Patent ID: 12207801

DETAILED DESCRIPTION

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.

The term “sample,” as used herein, generally refers to a specimen for processing and/or analysis. A sample may be a liquid sample. A sample may be a fluid (e.g., gas, liquid) sample.

A sample may be 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 non-fluid sample. 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).

The sample can be a solid or tissue sample. The sample can be a skin sample. 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.

Alternatively or in addition to, the sample can be a non-biological sample (e.g., soil sample). Any description herein of any specific type of sample, such as sputum or saliva, may apply to any other type of sample.

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

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,

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.).

As used herein, a reagent may refer to any kind of substance acting on the collected sample to achieve a desired effect. The reagent may be in any suitable form, such as a fluid (e.g., liquid, gas, solution, etc.) or a non-fluid (e.g., solid powder, etc.). 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.

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.

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.

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

FIG.1Ashows a cross-sectional view of a sample collection device100in an unengaged position.FIG.1Bshows a cross-sectional view of the sample collection device100in an engaged position. The sample collection device100can comprise a vessel102and a plunger104that is insertable in the vessel102. The vessel102can comprise one or more walls106that define a reservoir108for receiving a biological sample150and a reagent chamber110to hold a preservation reagent160. 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 reservoir108and the reagent chamber110can be separated by an integral web112. In some instances, the integral web112can be a part of the one or more walls106. Alternatively or in addition, the integral web112can be a separate structure fastened to the one or more walls106. The integral web112can have an aperture114through which the reservoir108and the reagent chamber110are in fluid communication. The reservoir108can have an opening116to receive the biological sample150from a user. The user may be a subject from whom the sample is collected. For example, the user can spit into the reservoir108through the opening. The reagent chamber110can comprise an opening118.

The plunger104can comprise a first end120and a second end122. The first end120can be configured to seal the opening118of the reagent chamber110to prevent the reagent160from leaving the reagent chamber110through the opening118. For example, the first end120can comprise a lower gasket124that spans an inner cross-section of the reagent chamber110.

The lower gasket124can have an interference fit to the inner dimensions of the reagent chamber110and provide a fluid-tight seal to prevent the reagent160from reaching or passing through the opening118. The seal can be a hermetic seal. Any description herein of a plunger may apply to any other implement, such as a rod, stage, plate, or other actuator.

The first end120can be configured to enter the reagent chamber110through the opening118when the plunger104is injected into the vessel102. The lower gasket124may continue to seal the opening118, such as via the interference fit, as the plunger104is injected into the vessel102. That is, the reagent160can be contained in the reagent chamber110between the lower gasket124and the integral web112.

The second end122can be configured to seal the aperture114in the integral web112to prevent the reagent160from entering the reservoir108through the aperture114and prevent the biological sample150from entering the reagent chamber110through the aperture114. For example, the second end122can comprise an upper gasket126at its tip that spans a cross-section of the aperture114. The upper gasket126can have an interference fit to the aperture114and provide a fluid-tight seal to fluidically isolate the reservoir108from the reagent chamber110when the upper gasket126is in place. The seal can be a hermetic seal.

The second end122can be configured to enter the reservoir108through the aperture114when the plunger104is injected into the vessel102. The seal (e.g., interference fit) from the upper gasket126can be broken (or released) as the tip of the second end122having the upper gasket126passes the aperture114. When the seal is broken, the reservoir108and the reagent chamber110can be in fluid communication with the other. That is, the biological sample150may enter the reagent chamber110and/or the reagent160may enter the reservoir108to form a mixture170of the biological sample150and the reagent160. When the plunger104is fully injected into the vessel102, the lower gasket126may reach the integral web112such that the mixture170is directed into the reservoir108.

In some instances, the plunger104may not be removed from the vessel102by the user. For example, a cross-section of a pre-inserted part of the first end120of the plunger120may be larger than a cross-section of the opening118of the reagent chamber110.

The opening116of the reservoir108can be closed by a cap or lid (not shown) that is fastened or coupled to the vessel102, such as to the one or more walls106of the vessel102, to cover the opening116. 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 vessel102. The seal can be fluid-tight. The seal can be a hermetic seal.

In application, the device100is provided to the user in an unengaged position (as inFIG.1A). The reagent160is pre-loaded in the reagent chamber110and the plunger104is disposed in the vessel102such that the upper gasket126is sealing the aperture114in the integral web112and the lower gasket124is sealing the opening118in the reagent chamber110. The plunger104is insertable into the vessel102. The user spits or otherwise deposits the biological sample150into the reservoir108through the opening116.

The user can close the opening116of the reservoir108with a cap or lid (not shown). Thereafter, the biological sample150is sealed in the reservoir108and fluidically isolated from the reagent compartment110, and the reagent160is sealed in the reagent compartment110and fluidically isolated from the reservoir108. The user then applies a force to inject the plunger104into the vessel102. In an example, this can be accomplished by using one or more hands to push or press the plunger104inwards. In another example, this can be accomplished by holding the vessel102and pushing the plunger104end of the vessel102against any surface (e.g., floor, wall, desk surface, etc.). Once injected, the seal of aperture114is broken (or released) and the reservoir108and the reagent chamber110are brought in fluid communication with each other. The biological sample150and the reagent160form a mixture170of the biological sample150and the reagent160.

When the plunger104is fully injected (as inFIG.1B), the lower gasket124reaches the integral web112, and the mixture170is directed into the reservoir108. In some instances, once injected, the plunger104can lock in the injected position such that the mixture170stays in the reservoir108. In other instances, after injection, the plunger104can be uninjected, and the mixture170can freely travel between the reservoir108and the reagent chamber110. The plunger104may not be removed from the vessel102by the user. For example, a cross-section of a pre-inserted part of the first end120of the plunger120may be larger than a cross-section of the opening118of the reagent chamber110.

The user may transport the device100, such as via shipping, to a remote location such as an outside lab for further processing and/or analysis. The device100may be shipped in a container with or without insulation. For example, the container can be an envelope, packaging, and/or a box. The device100may withstand routine forces received in shipping environments.

In some instances, the user may inject the plunger104before closing the opening116of the reservoir108with the cap or lid. In some instances, the user may inject the plunger104before depositing the biological sample150in the reservoir108.

In some instances, the integral web112can have a plurality of apertures, and the plunger104can have corresponding structures and components (e.g., plurality of gaskets) to seal the plurality of apertures. In some instances, the reagent compartment110can have a plurality of openings, and the plunger104can have corresponding structures and components (e.g., plurality of gaskets) to seal the plurality of openings.

In some instances, in the unengaged position (as inFIG.1A) the reagent chamber110may be fully pre-loaded with the reagent160to fill the reagent chamber110. Alternatively, the reagent chamber110may be partially pre-loaded with the reagent160.

In some instances, the one or more walls106of the vessel102may comprise one or more markings corresponding to fluid volume for reference to users (e.g., sample origin, lab technician, etc.) of the device100. For example, one or more markings may correspond to a volume of the reagent160in the reagent compartment110. One or more markings may correspond to a volume of the biological sample150in the reservoir108. One or more marking may correspond to a volume of the mixture170in the reservoir108. In some instances, at least a part of the one or more walls106of the vessel may be at least partially transparent and/or translucent, or clear, to permit visual recognition of the one or more markings.

WhileFIGS.1A and1Billustrate a device with the reservoir108and the reagent chamber110as vertically neighboring compartments, other configurations are available where the reservoir108and the reagent chamber110are fluidically communicating through the aperture114. For example, the reservoir108and the reagent chamber110can be horizontally neighboring compartments, diagonally neighboring compartments, or placed relative to the other in any other orientation with an aperture114fluidically connecting the two compartments.

In some instances, the aperture114can define a fluid path, such as a straight and/or curved cross-sectional path and the plunger104can have a corresponding structure to seal the aperture114and/or enter the aperture114. For example, the aperture114can have a curvature, and the second end122can have a corresponding curvature to travel through the aperture114. In some instances, the reagent chamber110can define a straight or curved path for the plunger104to be injected in, and the plunger104can have a corresponding structure to seal the opening118and/or enter the reagent chamber110. For example, the path can have a curvature, and the first end120can have a corresponding curvature to travel through the path.

In some instances, the user can deposit the biological sample150into the reservoir108on 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 sample150by absorbing. When the reagent160is directed to the reservoir108by actuation of the plunger104, the absorbent member may absorb the reagent160, thereby contacting the biological sample150therein with the reagent160to preserve and/or stabilize the biological sample150. The carrier can be other materials or device capable of carrying the biological sample150in a location that is in fluid communication with the reservoir108such as to allow the reagent160to contact the biological sample150on the carrier.

In an example, the user uses the device100to collect the biological sample150(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 sample150from the subject. The biological sample150is deposited into the sample reservoir108through the opening116. Next, the user actuates the plunger104, such as by pushing the plunger104into the vessel102. The reagent160is directed into the reservoir108and forms a mixture170with the biological sample150. The user closes the opening116with a lid (not shown). The closed device100is then transported (e.g., via mail), such as to a remote lab for further processing and/or analysis. The biological sample150is preserved and/or stabilized during such transportation with aid of the reagent160.

Any description herein of a biological sample (e.g., biological sample150) with reference to the device100can apply to a liquid sample. Any description herein of a reagent (e.g., reagent160) with reference to the device100can apply to a liquid solution. For example, the device100may be pre-loaded with a liquid solution and facilitate collection of a liquid sample.

FIG.2Ashows a cross-sectional view another sample collection device200in an open position.FIG.2Bshows a cross-sectional view of the sample collection device200in a closed position. The sample collection device200can comprise a vessel202and a lid204.

The vessel202can comprise one or more walls206that define a reservoir208for receiving a biological sample250from a user. The user may be a subject from whom the sample is collected. The one or more walls206can comprise a first lid engagement unit210, such as threads, to couple with the lid204. The vessel202can comprise a second lid engagement unit211, such as a rod or beam (whereinFIG.2Ashows a cross-section of a rod or beam which length is extending into the plane), to couple with the lid204.

The lid204can comprise an outer shell212, an inner wall214, and a sleeve216. The outer shell212can be fused or otherwise fastened to an inner wall214. When fastened, the inner wall214can be fixed relative to the outer shell212. The outer shell212and the inner wall214can enclose and define a reagent chamber218. The reagent chamber218can comprise a preservation and/or stabilization reagent260for preserving and/or stabilizing the biological sample250. The inner wall214can comprise an aperture220through which the reagent260may leave the reagent chamber218.

The inner wall214can be mechanically assembled or otherwise fastened to a sleeve216. A surface (e.g., bottom surface) of the inner wall214can interface a surface (e.g., top surface) of the sleeve216. When fastened, the surface of the inner wall214may rotate relative to the surface of the sleeve216while interfacing the surface of the sleeve216. In some instances, the inner wall214may rotate relative to the sleeve216only when sufficient torque is applied, such as to overcome frictional resistance. For example, this frictional resistance can be provided by a sealant225, adhesive, or other material disposed between the inner wall214and the sleeve216. The resistance can be provided by a mechanical element (e.g., stopper, blocking unit) in the mechanical assembly of the inner wall214and the sleeve216. In some instances, the inner wall214may rotate relative to the sleeve216only when a mechanical trigger is engaged (e.g., removal of a blocking unit, etc.).

The sleeve216can comprise a first vessel engagement unit222, such as threads complementary to the first vessel engagement unit210. The sleeve216can comprise a second vessel engagement unit223, such as a depression complementary to the second lid engagement unit211. The sleeve216can comprise an aperture224. In some instances, the sealant225can be disposed between the interfacing surface of the inner wall214and the interfacing surface of the sleeve216to provide a fluid-tight seal between the two surfaces such that fluid does not seep between the interfacing surfaces. The seal can be a hermetic seal. For example, the sealant225can be a silicone coating.

In an open position (as inFIG.2A), the sleeve216can be mechanically assembled to the inner wall214such that the first aperture220in the inner wall214is blocked by a surface (e.g., top surface) of the sleeve216and the second aperture224in the sleeve216is blocked by a surface (e.g., bottom surface) of the inner wall214. Because the first aperture220is blocked by the sleeve216, the reagent260is fluidically confined to the reagent compartment218defined by the outer shell212and the inner wall214.

To alternate to the closed position (as inFIG.2B), the vessel202can be closed with the lid204by coupling the first vessel engagement unit222with the first lid engagement unit210, such as via a threading motion. As the lid204descends to cover the vessel202, the second vessel engagement unit223in the sleeve216can engage with the second lid engagement unit211in the vessel202to fix the sleeve216in position relative to the vessel202. When the sleeve216is fixed relative to the vessel202, a continued threading motion of the lid204can provide sufficient torque to rotate the inner wall214(and the fixed outer shell212) relative to the sleeve216. As the inner wall214rotates relative to the sleeve216, the first aperture220in the inner wall214can at least partly align with the second aperture224in the sleeve216to bring the reagent chamber218in fluid communication with the reservoir208. When the first aperture220and the second aperture224at least partly align, the reagent260in the reagent chamber218can flow into the reservoir208to form a mixture270with the biological sample250. The biological sample250can thereby be preserved and/or stabilized in the mixture270.

In application, the user is provided the device200in an open position (as inFIG.2A). The reagent260is pre-loaded in the reagent chamber218in the lid204and fluidically isolated from the reservoir208or any other space external to the lid204. The inner wall214and the sleeve216are mechanically assembled such that the sleeve216is blocking the aperture220of the inner wall214. In some instances, the sealant225is disposed between the interfacing surfaces of the inner wall214and the sleeve216to provide a fluid tight seal in the interface of the inner wall214and the sleeve216. The user spits or otherwise deposits the biological sample250into the reservoir208through an opening of the reservoir208in the vessel202.

The user can close the vessel202with the lid204. As the lid204is brought in proximity to the vessel202, the first lid engagement unit210(e.g., threads) in the vessel202engages the first vessel engagement unit222(e.g., complementary threads) in the lid204. The lid204descends with a threading motion until the second lid engagement unit211(e.g., rod, beam, etc.) in the vessel202engages the second vessel engagement unit223(e.g., depression) in the lid204. The engagement of the second lid engagement unit211and the second vessel engagement unit223fixes the sleeve216relative to the vessel202. As the user continues the threading motion on the lid204, the user applies a sufficient torque to rotate the inner wall214(and the rest of the lid204assembly) relative to the sleeve216. Upon rotation of the inner wall214relative to the sleeve216, the aperture220in the inner wall214and the aperture224in the sleeve216at least partially align, thereby bringing into fluid communication the reagent chamber218and the reservoir208. The reagent260flows into the reservoir208to form a mixture270of the reagent260and the biological sample250. The biological sample250can thereby be preserved and/or stabilized in the mixture270. In some instances, the reagent260may flow into the reservoir208via gravitational forces.

Thereafter, the lid204is fastened to the vessel202and the mixture270is confined in the reservoir208and optionally in the reagent compartment218which is in fluid communication with the reservoir208. In some instances, the user may twist or rotate the lid204relative to the vessel202in some amount (e.g., 180°) in a direction opposite to the direction of closing to rotate the inner wall214relative to the sleeve216such that the aperture224in the sleeve216is blocked by the inner wall214and the mixture270is fluidically isolated in the reservoir208.

The user may transport the device200, such as via shipping, to a remote location such as an outside lab for further processing and/or analysis. The device200may be shipped in a container with or without insulation. For example, the container can be an envelope, packaging, and/or a box. The device200may withstand routine forces received in shipping environments.

In some instances, the user can deposit the biological sample250into the reservoir208on 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 sample250by absorbing. When the reagent260flows in the reservoir208, the absorbent member may absorb the reagent260, thereby contacting the biological sample250therein with the reagent260to preserve and/or stabilize the biological sample250. The carrier can be other materials or device capable of carrying the biological sample250in a location that is in fluid communication with the reservoir208such as to allow the reagent260to contact the biological sample250on the carrier.

In some instances, the inner wall214and the sleeve216may be mechanically assembled such that the inner wall214may rotate relative to the sleeve216with a limited degree of freedom. For example, the inner wall214may rotate relative to the sleeve216at most by 3 turns (1080°), 2.5 turns (900°), 2 turns (720°), 1.5 turns (540°), 1 turn (360°), 330°, 300°, 270°, 240°, 210°, 180°, 150°, 140°, 130°, 120°, 110°, 100°, 90°, 80°, 70°, 60°, 50°, 40°, 30°, 20°, 10°, 5°, or less. In some instances, the inner wall214and the sleeve216may be mechanically assembled such that the inner wall214may rotate relative to the sleeve216in either direction (e.g., clockwise, and counterclockwise). Alternatively, the inner wall214and the sleeve216may be mechanically assembled such that the inner wall214may rotate relative to the sleeve216in only one direction (e.g., clockwise, counterclockwise).

In some instances, the inner wall214can comprise a plurality of apertures, such as 2, 3, 4, 5, 6, 7, 8, 9, 20, or more apertures. The sleeve224can comprise an appropriate number of apertures to bring the reagent chamber218in fluid communication with the reservoir208through the plurality of apertures in the inner wall214when the device200is in a closed position.

In some instances, in the open position (as inFIG.2A) the reagent chamber218may be fully pre-loaded with the reagent260to fill the reagent chamber210. Alternatively, the reagent chamber218may be partially pre-loaded with the reagent260.

In some instances, the one or more walls206of the vessel202may comprise one or more markings corresponding to fluid volume for reference to users (e.g., sample origin, lab technician, etc.) of the device200. For example, one or more markings may correspond to a volume of the biological sample250in the reservoir208. One or more marking may correspond to a volume of the mixture270in the reservoir208. In some instances, at least a part of the one or more walls206of the vessel202may be at least partially transparent and/or translucent, or clear, to permit visual recognition of the one or more markings. In some instances, the outer shell212of the lid204may comprise one or more markings corresponding to fluid volume for reference to users (e.g., sample origin, lab technician, etc.) of the device200. For example, one or more markings may correspond to a volume of the reagent260in the reagent compartment210. In some instances, at least a part of the outer shell212of the lid204may be at least partially transparent and/or translucent, or clear, to permit visual recognition of the one or more markings.

In some instances, the lid204may be coupled to the vessel202via one or more other coupling or fastening mechanisms described elsewhere herein. As an example, the inner diameter of the sleeve216may form-fit the outer diameter of the vessel202and allow fastening of the two components without need for a threading motion or threading features, and the inner wall214may rotate relative to the sleeve216to open and/or close fluid communication between the reagent chamber218and the reservoir208. As another example, the locations of the threads may be inverted such that the threads are on the inner walls of the vessel202and on the outer walls of the sleeve216and the sleeve216threads inside the vessel202. In such a case, the inner wall214and outer shell212may be outside the vessel202when in a closed position.

In an example, the user uses the device200to collect the biological sample250(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 sample250from the subject. The biological sample250is deposited into the reservoir208. Next, the user closes the vessel202with the lid204, such as by engaging (e.g., threading) the lid204with the vessel202. Upon engagement, the first aperture220and the second aperture224at least partially align, bringing the reagent chamber218in fluid communication with the reservoir208. The reagent260is directed into the reservoir208through the first and second apertures220,224and forms a mixture270with the biological sample250. The closed device200is then transported (e.g., via mail), such as to a remote lab for further processing and/or analysis. The biological sample250is preserved and/or stabilized during such transportation with aid of the reagent260.

Any description herein of a biological sample (e.g., biological sample250) with reference to the device200can apply to a liquid sample. Any description herein of a reagent (e.g., reagent260) with reference to the device200can apply to a liquid solution. For example, the device200may be pre-loaded with a liquid solution and facilitate collection of a liquid sample.

FIG.3Ashows a cross-sectional view of another sample collection device300in an open position.FIG.3Bshows a cross-sectional view of the sample collection device300in a closed position. The sample collection device300can comprise a lid302, a vessel304, and an implement306.

The lid302can comprise a first vessel engagement unit308and a second vessel engagement unit310. The first vessel engagement unit308, for example, can be threads. The second vessel engagement unit310, for example, can be a protrusion configured to contact one or more components of the vessel304and/or the implement306.

The vessel304can comprise one or more walls312that define a cavity314with an open end and a closed end. The one or more walls312can comprise a first lid engagement unit315. The first lid engagement unit315, for example, can comprise threads complementary to the first vessel engagement unit310. The one or more walls312can comprise one or more serrations313facing or emanating into the inside of the cavity314located at and/or in proximity to the closed end or the bottom of the vessel. The number of serrations and distance between serrations may optionally be varied depending on the size (e.g., length and diameter) of the vessel and/or the size of the serrations. For example, if the vessel is configured to have a larger diameter at the closed end or bottom, more serrations may be included. The number of serrations may be from 1 to 6, 4 to 10, 8 to 16, 14 to 20, 18 to 40, 30 to 60, 40 to 100, 90 to 120, 100 to 150, 125 to 175, 150 to 200, 175 to 300, 200 to 400, or more, depending on the size of serrations. Alternatively, the number of serrations may be outside the above-recited ranges. The serrations313can be located at about 10 centimeters (cm), 9 cm, 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3 cm, 2 cm, 1 cm, or less, or 10 millimeters (mm), 9 mm, 8 mm, 7 mm, 6 mm, 5 mm, 4 mm, 3 mm, 2 mm, 1 mm, or less, distance from the inner wall of the closed end. Alternatively, the serrations313may be located more than 10 cm distance from the inner wall of the closed end. In some cases, the location of the serrations may depend on the size (e.g., length) of the vessel.

The serrations313can be micro-serrations. In some instances, the serrations313can be protrusions or micro-protrusions. The serrations313and/or protrusions can have sharp, jagged, and/or cutting edges. Alternatively or in addition, the serrations313can have rounded edges. In some instances, the serrations313can be molded or otherwise integrated in the one or more walls312. Alternatively or in addition, the serrations313can be separate structures fastened to be fixed to the one or more walls312.

The implement306can be displaceable, injectable, plungeable, retractable, dejectable, ascendible, descendible, and/or otherwise be movable or actuated relative to the vessel302. For example, the implement306can be a plunger. The implement306can be a second vessel, tube or vial. The implement306can be a rod, stage, plate, or other actuator. Any description herein of a plunger may apply to any other implement, such as a rod, stage, plate, or other actuator.

The implement306can be disposed in the cavity314. The implement306can be insertable in the cavity314towards the closed end. The implement306can comprise a base plate316, one or more sidewalls318, and a second lid engagement unit320. The one or more sidewalls318and the baseplate316can define a reservoir322for receiving a biological sample (not shown) from a user. In some instances, the baseplate316can be part (e.g., an integral part, a monolithic part, etc.) of the one or more sidewalls318. The baseplate316can be located towards the closed end of the cavity314. The baseplate316can be flat, curved, or have any other surface profile. The user may be a subject from whom the sample is collected. The one or more sidewalls318can comprise one or more openings324through which the reservoir322and the cavity314are in fluid communication. The second lid engagement unit320can engage with the second vessel engagement unit310of the lid302. In some instances, the second lid engagement unit320can be part of the one or more sidewalls318of the implement306. During closing of the vessel304, the second vessel engagement unit310(e.g., protrusion) of the lid302can apply a force (e.g., via push, press) on the second lid engagement unit320(e.g., sidewall perimeter) to actuate the implement306and inject the implement306towards the closed end of the cavity314.

The base plate316can span the cross-section of the cavity314to provide a seal325between the base plate316and the non-serrated portions of the one or more walls312defining the cavity314. The seal325can be a wiper seal. The seal325can be a fluid-tight seal. The seal325can be a hermetic seal. The seal325can be provided via an interference fit between the outer dimension of the base plate316and the inner dimension of the one or more walls316. The base plate316and the one or more walls316may comprise the same or different materials (e.g., polypropylene and polyethylene, etc.). The seal325can be maintained between the non-serrated (or non-protruded) portion of the one or more walls312as the implement306is injected (or dejected).

Thus, the base plate316can partition the cavity314to define a reagent chamber326that is fluidically isolated from the remainder of the cavity314. The base plate316and the one or more walls312at or in proximity to the closed end of the cavity314can define the reagent chamber326. The reagent chamber326can be fluidically isolated from the reservoir322which is in fluid communication with the rest of the cavity314. The reagent chamber326can comprise a preservation and/or stabilization reagent360.

When the device300is in an open position (as inFIG.3A), the base plate316can be located above the serrated and/or protruded portion of the one or more walls312such that the seal325is intact and the reagent chamber326is fluidically isolated from the reservoir322.

To alternate the device300to the closed position (as inFIG.3B), the lid302can be brought in proximity to the vessel304. The first vessel engagement unit308(e.g., threads) in the lid302can engage with the first lid engagement unit315(e.g., complementary threads) in the vessel304to couple the lid302and the vessel304. For example, the lid302can descend onto the vessel304in a threading motion. As the lid302descends, the second vessel engagement unit310(e.g., protrusion) in the lid302can engage the second lid engagement unit320(e.g., sidewall perimeter) of the implement306, and translate the descending motion to actuate the implement306and inject the implement306towards the closed end of the cavity314of the vessel302.

As the implement306is injected, the base plate316of the implement can continue to provide the seal325between the one or more walls312of the vessel302and the base plate316until the base plate316engages the one or more serrations313on the one or more walls312of the vessel302and the seal325is disrupted. For example, the protrusions and/or serrations may reduce the contact area of the seal325to bring the reagent chamber326in fluid communication with the remainder of the cavity314and, by extension, to the reservoir322via the one or more openings324. As the implement306is injected, and the reagent chamber326decreases in volume, the reagent360may flow around the disrupted seal325into the cavity314and into the reservoir322to form a mixture370of the biological sample (not shown) and the reagent360. The reagent360may preserve and/or stabilize the biological sample in the mixture370.

In application, the device300is provided to the user in an open position (as inFIG.3A). The reagent360is pre-loaded in the reagent chamber326and the implement306is disposed in the vessel304such that the base plate316is interfacing a non-serrated portion of the one or more walls312and the seal325is intact. The implement306is insertable into the vessel304. The user spits or otherwise deposits the biological sample (not shown) into the reservoir322through an opening328of the reservoir322. In some instances, the opening328of the reservoir322can be the only opening to the vessel304. The biological sample and the reagent360are fluidically isolated.

The user can close the opening328of the reservoir322with the lid302, such as by engaging the first vessel engagement unit308of the lid302and the first lid engagement unit315of the vessel304. Upon descent of the lid302, the second vessel engagement unit310of the lid302can engage the second lid engagement unit320of the implement308, and the implement308can be injected towards the closed end of the cavity314. Once injected, the base plate316of the implement306engages the one or more serrations313on the one or more walls312of the vessel304and the seal325is disrupted. The reagent chamber326and the remaining cavity314space are brought into fluid communication. As the implement decreases the volume of the reagent chamber326, the reagent360escapes the reagent chamber326around or through the disrupted seal325to enter the remaining cavity314space and thereafter enter the reservoir322through the one or more openings324on the one or more sidewalls318of the implement306.

The biological sample and the reagent360form a mixture370of the biological sample and the reagent360. The reagent360can preserve and/or stabilize the biological sample in the mixture370. The mixture370may be stored in the reservoir322and/or the cavity314.

The device300can be configured such that the implement306is fully injected (as inFIG.3B) when the lid302is securely fastened to the vessel304. When the implement306is fully injected, the base plate316may contact the closed end of the cavity314such that there is substantially no volume in the reagent chamber326and as a result all of the reagent360comes in contact with the biological sample to form the mixture370. Alternatively, when the lid302is securely fastened to the vessel304, the implement306may be partially injected, and the base plate316may not necessarily contact the closed end of the cavity314.

In some instances, once injected, the implement306can lock in the injected position such that it cannot be dejected and the mixture370stays in the reservoir322and/or cavity314space above the base plate316. In other instances, after injection, the implement306can be un-injected (or dejected), such as when the lid302is removed and the mixture370may travel between the reservoir322, cavity314, and/or the reagent chamber326. In some instances, the implement306may not be removed from the vessel304by the user. For example, a cross-section of a pre-inserted part of the implement306may be larger than a cross-section of the open end of the cavity314.

In some instances, the seal325may re-seal after disruption when the base plate316returns to interfacing a non-serrated portion of the one or more walls312of the vessel304. Alternatively, the seal325may remain disrupted even after the base plate316returns to interfacing a non-serrated portion of the one or more walls312of the vessel304.

The user may transport the closed device300, such as via shipping, to a remote location such as an outside lab for further processing and/or analysis. The device300may be shipped in a container with or without insulation. For example, the container can be an envelope, packaging, and/or a box. The device300may withstand routine forces received in shipping environments.

In some instances, in the open position (as inFIG.3A) the reagent chamber326may be fully pre-loaded with the reagent360to fill the reagent chamber326. Alternatively, the reagent chamber326may be partially pre-loaded with the reagent360.

In some instances, the one or more walls312of the vessel304or other components of the vessel304and/or the implement306may comprise one or more markings corresponding to fluid volume for reference to users (e.g., sample origin, lab technician, etc.) of the device300. For example, one or more markings may correspond to a volume of the reagent360in the reagent compartment326. One or more markings may correspond to a volume of the biological sample in the reservoir322. One or more marking may correspond to a volume of the mixture370in the reservoir322and/or the cavity314. In some instances, at least a part of the one or more walls312of the vessel may be at least partially transparent and/or translucent, or clear, to permit visual recognition of the one or more markings. In some instances, at least a part of the other components of the vessel304and/or the implement306can be at least partially transparent and/or translucent, or clear, to permit visual recognition of the one or more markings.

WhileFIGS.3A and3Billustrate a device with the reservoir322and the reagent chamber326as generally vertically neighboring compartments, other configurations are available. For example, the reservoir322and the reagent chamber326can be horizontally neighboring compartments, diagonally neighboring compartments, or placed relative to the other in any other orientation relative to the cavity314.

In some instances, the user can deposit the biological sample into the reservoir322on 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 by absorbing. When the reagent360is directed to the reservoir322by actuation of the implement306, the absorbent member may absorb the reagent360, thereby contacting the biological sample therein with the reagent360to preserve and/or stabilize the biological sample. The carrier can be other materials or device capable of carrying the biological sample in a location that is in fluid communication with the reservoir322such as to allow the reagent360to contact the biological sample on the carrier.

In an example, the user uses the device300to collect the biological sample (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 from the subject. The biological sample is deposited into the reservoir322through the opening328. Next, the user closes the vessel304with the lid302, such as by engaging (e.g., threading) the lid302with the vessel304. Upon engagement, the lid302actuates the implement306, such as by pushing the implement306inwards the vessel304. Actuation of the implement306brings the reagent chamber326in fluid communication with the reservoir322. The reagent360is directed into the reservoir322and forms a mixture370with the biological sample. The closed device300is then transported (e.g., via mail), such as to a remote lab for further processing and/or analysis. The biological sample is preserved and/or stabilized during such transportation with aid of the reagent360.

Any description herein of a biological sample with reference to the device300can apply to a liquid sample. Any description herein of a reagent (e.g., reagent360) with reference to the device300can apply to a liquid solution. For example, the device300may be pre-loaded with a liquid solution and facilitate collection of a liquid sample.

FIG.4shows a cross-sectional view of another sample collection device400in an open position. The sample collection device400can comprise a lid402, a vessel404, and an implement406.

The lid402can comprise a first vessel engagement unit408and a second vessel engagement unit410. The first vessel engagement unit408, for example, can be threads. The second vessel engagement unit410, for example, can be a protrusion configured to contact one or more components of the vessel404and/or the implement406.

The vessel404can comprise one or more walls412that define a cavity414with an open end and a closed end. The one or more walls412can comprise a first lid engagement unit415. The first lid engagement unit415, for example, can be threads complementary to the first vessel engagement unit410. The one or more walls412can comprise one or more protrusions413facing the inside of the cavity414located in proximity to the closed end. For example, the protrusions413can be located at most 10 centimeters (cm), 9 cm, 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3 cm, 2 cm, 1 cm, or less distance from the inner wall of the closed end. The protrusions413can be micro-protrusions. The protrusions413can be annular features. Alternatively or in addition, the protrusions413can extend with substantially even height around a cross-section perimeter (not necessarily circular or curved) of an inner surface of the vessel404. InFIG.4, two sets of annular protrusions are illustrated. In some instances, the protrusions413can be molded or otherwise integrated in the one or more walls412. Alternatively or in addition, the protrusions413can be separate structures fastened to be fixed to the one or more walls412.

The implement406can be displaceable, injectable, plungeable, retractable, dejectable, ascendible, descendible, and/or otherwise be movable or actuated relative to the vessel404. For example, the implement406can be a plunger. The implement406can be a second vessel, tube or vial. The implement406can be a rod, stage, plate, or other actuator. Any description herein of a plunger may apply to any other implement, such as a rod, stage, plate, or other actuator.

The implement406can be disposed in the cavity414. The implement406can be insertable in the cavity414towards the closed end. The implement406can comprise a protrusion416, one or more sidewalls418, and a second lid engagement unit420. The one or more sidewalls418can define a reservoir422therein for receiving a biological sample (not shown) from a user. The user may be a subject from whom the sample is collected. The one or more sidewalls418can comprise one or more openings424through which the reservoir422and the cavity414are in fluid communication. The second lid engagement unit420can engage with the second vessel engagement unit410of the lid402. In some instances, the second lid engagement unit420can be part of the one or more sidewalls418of the implement. During closing of the vessel404, the second vessel engagement unit410(e.g., protrusion) of the lid402can apply a force (e.g., via push, press) on the second lid engagement unit420(e.g., sidewall perimeter) to actuate the implement406and inject the implement406towards the closed end of the cavity414.

The one or more sidewalls418of the implement406can comprise a protrusion416towards the end of the implement406that is closer to the closed end of the cavity414. The protrusion416can be an annular feature. Alternatively or in addition, the protrusion416can extend with substantially even height around a cross-section perimeter (not necessarily circular or curved) of an outer surface of the implement406. InFIG.4, an annular protrusion is illustrated. In some instances, the protrusion416can be molded into or otherwise integrated as part of the one or more sidewalls418. In some instances, the protrusion416can be separate structures fastened and fixed on the one or more sidewalls418.

In an open position (as inFIG.4) the protrusion416on the one or more sidewalls418of the implement406can engage with the one or more protrusions413on the one or more walls412of the vessel404to provide a seal425between the respective walls of the implement406and the vessel404. The seal425can be a fluid-tight seal. The seal425can be a hermetic seal. The seal425can be an interference seal. For example, the cross-section dimension (e.g., outer diameter) of the implement406with the protrusion416can be greater than the cross-section dimension (e.g., inner diameter) of the cavity414with the one or more protrusions413. The cross-section dimension (e.g., outer diameter) of the implement406with the protrusion416can be less than the cross-section dimension (e.g., inner diameter) of the cavity414without the one or more protrusions413such as to allow for fluid movement between the two cross-sections when the respective protrusions are unengaged. In some instances, the one or more walls412of the vessel may comprise at least two protrusions spaced accordingly to sandwich the protrusion416, such that the implement406is fixed in place prior to application of force while providing the seal425.

A reagent chamber426can be defined between the closed end of the cavity414and the seal425. The reagent chamber426can comprise a preservation and/or stabilization reagent460for preserving and/or stabilizing the biological sample. The reagent chamber426can be fluidically isolated from the remainder of the cavity414. The reagent chamber426can be fluidically isolated from the reservoir422which is in fluid communication with the rest of the cavity414.

When the device400is in an open position (as inFIG.4), the protrusion416can be engaged with the one or more protrusions413such that the seal425is intact and the reagent chamber426is fluidically isolated from the reservoir422.

To alternate the device400to the closed position (not shown), the lid402can be brought in proximity to the vessel404. The first vessel engagement unit408(e.g., threads) in the lid402can engage with the first lid engagement unit415(e.g., complementary threads) in the vessel404to couple the lid402and the vessel404. For example, the lid402can descend onto the vessel404in a threading motion. As the lid402descends, the second vessel engagement unit410(e.g., protrusion) in the lid402can engage the second lid engagement unit420(e.g., sidewall perimeter) of the implement406, and translate the descending motion to actuate the implement406and inject the implement406towards the closed end of the cavity414of the vessel402.

As the implement406is injected, the protrusion416can move past the interference of the one or more protrusions413, thereby disrupting the seal425. This can bring the reagent chamber426in fluid communication with the remainder of the cavity414and, by extension, to the reservoir422via the one or more openings424. As the implement406is injected, and the reagent chamber426decreases in volume, the reagent460may flow around the one or more sidewalls418of the implement406into the cavity414and into the reservoir422via the one or more openings424to form a mixture of the biological sample (not shown) and the reagent460. The reagent460may preserve and/or stabilize the biological sample in the mixture.

In application, the device400is provided to the user in an open position (as inFIG.4). The reagent460is pre-loaded in the reagent chamber426and the implement406is disposed in the vessel404such that the protrusion416is engaged with the one or more protrusions413and the seal425is intact. The implement406is insertable into the vessel404. The user spits or otherwise deposits the biological sample (not shown) into the reservoir422through an opening428of the reservoir422. In some instances, the opening428of the reservoir422can be the only opening to the vessel404. The biological sample and the reagent460are fluidically isolated.

The user can close the opening428of the reservoir422with the lid402, such as by engaging the first vessel engagement unit408of the lid402and the first lid engagement unit415of the vessel404. Upon descent of the lid402relative to the vessel404, the second vessel engagement unit410of the lid402can engage the second lid engagement unit420of the implement406, and the implement406can be injected towards the closed end of the cavity414. Once injected, the protrusion416moves past the one or more protrusions413thus becoming disengaged and the seal425is disrupted. The reagent chamber426and the remaining cavity414space are brought into fluid communication. As the implement406decreases the volume of the reagent chamber426, the reagent460escapes the reagent chamber426around the one or more sidewalls418of the implement406to enter the remaining cavity414space and thereafter enter the reservoir422through the one or more openings424on the one or more sidewalls418of the implement406. The biological sample and the reagent460form a mixture of the biological sample and the reagent460. The reagent460can preserve and/or stabilize the biological sample in the mixture. The mixture may be stored in the reservoir422and/or the cavity414.

The device400can be configured such that the implement406is fully injected when the lid402is securely fastened to the vessel404. When the implement406is fully injected, a tip of the implement406may contact the closed end of the cavity414such that there is substantially no volume in the reagent chamber426and as a result all of the reagent460comes in contact with the biological sample to form the mixture. In some instances, the tip of the implement406and the closed end of the cavity414can be complementary shapes or figures (e.g., conical pairs as shown inFIG.4). Alternatively, when the lid402is securely fastened to the vessel404, the implement406may be partially injected, and the tip of the implement406may not necessarily contact the closed end of the cavity414.

In some instances, once injected, the implement406can lock in the injected position such that it cannot be dejected and the mixture stays in the reservoir422and/or cavity414space above the protrusion416. In other instances, after injection, the implement406can be un-injected, such as when the lid402is removed and the mixture may travel between the reservoir422, cavity414, and/or the reagent chamber426. In some instances, the implement406may not be removed from the vessel404by the user. For example, a cross-section of a pre-inserted part of the implement406may be larger than a cross-section of the open end of the cavity414.

Alternatively or in addition, the implement406may be removable from the vessel, such as by a lay user or lab technician.

In some instances, the seal425may re-seal after disruption when the respective protrusions re-engage. Alternatively, the seal425may remain disrupted after the first disruption by the user. For example, the first disruption may or may not permanently damage (e.g., break off) the one or more protrusions313or the protrusion316.

The user may transport the closed device400, such as via shipping, to a remote location such as an outside lab for further processing and/or analysis. The device400may be shipped in a container with or without insulation. For example, the container can be an envelope, packaging, and/or a box. The device400may withstand routine forces received in shipping environments.

In some instances, in the open position (as inFIG.4) the reagent chamber426may be fully pre-loaded with the reagent460to fill the reagent chamber426. Alternatively, the reagent chamber426may be partially pre-loaded with the reagent460.

In some instances, the one or more walls412of the vessel404or other components of the vessel404and/or the implement406may comprise one or more markings corresponding to fluid volume for reference to users (e.g., sample origin, lab technician, etc.) of the device400. For example, one or more markings may correspond to a volume of the reagent460in the reagent compartment426. One or more markings may correspond to a volume of the biological sample in the reservoir422. One or more marking may correspond to a volume of the mixture in the reservoir422and/or the cavity414. In some instances, at least a part of the one or more walls412of the vessel may be at least partially transparent and/or translucent, or clear, to permit visual recognition of the one or more markings. In some instances, at least a part of the other components of the vessel404and/or the implement406can be at least partially transparent and/or translucent, or clear, to permit visual recognition of the one or more markings.

WhileFIG.4illustrates a device with the reservoir422and the reagent chamber426as generally vertically neighboring compartments, other configurations are available. For example, the reservoir422and the reagent chamber426can be horizontally neighboring compartments, diagonally neighboring compartments, or placed relative to the other in any other orientation relative to the cavity414.

In some instances, the user can deposit the biological sample into the reservoir422on 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 by absorbing. When the reagent460is directed to the reservoir422by actuation of the implement306, the absorbent member may absorb the reagent460, thereby contacting the biological sample therein with the reagent460to preserve and/or stabilize the biological sample. The carrier can be other materials or device capable of carrying the biological sample in a location that is in fluid communication with the reservoir422such as to allow the reagent460to contact the biological sample on the carrier.

In an example, the user uses the device400to collect the biological sample (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 from the subject. The biological sample is deposited into the reservoir422through the opening428. Next, the user closes the vessel404with the lid402, such as by engaging (e.g., threading) the lid402with the vessel404. Upon engagement, the lid402actuates the implement406, such as by pushing the implement406inwards the vessel404. Actuation of the implement406brings the reagent chamber426in fluid communication with the reservoir422. The reagent460is directed into the reservoir322and forms a mixture with the biological sample. The closed device400is then transported (e.g., via mail), such as to a remote lab for further processing and/or analysis. The biological sample is preserved and/or stabilized during such transportation with aid of the reagent460.

Any description herein of a biological sample with reference to the device400can apply to a liquid sample. Any description herein of a reagent (e.g., reagent460) with reference to the device400can apply to a liquid solution. For example, the device400may be pre-loaded with a liquid solution and facilitate collection of a liquid sample.

FIGS.5A-5Dshow another sample collection device500. The sample collection device500can comprise a lid502, a funnel503, a vessel504, and an implement506.FIG.5Ashows a cross-sectional view of the sample collection device500with the funnel503.FIG.5Bshows a perspective view of the funnel503.FIG.5Cshows a cross-sectional view of the sample collection device500without the funnel503.FIG.5Dshows a perspective view the vessel504. The device500may comprise a funneled position (as inFIG.5A), an open position (as inFIG.5C), and a closed position (not shown).

The lid502can comprise a first vessel engagement unit508and a second vessel engagement unit510. The first vessel engagement unit508, for example, can comprise threads. The second vessel engagement unit510, for example, can be a protrusion configured to contact one or more components of the vessel504and/or the implement506.

The funnel503can comprise a first opening512and a second opening514, and a fluid flow path therethrough. The funnel503may receive a biological sample550through the first opening512and direct the biological sample550to exit the funnel503through the second opening514. In some instances, the first opening512may have a larger cross-section area than a cross-section area of the second opening514.

The funnel503can comprise a third vessel engagement unit516at or near the second opening514. The third vessel engagement unit516, for example, can be a pinching structure configured to pinch a wall of the vessel504and/or a wall of the implement506. The pinching structure may be configured to pinch together a wall of the vessel504and the wall of the implement506, for example by applying a force on an inner wall of the implement506outwards towards an inner wall of the vessel504and/or by applying a force on an outer wall of the vessel504inwards towards an outer wall of the implement506. The pinching structure can be a clip-like structure with two structures biased to pinch. In some instances, the pinching structure can comprise an outer wall518and an inner wall520defining a cavity therebetween. The outer wall518and the inner wall520can be configured to pinch one or more objects (e.g., wall of the vessel504, wall of the implement506, etc.) disposed in the cavity. In some instances, the pinching structure may comprise threads on the outer wall518and/or the inner wall520to further engage with the vessel504.

The vessel504can comprise one or more walls522that define a cavity524with an open end and a closed end. The one or more walls522can comprise a first lid engagement unit526at or near the open end. The first lid engagement unit526, for example, can be threads complementary to the first vessel engagement unit508. The first lid engagement unit526, for example, can be threads complementary to threads on the third vessel engagement unit516. The first lid engagement unit526may be configured to engage with both the first vessel engagement unit508on the lid502and the third vessel engagement unit516on the funnel503.

The one or more walls522of the vessel504can comprise one or more depressions528or dents facing the inside of the cavity524. The depressions528or dents can be micro-depressions or micro-dents. The depressions528can be annular features. Alternatively or in addition, the depressions528can extend with substantially even depth around a cross-section perimeter (not necessarily circular or curved) of an inner surface of the vessel504. In some instances, the depressions528can be molded (or carved out) or otherwise integrated in the one or more walls522.

The one or more walls522of the vessel504can comprise one or more vents542facing the inside of the cavity524. The vents542may be a depression or dent defining a substantially vertical path from near the closed end of the cavity524to near the open end of the cavity524.

The implement506can be displaceable, injectable, plungeable, retractable, dejectable, ascendible, descendible, and/or otherwise be movable or actuated relative to the vessel504. For example, the implement506can be a plunger. The implement506can be a second vessel, tube or vial. The implement506can be a rod, stage, plate, or other actuator. Any description herein of a plunger may apply to any other implement, such as a rod, stage, plate, or other actuator.

The implement506can be disposed in the cavity524. The implement506can be insertable in the cavity524towards the closed end. The implement506can comprise one or more sidewalls532and a second lid engagement unit534. The one or more sidewalls532can define a reservoir536therein for receiving the biological sample550from a user. The user may be a subject from whom the sample is collected. The one or more sidewalls532can comprise one or more openings538through which the reservoir536and the cavity524are in fluid communication. The second lid engagement unit534can engage with the second vessel engagement unit510of the lid502. In some instances, the second lid engagement unit534can be part of the one or more sidewalls532of the implement. During closing of the vessel504, the second vessel engagement unit510(e.g., protrusion) of the lid502can apply a force (e.g., via push, press) on the second lid engagement unit534(e.g., sidewall perimeter) to actuate the implement506and inject the implement506towards the closed end of the cavity524.

The one or more sidewalls532of the implement506can comprise a protrusion530facing the one or more walls522of the vessel504. The protrusion530can be an annular feature. Alternatively or in addition, the protrusion530can extend with substantially even height around a cross-section perimeter (not necessarily circular or curved) of an outer surface of the implement506. In some instances, the protrusion530can be molded into or otherwise integrated as part of the one or more sidewalls532. In some instances, the protrusion530can be a separate structure fastened and fixed on the one or more sidewalls532.

In the open position (as inFIG.5C) or the funneled position (as inFIG.5A), the protrusion530on the one or more sidewalls532of the implement506can engage with the one or more depressions528on the one or more walls522of the vessel504to retain a position of the implement506relative to the vessel504. In some instances, the engagement of the protrusion530and the one or more depressions528may provide a seal between the respective walls of the implement506and the vessel504. The seal can be a fluid-tight seal. The seal can be a hermetic seal. The seal can be an interference seal. Alternatively, the engagement of the protrusion530and the one or more depressions528may not provide a seal.

In the funneled position (as inFIG.5A), the funnel503can be fastened to the vessel504upon engagement of the third vessel engagement unit516with the vessel504and/or the implement506. When engaged, at least a part of the outer wall518of the funnel503may encompass at least a portion of the outer wall of the vessel504and at least a part of the inner wall520of the funnel503may be disposed within the reservoir536such that the inner wall520blocks (or covers) the one or more openings538in the one or more sidewalls532of the implement506. When engaged, the outer wall518and the inner wall520of the funnel503can pinch the wall of the vessel504and the wall of the implement506together to provide a seal between the funnel503and the implement506and between the funnel503and the vessel504. The seal can be a fluid-tight seal. The seal can be a hermetic seal. The seal can be an interference seal. In the funneled position, the reservoir536can be fluidically isolated from the cavity524via the seal provided by the funnel503.

A reagent chamber540can be defined between the closed end of the cavity524and the one or more sidewalls of the implement506. The reagent chamber540can comprise a preservation and/or stabilization reagent560for preserving and/or stabilizing the biological sample550. In the funneled position, the reagent chamber540can be fluidically isolated from the reservoir536via the inner wall520of the funnel503blocking the one or more openings538in the one or more sidewalls532of the implement506. The reagent chamber540can be brought into fluid communication with the reservoir536when the device500is in the open position (as inFIG.5C) and/or the closed position (not shown) upon removal of the funnel503.

When the device500is in an open position (as inFIG.5C), the funnel503can be removed from the vessel504such as to unblock the one or more openings538in the implement506. The reagent chamber540can be in fluid communication with the reservoir536. In the open position, the implement506may float, or at least partially float, on the reagent560. The reagent560and the biological sample550may remain isolated, for example, due to the reagent560being unable to overcome gravitational forces to climb the one or more sidewalls522of the implement506and enter the reservoir536through the one or more openings538and/or, similarly, the biological sample550being unable to overcome gravitational forces to climb the one or more sidewalls522of the implement506and exit the reservoir536through the one or more openings538.

To alternate the device500to the closed position (not shown) from the open position, the lid502can be brought in proximity to the vessel504. The first vessel engagement unit508(e.g., threads) in the lid502can engage with the first lid engagement unit526(e.g., complementary threads) in the vessel504to couple the lid502and the vessel504. For example, the lid502can descend onto the vessel504in a threading motion. As the lid502descends, the second vessel engagement unit510(e.g., protrusion) in the lid502can engage the second lid engagement unit534(e.g., sidewall perimeter) of the implement506, and translate the descending motion to actuate the implement506and inject the implement506towards the closed end of the cavity524of the vessel502.

As the implement506is injected, the protrusion530can move past the one or more depressions528. The implement506may intrude the volume of the reagent chamber540and displace the reagent560. The reagent560may flow around the one or more sidewalls418of the implement406, such as by travelling through the one or more vents542in the one or more walls522of the vessel504, and enter the reservoir536via the one or more openings538. The reagent560and the biological sample550can form a mixture (not shown). The reagent560may preserve and/or stabilize the biological sample550in the mixture.

In application, the device500is provided to the user in the funneled position (as inFIG.5A). The reagent560is pre-loaded in the reagent chamber540and the implement506is disposed in the vessel504such that the protrusion530is engaged with the one or more depressions528. The funnel503is engaged to the vessel504and the implement506such that the walls of the vessel504and the implement506are pinched together, and the one or more openings538are blocked and sealed by the funnel503. The implement506is insertable into the vessel504. The user spits or otherwise deposits the biological sample550into the reservoir536through the first opening512of the funnel503. The funnel503directs the biological sample550out of the funnel503through the second opening514. The second opening514of the funnel is in fluid communication with an opening of the reservoir536. In some instances, the opening of the reservoir536can be the only opening to the vessel504. The biological sample550and the reagent560are fluidically isolated via the funnel503.

The user can remove the funnel503, thereby unpinching the vessel504and the implement506, and unsealing the one or more openings538. The reagent chamber540and the reservoir550are in fluid communication, but the reagent560and the biological sample550remain isolated. The implement506can at least partially float in the cavity524on the reagent560.

The user can close the opening of the reservoir536with the lid502, such as by engaging the first vessel engagement unit508of the lid502and the first lid engagement unit526of the vessel504. Upon descent of the lid502relative to the vessel504, the second vessel engagement unit510of the lid502can engage the second lid engagement unit534of the implement508, and the implement506can be injected towards the closed end of the cavity524. Once injected, the protrusion530moves past the one or more depressions528and intrudes the volume of the reagent chamber540. The reagent560is displaced from the reagent chamber540by the implement506. The reagent560escapes the reagent chamber540around the one or more sidewalls532of the implement506, such as through the one or more vents542to enter the reservoir536through the one or more openings538on the one or more sidewalls532of the implement506. The biological sample550and the reagent560form a mixture of the biological sample550and the reagent560. The reagent560can preserve and/or stabilize the biological sample550in the mixture.

The device500can be configured such that the implement506is fully injected when the lid502is securely fastened to the vessel504. When the implement506is fully injected, a tip of the implement506may contact the closed end of the cavity524such that there is substantially no volume in the reagent chamber540and as a result all of the reagent560comes in contact with the biological sample550to form the mixture. In some instances, the tip of the implement506and the closed end of the cavity524can be complementary shapes or figures (e.g., conical pairs as shown inFIG.5C). Alternatively, when the lid502is securely fastened to the vessel504, the implement506may be partially injected, and the tip of the implement506may not necessarily contact the closed end of the cavity524.

In some instances, once injected, the implement506can lock in the injected position such that it cannot be dejected and the mixture stays in the reservoir536and/or cavity524space between the implement506and the vessel504. In other instances, after injection, the implement506can be un-injected, such as when the lid502is removed and the mixture may travel between the reservoir536, the cavity524, and/or the reagent chamber540. In some instances, the implement506may not be removed from the vessel504by the user. For example, a cross-section of a pre-inserted part of the implement506may be larger than a cross-section of the open end of the cavity524. Alternatively or in addition, the implement506may be removable from the vessel, such as by a lay user or lab technician.

The user may transport the closed device500, such as via shipping, to a remote location such as an outside lab for further processing and/or analysis. The device500may be shipped in a container with or without insulation. For example, the container can be an envelope, packaging, and/or a box. The device500may withstand routine forces received in shipping environments.

In some instances, in the funneled position the reagent chamber540may be fully pre-loaded with the reagent560to fill the reagent chamber540. Alternatively, the reagent chamber540may be partially pre-loaded with the reagent560.

In some instances, the one or more walls522of the vessel504or other components of the vessel504and/or the implement506may comprise one or more markings corresponding to fluid volume for reference to users (e.g., sample origin, lab technician, etc.) of the device500. For example, one or more markings may correspond to a volume of the reagent560in the reagent compartment540. One or more markings may correspond to a volume of the biological sample550in the reservoir536. One or more marking may correspond to a volume of the mixture in the reservoir536and/or the cavity524. In some instances, at least a part of the one or more walls522of the vessel504may be at least partially transparent and/or translucent, or clear, to permit visual recognition of the one or more markings. In some instances, at least a part of the other components of the vessel504and/or the implement506can be at least partially transparent and/or translucent, or clear, to permit visual recognition of the one or more markings.

WhileFIG.5illustrates a device with the reservoir536and the reagent chamber540as generally vertically neighboring compartments, other configurations are available. For example, the reservoir536and the reagent chamber540can be horizontally neighboring compartments, diagonally neighboring compartments, or placed relative to the other in any other orientation relative to the cavity524.

In some instances, the user can deposit the biological sample550into the reservoir536on 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 by absorbing. When the reagent560is directed to the reservoir536by actuation of the implement506, the absorbent member may absorb the reagent560, thereby contacting the biological sample550therein with the reagent560to preserve and/or stabilize the biological sample550. The carrier can be other materials or device capable of carrying the biological sample550in a location that is in fluid communication with the reservoir536such as to allow the reagent560to contact the biological sample550on the carrier.

In an example, the user uses the device500to collect the biological sample (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 from the subject. The user receives the device500in the funneled position. The biological sample is deposited into the reservoir536through the first opening512of the funnel503. Next, the user removes the funnel503. Next, the user closes the vessel504with the lid502, such as by engaging (e.g., threading) the lid502with the vessel504. Upon engagement, the lid502actuates the implement506, such as by pushing the implement506inwards the vessel504. Actuation of the implement506displaces the reagent560in the reagent chamber540. The reagent560is directed through the vents542and the one or more openings538into the reservoir536. The reagent560forms a mixture with the biological sample550. The closed device500is then transported (e.g., via mail), such as to a remote lab for further processing and/or analysis. The biological sample is preserved and/or stabilized during such transportation with aid of the reagent560.

Any description herein of a biological sample (e.g., biological sample550) with reference to the device500can apply to a liquid sample. Any description herein of a reagent (e.g., reagent560) with reference to the device500can apply to a liquid solution. For example, the device500may be pre-loaded with a liquid solution and facilitate collection of a liquid sample.

FIG.6Ashows a cross-sectional view of another sample collection device600in an open position.FIG.6Bshows a cross-sectional view of the sample collection device600in a closed position. The sample collection device600can comprise a vessel602and a lid604.

The vessel602can comprise one or more walls606that define a reservoir608for receiving a biological sample650from a user. The user may be a subject from whom the sample is collected. The one or more walls606can comprise a lid engagement unit610, such as threads, to couple with the lid604. The vessel602can comprise rim612, such as to act as a stopping guide for the lid604.

The lid604can comprise an outer shell614and an inner wall616. The outer shell614can comprise a vessel engagement unit618, such as complementary threads to the lid engagement unit610.

The inner wall616can be mechanically assembled to the outer shell614. The inner wall616and the outer shell614can define a reagent chamber620. The reagent chamber620can comprise an absorbent member622(A, B). The absorbent member622can have absorbed therein a preservation and/or stabilization reagent660for preserving and/or stabilizing the biological sample650. The absorbent member622can be compressible (e.g., deformable). For example, the absorbent member622can have at least an uncompressed state622A and a compressed state622B. The absorbent member622can be an absorbent matrix, such as an air matrix or a fiber matrix. The absorbent matrix can be porous. The absorbent member can be formed of a polymeric material. For example, the absorbent member is formed of an absorbent matrix that includes a polymeric material (e.g., poly(vinyl formal) (PVF), polypropylene (PP), (PTFE), polyethylene terephthalate (PET) polyester, polyurethane, ethylene vinyl alcohol, polyvinyl alcohol, polycaprolactone, polylactic acid, starch, etc.). For example, the absorbent member622can be a foam or sponge. The absorbent member622can be open cell or closed cell foam. In some instances, in the uncompressed state622A, the absorbent member622may retain the reagent660absorbed therein without spillage or leakage, such as via capillary action and/or other adhesive/cohesive forces. In some instances, the quantity of reagent660loaded into the absorbent member622can be controlled for secure containment in the uncompressed state622A. At least some of the reagent660in the absorbent member622may exit (e.g., flow out of) the absorbent member622upon compression, such as in the compressed state622B.

When mechanically assembled, the inner wall616may move with some degree of freedom relative to the outer shell614. For example, the inner wall616may be capable of moving inwards into the reagent compartment620to compress the absorbent member622. The inner wall616can comprise an aperture624through which the reagent660may leave the reagent chamber620.

In an open position (as inFIG.6A), the inner wall616may be disposed relative to the outer shell614such the absorbent member622in the reagent chamber620is in an uncompressed state622A. The reagent chamber620can be in fluid communication with spaces external to the reagent chamber620via the aperture624in the inner wall616. The reagent620absorbed in the absorbent member622may remain contained in the absorbent member622in the reagent chamber620.

To alternate to the closed position (as inFIG.6B), the vessel602can be closed with the lid604by coupling the vessel engagement unit618with the first lid engagement unit610, such as via a threading motion. Alternatively, other coupling or fastening mechanisms described elsewhere herein may be applied, such as using form-fitting structures, snaps, latches, and/or other fasteners. As the lid604descends to cover the vessel602, the inner wall616can engage with the one or more walls612of the vessel, such as the top perimeter of the sidewalls. A continued descending motion can push the inner wall612into the reagent chamber620. The absorbent member622can compress, such as to compressed state622B, to accommodate the decreasing volume of the reagent chamber620. The reagent660contained therein the absorbent member622may flow out of the absorbent member622and into the reservoir608which is in fluid communication with the reagent chamber620via the aperture624. The reagent660can contact the biological sample650in the reservoir608to form a mixture670with the biological sample650. The biological sample650can thereby be preserved and/or stabilized in the mixture670.

In application, the user is provided the device600in an open position (as inFIG.6A). The reagent660is pre-loaded in the absorbent member622in the reagent chamber620in the lid604. The inner wall616and the outer shell614are mechanically assembled such that the inner wall614is not compressing the absorbent member622. The absorbent member622is in the uncompressed state622A, and the reagent660may be contained therein without leakage. The user spits or otherwise deposits the biological sample650into the reservoir608through an opening of the reservoir608in the vessel602.

The user can close the vessel602with the lid604. As the lid604is brought in proximity to the vessel602, the lid engagement unit610(e.g., threads) in the vessel602engages the vessel engagement unit618(e.g., complementary threads) in the lid604. The lid604descends relative to the vessel602until the inner wall616engages the top of the one or more walls505of the vessel602. As the lid604continues to descend relative to the vessel602, the inner wall616is pushed into the reagent chamber620to compress the absorbent member622. In the compressed state622B, the absorbent member622releases the reagent660absorbed therein. The reagent660flows into the reservoir608via the aperture624to form a mixture670of the reagent660and the biological sample650. The biological sample650can thereby be preserved and/or stabilized in the mixture670. In some instances, the reagent660may flow into the reservoir608via gravitational forces.

Thereafter, the lid604is fastened to the vessel602and the mixture670is confined in the reservoir608and optionally in the reagent compartment620which is in fluid communication with the reservoir608.

The user may transport the closed device600, such as via shipping, to a remote location such as an outside lab for further processing and/or analysis. The device600may be shipped in a container with or without insulation. For example, the container can be an envelope, packaging, and/or a box. The device600may withstand routine forces received in shipping environments.

In some instances, the user can deposit the biological sample650into the reservoir608on a carrier. For example, the carrier can be an absorbent device, such as a swab, cotton, pad, sponge, foam, or other material or device capable of carrying the biological sample650by absorbing. When the reagent660flows in the reservoir608, the absorbent device may absorb the reagent660, thereby contacting the biological sample650therein with the reagent660to preserve and/or stabilize the biological sample650. The carrier can be other materials or devices capable of carrying the biological sample650in a location that is in fluid communication with the reservoir608such as to allow the reagent660to contact the biological sample650on the carrier.

In some instances, the inner wall616and the outer shell614may be mechanically assembled such that the inner wall616may move relative to the outer shell614with a limited degree of freedom. For example, the inner wall616may move relative to the outer shell614by at most 10 centimeters (cm), 9 cm, 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3 cm, 2 cm, 1 cm, 0.5 cm, or less. Alternatively, the inner wall616may move relative to the outer shell614by more than 10 cm. In some instances, the inner wall616and the outer shell614may be mechanically assembled such that the inner wall616may move relative to the outer shell614in limited directions (e.g., 1 axis, 2 axes, 3 axes, etc.). Alternatively, the inner wall616and the sleeve614may be mechanically assembled such that the inner wall616may move relative to the outer shell614in any direction.

In some instances, the inner wall620can comprise a plurality of apertures, such as 2, 3, 4, 5, 6, 7, 8, 9, 20, or more apertures. In some instances, the inner wall620can comprise a mesh.

In some instances, in the open position (as inFIG.6A) the uncompressed absorbent member622A may be fully pre-loaded (e.g., saturated) with the reagent660. Alternatively, the uncompressed absorbent member622A may be partially pre-loaded with the reagent660. For example, the absorbent member622can be at least about 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99% saturated or higher. Alternatively or in addition, the absorbent member622can be at most about 99%, 98%, 97%, 96%, 95%, 94%, 93%, 92%, 91%, 90%, 80%, 70%, 60%, 50%, 45%, 40%, 35%, 30%, 25%, 20%, 15%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1% saturated or lower. Alternatively or in addition, the absorbent member622can be saturated by less than 1% or more than 99%.

In some instances, the one or more walls606of the vessel602may comprise one or more markings corresponding to fluid volume for reference to users (e.g., sample origin, lab technician, etc.) of the device600. For example, one or more markings may correspond to a volume of the biological sample650in the reservoir608. One or more marking may correspond to a volume of the mixture670in the reservoir608. In some instances, at least a part of the one or more walls606of the vessel602may be at least partially transparent and/or translucent, or clear, to permit visual recognition of the one or more markings. In some instances, the outer shell614of the lid604may comprise one or more markings corresponding to fluid volume for reference to users (e.g., sample origin, lab technician, etc.) of the device600. For example, one or more markings may correspond to a volume of the reagent660or a height of the absorbent member622in the reagent compartment210. In some instances, at least a part of the outer shell614of the lid604may be at least partially transparent and/or translucent, or clear, to permit visual recognition of the one or more markings.

In some instances, the inner wall616may comprise a flexible material. In some instances, the inner wall616may be a pierceable, puncturable, tearable, and/or otherwise breakable membrane or barrier that pierces, punctures, tears, and/or breaks when the inner wall616engages the side walls of the vessel602.

In an example, the user uses the device600to collect the biological sample650(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 sample650from the subject. The biological sample650is deposited into the reservoir608. Next, the user closes the vessel602with the lid604, such as by engaging (e.g., threading) the lid604with the vessel602. Upon engagement, the inner wall616is pushed inwards towards the reagent chamber620, compressing the absorbent member622. Upon compression, the reagent660that was absorbed in the absorbent member622is released from the absorbent member622and directed into the reservoir608through the aperture624, and forms a mixture670with the biological sample650. The closed device600is then transported (e.g., via mail), such as to a remote lab for further processing and/or analysis. The biological sample650is preserved and/or stabilized during such transportation with aid of the reagent660.

Any description herein of a biological sample (e.g., biological sample650) with reference to the device600can apply to a liquid sample. Any description herein of a reagent (e.g., reagent660) with reference to the device600can apply to a liquid solution. For example, the device600may be pre-loaded with a liquid solution and facilitate collection of a liquid sample.

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.

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.

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.

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 0.1 mL 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.

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.

While different embodiments have been shown and described separately, components of different embodiments may be used in various combinations. By way of example, the absorbent member622in the reagent chamber620inFIGS.5A and5Bmay also be located in the reagent chamber110inFIG.1A, the reagent chamber326inFIGS.3A and3B, and/or the reagent chamber426inFIG.4.

Kit

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.

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.

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

Another aspect provides methods for collecting a sample from a subject, receiving the sample and processing the sample. 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.

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.

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.

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).

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.

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.

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 contemplated that the invention shall also cover any such alternatives, modifications, variations or equivalents. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.