflow port”) having a releasable vent cover 120. In this embodiment, the vent 118 comprises an aperture through a top surface of the collection lid 116, having a raised circumference providing a neck (not shown), and the releasable vent cover 120 comprises a threaded cap configured to releasably connect to the neck. In this embodiment, unscrewing or twisting the releasable vent cover 120 from the vent 118, after the fluid sample has been collected in the sample collection chamber 102, may allow air to ingress into the sample collection chamber 102 to facilitate transfer of the sample fluid to the sample transfer docking structure 106 under the force of gravity. Indeed, the vent 118 may be configured to avoid suction in the sample collection chamber 102 (when sealed by the collection lid 122 to keep the fluid sample sterile) caused by the flow of the fluid sample from the sample collection chamber 102 to the sample transfer docking structure 106 when in use. Advantageously, in this embodiment, sample transfer from the sample collection chamber 102 to the sample transfer docking structure 106 by means of gravity and/or capillary forces negates the need for a separate pump to transfer the fluid sample between these chambers 102, 106. As such, overall cost and/or complexity of the container 100 (and/or the overall sample transfer system) may be reduced in this embodiment.

[00107] In this embodiment, as shown in Figure 2, the container 100 further comprises a removable transfer lid 122 (or “removable protective barrier”) configured to removably cover the transfer outlet 108 to avoid contamination of the sample transfer docking structure 106. In this embodiment, the removable transfer lid 122 covers the transfer outlet 108, snugly engaging the external surface of the container 100 by means of friction fit. In use, during sample collection, the removable transfer lid 122 is intended to be connected to and cover the transfer outlet 108, such that no fluid sample enters the transfer outlet 108 or is accidentally inserted therein. Indeed, the removable transfer lid 122 endeavors to keep the sample transfer docking structure 106 substantially sterile during sample collection, transport, storage and/or thereafter. In use, when the fluid sample is to be transferred from the sample collection chamber 102 to the sample transfer docking structure 106, and in turn the sample preparation device 200, the removable transfer lid 122 is removed, the sample transfer docking structure 106 is immediately, or as soon as possible thereafter to avoid contamination, connected to the sample preparation device 200 (comprising the connector tube 212 and filter assembly 206, either as separate parts or combined), and the fluid flow mechanism 112 is actuated to switch it over to the fluid flow (or “open”) configuration allowing the fluid sample to flow from the sample collection chamber 102 to the sample transfer docking structure 106 to the sample preparation device 200. Details of the sample preparation device 200, to which the container 100 docks or connects and which forms another aspect of the disclosure, are provided hereunder.

[00108] In this embodiment, the fluid sample comprises a urine sample. The urine sample in this specific example is intended for testing for urinary tract infection (UTI), and/or for antibiotic susceptibility, however the instant disclosure is not limited thereto.

[00109] In this embodiment, the container 100 is manufactured to be a single-use disposable. As such, a fresh, unused container 100 would be used for each urinary test of each patient. The container 100 is further manufactured to be lightweight and suitable for transporting to clinics for on-site testing or analysis.

[00110] It is to be appreciated that various alternative embodiments of the container 100 are envisaged, without departing from the general nature and scope of the instant disclosure. Some of these embodiments or variations are briefly described hereunder, without limitation.

[00111] In other embodiments, the container 100 may be manufactured of any other material(s) suitable for sample collection, such material(s) not being reactive with the fluid sample collected. For example, the container 100 may manufactured of rubber. In some embodiments, the container 100 may be manufactured of one or more recyclable materials.

[00112] In other embodiments, the sample collection chamber 102 and the sample transfer docking structure 106 may be formed as separate parts or members, adapted to be connected together by the septum 110, or another part(s), to form the container 100.

[00113] In other embodiments, the sample collection chamber 102 may be located adjacent to the sample transfer docking structure 106, such that chambers 102, 106 longitudinally abut one another. In such embodiments, transfer of the fluid sample from the sample collection chamber 102 to the sample transfer docking structure 106 may be aided by tilting the container 100 towards the sample transfer docking structure 106, or the like, or otherwise may be mechanically aided by a pump or the like.

[00114] In other embodiments, the container 100 may take on any shape and/or dimensions suited to collection and/or transfer of the fluid sample. For example, the container 100 may be generally square-shaped, triangular-shaped, quadrilaterally- shaped or the like, in various embodiments.

[00115] In other embodiments, the sample inlet 104 may be arranged at any other position to allow fluid to flow into the sample collection chamber 102. Similarly, the transfer outlet 108 may be arranged at any other position to allow fluid to flow from the sample transfer docking structure 106 to the sample preparation device 200. For example, the transfer outlet 108 may be provided on a side of the sample transfer container 106, particularly where sufficient fluid sample has been collected to ensure outflow. In other embodiments, the sample inlet 104 may take on any shape and/or dimensions for receiving therethrough the fluid sample. For example, the fluid sample may be received via a supply tube or the like, on the side of the sample collection chamber 102, in other embodiments.

[00116] In other embodiments, the septum 110 may be located at any point along the length or width of the container 100, such that the sample collection chamber 102 and the sample transfer docking structure 106 have differing capacities. For example, the septum 110 may be positioned closer to the transfer outlet 108 such that the sample collection chamber 102 has a capacity or volume greater than that of the sample transfer docking structure 106, particularly where a certain amount of fluid sample is required (potentially less than collected) and/or where the sample transfer docking structure 106 need not temporarily store the fluid sample. In other embodiments, the capacity or volume of the sample transfer docking structure 106 may be substantially smaller than that of the sample collection chamber 102. Indeed, in some embodiments, the sample transfer docking structure 106 may be specifically configured to not hold or retain the fluid sample (i.e. , not defining a specific volume or capacity), but instead to serve as a transfer stage or apparatus between the sample collection chamber 102 and the sample preparation device 200 or other componentry. In such embodiments, the sample transfer docking structure 106 may form a docking structure, as opposed to a defined chamber.

[00117] In other embodiments, the septum 110 may be distinct or separate from the container 100 and/or the chambers 102, 106. In other embodiments, the septum 110 may be manufactured of any other material or combination of materials. In some embodiments, the septum 110 may be manufactured of one or more materials that are relatively rigid and which may be optionally deformable but without compromising the impermeability of the septum 110. In some embodiments, the septum 110 may be manufactured of one or more materials generally pierceable by a sharp object. For example, the septum 110 may be manufactured of silicone, butyl rubber, or the like. In other embodiments, the septum 110 may be manufactured of hard plastic or another rigid material(s) that is impermeable but can be punctured or pierced by a sharp object (e.g., needle or probe), such as by a metal object having a material strength greater than that of the septum 110. In yet other embodiments, the septum 110 may be formed by a combination of materials. For example, the septum 110 may have an outer portion manufactured of plastic, which may or may not be unitary with the rest of the container 100, and a smaller inner portion manufactured of a pierceable material, such as silicone. Such an embodiment may be advantageous, for example, where manufacturing the entire septum 210 of silicone for piercing would be cost prohibitive. In yet other embodiments, the septum 1 10 may be manufactured of laminated paper. In yet further embodiments, the septum 110 may comprise one or more coatings on either or both of an upper surface and a lower surface. For example, the septum 110 may comprise an impermeable coating of a plasticized or rubberized material on an upper surface facing the sample collection chamber 102.

[00118] In other embodiments, the septum 110 and/or the fluid flow mechanism 112 may be configured to provide filtration and/or concentration of the fluid sample. For example, a filter may be positioned within the fluid flow mechanism 112 (or septum 110) such that upon activation, fluid flowing from the sample collection chamber 102 to the sample transfer docking structure 106 is filtered. In one embodiment, the filter may comprise a membrane filter of known pore size and/or fiber chemistry. [00119] In other embodiments, the fluid flow mechanism 112 may comprise any one or number of parts or structures adapted to enable flow from the sample collection chamber 102 to the sample transfer docking structure 106 upon activation. In some embodiments, the fluid flow mechanism 112 may comprise a one-way value. In other embodiments, the mechanical valve may comprise any one of a pull tab, a slide tab, a push button, a stop cock, a plunger, or the like. In various embodiments, the mechanical valve may be opened by pulling, pushing, sliding, twisting, plunging, or the like. In other embodiments, the fluid flow mechanism 112 may comprise a two-way valve or aperture.

[00120] In other embodiments, the fluid flow mechanism 112 may comprise a piercing member arranged to pierce the impermeable membrane 110 upon activation. In some embodiments, the piercing member may comprise an embedded needle. In some embodiments, the needle may be embedded in the connector tube 212 or the complementary docking station of the sample preparation device 200. In some embodiments, the embedded needle may be configured to ensure the connector tube 212 and/or container 100 are safe for handling. For example, the embedded needle may include a protective covering and/or may be sufficiently embedded to ensure no external exposure of the needle before, during and/or after use. In some embodiments, therefore, when the fluid sample is collected in the sample collection chamber 102 of a fresh, unused container 100, the septum 110 is intact and the fluid flow mechanism 1 12 is maintained in the closed configuration (i.e., with the needle retracted). As such, the fluid sample collects within the sample collection chamber 102. When the fluid sample is to be transferred to the sample transfer docking structure 106, the fluid flow mechanism may be actuated from the closed configuration to the fluid flow configuration, causing the needle to protract and pierce the septum 110, such that at least a portion of the fluid sample flows from the sample collection chamber 102 to the sample transfer docking structure 106 through the needle of the fluid flow mechanism 112. Notably, in such an embodiment, once the septum 110 is pierced by the needle, the container 100 generally cannot be used for further sample collection without sample fluid dripping into the sample transfer docking structure 106. Put differently, once the fluid flow mechanism 112 has been actuated to the fluid flow configuration in this embodiment, it cannot be reversed to the closed configuration. [00121] In various embodiments, the fluid flow mechanism 1 12 may be integrated with any one or combination of the sample collection chamber 102, the septum 110, the sample transfer docking structure 106, the removable transfer lid 116, a connector tube 212, or a complementary docking station of the sample preparation device 200, without limitation, provided the fluid flow mechanism 112 is configured to, upon activation, allow the fluid sample to flow from the sample collection chamber 102 to the sample transfer docking structure or docking formation 106. In some embodiments, the fluid flow mechanism 112 is specifically configured to avoid accidental activation or actuation.

[00122] In other embodiments, the coupling formation 114 may comprise various other coupling or engaging formation types and may be positioned at various other locations proximate the sample transfer docking structure 106. For example, the coupling formation 114 may be positioned on an external wall of the sample transfer docking structure 106 for engagement with the sample preparation device 200. In other embodiments, the coupling formation 114 may facilitate alignment between an aperture in the septum 110 and the preparation inlet 204 of the complementary docking structure (whether a connector tube 212 or otherwise).

[00123] In other embodiments, the sample transfer docking structure 106 may configured to sterilely connect to a sample preparation device 200 via a conduit or the like.

[00124] In other embodiments, the collection lid 116 may be hingedly attached to the container 100 to cover and/or expose the sample inlet 104. In yet other embodiments, the collection lid 116 may be snap-fittable or clippable to the container 100 and may have snap- fittable or clippable formations for this purpose. In other embodiments, the collection lid 116 may take on any shape and/or dimensions to fit the sample inlet 104 to be covered.

[00125] In other embodiments, the vent 118 in the collection lid 116 may comprise another vent type, such as a small aperture vent, through which air may ingress into the sample collection chamber 102 to facilitate transfer of the sample fluid to the sample transfer docking structure 106. In other embodiments, to seal the vent 118, the releasable vent cover 120 may be hingedly or pivotably attached to the container 100, may be snap- fittable to the container 100, may be clippable to the container 100, may be slidable relative the vent 118, may be interlocking with the vent 118, or the like. In other embodiments, the releasable vent cover 120 may simply be snugly fitting with the vent 118, requiring only pulling to remove it. In yet other embodiments, the vent 118 may not require the releasable vent cover 120.

[00126] In other embodiments, the removable transfer lid 122 may comprise a bung, having a stopper portion which snugly fits within the transfer outlet 108 to substantially seal it. In other embodiments, the removable transfer lid 122 may not be required, particularly where it is clear from the container 100 itself that only one sample collection chamber 102 is present and/or where the sample transfer docking structure 106 has limited volume. In other embodiments, the sample collection chamber 102 may be kept substantially sterile with, for example, a thin plastic film covering or the like.

[00127] In other embodiments, the container 100 may be sterilely packaged in an individual sterile packaging, such as in a heat-sealed sterile plastic wrapping, prior to use. In some embodiments, the container 100 may be sterilized post-manufacture, prior to packaging, to ensure that no contaminants will enter the fluid sample in use.

[00128] In other embodiments, the fluid sample may comprise any one of: blood, semen, saliva, or other biofluids, for suitable testing or analysis. In yet other embodiments, the fluid sample may comprise any other fluid sample obtained from an environment or system, such as water, oil, culture, or the like, to name but a few examples. Indeed, it is to be appreciated that the container, kit and system disclosed herein are envisaged to be adaptable to various sample types from various environments or systems, and such embodiments are intended to fall within the scope of the instant disclosure.

[00129] It is to be appreciated that any two or more of the embodiments described herein may be combined in other embodiments and indeed, such combinations are intended by the inventors to fall within the scope of the instant disclosure. For example, in other embodiments, the container 100 and the sample preparation device 200 (described below) may be combined into a single device or apparatus for fluid sample collection and preparation (filtering and/or concentration). In other embodiments, the sample preparation device 200 and the microfluidic test cassette or chip may be combined into a single device or apparatus for fluid sample preparation (filtering and/or concentration) and testing. In yet other embodiments, all three of the container 100, the sample preparation device 200 and the microfluidic test cassette or chip may be combined into a single device or apparatus for fluid sample collection, preparation (filtering and/or concentration) and testing.

[00130] With reference now to Figures 1, 3 and 4, and in accordance with another exemplary embodiment falling within the scope of the instant disclosure, a sample preparation device, generally referred to using the numeral 200, will now be described. In this context, “sample preparation” may be considered the pre-processing or preparation steps taken with a fluid sample prior to testing or analysis, and it is to be appreciated therefore that the configuration of the sample preparation device 200 is typically suited for specific testing or analysis to be conducted on the fluid sample. For example, sample preparation may comprise any one or both of sample filtration and sample concentration.

[00131] In this embodiment, the sample preparation device 200 is configured to be receive (and/or be connectable to) the container 100 described above, for sample preparation. More specifically, the sample preparation device 200 comprises a complementary docking structure for receiving the sample transfer docking structure of the container 100. In this embodiment, as shown in Figure 3, the complementary docking structure of the sample preparation device 200 comprises a complementary coupling formation 202 which is configured to be sterilely couplable or connectable with the coupling formation 114 of the container 100. The complementary docking structure further comprises a preparation inlet 204 through which the fluid sample is transferrable from the sample transfer docking structure 106 of the container 100 to the sample preparation device 200. The sample preparation device 200 in this embodiment further comprises a sample preparation assembly 206 downstream of the preparation inlet 204 for preparing the fluid sample for sample testing, as detailed below.

[00132] In this embodiment, the sample preparation device 200 comprises a generally elongate body, having one end which receives and/or is connectable to the container 100 and another end intended to engage, with or without contact, a microfluidic test cassette or chip (not specifically shown). As shown in Figure 4, the sample preparation assembly 206 may form a generally enlarged structure on one end of the sample preparation device 200, thereby to accommodate the componentry necessary for sample preparation.

[00133] In this embodiment, as shown in Figure 3, the complementary coupling formation 202 comprises an interlockable, snap-fittable, or clippable, coupling formation which is complementary to the coupling formation 114 on the sample transfer docking structure 106 of the container 100. In this embodiment, the complementary coupling formation 202 specifically comprises a groove or slot which is configured to receive the protuberance of the coupling formation 114 in use. As such, the container 100 can be reversibly docked or connected to the sample preparation device 200 by aligning and interlocking the protuberance 114 with the groove or slot 202. Such alignment and interlocking provides further that the transfer outlet 108 and the preparation inlet 204 are at least substantially aligned for fluid flow from the sample transfer docking structure 106 to the sample preparation device 200 when in use. Indeed, in this embodiment, although not necessarily so in all embodiments, the protuberance 114 and groove or slot 202 are specifically configured to facilitate such alignment and positional interlocking, thereby to provide that the transfer outlet 108 of the sample transfer docking structure 106 aligns with the preparation inlet 204 of the complementary docking structure (whether the connector tube 212 or otherwise) for transfer of the fluid sample. Furthermore, the fitting or mating of the protuberance 114 and groove or slot 202, in this embodiment, is such that any leakage or wastage of the fluid sample during transfer is minimized.

[00134] As shown in Figure 3, the sample preparation device 200 in this embodiment further includes upward protuberances 208 (or “keys”) which fit snugly within the lower diameter of the sample transfer docking structure 106. Although the structure, shapes and/or dimensions of these upward protuberances 208 may vary in different embodiments, indeed not being limited to protuberances, the upward protuberances 208 are configured to ensure secure engagement between the container 100, specifically the sample transfer docking structure 106, and the sample preparation device 200, specifically the complementary docking station. Such secure engagement, in this embodiment, serves to prevent accidental or unintentional removal or release of the container 100 from the sample preparation device 200 (or vice versa), thereby to avoid fluid sample leakage and/or wastage. In this embodiment, the upward protuberances 208 snugly mate with the transfer outlet 108 of the sample transfer docking structure 106, as shown, in a manner which is substantially airtight in this embodiment. The upward protuberances 208 may further assist with aligning the sample preparation device 200 to the transfer outlet 108 of the sample transfer docking structure 106, although not necessarily so in all embodiments.

[00135] As shown in Figures 1 and 3, downstream from the preparation inlet 204, the sample preparation device 200 defines a flow channel 210 which extends from the preparation inlet 204 to the sample preparation assembly 206. The flow channel 210 has a diameter suited to the desired flow speed of the fluid sample to the sample preparation assembly 206. It is to be appreciated that in use, fluid sample may be stored in any one or both of the sample collection chamber 102 and/or sample transfer docking structure 106, with the gravity feed thereof to the sample preparation assembly 206 being at least partially regulated by the dimensions of the flow channel 210.

[00136] In this embodiment, as shown in Figure 3, the complementary coupling formation 202, upward protuberances 208, preparation inlet 204, and flow channel 210, collectively form a sample preparation connector tube 212 (or “connector tube”, “sample transfer tube”). Thus, the sample preparation connector tube 212 is in this embodiment arrangeable between the transfer outlet 108 of the sample transfer docking structure 106 and the sample preparation assembly 206. In this embodiment, a tube connector portion 214 is provided to couple the sample preparation connector tube 212 to the sample preparation assembly 206. As shown in Figure 1, the tube connector portion 214 is configured so as couple the sample preparation connector tube 212 and the sample preparation assembly 206, without obstructing flow of the fluid sample. In this embodiment, the tube connector portion 214 comprises one or more ferrules. In this embodiment, the tube connector portion 214 allows for the size reduction (which is optional) from the flow channel 210 to a circular filter conduit 222, described below.

[00137] In this embodiment, the sample preparation assembly 206 specifically comprises a filter assembly which is configured to provide tangential flow filtration of the fluid sample (“TFF”, or cross-flow filtration). As shown in Figure 4, the filter assembly 206 comprises a filter 216, a circular filter conduit 222 connectable to either end of the filter 216, at least one roller 218 configurable to engage the circular filter conduit 222, and a peristaltic pump 220 connectable to move the at least one roller 218 in use. In this embodiment, the filter assembly 206 further comprises a filter clamp 228 (see Figures 4 and 5) arranged on one end of the filter assembly 206, specifically in this embodiment between the connector tube 212 and the circular filter conduit 222, such that when engaged, the filter clamp 228 prevents backflow of the fluid sample (or the filter retentate) into the connector tube 212. When the filter clamp 228 is open (or released, repositioned), the fluid sample is able to flow from the connector tube 212 into the filter assembly 216. In this embodiment, the fluid sample flows from the connector tube 212 to the filter assembly 216 under gravity and/or capillary pressure. Once at least a portion, or otherwise all of, the fluid sample has entered the filter assembly 216, the filter clamp is closed (or sealed, repositioned) to prevent backflow of the fluid sample (or filter retentate). In use, after transfer of the fluid sample to the filter assembly 206, the connector tube 212 may be disconnected from the filter assembly 206 at the tube connector portion 214, and optionally, the microfluidic test cartridge 300 may be connected to the filter apparatus 206.

[00138] As shown by the arrow in Figure 4, the filter assembly 206 is configured such that the fluid sample flows in a continuous forward circle (e.g., clockwise or anticlockwise) within the circular filter conduit 222 in use. In particular, the peristaltic pump 220, when activated, adjusts and/or maintains the speed of pumping such that the at least one roller 218 (or rollers) contact the circular filter conduit 222 to continuously circulate the fluid sample over the filter 216. As such, fluid sample entering or having entered the circular filter conduit 222 from the flow channel 210 is propelled forward and enters the filter 216 at one end 216.1 of the filter 216, the filter retentate exiting the filter 216 at an opposed end 216.2. The filter retentate which exits the filter 216 is then recycled, being again propelled through the circular’ filter conduit 222 by the at least one roller 218 for further contact with the filter 216. Over time, as the fluid sample is continuously filtered and at least a portion thereof becomes filter permeate stored in a permeate reservoir 224, the filter retentate increases in concentration, as discussed further below. [00139] In this embodiment, the filter 216 comprises a filter membrane (not separately shown) with a pore size of between approximately 0.15 microns and 0.45 microns. Put differently, the filter membrane in this embodiment has a Molecular Weight Cut Off (MWCO) of 100 Kd (Kilodaltons) or less. Nonetheless, it is to be appreciated that pore size (and relatedly, filter or fiber chemistry) may be variable in different embodiments or implementations based on desired filtration quality and/or characteristics. Indeed, the filter membrane may be exchangeable between distinct uses of the filter 216. The fluid sample, when entering the filter 216, thus flows in parallel to the filter membrane. In this embodiment, use of such tangential flow may prevent the filter membrane from being clogged by larger particles found in the fluid sample. Indeed, such larger particles or solute molecules will typically remain in the continuous filter flow/feed of the filter retentate, whilst fluid permeating through the filter membrane into the filter permeate will have little to no such particles. Notably, in this embodiment, the filter assembly 206 further concentrates the fluid sample within the circular’ filter conduit 222, such that the filter retentate has a higher concentration than that of the fluid sample initially collected. The filter retentate, which remains in the circular filter conduit 222 during filtration and/or concentration, will be later removed for further testing.

[00140] In this embodiment, the peristaltic pump 220, circular- filter conduit 222, rollers 218 and filter housing unit of the filter assembly 206 are intended to be reusable, such that these parts are employable in various sample preparations, optionally with sterilization steps between uses. As such, in use, the circular filter conduit 222 of the sample preparation device 200 is engaged with the peristaltic pump 220, typically before the fluid sample is transferred from the sample collection chamber 102 to the sample transfer docking structure 106. In this embodiment, the peristaltic pump 220 is powered by a battery electrically coupled thereto. Notably, in this embodiment, use of the powered peristaltic pump 220 to move the at least one roller 218 in use may provide that tedious manual user pumping of the fluid sample is not required.

[00141] In this embodiment, as noted, the filter assembly 206 further comprises a permeate reservoir 224 arranged for receiving the filter permeate which permeated through the filter 216. The permeate reservoir 224 further comprises a permeate outlet 226 from which the filter permeate may egress. In this embodiment, the permeate outlet 226 is maintained in a closed configuration during filtration and/or concentration, and is opened to empty the filter permeate from the permeate reservoir 224 once filtration and/or concentration is complete. It is to be appreciated that the filter permeate is in this embodiment considered a waste product that is potentially biohazardous and is thus appropriately disposed of.

[00142] Once filtration and/or concentration of the fluid sample is complete, the filter retentate will comprise the concentrated fluid sample for testing. In this embodiment, to sterilely extract the filter retentate from the filter assembly 206, the microfluidic test cartridge 300 is connected or attached in fluid communication with the circular filter conduit 222. In this embodiment, as shown in Figure 5, the micro fluidic test cartridge 300 is connected or connectable at the same filter assembly port as where the connector tube 212 was previously connected. As such, if the connector tube 212 was not previously removed after transferring the fluid sample to the filter assembly 206, it would be removed at this stage to connect the microfluidic test cartridge 300. In this embodiment, the microfluidic test cartridge 300 includes a cartridge connector portion which couples with the filter assembly 206 such that a test cartridge inlet (not shown) aligns with the filter conduit 222. In this embodiment, the cartridge connector portion snugly engages the filter assembly 206, thereby to prevent leakage and/or wastage of the filter retentate (i.e., concentrated sample) during transfer from the filter conduit 222 to the test cartridge inlet. Furthermore, this connection also prevents contamination of the filter retentate. In this embodiment, once the microfluidic test cartridge 300 is connected to the filter assembly 206, the filter clamp 228 is released and/or repositioned to allow the filter retentate to exit the filter conduit 222. In this embodiment, the peristaltic pump 220 is further employed at this stage to provide flow pressure from the filter conduit 222 to the microfluidic test cartridge 300.

[00143] In this embodiment, the sample preparation device 200 is specifically configured to prepare (filter and concentrate, in this embodiment) a urinary sample for urinary testing such as to identify, for example, a urinary tract infection. Thus, the fluid sample is urine and the filter permeate is concentrated urine. [00144] In this embodiment, as noted, the microfluidic test cartridge 300 comprises the cartridge connector portion configured to stcrilcly couple with the sample preparation device 200 and the test cartridge inlet configured to receive the filter permeate from the sample preparation device 200. The microfluidic test cartridge 300 further comprises a fluid flow path from the test cartridge inlet to a test sample reservoir (not shown), where the filter retentate is (temporarily) stored. In use, the filter retentate is released from the test sample reservoir to flow through a plurality of fluid flow paths (e.g., capillary conduits) to a plurality of test wells (or “observation wells”). In some embodiments, antibiotics may be added or relayed to one or more of the test wells for testing, whilst at least one well is used as a control. In some embodiments, the one or more test wells may be observed over time for morphological cell changes and/or bacterial population growth changes in the presence of antibiotics. Such observations may be recorded by an optical system as images or video feed over time (i.e., data collection). In turn, the optical system may be coupled to a suitable processor on which image processing software is executable to characterize the morphological cell changes and/or bacterial population growth changes (i.e., data processing)., and/or to identify any diagnosis, susceptibility, prescription or other output associated therewith. For example, the output may indicate that antibiotic type A exhibits improved cytotoxicity over antibiotic type B, or that antibiotic A exhibits improved cytotoxicity over antibiotic B and equal cytotoxicity to antibiotic C. In some embodiments, the output may indicate an appropriate antibiotic for the fluid sample collected (and this, associated patient).

[00145] In this embodiment, the sample preparation device 200, including the connector tube 212 and the filter assembly 206, as well as the microfluidic test cartridge 300, are configured so as reduce technician input or interaction required for sample transfer and/or preparation prior to testing, thereby to reduce the overall risk of contamination of the fluid sample and/or filter retentate (concentrated urine sample). Furthermore, the container 100, connector tube 212 and filter assembly 206 are configured to be easy to assemble in use, such that a non-trained technician would readily be able to transfer, prepare and/or test the fluid sample or filter retentate. [00146] In this embodiment, the connector tube 212 and the filter membrane within the filter 216 arc manufactured to be a single-use disposables, in addition to the container 100. As such, a fresh, unused connector tube 212 and a fresh, unused filter membrane 216 would be used for each urinary test of each patient. In this embodiment, the container 100, connector tube 212 and filter membrane 216, are individually sterilely packaged, such as in a heat-sealed sterile plastic wrapping, and are removed from such packaging immediately prior to use to avoid sample contamination. Notably, the filter membrane may be provided separately.

[00147] In this embodiment, the sample preparation device 200 is further manufactured to be lightweight, and therefore lightweight materials are selected for the various components, where applicable. For example, lightweight (optionally recyclable) plastic materials may be employed for the connector tube 212. Furthermore, the materials used in the manufacture of any one or combination of the container 100, the connector tube 212 and the filter assembly 206, may be selected to be economical for mass production.

[00148] It is to be appreciated that various alternative embodiments of the sample preparation device 200 are envisaged, without departing from the general nature and scope of the instant disclosure. Some of these embodiments or variations are briefly described hereunder, without limitation.

[00149] In other embodiments, the complementary coupling formation 202 may comprise various other coupling or engaging formation types and may be positioned at various other locations on the sample preparation device 200. For example, the complementary coupling formation 202 may comprise a pin, a latch, an adhesive, or the like, to provide but a few examples.

[00150] In other embodiments, the sample preparation device 200 may further comprise a piercing member arranged to pierce the septum 110 upon activation to allow the sample fluid to flow from the sample transfer docking structure 106 to the sample preparation device 200. In some embodiments, the piercing member may be embedded within the complementary docking station. [00151] In other embodiments, the flow channel 210 may have various alternative dimensions. In some embodiments, the fluid sample may flow from the sample transfer docking structure 106 directly into the sample preparation assembly 206 such that no separate flow channel 210 is provided. Indeed, in some embodiments, the flow channel 210 and/or connector tube 212 may be omitted entirely, the fluid sample being transferrable from the sample transfer docking structure 106 directly into the filter assembly 206.

[00152] In other embodiments, the tube connector portion 214 may comprise any one or more connecting structures or components. In yet other embodiments, the sample preparation device 200 may be devoid of the sample preparation connector tube 212 and/or the tube connector portion 214 entirely, as noted.

[00153] In other embodiments, the filter conduit 222 need not be circular, and may comprise, for example, a linear conduit. In other embodiments, the filter assembly 206 may comprise a hollow filter for TFF. For example, the filter assembly 206 may comprise a hollow fiber filter such as those manufactured by Repligen™. In some embodiments, the hollow filter may define the filter conduit 222.

[00154] In other embodiments, the filter assembly 206 may be configured to provide other forms of filtration and/or concentration of the fluid sample. For example, gravity filtration, vacuum filtration, multilayer filtration, or the like, may be employed in different embodiments. Accordingly, in other embodiments, the filter assembly 206 may comprise any number and configuration of parts to achieve the filtration and/or concentration required for the particular fluid sample to be tested. In other embodiments, the filter assembly 206 may be devoid of a pump or the like, relying on gravity-based feed, for example, or otherwise manual pumping using plungers or the like. In other embodiments, the fluid sample may be filtered only once (as opposed to continuously).

[00155] In other embodiments, the peristaltic pump 220 may be powered by an alternative electrical input, such as provided by an electrical outlet in a clinic. In other embodiments, any number or configuration of rollers 218 may be employed. In some embodiments, the circular filter conduit 222 is intended to be reusable with sterilization between uses. In other embodiments, the circular filter conduit 222 is intended to be a single-use disposable.

[00156] In some embodiments, the filter clamp 228 may comprise a quick-release clamp. In other embodiments, the filter assembly 206 may include alternative means for preventing backflow of the fluid sample. For example, sliding members, lids, or the like, may be employed in alternative embodiments.

[00157] In other embodiments, the sample preparation device 200 further comprises a removable cap configured to seal the permeate reservoir 224 and/or the permeate outlet 226. In other embodiments, the sample preparation device 200 may include a filter retentate reservoir and/or a filter retentate outlet arranged on the circular filter conduit 222 to allow for extraction of the filter retentate at a position spaced-apart from the port at which the connector tube 212 connects. Such an embodiment may avoid the need to disconnect the connector tube 212 to connect the microfluidic test cartridge 300 for further sample transfer.

[00158] In embodiments where the container 100 is directly connectable to the filter apparatus 206 (not illustrated), it is to be appreciated after filtration and/or concentration of the fluid sample, the container 100 may be disconnected from the filter apparatus 206 at the sample transfer docking structure 106, and the microfluidic test cartridge 300 may be connected to the filter apparatus 206 via the complementary docking structure. Otherwise, the microfluidic test cartridge 300 may be connectable in fluid communication with the circular filter conduit 222 at another spaced-apart location.

[00159] In other embodiments, the container 100 and/or the sample preparation device 200 may comprise any one or number of valves, seals, o-rings, or the like, so as to facilitate fluid flow throughout the system.

[00160] As generally shown in Figure 1, in accordance with yet a further exemplary embodiment of the instant disclosure, a system for sample collection and preparation of a fluid sample (“system”), will now be described. The system is generally configured to avoid contamination of the fluid sample and to be usable by non-trained technicians. [00161] In this embodiment, the system generally comprises a container for sample collection of the fluid sample (or a fluid sample collection and transfer container) and a sample preparation device with or to which the container is engageable or connectable, for sample preparation.

[00162] In this embodiment, the container generally comprises a sample collection chamber having a sample inlet through which the fluid sample is collectable, a sample transfer docking structure configured for engaging with a complementary docking station located on the sample preparation device, the sample transfer docking structure having a transfer outlet from which the fluid sample is transferable to said sample preparation device, and a septum arranged between the sample collection chamber and the sample transfer docking structure, the septum being configured to selectively permit transfer of at least a portion of the fluid sample thereacross. In this embodiment, the container reflects any of the embodiments of the container 100 described above.

[00163] In this embodiment, the sample preparation device generally comprises a complementary docking station configured to securely receive the sample transfer docking structure of the container, a preparation inlet through which the fluid sample is transferrable from the sample transfer docking structure of the container to the complementary docking station of the sample preparation device, and a sample preparation assembly downstream of the preparation inlet for preparing the fluid sample for sample testing. In this embodiment, the sample preparation device reflects any of the embodiments of the sample preparation device 200 described above.

[00164] In this embodiment, the sample transfer docking structure comprises a coupling formation and the complementary docking station comprises a complementary coupling formation, whereby the coupling formation and complementary coupling formation are used to connect or dock the container to the sample preparation device for sample transfer. In some embodiments, the sample transfer docking structure and the complementary docking station may be correspondingly mateable. [00165] In various embodiments, the coupling formation and the complementary coupling formation may be intcrlockablc, snap-fittablc, clippablc, or the like, to ensure a secure coupling between the container and the sample preparation device.

[00166] In some embodiments, the system and/or the sample preparation device further comprises a connector tube 212 arrangeable between the transfer outlet of the sample transfer docking structure and the preparation inlet of the sample preparation device.

[00167] In some embodiments, the system further comprises a microfluidic test cartridge, cassette or chip, such as the microfluidic test cartridge 300 shown in Figure 5. In some embodiments, the microfluidic test cartridge, cassette or chip is a single-use disposable. In some embodiments, the sample preparation device is configured to sterilely engage with or connect to the microfluidic test cartridge.

[00168] In other embodiments, the system may be considered or provided as a sample collection and preparation kit of parts, generally comprising a container, a connector tube, and a filter assembly (e.g., a circular tangential flow filter). In such embodiments, the foregoing parts may be connectable by means of docking, interlocking, snap-fitting or clipfitting, or otherwise as envisaged herein, to provide a disposable, lightweight, single use, sterile sample collection and transfer apparatus.

[00169] With reference now to Figure 6 and in accordance with a further embodiment, there is provided a system for sterilely enriching (and/or transfer and preparation of) a fluid medical specimen for testing, typically diagnostic testing, generally referred to with reference numeral 400.

[00170] In this embodiment, the system 400 comprises a docking platform 402 for releasably engaging or docking a receptacle 404 containing the fluid medical specimen 406. Whilst embodiments employing customized receptacles such as container 100 are envisaged, this embodiment of the system 400 employs an off-the-shelf receptacle 404 (e.g., a urine sample cup with lid). In this embodiment, although not shown, the docking platform 402 includes a housing with a lid which can be opened to insert the receptacle 404 on the docking platform 402. The docking platform 402 includes a docking formation 408 for docking the receptacle 404 in this embodiment. Tn this embodiment, the docking formation 408 is in the form of a friction-fit cavity shaped and dimensioned to match a circumference of a lower end of the receptacle 404. In other embodiments, other docking formations are envisaged, including for example, friction fit surfaces, snap-fitting, claspdocking or the like. In yet other embodiments, the docking formation simply comprises a non-slip friction surface.

[00171] In this embodiment, the docking platform 402 further defines functional zones, including a receptacle receiving zone 410, a specimen accessing zone 412 and a specimen transfer zone 414. The docking platform 402 (or “docking station” or “linear stage”) in this embodiment is configured to be linearly translatable, such that the receptacle 404 is moved in a horizontal direction between zones. In this embodiment, the docking platform 402 allows for the translation of the receptacle 404 from the receptacle receiving zone 410 to the specimen accessing zone 412 and to the specimen transfer zone 414 in use. Furthermore, in this embodiment, the docking platform 402 allows for the (reverse) translation of the receptacle 404, typically once at least a portion of specimen 406 has been transferred therefrom, from the specimen transfer zone 414 to the specimen accessing zone 412 (here considered a receptacle closing zone 412, for example) and in turn to the receptacle receiving zone 410 (here considered a receptacle removal or discharge zone, for example) in use. In this embodiment, the translation or movement of the docking platform 402 is driven by a motor 416. Ultimately, once the fluid medical specimen 406 has been transferred (and/or processed), the docking platform 402 and/or system 400 provides for the release, removal or discharge of the receptacle 404 from the system 400, in various embodiments.

[00172] In this embodiment, the system 400 further comprises a receptacle accessing mechanism 418 arranged proximate the docking platform 402 (specifically at the specimen accessing zone 412 in this embodiment) for sterilely accessing an internal chamber 420 of the receptacle 404. In this embodiment, the receptacle accessing mechanism 418 comprises a lid opener for opening a lid 422 on the receptacle 404. As shown in Figure 6, this embodiment of the lid opener 418 comprises a motor-driven lid engaging member 424 which is shaped and dimensioned to releasably engage the lid 422 of the receptacle 404. The motor-driven lid engaging member 424 is thus connected to and driven by an electric motor 426 in this embodiment, specifically a servo motor. In this embodiment, the motor- driven lid engaging member 424 is movable in both vertical and horizontal directions to engage the receptacle lid 422. The upper end of the motor-driven lid engaging member 424 comprises a rod (optionally threaded) which rotates upwards and downwards relative to the docking platform 402. The lower end of the motor-driven lid engaging member 424 in this embodiment comprises a clamping member 428 which includes a frame and movable jaws which are movable inwards and outward relative to one another. In use, the motor-driven lid engaging member 424 is raised to allow the receptacle to enter the specimen accessing zone 412 of the docking platform 402, then the motor-driven lid engaging member 424 is lowered such that the jaws engage the receptacle lid 422, before the jaws are actuated to move together to securely engage the lid 422, whereafter the rod is rotated (e.g., anticlockwise) so as to unscrew the lid 422 from the receptacle 404. In this embodiment, as discussed below, the system 400 includes means to reattach the lid 422 to the receptacle 404. In other embodiments, the system 400 includes means to release and/or dispose of the lid 422 from the system 400. Notably, in other embodiments, the receptacle accessing mechanism 418 may take on the form of any alternative mechanized means for accessing at least a portion of the specimen 406 within the receptacle 404. For example, the receptacle accessing mechanism 418 may puncture the receptacle 404 or otherwise actuate a release mechanism of the receptacle 404 to release a portion of the specimen 406 for downstream transfer.

[00173] As shown in Figure 6, the system 400 further includes a pressure-driven transfer assembly 430 for sterilely automatically and sterilely transferring at least a portion of the fluid medical specimen 406 from the internal chamber 420 of the receptacle 404 to a specimen enrichment apparatus 440. In this embodiment, the pressure-driven transfer assembly 430 is provided proximate the specimen transfer zone 414 of the docking platform 402. Whilst various embodiments of the pressure-driven transfer assembly 430 are envisaged, this embodiment includes a first (inlet) conduit 432, a pump 434 and a second (outlet) conduit 436. The first inlet conduit 432 is arranged such that a first end thereof is biased towards or otherwise insertable into the interior chamber 420 of the receptacle 404. In this embodiment, although not shown in Figure 6, the first inlet conduit 432 is attached or attachable to a motorized vertical actuator (also arranged at the specimen transfer zone 414 in this embodiment) which is operable to cause the tip of the first inlet conduit 432 to enter the receptacle 404 for insertion in the specimen 406. For example, the motorized vertical actuator may cause the tip of the conduit 432 to descend a fixed distance to immerse the tip in specimen 406, or otherwise to descend until it encounters a bottom internal surface of the receptacle 404 (sensed, for example, by a pressure sensor or other related sensor), before ascending or retreating several millimeters or centimeters to ensure immersion of the tip in specimen 406. In this embodiment, the first inlet conduit 432 is attached to the motorized vertical actuator proximate the tip via a fastener, such as a zap strap.

[00174] In this embodiment, once the tip is immersed in the specimen 406, the pump 434 then applies negative pressure to the first inlet conduit 432 to draw or extract at least a portion of the fluid medical specimen from the internal chamber 420 of the receptacle 404 through the inlet conduit 432 to the second outlet conduit 436, and positive pressure to the second outlet conduit 436 to expel the portion of the fluid medical specimen 406 therefrom. The second outlet conduit 436 is connected on an opposed end to the specimen enrichment apparatus 440 to transfer the specimen 406 thereto. In this embodiment, the pump 434 comprises a piston pump, although other pumping options, including a peristaltic pump, are envisaged for other embodiments. In embodiments employing a peristaltic pump, it is to be appreciated that the pressure-driven transfer assembly 430 may comprise a single conduit (not two) which defines both the inlet and outlet, the peristaltic pump rotationally engaging a length of the conduit to draw at least a portion of the specimen 406 from the receptacle 404 and expel it to the specimen enrichment apparatus 440. Indeed, both positive and/or negative (or vacuum) pressure assemblies are workable in different embodiments. One example of another embodiment of the pressure-driven transfer assembly 430 includes a conduit, whereby at least a portion of the fluid medical specimen 406 is transferred therein via gravity.

[00175] The system 400 comprises the specimen enrichment apparatus 440, as shown, which receives at least a portion of the fluid medical specimen 406 from the pressure-driven transfer assembly 430 (specifically the opposed end of the outlet conduit 436 in this embodiment) for enrichment. In this embodiment, the specimen enrichment apparatus 440 comprises a foam fractionator configured to fractionate components of the specimen 406 for enrichment. Put differently, the foam fractionator 440 selectively fractionates the specimen 406 to concentrate components of interest and/or concentrate the specimen 406 for diagnostic testing. In this particular embodiment, for example, the foam fractionator 440 is employed to fractionate all organic matter of the specimen 406 in the foam layer. In the context of a urine specimen, the foam fractionator 440 fractionates organic matter including bacteria, blood cells (red and white blood cells, platelets), dead skin cells and other biological matter in urine, in the foam layer. Other inorganic matter, including minerals, salts, ammonia, a majority of the water, and other inorganic matter in urine, remains in the liquid layer.

[00176] The foam fractionator 440 in this embodiment receives the transferred portion of specimen 406 as the liquid phase into a foam fractionator column 442. Thus, in this embodiment, the liquid phase comprises urine, although other embodiments may comprise other liquid medical specimens and/or specimen solutions. The foam fractionator 440 further includes a sparger (not shown) or similar device which introduces gas such as air or nitrogen into the liquid phase of the fractionator column 442 to form bubbles 444, as shown in Figure 6. The sparger which forms part of the system 400 is configured for, or otherwise controllable to, maintain a desired gas flow rate suited for effective separation and/or enrichment of the intended specimen of the system 400. It is to be appreciated that the gas-liquid interface(s) created by the bubbles 444 attract surface-active components such as proteins, lipids, biomolecules, or cells containing same, thereby partitioning these amphiphilic components in the forming foam, whilst other components remain in the liquid phase. Indeed, as noted, the majority of organic matter in the specimen (approximately 90- 100% thereof) will be captured in the foam layer, which ultimately collapses to return to liquid, and the majority of inorganic matter, if not all, will remain in the liquid layer within the foam fractionator 440. Notably, the primary organic matter in a urine sample is expected to be bacteria, if present (e.g., in a specimen from a patient with a UTI), which are thus fractionated out of the specimen via the foam for testing. Other organic matter may fractionate out at low concentrations or trace amounts; however, these are not expected to (substantially) impact downstream diagnostic testing. [00177] In this embodiment of the foam fractionator 440, the foam forming or formed (not shown) during fractionation is separated from the liquid phase by allowing spillover at a fractionator top end 446 into a collapse conduit 448. As foam enters and collects in the collapse conduit 448, it collapses (and/or cools) to form an enriched specimen suited for diagnostic testing. In this embodiment, the enriched specimen is collected in an enriched specimen reservoir 450 which forms part of system 400.

[00178] In this embodiment, the system 400 further includes an outlet 460 which is in fluid communication with (and optionally forms part of) the specimen enrichment apparatus 440, specifically (via) the enriched specimen reservoir 450 in this embodiment, which is connectable to a microfluidic test cartridge 300 to receive enriched specimen for diagnostic testing. The outlet 460 is configured for connection to the microfluidic test cartridge 300 in a manner such that contamination of the enriched sample is prevented if not impossible. Indeed, the enriched sample 406 flows directly from the reservoir 460 to the cartridge 300 without manual handling or intervention. In this embodiment, the outlet 460 includes a snap-fit connection formation which securely engages a complementary snap-fit connection formation on the cartridge 300. In Figure 6, reference character 302 shows an enlarged view of the cartridge 300 which defines a fluid flow path from a test cartridge inlet to a test sample reservoir, to a plurality of fluid flow paths (e.g., capillary conduits), and to a plurality of test wells where the enriched specimen undergoes diagnostic testing. Further disclosure on this cartridge 300 is not repeated here for the sake of brevity, but it is to be appreciated that in this embodiment of the system 400, only the receptacle 404 and lid 422, as well as the test cartridge 300, are intended to be single-use disposables. The remaining componentry of the system 300 are configured for reuse and sterilization between uses (e.g., whether via ethanol wash, UV sterilization, autoclaving or the like). In this particular non-limiting embodiment, the system 400 is configured to be sterilized between uses with a combination of flushing (e.g., with alcohol and/or other cleaning and/or sterilizing agents) and the application of ultraviolet light, specifically ultraviolet light in the class C spectrum in the range of 200 to 280 nm wavelength (i.e., UV-C light). It is to be appreciated that the use of UV-C light within system 400, for overall system sterilization and/or sterilization of one or more particular components thereof, provides a rapid and effective means of sterilization between uses. In some embodiments, therefore, the system 400 includes a UV-C light source integrated within system 400 and arranged to at least sterilize one or more components which come into contact with the specimen 406.

[00179] In this embodiment, the system 400 further comprises a cartridge outflow port through which waste (e.g., tested specimen, sterilization solution or the like) can be discharged from. Connected to the cartridge outflow port, the system 300 includes a pump 462 which is operable in one or more modes, including a specimen suction mode, configured to apply pressure to the cartridge outflow port and/or cartridge 300 so as to draw the specimen into the cartridge 300 for diagnostic testing, and a waste removal mode, configured to apply pressure to the cartridge outflow port and/or cartridge 300 so as to extract waste after diagnostic testing is completed. In this embodiment, the system 300 further includes a waste capture vessel 464 arranged to collect waste pumped from the outflow port.

[00180] In this embodiment, the system 400 provides for the reattachment (closing and/or sealing) of the lid 422 on/to the receptacle 404, and in turn a receptacle discharge mechanism or means. Once at least a portion of the specimen 406 has been transferred to the foam fractionator 440, in this embodiment, the linear translation of the docking platform 402 is reversed such that the (at least partially emptied) receptacle 404 is moved from the specimen transfer zone 414 to the specimen accessing zone 412 and in turn, the receptacle receiving zone 410. At the specimen accessing zone 412, in this embodiment, the receptacle accessing mechanism 418 is operated as a receptacle closing mechanism, whereby the motor-driven lid engaging member 424 reengages the lid 422 onto the receptacle 404. The rod of the motor-driven lid engaging member 424 rotates downwards relative to the docking platform 402 such that the clamping member 428, having the lid 422 releasably secured in the movable jaws, is lowered onto the receptacle 404. The rod of the motor-driven lid engaging member 424 is then rotated (e.g., clockwise) to screw the lid 422 onto the receptacle 404. The jaws of the clamping member 428 are then actuated to move outwards to release the lid 422, and the rod is rotated so as to raise the motor-driven lid engaging member 424 upwards to allow further (reverse) movement of the receptacle 404 to the receptacle receiving zone 414. With further reversal of the docking platform 402, the receptacle 404 with lid 422 resecured returns to the receptacle receiving zone 414, where a user can access (optionally, after opening a lid to a system housing) and discard same. It is to be appreciated that in other embodiments, where a lid is not removed from the receptacle 404 but the specimen 406 is otherwise accessed (e.g., via a septum or puncture), the system 400 may not include such receptacle closing mechanism, but may, for example, include a receptacle discharge mechanism whereby the receptacle 404 is discharged or expelled from system 400.

[00181] In this embodiment, the system 400 comprises a digital controller (not shown, or microcontroller and/or microprocesor) which, when executing stored instructions, monitors and/or manages the various components the system 400, as well as a receptacle 404 contained therein. Indeed, in this embodiment, the system 400 is automated such that an unskilled technician or layperson can insert or dock the receptacle 404 to one location of the system 400, and connect the microfluidic test cartridge 300 at another location of the system 400, before activating the system 400. Upon activation, the processes of moving the receptacle 404, opening of the receptacle 404, transferring specimen 406 from the receptacle 404 to the foam fractionator 440, and transferring enriched specimen from the foam fractionator 440 to the microfluidic test cartridge 300 for testing, are automatically performed by system 400 without further user handling of the specimen 406 or receptacle 404. In this embodiment, the system 400 is further configured for automation of the reconnection of the receptacle lid 422, and for the moving of the receptacle 404 with lid 422 to a location for discharge. It is to be appreciated, however, that different embodiments may include different levels of automation or hands-free handling of the receptacle 404 and/or specimen 406. Furthermore, one or more steps or processes may require user intervention, although ideally any such user intervention is hand-free in the sense that alternative parts or mechanisms are actuated or employed by the user for that step or process, such that the user does not directly contact the receptacle 404 and/or specimen 406 to avoid the introduction of contaminants.

[00182] Generally and without limitation, system 400 provides a point-of-care sample enrichment system. [00183] It is to be appreciated that various alternative embodiments of the system 400 arc envisaged, without departing from the general nature and scope of the instant disclosure. Some of these embodiments or variations are described above, and others are briefly described hereunder, without limitation.

[00184] In other embodiments, the first inlet conduit 432 may be attached or attachable to a motorized vertical actuator which ascends upwards from a position generally lower than that of the docking station 402. The motorized vertical actuator in this embodiment is in the form of a hook-shaped vertical actuator which is operable to cause the tip of the first inlet conduit 432 to enter the receptacle 404 for insertion in the specimen 406 by ascending from the lower position until it engages the receptacle 404 such that the tip of conduit 432 is held within the specimen 406. For example, the hook- shaped vertical actuator may arise parallel to the docking station 402, pivot 90 degrees, and then lower to hang on an edge or rim of the receptacle 404, thereby inserting the tip in the specimen 406. In this embodiment, the hook-shaped vertical actuator extends to a length which is fixed so as to hold the tip of conduit 432 in the specimen 406 contained in the receptacle 404. In this embodiment, the first inlet conduit 432 is attached to the ascending end of the hook- shaped vertical actuator proximate the tip via a fastener, such as a zap strap.

[00185] In yet other embodiments, the first inlet conduit 432 may be attached or attachable to a motorized horizontal actuator which extends from a side of the system 400 (e.g., a side wall of system housing) and lowers to cause the tip of the first inlet conduit 432 to enter the receptacle 404 for insertion in the specimen 406 (or raises to remove the tip therefrom post specimen transfer to the sample enrichment apparatus 440). The motorized horizontal actuator may optionally include a sliding rail, an adjustable lever or the like, which is configured to provide the lowering of the tip into the receptacle 404 (and/or raising in due course). For example, the system 400 may include a sliding rail arranged on a side wall of the system housing, allowing vertical adjustment of the horizontal actuator. Indeed, various embodiments of mechanically inserting the tip of the conduit 432 (or of another conduit) into the receptacle 404 at a depth sufficient to engage the specimen 406 are envisioned, without limitation, including embodiments which are fully automated to provide for sterile specimen transfer to the sample enrichment apparatus 440.

[00186] In other embodiments employing a foam fractionator 440 for enrichment of the specimen 406, the system 100 may include one or more filters adapted to filter the specimen 406 upstream or downstream of the foam fractionator. For example, a filter may be arranged downstream of the foam fractionator 440 and upstream of the enriched specimen reservoir 450, such that organic matter which has fractionated out of the specimen 406 in the foam is filtered as it collapses to remove cells having dimensions indicative of human cells (e.g., blood cells, skin cells, platelets). Here, the size differential between bacterial and human cells may be exploited to further enrich the specimen of bacterial cells prior to diagnostic testing.

[00187] It is to be appreciated that many of the components and/or benefits described with respect to system 200 may be applicable mutatis mutandis to system 400, and vice versa, and are not repeated merely for the sake of brevity. For example, instead of a foam fractionator, system 400 may employ a tangential flow filtration system, and vice versa. As another example, the system 400 may include any one or more of the backflow stops, seals, or the like, described with reference to system 200 above.

[00188] While the present disclosure describes various embodiments for illustrative purposes, such description is not intended to be limited to such embodiments. On the contrary, the inventors’ teachings described and illustrated herein encompass various alternatives, modifications, and equivalents, without departing from the embodiments, the general scope of which is defined in the appended claims.

[00189] Information as herein shown and described in detail is fully capable of attaining the above-described object(s) of the present disclosure, the presently preferred embodiment of the present disclosure, and is, thus, representative of the subject matter which is broadly contemplated by the present disclosure. The scope of the present disclosure fully encompasses other embodiments which may become apparent to those skilled in the art, and is to be limited, accordingly, by nothing other than the appended claims, wherein any reference to an element being made in the singular is not intended to mean "one and only one" unless explicitly so stated, but rather "one or more." All structural and functional equivalents to the elements of the above-described preferred embodiment and additional embodiments as regarded by those of ordinary skill in the art are intended to be encompassed by the present claims. Moreover, no requirement exists for a device, system or method to address each and every problem sought to be resolved by the present disclosure, for such to be encompassed by the present claims. Furthermore, no element, component, or method step in the present disclosure is intended to be dedicated to the public regardless of whether the element, component, or method step is explicitly recited in the claims. However, that various changes and modifications in form, material, work- piece, and fabrication material detail may be made, without departing from the spirit and scope of the present disclosure, as set forth in the appended claims, as may be apparent to those of ordinary skill in the art, are also encompassed by the disclosure.

Claims

CLAIMS What is claimed is:

1. A system for sterilely enriching a fluid medical specimen for testing, the system comprising a docking platform for docking a receptacle containing the fluid medical specimen; a receptacle accessing mechanism for sterilely accessing an internal chamber of said receptacle after docking; a pressure-driven transfer assembly for automatically and sterilely transferring at least a portion of the fluid medical specimen from said internal chamber of said receptacle to a specimen enrichment apparatus; the specimen enrichment apparatus for receiving said at least a portion of the fluid medical specimen from said pressure-driven transfer assembly for enrichment, said specimen enrichment apparatus comprising an enriched specimen outlet fluidly connectable to a microfluidic test cartridge to sterilely output an enriched specimen thereto for testing.

2. The system of Claim 1, wherein said receptacle accessing mechanism comprises a lid opener for opening a lid on said receptacle once docked.

3. The system of Claim 2, wherein said lid opener comprises a motor-driven lid engaging member shaped and dimensioned to releasably engage said lid for removal from said receptacle.

4. The system of Claim 3, wherein said motor-driven lid engaging member is connected to a motor and is configured to rotate so as to at least partially open and/or remove said lid from said receptacle.

5. The system of any one of Claims 1 to 4, wherein said pressure-driven transfer assembly comprises at least one conduit operatively connected to a pump for transferring said at least a portion of the fluid medical specimen from said receptacle to said specimen enrichment apparatus.

6. The system of Claim 5, wherein one end of said at least one conduit is arranged for insertion into said receptacle.

7. The system of Claim 5, wherein said at least one conduit comprises a first conduit and a second conduit, said first conduit connected to said pump and arranged for insertion into said receptacle, and said second conduit arranged between said pump and said specimen enrichment apparatus.

8. The system of any one of Claims 1 to 7, wherein said docking platform is linearly actuatable between a receptacle receiving zone, a specimen accessing zone and a specimen transfer zone.

9. The system of any one of Claims 1 to 8, wherein said docking platform is powered by a motor.

10. The system of any one of Claims 1 to 9, wherein said docking platform comprises a docking formation for gripping a lower end of said receptacle.

11. The system of any one of Claims 1 to 10, wherein any one or combination of said receptacle accessing mechanism, said pressure-driven transfer assembly and said specimen enrichment apparatus are configured to be hands-free operable to ensure sterility of the fluid medical specimen.

12. The system of any one of Claims 1 to 11, wherein said receptacle accessing mechanism is reversibly operable as a receptacle closing mechanism.

13. A system for sterilely enriching a fluid medical specimen for testing, the system comprising a dock configured to dock a receptacle containing the fluid medical specimen, said receptacle having an actuatablc specimen release mechanism for stcrilcly releasing at least a portion of the fluid medical specimen to a specimen release chamber of said receptacle; a fluid inlet arranged at said dock to be in sterile fluid communication with said specimen release chamber of said receptacle when docked; a specimen transfer conduit extending from said fluid inlet for sterilely transferring the fluid medical specimen from said specimen release chamber of said receptacle downstream; and a specimen enrichment apparatus for receiving at least a portion of the fluid medical specimen from said specimen transfer conduit for enrichment, said specimen enrichment apparatus comprising an enriched specimen outlet fluidly connectable to a microfluidic test cartridge to sterilely output an enriched specimen thereto for testing.

14. The system of Claim 13, wherein said dock comprises a docking formation for securely docking said receptacle such that said fluid inlet is at least partially aligned with said chamber of said receptacle.

15. The system of either one of Claim 13 or Claim 14, wherein said actuatable specimen release mechanism comprises a mechanical valve, a pull tab, a slide tab, a push button, a stop cock, a plunger or a piercing member.

16. The system of any one of Claims 13 to 15, wherein said receptacle comprises a specimen collection chamber in juxtaposition with said specimen release chamber.

17. The system of Claim 16, wherein said specimen collection chamber and said specimen release chamber are fluidly separated by a septum.

18. The system of any one of Claims 13 to 17, wherein said the fluid medical specimen flows in said specimen transfer conduit under a force of gravity or under a pressure differential.

19. A system for sterilely enriching a fluid medical specimen for testing, the system comprising a dock configured to dock a receptacle containing the fluid medical specimen; a sterile specimen transfer mechanism operable in fluid communication with the receptacle once docked to sterilely access and transfer at least a portion of the fluid medical specimen under pressure from the receptacle to a specimen enrichment apparatus; and the specimen enrichment apparatus for receiving the at least a portion of the fluid medical specimen from the specimen transfer mechanism for enrichment prior to testing, the specimen enrichment apparatus comprising an enriched specimen outlet fluidly connectable to a microfluidic test cartridge to sterilely output an enriched specimen thereto for testing.

20. The system of Claim 19, wherein said sterile specimen transfer mechanism comprises a conduit and wherein said pressure comprises gravity pressure.

21. The system of Claim 19, wherein said sterile specimen transfer mechanism comprises a pump and at least one conduit, and wherein said pressure comprises any one or both of positively applied pressure and negatively applied pressure.

22. The system of any one of Claims 19 to 21, wherein any one or combination of said sterile specimen transfer mechanism and said specimen enrichment apparatus are configured to be hands-free operable to ensure sterility of the fluid medical specimen.

23. The system of any one of Claims 1 to 22, wherein the system is configured to be automated such that said receptacle containing the fluid medical specimen and said microfluidic test cartridge are respectively connected, and specimen enrichment and transfer to the microfluidic test cartridge is automated.

24. The system of any one of Claims 1 to 23, wherein said specimen enrichment apparatus comprises any one or combination of: an enrichment device, a fractionation device and a filtration device.

25. The system of any one of Claims 1 to 24, wherein said specimen enrichment apparatus comprises a foam fractionator.

26. The system of any one of Claims 1 to 25, further comprising a digital controller which executes stored instructions to automate at least specimen transfer and enrichment within the system.

27. The system of any one of Claims 1 to 26, further comprising a sample reservoir arranged upstream of said enriched specimen outlet to collect said enriched specimen from said specimen enrichment apparatus.

28. The system of any one of Claims 1 to 27, wherein the system is configured for sterilization between uses.

29. The system of Claim 28, further comprising an ultraviolet light source arranged within the system for sterilization of one or more components between uses.

30. A method for sterilely enriching a fluid medical specimen for testing, the method comprising docking a receptacle containing the fluid medical specimen to a dock; operating a sterile specimen transfer mechanism which is in fluid communication with the receptacle once docked, to sterilely access and transfer at least a portion of the fluid medical specimen under pressure from the receptacle to a specimen enrichment apparatus; and operating the specimen enrichment apparatus to enrich the at least a portion of the fluid medical specimen received from the specimen transfer mechanism, the specimen enrichment apparatus comprising an enriched specimen outlet fluidly connectable to a microfluidic test cartridge to sterilely output an enriched specimen thereto for testing.

31. The method of Claim 30, further comprising, after docking, operating a receptacle accessing mechanism for sterilely accessing an internal chamber of said receptacle.

32. The method of Claim 31 , wherein said operating said receptacle accessing mechanism comprises at least partially opening said receptacle.

33. The method of Claim 31, wherein said operating said receptacle accessing mechanism comprises removing a lid from said receptacle.

34. The method of any one of Claims 30 to 33, wherein said operating said receptacle accessing mechanism comprises releasing the fluid medical specimen from said receptacle.

35. The method of any one of Claims 30 to 34, wherein said docking comprises engaging a docking formation on said dock with a complementary docking formation on said receptacle.

36. The method of any one of Claims 30 to 35, wherein said sterile sample transfer mechanism comprises a pump and at least one conduit, and wherein operating said sterile sample transfer mechanism comprises pumping at least a portion of the fluid medical specimen from said receptacle to said specimen enrichment apparatus.

37. The method of any one of Claims 30 to 35, wherein said sterile sample transfer mechanism comprises at least one conduit, and wherein operating said sterile sample transfer mechanism comprises allowing at least a portion of the fluid medical specimen to flow under gravity pressure from said receptacle to said specimen enrichment apparatus.

38. The method of any one of Claims 30 to 37, wherein operating the specimen enrichment apparatus includes any one or combination of: filtering said portion of the fluid medical specimen; fractionating said portion of the fluid medical specimen; and enriching said portion of the fluid medical specimen.

39. The method of any one of Claims 30 to 38, wherein one or more steps of the method is automated or hands-free to ensure sterility of said enriched specimen.

40. A fluid sample collection and transfer container, comprising a sample collection chamber having a sample inlet for receiving therethrough a fluid sample into said sample collection chamber; a sample transfer docking structure configured for engaging with a complementary docking station located on a sample preparation device, said sample transfer docking structure having a transfer outlet from which at least a portion of said fluid sample is transferable to said sample preparation device; and a septum arranged to fluidly separate said sample collection chamber and said sample transfer docking structure, said septum being configured to selectively permit transfer of at least a portion of said fluid sample thereacross.

41. The container of Claim 40, further comprising a fluid flow mechanism to selectively permit fluid transfer of at least a portion of said fluid sample across said septum.

42. The container of Claim 41, wherein said sample collection chamber is located above said sample transfer docking structure such that fluid flow from said sample collection chamber across said septum to said transfer outlet is gravity-assisted.

43. The container of either one of Claim 40 or Claim 41, wherein said septum comprises an impermeable membrane.

44. The container of any one of Claims 40 to 43, wherein said fluid flow mechanism is actuatable between a closed configuration and a fluid flow configuration.

45. The container of Claim 41, wherein said fluid flow mechanism comprises a mechanical valve.

46. The container of Claim 45, wherein said mechanical valve comprises any one of a pull tab, a slide tab, a push button, a stop cock, or a plunger.

47. The container of Claim 41 , wherein said fluid flow mechanism comprises a piercing member arranged to selectively pierce said septum to selectively permit fluid transfer of at least a portion if said fluid sample across said septum.

48. The container of any one of Claims 40 to 47, wherein said sample transfer docking structure comprises a sample transfer chamber configured to at least partially retain said fluid sample therein during sample transfer.

49. The container of any one of Claims 40 to 48, wherein said sample transfer docking structure comprises a coupling formation configured to securely couple to a complementary coupling formation on said complementary docking station.

50. The container of any one of Claims 40 to 49, further comprising a collection lid configured to permit access to said sample inlet for depositing said fluid sample in said sample collection chamber.

51. The container of Claim 50, wherein said collection lid comprises a vent having a releasable vent cover.

52. The container of any one of Claims 40 to 51, further comprising a removable transfer lid configured to removably cover said transfer outlet to avoid contamination of said sample transfer docking structure.

53. The container of Claim 40, wherein at least a portion of said fluid flow mechanism is integrated with or engageable with said complementary docking station of said sample preparation device.

54. The container of any one of Claims 40 to 53, wherein the fluid sample comprises a bodily fluid sample.

55. The container of any one of Claims 40 to 54, wherein said container is a single-use disposable.

56. A system for sample collection and preparation of a fluid sample, the system comprising a fluid sample collection and transfer container as claimed in any one of Claims 40 to 55; and a sample preparation device with which said container is engageable, said sample preparation device comprising a complementary docking station configured to engage said sample transfer docking structure of said container; a preparation inlet formed in said complementary docking station, through which said fluid sample is receivable from said sample transfer docking structure; and a sample preparation assembly downstream of said preparation inlet for preparing said fluid sample for sample testing.

57. The system of Claim 56, wherein said sample transfer docking structure comprises a coupling formation and wherein said complementary docking station comprises a complementary coupling formation, whereby said coupling formation and said complementary coupling formation, when engaged, dock said container to said sample preparation device for sample transfer.

58. The system of Claim 57, wherein said coupling formation and said complementary coupling formation are interlockable, clippable, or snap-fittable.

59. The system of any one of Claims 56 to 58, wherein said sample preparation device comprises a piercing member arranged to pierce said septum upon activation to allow the sample fluid to flow from said sample collection chamber to said sample preparation device.

60. The system of any one of Claims 56 to 59, wherein said sample preparation assembly comprises a filter assembly.

61. The system of Claim 60, wherein said filter assembly is configured to provide tangential flow filtration of the fluid sample.

62. The system of Claim 61, wherein said filter assembly comprises a filter; a circular filter conduit connectable to either end of said filter; at least one roller configurable to engage said circular' filter conduit; and a peristaltic pump connectable to move said at least one roller when activated.

63. The system of either one of Claim 60 or Claim 61, wherein said filter assembly comprises a hollow filter arranged within a filter housing.

64. The system of any one of Claims 60 to 63, wherein said filter assembly further comprises a permeate reservoir for receiving filter permeate after filtration, wherein said permeate reservoir comprises a permeate outlet, and wherein said sample preparation device further comprises a removable cap configured to seal said permeate outlet.

65. The system of any one of Claims 56 to 58, wherein said sample preparation device further comprises a connector tube arrangeable between said sample transfer docking structure and said preparation inlet of said sample preparation device.

66. The system of Claim 65, wherein said connector tube comprises a piercing member arranged to pierce said septum upon activation to allow the sample fluid to flow from said sample collection chamber to said sample preparation device.

67. The system of either one of Claim 65 or Claim 66, wherein said connector tube is a single-use disposable.

68. The system of any one of Claims 56 to 67, further comprising a microfluidic test cartridge connectable in fluid communication with said sample preparation device.

69. The system of Claim 68, wherein said microfluidic test cartridge comprises: a test cartridge inlet configured to receive filter permeate from said sample preparation device; a fluid flow path from said test cartridge inlet to a test sample reservoir; and a plurality of fluid flow paths from said test sample reservoir to a plurality of test wells.

70. The system of any one of Claims 1 to 29, or 56 to 69, configured for point-of-care sample enrichment and testing.

71. The method of any one of Claims 30 to 39, executed at point-of-care.