SAMPLING DEVICES

Description

BACKGROUND

[0001] Bodily fluids, such as saliva, sweat, urine, and blood, can be collected from a subject and analyzed to determine information contained in such samples of bodily fluids. For example, a sample may contain information pertaining to the subject. The sample may contain information pertaining to the environment inhabited by the subject. In some instances, the samples may comprise deoxyribonucleic acid (DNA) molecules that can be further processed and / or analyzed to determine genetic information about the subject.

[0002] Saliva is a bodily fluid generally secreted by the major salivary glands, such as the parotid, submandibular, and sublingual glands. Saliva may be collected non-invasively, such as by expelling directly from the mouth or inserting a collector, such as a swab, in the mouth to collect.

[0003] US 2017 / 0001191 A1 discloses a bodily fluid sample collection device for the collection of naturally expressed bodily fluids and includes a cap engageable with a tube to close a mouth of the tube WO 2012 / 177656 A1 discloses devices, solutions, and methods for collecting and processing samples of bodily fluids containing cells (as well as embodiments for the collection, and processing and / or analysis of other fluids including toxic and / or hazardous substances / fluids).

[0004] US 4409988 discloses a swab packaged in a tube having an open end and containing a culture-sustaining or bacteria identification liquid at the bottom of a tube, and a plug including a one-way isolating valve located above the liquid and a barrier member forming a leak-proof chamber between the plug and the barrier member.

[0005] US 2013 / 0092690A1 discloses a seal cap assembly for use with a biological specimen container, the cap assembly including an integral ampoule that holds a pre-filled agent

[0006] WO 2016 / 131859A1 discloses a method and system for processing a sample in a fluid.

[0007] US 3477431 A discloses a combined mixing syringe and container for minimizing contamination of pharmaceutical preparations. Mixing is enabled by an enlarged portion of the syringe body that allows for fluid flow from a first compartment around a plunger into a second compartment immediately prior to injection.

[0008] US 2014 / 005636 A1 discloses a multi-compartment pre-filled mixing syringe with a bypass that likewise minimizes contamination of biomedical components by providing an enlarged portion of a syringe body through which fluid may flow from one compartment around a plunger or gasket into another compartment to facilitate in-syringe mixing.SUMMARY

[0009] On-site collection of biological samples, while relatively safe and guaranteeing a certain standard, can be inconvenient for several reasons. For example, a subject may have to travel a long distance to reach an on-site center (e.g., labs, hospitals, clinics, etc.), wasting valuable time, expenses, and other resources for a sample collection procedure that can be relatively simple especially for the types of samples (e.g., saliva) that can be collected non-invasively. For many subjects, no on-site center may be reasonably accessible. Furthermore, biological samples collected remotely and delivered to a lab for further processing or analysis are prone to contamination, spoiling, leakage, and / or loss which can present difficulties during such analysis, which can affect the cost of analysis, as well as both the speed and accuracy of the results. Thus recognized herein is a need for systems, devices, and methods for sample collection that can safely and securely deliver a biological sample between remote locations while preserving the integrity of the sample. There is a need for simple systems, devices, and methods that permit non-sophisticated users to collect a biological sample for delivery to a remote location.

[0010] According to the present invention, there is provided a device for storing a liquid biological sample according to claim 1. Further preferred features of embodiments of the device are defined in the dependent claims.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings (also "Figure" and "FIG." herein) of which: FIG. 1A shows a cross-sectional view of a sample collection device in an unengaged position, according to an embodiment. FIG. 1B shows a cross-sectional view of the sample collection device of FIG. 1A in an engaged position, according to an embodiment. DETAILED DESCRIPTION

[0012] While various embodiments of the invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions may occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed.

[0013] The term "sample," as used herein, generally refers to a specimen for processing and / or analysis. A sample, when used in the present invention, is a liquid sample.

[0014] A sample is a biological sample. The sample may be a bodily fluid. In an example, the bodily fluid is saliva, sputum, blood, perspiratory fluid (e.g., sweat), pus, tear, mucosal excretion, vomit, urine, stool, semen, vaginal fluids, or other type of bodily fluid. The sample can be a cell-free sample, such as a cell-free nucleic acid sample. The sample can include cell-free deoxyribonucleic acid (DNA), cell-free ribonucleic acid (RNA), and / or cell-free protein. The sample can include one or more cells (e.g., circulating tumor cells).

[0015] The sample can be a cheek swab or a swab of a different bodily part. The sample can be a homogenous sample or a heterogeneous sample. The sample can be a tumor sample, for instance. The sample can include one or more types of different biological samples (e.g., saliva and skin tissue). The sample may be derived from another sample. The sample can be a plasma or serum sample.

[0016] The term "engagement unit," as used herein, generally refers to one or more features that are configured to engage with one or more other features. Examples of engagement units include, without limitation, one or more threads, interference fitting, hooks and loops, latches, screws, staples, clips, clamps, prongs, rings, brads, rubber bands, rivets, grommets, pins, ties, snaps, velcro, adhesives, tapes, vacuum, seals, or a combination thereof. SYSTEMS, DEVICES, AND METHODS FOR SAMPLE COLLECTION

[0017] A sample may be collected from a subject and preserved and / or stabilized until such time of further processing and / or analysis, such as by contacting, or otherwise being exposed to, one or more reagents. For example, the collected sample, or one or more components thereof, may be preserved in their original state until such time of further processing and / or analysis. The collected sample, or one or more components thereof, may be preserved and / or stabilized to prevent bacterial or fungal growth. The collected sample may be preserved for at least 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 12 hours, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days,

[0018] 7 days, 1 week, 2 weeks, 3 weeks, 4 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 1 year, 2 years, 3 years, or for longer durations. The collected sample may be preserved and stored at room temperature or lower for prolonged periods of time, such as during transit and / or storage. The collected sample may be preserved and stored at ambient temperatures or lower for prolonged periods of time, such as to ensure preservation during transit (e.g., shipping warehouses, etc.) and / or storage. Alternatively or in addition, the collected sample may be preserved at temperatures of up to about 60° Celsius (°C).

[0019] As used herein, a reagent may refer to any kind of substance acting on the collected sample to achieve a desired effect. The reagent is in the form of a liquid solution. In some instances, the reagent can be configured to preserve deoxyribonucleic acid (DNA), ribonucleic acid (RNA), proteins, or other components of proteins in the sample. In some instances, the reagent can be configured to prevent one or more cells from having their antigens degraded and / or prevent alterations in the cellular epigenome of one or more cells. The reagent may permit extraction of one or more constituents (e.g., nucleic acid molecules) from a cell from the collected sample. The reagent may be configured to otherwise process the collected sample and / or one or more constituents thereof. A liquid solution may comprise one or more reagents configured to achieve one or more desired affects.

[0020] Beneficially, the systems, devices, and methods provided herein may facilitate convenient and simple at-home, on-site, or remote collection of samples. Non-sophisticated users, and even minors, may be capable of collecting samples without direct supervision. Users of a sample collection device may advantageously be shielded from direct exposure to chemical reagents, which may or may not be toxic, that are pre-loaded in the sample collection device at any point during the sample collection process. In some instances, users may be provided with easy-to-follow instructions. The instructions may instruct on how to use a device, collect a sample using the device, dispose (e.g., ship to a remote location) of the device after use, access results from analysis of the sample, or other instructions. The collected sample may be transported, such as via shipping (e.g., through the mail or a carrier), to a remote lab for further processing and / or analysis.

[0021] The stabilized and / or preserved sample can be further processed and analyzed at an outside facility (e.g., remote facility). For example, nucleic acids (e.g., DNA, etc.) from the sample can be isolated and extracted for amplification and / or sequencing applications.

[0022] Reference is now made to the figures. It will be appreciated that the figures and features therein are not necessarily drawn to scale.

[0023] FIG. 1A shows a cross-sectional view of a sample collection device 100 in an unengaged position. FIG. 1B shows a cross-sectional view of the sample collection device 100 in an engaged position. The sample collection device 100 can comprise a vessel 102 and a plunger 104 that is insertable in the vessel 102. The vessel 102 comprises one or more walls 106 that define a reservoir 108 for receiving a biological sample 150 and a reagent chamber 110 to hold a preservation reagent 160. The one or more walls can be formed of a polymeric material (e.g., polypropylene, polystyrene, polycarbonate, etc.), metallic material (e.g., aluminum), and / or composite material. The reservoir 108 and the reagent chamber 110 are separated by an integral web 112. In some instances, the integral web 112 can be a part of the one or more walls 106. Alternatively or in addition, the integral web 112 can be a separate structure fastened to the one or more walls 106. The integral web 112 has an aperture 114 through which the reservoir 108 and the reagent chamber 110 are in fluid communication. The reservoir 108 has an opening 116 to receive the biological sample 150 from a user. The user may be a subject from whom the sample is collected. For example, the user can spit into the reservoir 108 through the opening. The reagent chamber 110 comprises an opening 118.

[0024] The plunger 104 comprises a first end 120 and a second end 122. The first end 120 is configured to seal the opening 118 of the reagent chamber 110 to prevent the reagent 160 from leaving the reagent chamber 110 through the opening 118. The first end 120 comprises a lower gasket 124 that spans an inner cross-section of the reagent chamber 110.

[0025] The lower gasket 124 can have an interference fit to the inner dimensions of the reagent chamber 110 and provide a fluid-tight seal to prevent the reagent 160 from reaching or passing through the opening 118. The seal can be a hermetic seal.

[0026] The first end 120 can be configured to enter the reagent chamber 110 through the opening 118 when the plunger 104 is injected into the vessel 102. The lower gasket 124 may continue to seal the opening 118, such as via the interference fit, as the plunger 104 is injected into the vessel 102. That is, the reagent 160 can be contained in the reagent chamber 110 between the lower gasket 124 and the integral web 112.

[0027] The second end 122 is configured to seal the aperture 114 in the integral web 112 to prevent the reagent 160 from entering the reservoir 108 through the aperture 114 and prevent the biological sample 150 from entering the reagent chamber 110 through the aperture 114. The second end 122 comprises an upper gasket 126 at its tip that spans a cross- section of the aperture 114. The upper gasket 126 can have an interference fit to the aperture 114 and provide a fluid-tight seal to fluidically isolate the reservoir 108 from the reagent chamber 110 when the upper gasket 126 is in place. The seal can be a hermetic seal.

[0028] The second end 122 is configured to enter the reservoir 108 through the aperture 114 when the plunger 104 is injected into the vessel 102. The seal (e.g., interference fit) from the upper gasket 126 is broken (or released) as the tip of the second end 122 having the upper gasket 126 passes the aperture 114. When the seal is broken, the reservoir 108 and the reagent chamber 110 are in fluid communication with the other. That is, the biological sample 150 may enter the reagent chamber 110 and / or the reagent 160 may enter the reservoir 108 to form a mixture 170 of the biological sample 150 and the reagent 160. When the plunger 104 is fully injected into the vessel 102, the lower gasket 126 may reach the integral web 112 such that the mixture 170 is directed into the reservoir 108.

[0029] In some instances, the plunger 104 may not be removed from the vessel 102 by the user. According to the invention, a cross-section of a pre-inserted part of the first end 120 of the plunger 120 is larger than a cross-section of the opening 118 of the reagent chamber 110.

[0030] The opening 116 of the reservoir 108 can be closed by a cap or lid (not shown) that is fastened or coupled to the vessel 102, such as to the one or more walls 106 of the vessel 102, to cover the opening 116. Fastening or coupling can be achieved by engagement units, such as via fastening or coupling mechanisms. Example of engagement units include, but are not limited to, complementary threading, form-fitting pairs, interference fitting, hooks and loops, latches, screws, staples, clips, clamps, prongs, rings, brads, rubber bands, rivets, grommets, pins, ties, snaps, velcro, adhesives, tapes, vacuum, seals, or a combination thereof. Any description herein of any specific type of fasteners, engagement units, fastening mechanisms, coupling mechanisms, or engagement mechanisms, such as threads or threading, may apply to any other type of fasteners, engagement units, fastening mechanisms, coupling mechanisms, or engagement mechanisms. For example, a cap with threads fastened to a vessel with complementary threads by threading to close the vessel may be interchanged with a stopper fastened to the vessel via form-fitting seal to close the vessel. The cap may seal the vessel 102. The seal can be fluid-tight. The seal can be a hermetic seal.

[0031] In application, the device 100 is provided to the user in an unengaged position (as in FIG. 1A). The reagent 160 is pre-loaded in the reagent chamber 110 and the plunger 104 is disposed in the vessel 102 such that the upper gasket 126 is sealing the aperture 114 in the integral web 112 and the lower gasket 124 is sealing the opening 118 in the reagent chamber 110. The plunger 104 is insertable into the vessel 102. The user spits or otherwise deposits the biological sample 150 into the reservoir 108 through the opening 116.

[0032] The user can close the opening 116 of the reservoir 108 with a cap or lid (not shown). Thereafter, the biological sample 150 is sealed in the reservoir 108 and fluidically isolated from the reagent compartment 110, and the reagent 160 is sealed in the reagent compartment 110 and fluidically isolated from the reservoir 108. The user then applies a force to inject the plunger 104 into the vessel 102. In an example, this can be accomplished by using one or more hands to push or press the plunger 104 inwards. In another example, this can be accomplished by holding the vessel 102 and pushing the plunger 104 end of the vessel 102 against any surface (e.g., floor, wall, desk surface, etc.). Once injected, the seal of aperture 114 is broken (or released) and the reservoir 108 and the reagent chamber 110 are brought in fluid communication with each other. The biological sample 150 and the reagent 160 form a mixture 170 of the biological sample 150 and the reagent 160.

[0033] When the plunger 104 is fully injected (as in FIG. 1B), the lower gasket 124 reaches the integral web 112, and the mixture 170 is directed into the reservoir 108. In some instances, once injected, the plunger 104 can lock in the injected position such that the mixture 170 stays in the reservoir 108. In other instances, after injection, the plunger 104 can be uninjected, and the mixture 170 can freely travel between the reservoir 108 and the reagent chamber 110. The plunger 104 may not be removed from the vessel 102 by the user. For example, a cross-section of a pre-inserted part of the first end 120 of the plunger 120 may be larger than a cross-section of the opening 118 of the reagent chamber 110.

[0034] The user may transport the device 100, such as via shipping, to a remote location such as an outside lab for further processing and / or analysis. The device 100 may be shipped in a container with or without insulation. For example, the container can be an envelope, packaging, and / or a box. The device 100 may withstand routine forces received in shipping environments.

[0035] In some instances, the user may inject the plunger 104 before closing the opening 116 of the reservoir 108 with the cap or lid. In some instances, the user may inject the plunger 104 before depositing the biological sample 150 in the reservoir 108.

[0036] In some instances, the integral web 112 can have a plurality of apertures, and the plunger 104 can have corresponding structures and components (e.g., plurality of gaskets) to seal the plurality of apertures. In some instances, the reagent compartment 110 can have a plurality of openings, and the plunger 104 can have corresponding structures and components (e.g., plurality of gaskets) to seal the plurality of openings.

[0037] In some instances, in the unengaged position (as in FIG. 1A) the reagent chamber 110 may be fully pre-loaded with the reagent 160 to fill the reagent chamber 110. Alternatively, the reagent chamber 110 may be partially pre-loaded with the reagent 160.

[0038] In some instances, the one or more walls 106 of the vessel 102 may comprise one or more markings corresponding to fluid volume for reference to users (e.g., sample origin, lab technician, etc.) of the device 100. For example, one or more markings may correspond to a volume of the reagent 160 in the reagent compartment 110. One or more markings may correspond to a volume of the biological sample 150 in the reservoir 108. One or more marking may correspond to a volume of the mixture 170 in the reservoir 108. In some instances, at least a part of the one or more walls 106 of the vessel may be at least partially transparent and / or translucent, or clear, to permit visual recognition of the one or more markings.

[0039] While FIGs. 1A and 1B illustrate a device with the reservoir 108 and the reagent chamber 110 as vertically neighboring compartments, other configurations are available where the reservoir 108 and the reagent chamber 110 are fluidically communicating through the aperture 114. For example, the reservoir 108 and the reagent chamber 110 can be horizontally neighboring compartments, diagonally neighboring compartments, or placed relative to the other in any other orientation with an aperture 114 fluidically connecting the two compartments.

[0040] In some instances, the aperture 114 can define a fluid path, such as a straight and / or curved cross-sectional path and the plunger 104 can have a corresponding structure to seal the aperture 114 and / or enter the aperture 114. For example, the aperture 114 can have a curvature, and the second end 122 can have a corresponding curvature to travel through the aperture 114. In some instances, the reagent chamber 110 can define a straight or curved path for the plunger 104 to be injected in, and the plunger 104 can have a corresponding structure to seal the opening 118 and / or enter the reagent chamber 110. For example, the path can have a curvature, and the first end 120 can have a corresponding curvature to travel through the path.

[0041] In some instances, the user can deposit the biological sample 150 into the reservoir 108 on a carrier. For example, the carrier can be an absorbent member, such as a swab, cotton, pad, sponge, foam, or other material or device capable of carrying the biological sample 150 by absorbing. When the reagent 160 is directed to the reservoir 108 by actuation of the plunger 104, the absorbent member may absorb the reagent 160, thereby contacting the biological sample 150 therein with the reagent 160 to preserve and / or stabilize the biological sample 150. The carrier can be other materials or device capable of carrying the biological sample 150 in a location that is in fluid communication with the reservoir 108 such as to allow the reagent 160 to contact the biological sample 150 on the carrier.

[0042] In an example, the user uses the device 100 to collect the biological sample 150 (e.g., saliva or cheek swab) from a subject. The user can be the subject. Alternatively, the user can be one or more other individuals (e.g., supervisor, guardian, lab technician, worker, etc.) that collect the biological sample 150 from the subject. The biological sample 150 is deposited into the sample reservoir 108 through the opening 116. Next, the user actuates the plunger 104, such as by pushing the plunger 104 into the vessel 102. The reagent 160 is directed into the reservoir 108 and forms a mixture 170 with the biological sample 150. The user closes the opening 116 with a lid (not shown). The closed device 100 is then transported (e.g., via mail), such as to a remote lab for further processing and / or analysis. The biological sample 150 is preserved and / or stabilized during such transportation with aid of the reagent 160.

[0043] Any description herein of a biological sample (e.g., biological sample 150) with reference to the device 100 can apply to a liquid sample. Any description herein of a reagent (e.g., reagent 160) with reference to the device 100 can apply to a liquid solution. For example, the device 100 may be pre-loaded with a liquid solution and facilitate collection of a liquid sample.

[0044] In some instances, one or more portions of a sample collection device may be made of any suitable plastics, such as polypropylene, polystyrene, and / or polycarbonate. For example, an outer component, such as the vessel body and the lid body (e.g., outer shell) may be made of one or more plastics. Alternatively or in addition, one or more portions of the sample collection device may be made of metallic material (e.g., aluminum, etc.), or composite material.

[0045] Individual components within the sample collection device (e.g., plunger, protrusions, etc.) may comprise the same or different materials as the body of the device suited for the function of the individual components. The sample collection device may comprise a material resistant (e.g., chemically non-reactive) to the reagent contained therein.

[0046] The sample collection device may have varying dimensions. In some instances, the sample collection device may have dimensions smaller than about a standard 500 mL water bottle. In some instances, a closed sample collection device may have a maximum dimension of at most about 20 centimeters (cm), 18 cm, 16 cm, 14 cm, 12 cm, 10 cm, 9 cm, 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3 cm, 2 cm, 1 cm or less. Alternatively, a closed sample collection device may have a maximum dimension greater than about 20 cm. In some cases, the closed sample collection device may have a length from about 6 cm to about 15 cm. Alternatively, the closed sample collection device may have a length less than about 6 cm or greater than about 15 cm. In some instances, the device may have a maximum cross-section diameter (e.g., not the length) of about 7 cm, 6 cm, 5 cm, 4 cm, 3 cm, 2 cm, 1 cm or less. Alternatively, the device may have a maximum cross-section diameter of greater than about 7 cm. In some cases, the device may have an outer diameter from about 1 cm to about 2 cm. Alternatively, the device may have an outer diameter less than about 1 cm or greater than about 2 cm. In some instances, a reservoir for receiving a biological sample can have volume dimensions of at most about 200 milliliters (mL), 150 mL, 100 mL, 95 mL, 90 mL, 85 mL, 80 mL, 75 mL, 70 mL, 65 mL, 60 mL, 55 mL, 50 mL, 45 mL, 40 mL, 35 mL, 30 mL, 25 mL, 20 mL, 15 mL, 10 mL, 5 mL, 4 mL, 3 mL, 2 mL, 1 mL or less. Alternatively, the reservoir can have volume dimensions greater than about 200 mL. In some instances, a reagent compartment in a vessel can have volume dimensions of at most about 200 milliliters (mL), 150 mL, 100 mL, 95 mL, 90 mL, 85 mL, 80 mL, 75 mL, 70 mL, 65 mL, 60 mL, 55 mL, 50 mL, 45 mL, 40 mL, 35 mL, 30 mL, 25 mL, 20 mL, 15 mL, 10 mL, 5 mL, 4 mL, 3 mL, 2 mL, 1 mL or less. Alternatively, the reagent compartment in a vessel can have volume dimensions greater than about 200 mL. In some instances, a reagent compartment in a lid can have volume dimensions of at most about 200 milliliters (mL), 150 mL, 100 mL, 95 mL, 90 mL, 85 mL, 80 mL, 75 mL, 70 mL, 65 mL, 60 mL, 55 mL, 50 mL, 45 mL, 40 mL, 35 mL, 30 mL, 25 mL, 20 mL, 15 mL, 10 mL, 5 mL, 4 mL, 3 mL, 2 mL, 1 mL or less. Alternatively, the reagent compartment in a lid can have volume dimensions greater than about 200 mL.

[0047] Any embodiment of a sample collection device described herein may comprise from about 0.1 mL to about 5 mL, from about 0.1 mL to about 10 mL, from about 0.1 mL to about 100 mL, from about 5 mL to about 10 mL, from about 5 mL to about 100 mL, from about 10 mL to about 100 mL, or other ranges of the reagent. The sample collection device may comprise less than 0.1mL of the reagent. The sample collection device may comprise more than about 100 mL of the reagent. In some instances, about an equal volume of each of the biological sample and the reagent can be mixed together, such as within 0.1 mL difference, 1 mL difference, or 10 mL difference of each other.

[0048] The sample collection device may be used by a subject from whom the biological sample originates. The sample collection device may be used by an unsophisticated user with or without direct supervision. The sample collection device may be used by a non-subject, such as a technician, guardian, parent, or other individual, to collect the subject's biological sample.KIT

[0049] In some instances, the sample collection device may be provided as part of a kit. The kit can be a sample collection kit. The kit can be a sample processing kit. The kit can be a sample collection and processing kit. The kit may be provided to a user. In some instances, the user may be a subject from whom the sample is collected. In some instances, the user may be a supervisor, guardian, or assistant of the subject. In some instances, the user may be a lab personnel (e.g., technician, operator, etc.) receiving a sample from the subject.

[0050] The kit can comprise one or more sample collection devices as described elsewhere herein. The kit can comprise instructions or a set of instructions for sample collection and / or sample processing. The instructions may be directed to non-sophisticated users, including minors, and / or sophisticated users. The instructions may instruct on how to use a sample collection device, collect a sample using the device, dispose (e.g., ship to a remote location) of the device after use, access results from analysis of the sample, or other instructions. The instructions may provide safety instructions. The instructions can be pictorial. In some instances, the instructions may instruct on how to retrieve a sample from a sample collection device. In some instances, the instructions may instruct on how to process the sample retrieved from a sample collection device.

[0051] The kit can comprise one or more containers for shipping the one or more sample collection devices to a remote location, such as a remote lab for further processing and / or analysis. For example, the one or more containers can be boxes, envelopes, and / or other packaging material (e.g., insulating material, self-sealing or other sealing mechanism, postage, etc.). The kit can comprise a return label and / or a prepaid label, such as for use with a mail, shipping, and / or a carrier service. The collected sample may be transported, such as via shipping (e.g., through the mail or a carrier), to a remote lab for further processing and / or analysis.SAMPLE PROCESSING

[0052] A sample from a subject may be collected, received and processed. The sample may be collected using any of the sample collection devices provide herein. The sample may be collected from the subject. In an example, the subject may use the sample collection device to collect the sample from the subject directly. As an alternative, another individual (e.g., laboratory technician, nurse, or physician) may use the sample collection device to collect the sample from the subject. The sample collection devices provided herein may retain and / or store the collected sample until the sample is retrieved for further processing and / or analysis.

[0053] The collected sample can be transported to a processing center, such as a laboratory or research facility. The processing center can be remote from a point of collection. The collected sample can be transported via shipping (e.g., through the mail or a carrier). During transportation, the sample can be preserved and / or stabilized with aid of the reagents in the sample collection device. The sample may be preserved and / or stabilized on the order of hours, days, weeks, months, and / or years during transportation and / or storage. A sample collection device comprising the collected sample may be received at the processing center. The sample may be retrieved from the sample collection device and processed.

[0054] Processing may include nucleic acid amplification, such as via polymerase chain reaction (PCR). The nucleic acid amplification can involve thermal cycling, such as the reiterative cycling of a reaction cocktail between different reaction temperatures. Thermal cycling conditions (e.g., number of thermal cycles, temperatures utilized, cycle time, total run time, etc.) can be controlled to change the different parameters of amplification products. The nucleic acid amplification can be an isothermal amplification. Isothermal amplification can involve amplification at a single and constant temperature or single and constant range of temperature.

[0055] Processing may include obtaining sequencing information. Sequencing can include methods and technologies for determining the sequence of nucleotide bases in one or more polynucleotides. The polynucleotides can be, for example, deoxyribonucleic acid (DNA) or ribonucleic acid (RNA), including variants or derivatives thereof (e.g., single stranded DNA).

[0056] Sequencing may involve digital PCR. Sequencing can be performed by various systems currently available, such as, without limitation, a sequencing system by Illumina, Pacific Biosciences, Oxford Nanopore, or Life Technologies (Ion Torrent). Sequencing may be next generation sequencing (e.g., Illumina or Pacific Biosciences of California). Sequencing may use a probe array, such as a gene chip (e.g., Affymetrix gene chip). Sequencing may be massively parallel array sequencing (e.g., Illumina) and / or single molecule sequencing (e.g., Oxford Nanopore). Such devices may provide a plurality of raw genetic data corresponding to the genetic information of a subject (e.g., humans), as generated by the device from a sample provided by the subject. Alternatively or in addition, processing may include proteomic information.

[0057] Processing can yield data. The data may be sequencing data. The data may be proteomic data. The processed data may be analyzed to provide an output. The output may be in the form of a report. The report may be an electronic report. The report may be delivered to the subject or another user (e.g., healthcare provider) electronically, such as via electronic mail. The report may be delivered to the subject, over one or more servers and / or networks, such as via a web interface.

[0058] While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. It is not intended that the invention be limited by the specific examples provided within the specification. While the invention has been described with reference to the aforementioned specification, the descriptions and illustrations of the embodiments herein are not meant to be construed in a limiting sense. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. Furthermore, it shall be understood that all aspects of the invention are not limited to the specific depictions, configurations or relative proportions set forth herein which depend upon a variety of conditions and variables. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is therefore intended that the following claims define the scope of the invention and that structures within the scope of these claims be covered thereby.

Claims

1. A device (100) for storing a liquid biological sample (150), comprising: one or more walls (106) defining a reservoir (108) for receiving said liquid biological sample, wherein said reservoir comprises an opening (116) for receiving and storing said liquid sample and a first aperture (114); a chamber (110) comprising a liquid solution of a reagent for stabilizing said liquid biological sample, wherein said chamber is in controllable fluid communication with said reservoir (108) through said first aperture (114), said chamber further comprising a second aperture (118); and an injectable plunger (104) comprising a first part (120) and a second part (122), wherein said injectable plunger is movable between a first position and a second position, wherein (i) when said injectable plunger is at said first position, at least a portion of said first part (120) is disposed in said chamber (110) and seals said second aperture (118) of said chamber, and said second part of said injectable plunger seals said first aperture (114), (ii) when said injectable plunger is at said second position, at least a portion of said second part (122) is disposed in said reservoir (108), wherein movement of said injectable plunger (104) from said first position to said second position subjects said liquid solution to flow from said chamber (110) through said first aperture (114) to said reservoir (108), wherein said reservoir (108) and said chamber (110) are separated by an integral web (112); said first part (120) comprises a lower gasket (124) that spans an inner cross-section of said chamber (110); and said second part (122) comprises an upper gasket (126) at its tip that spans a cross-section of the first aperture (114), wherein a cross-section of said first part (120) is larger than a cross-section of said second aperture (118).

2. The device (100) of claim 1, further comprising a lid for closing said opening (116).

3. The device (100) of claim 1, wherein said movement of said injectable plunger (104) from said first position to said second position disrupts a seal (126) between said second part (122) of said injectable plunger and said first aperture (114).

4. The device (100) of claim 1, wherein said first part (120) seals said second aperture (118) through said movement of said plunger from said first position to said second position.

5. The device (100) of claim 4, wherein a mixture of said liquid sample and said liquid solution is retained in said reservoir (108) at said second position.

6. The device (100) of claim 1, wherein a diameter of said second aperture (118) is greater than or equal to a diameter of said first aperture (114).

7. The device (100) of claim 1, wherein, at said first position, said chamber (110) comprises said liquid solution in an amount that substantially fills said chamber.

8. The device (100) of claim 1, wherein said lower gasket has an interference fit with said second aperture (118).

9. The device (100) of claim 1, wherein said upper gasket has an interference fit with said first aperture (114).

10. The device (100) of claim 1, wherein said injectable plunger (104) is configured to lock at said second position.

11. The device (100) of claim 1, wherein said integral web (112) is part of the one or more walls (106).

12. The device (100) of claim 1, wherein said integral web (112) is a separate structure fastened to the one or more walls (106).

13. The device (100) of claim 1, wherein said first aperture (114) is defined through a thickness of said integral web (112).

14. The device (100) of claim 1, wherein said reservoir (108) and said chamber (110) are arranged as vertically neighboring compartments.