Sample collection device

Abstract

A device for collecting a sample from specimen material, particularly soft or semisolid materials such as stool, foods, soil, environmental, and / or industrial materials, and methods and kits for using the technology for collection of samples of material for analysis.

Description

[0001] PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 SAMPLE COLLECTION DEVICE

[0002] The present application claims priority to U.S. Provisional Application Serial No. 63 / 746816, filed January 17, 2025, U.S. Design Application Serial No. 29 / 986,494, filed January 17, 2025, and Industrial Design Application Serial No. WIPO165937 , filed July 17, 2025, now International Registration No. DM / 252545, each of which is incorporated herein by reference in its entirety.

[0003] FIELD OF THE INVENTION

[0004] Provided herein is technology relating to collecting and preparing samples. For example, the technology relates particularly, but not exclusively, to devices, systems, and kits that allow for the collection and preparation of a sample of soft matter compositions, e.g., fecal material, for analysis, and methods using the devices.

[0005] BACKGROUND OF THE INVENTION

[0006] Producing a defined volume or mass of a sample for subsequent testing is an important initial step in many settings, e.g., in the food industry, for environmental testing, in medicine, etc. For instance, in a medical setting, laboratory examination of soft matter compositions, e.g., stool samples, is an important component of some diagnoses. In the food testing settings, sampling soft matter compositions may comprise sampling prepared foods, e.g., canned entrees, spreadable or spoonable foods such as nut butters, cheeses, yogurts, pastes, etc., and in environmental testing settings, soft matter compositions to be sampled may comprise wet soils, clays, sludges, etc.

[0007] Diagnostic testing often requires isolating and assaying biomolecules from a specimen (tissue, body fluid, stool, e.g.) collected from a subject. Biomolecules for analysis include, e.g., nucleic acids, proteins, fats, or other molecules present in the specimen.

[0008] Stool samples for testing are preferably collected by a subject in the home, at the convenience of the subject. For reliability and compliance, devices used for sample collection at home by an untrained person (i.e., a person not trained in medical sample collection) are preferably easy to use correctly, and can be reliably sealed for shipping the sample to a medical facility. For samples that some subjects may find distasteful to handle, e.g., stoolPATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 samples, devices are preferably configured to minimize exposure of the subject to the sample material. Sample integrity and reproducibility of the sample size are also critically important for the subsequent processing and testing steps.

[0009] Available devices for at-home stool sample collection typically collect either large or very small samples. Large kits, typically configured to collect whole stools from a subject, e.g., for nucleic acid testing, are more costly to manufacture and to ship. Further, the collected samples and the devices used are all discarded after testing, and all must be handled and disposed of as hazardous waste. Thus, collection of larger samples produces a larger outflow of hazardous waste. Further, only a portion of a whole stool sample, e.g, typically about 10 to 15 grams, is required to produce sufficient quantities of analytes, e.g., human nucleic acids, proteins, or other analytes for analysis, while whole stool specimens collected using large containers may provide hundreds of grams of material.

[0010] Additionally, collection of whole stool samples creates a large variation in the ratio between the stool sample and the stabilizing buffers added at home by the subject prior to returning the collected sample. For example, whole stool specimens collected at home vary in mass from 1 to nearly 1000 grams. However, a fixed volume of stabilizing buffer is typically provided to subjects to stabilize the whole stool specimen after collection and during transport. If the specimen is small, the buffer volume may over-dilute the sample, resulting in low yields of nucleic acids or other analytes. If the specimen is large, the amount of stabilizing buffer may be inadequate to properly stabilize the nucleic acids or other analytes in the sample. Still further, processing of whole stool samples in large collection containers, e.g., homogenizing samples in the buffer prior to nucleic acid extraction, requires larger, specialized laboratory equipment.

[0011] Available smaller devices are typically configured to collect a few milligrams of stool, e.g., for immunoassay of blood proteins (fecal immunochemical test, or “FIT”), amounts that can be gathered from a whole stool with, e.g., a small spoon, paddle, brush, swab, or the like.PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 SUMMARY OF THE INVENTION

[0012] Provided herein are technologies for collecting samples of soft matter compositions wherein the samples have a defined size or are of a size within an acceptable size range for analysis of an analyte in the sample. In particular, the technology provides devices, kits and methods relating to collection of samples, such as metered samples, from soft matter compositions, e. ., stool specimens. Embodiments of the technology include but are not limited to:

[0013] 1. A device for collecting and containing a sample, the device comprising a sampler wand comprising a sampler head and a collection tube, wherein the sampler head comprises:

[0014] i) a sampler head side wall comprising a plurality of ports therethrough;

[0015] ii) a sampler head closed end; and

[0016] iii) a sampler head opening bounded by a distal edge; wherein the sampler head side wall, sampler head closed end and sampler head opening define and contain a sampler head interior void having an interior volume, wherein the collection tube comprises a bottom wall joined around a circumference to a tube wall, a top edge of the tube wall defining a tube opening, the collection tube comprising a tube interior void bounded by the tube wall, the tube opening, and the bottom wall,

[0017] wherein the collection tube comprises:

[0018] a) a displacing member projecting from the bottom wall into the tube interior void toward the tube opening,

[0019] b) an alignment element; and / or

[0020] c) a clocking element.

[0021] 2. The device of embodiment 1, wherein the displacing member is formed by an indent formed in the bottom wall of the collection tube and having an indent opening at an exterior surface of the bottom wall, the indent defining an indent void space bounded by the indent opening in the bottom wall.PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214

[0022] 3. The device of embodiment 2, wherein the collection tube has a central axis defined by center points of the collection tube opening, the displacing member and the indent opening.

[0023] 4. The device of embodiment 3, wherein the alignment element and / or the clocking element are within the indent and project into the indent void space.

[0024] 5. The device of embodiment 4, wherein the alignment element comprises antirotation elements, preferably a spike comprising anti-rotation elements.

[0025] 6. The device of embodiment 5, wherein the spike has a spike central axis that is collinear with the collection tube central axis.

[0026] 7. The device of any one of embodiments 4 to 6, wherein the indent comprises a side having a radial distance from the collection tube central axis, wherein the clocking element projects from the side of the indent into the indent void space, wherein the clocking element identifies a rotational position of the device with respect to the tube central axis.

[0027] 8. The device of any one of embodiments 1 to 7, wherein the displacing member is formed as an integral part of the collection tube.

[0028] 9. The device of any one of embodiments 1 to 8, wherein the alignment element is formed as an integral part of the collection tube.

[0029] 10. The device of any one of embodiments 1 to 9, wherein the clocking element is formed as an integral part of the collection tube.PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 11. The device of any one of embodiments 1 to 10, wherein the sampler head opening is on a plane defined by the distal edge.

[0030] 12. The device of any one of embodiments 1 to 11, wherein the sampler head has a sampler head central axis, wherein the sampler head opening has a center point on the sampler head central axis.

[0031] 13. The device of any one of embodiments 1 to 12, wherein the sampler wand comprises a cap.

[0032] 14. The device of embodiment 13, wherein the cap is attached to the sampler head, preferably to the sampler head closed end, by a stem.

[0033] 15. The device of embodiment 13 or embodiment 14, wherein the cap has a center point on a cap central axis, and wherein the sampler wand has a wand central axis defined by the center point of the cap and the center point of the sampler head opening.

[0034] 16. The device of any one of embodiments 1 to 15, wherein the distal edge of the sampler head comprises one or more teeth.

[0035] 17. The device of any one of embodiments 1 to 16, wherein the sampler head interior void is sized to contain from about 0.1 grams to about 50 grams of sample material, preferably stool sample material.

[0036] 18. The device of embodiment 17, wherein the sampler head interior void is sized to contain about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 grams, including any intermediate fractions thereof, of sample material, preferably stool sample material.PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 19. The device of embodiment 18, wherein the sampler head interior void is sized to contain about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 grams, including any intermediate fractions thereof, of sample material, preferably stool sample material.

[0037] 20. The device of any one of embodiments 13 to 19, wherein the cap comprises a cap engagement portion and the collection tube comprises a mated engagement portion.

[0038] 21. The device of embodiment 20, wherein the cap engagement portion comprises cap threads and wherein the mated engagement portion comprises tube threads.

[0039] 22. The device of embodiment 20 or embodiment 21, wherein when the cap engagement portion and the mated engagement portion are engaged, the sampler wand and the collection tube form a sealed device.

[0040] 23. The device of embodiment 22, wherein the cap comprises a cap click feature and / or the collection tube comprises a tube click feature, wherein, when the cap engagement portion and the mated engagement portion are engaged, the cap click feature and / or the collection tube click feature produce a tactile or audible click that indicate when the sample wand and the collection tube have formed a sealed device.

[0041] 24. The device of embodiment 23, wherein the cap click feature interacts with the collection tube click feature to produce the tactile or audible click.

[0042] 25. The device of embodiment 22, wherein the cap comprises a cap alignment marking and the collection tube comprises a tube alignment marking, wherein, when the cap engagement portion and the mated engagement portion are engaged, positions of the cap alignment marking and the tube alignment marking indicate when the sample wand and the collection tube have formed a sealed device.PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 26. The device of any one of embodiments Ito 25, wherein the collection tube has an interior void bounded by the tube wall, the bottom wall, and a plane defined by the top edge, the tube interior void having an interior void maximum volume of at least 5 mL, preferably between about 5 mL and 250 mL, including any intermediate number of mL or fractions thereof, preferably between about 10 mL and 100 mL, including 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, and 99.999 mL, including any intermediate fractions thereof.

[0043] 27. The device of any one of embodiments 1 to 26, wherein, when the sampler wand and the collection tube form a sealed device, the displacing member of the collection tube is positioned within the sampler head and fills at least a portion of the sampler head interior void.

[0044] 28. The device of embodiment 27, wherein, when the sampler wand and the collection tube form a sealed device, the displacing member of the collection tube fills at least 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90% 95%, 96%, 97%, 98%, 99% of the interior volume of the sampler head interior void.

[0045] 29. The device of embodiment 28, wherein the displacing member of the collection tube fills substantially all of the sampler head interior void.

[0046] 30. The device of any one of embodiments 26 to 29, wherein the device has a primary remaining volume of the interior void of the collection tube that equals the interior void maximum volume less the interior void volume displaced by a sampler head and sampler stem.PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 31. The device of embodiment 30, wherein a ratio (v:v) of the interior void of the sampler head to the primary remaining volume of the interior void of the collection tube is at least about 1:2, preferably between about 1:2 and 1:300, preferably between about 1:2 and 1:100, preferably between about 1:2 and 1:75, 1:50, 1:40, 1:30, 1:20, 1:10, or 1:5.

[0047] 32. The device of any one of embodiments 1 to 31, wherein the device further comprises a volume of solution contained in the collection tube.

[0048] 33. The device of embodiment 32, wherein a ratio (v:v) of the volume of the interior void of the sampler head to the volume of solution in the collection tube is at least about 1:2, preferably between 1:2 and 1:300 , preferably between 1:2 and 1:100, preferably between 1:2 and 1:75, 1:50, 1:40, 1:30, 1:20, 1:10, or 1:5.

[0049] 34. The device of embodiment 32 or embodiment 33, wherein the solution comprises one or more reagents selected from the group consisting of:

[0050] i) a buffer;

[0051] ii) a salt;

[0052] iii) a preservative;

[0053] iv) a detergent;

[0054] v) a sugar or polysaccharide;

[0055] vi) a protoporphyrin;

[0056] vii) a polyvalent cation;

[0057] viii) an osmolyte;

[0058] ix) a horse radish peroxidase (HRP) stabilization component; x) a surfactant;

[0059] xi) a nuclease inhibitor;

[0060] xii) a protease inhibitor;

[0061] xiii) a chelator;

[0062] xiv) a chaotropic salt;

[0063] xv) a protein;PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 xvi) a nucleic acid;

[0064] xvii) an inhibitor binding agent; and

[0065] xviii) silica particles.

[0066] 35. The device of any one of embodiments 1 to 31, wherein the device further comprises at least one dried agent contained in the collection tube.

[0067] 36. The device of embodiment 35, wherein the at least one dried agent comprises one or more reagents selected from the group consisting of:

[0068] i) a buffer;

[0069] ii) a salt;

[0070] iii) a preservative;

[0071] iv) a detergent;

[0072] v) a sugar or polysaccharide;

[0073] vi) a protoporphyrin;

[0074] vii) a polyvalent cation;

[0075] viii) an osmolyte;

[0076] ix) a horse radish peroxidase (HRP) stabilization component; x) a surfactant;

[0077] xi) a nuclease inhibitor;

[0078] xii) a protease inhibitor;

[0079] xiii) a chelator;

[0080] xiv) a chaotropic salt;

[0081] xv) a protein;

[0082] xvi) a nucleic acid;

[0083] xvii) an inhibitor binding agent;

[0084] xviii) a desiccant; and

[0085] xvix) silica particles.PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 37. The device of any one of embodiments 30 to 36, wherein the device has a secondary remaining volume of the interior void of the collection tube that equals the interior void maximum volume less the volume displaced by a sampler head and sampler stem, less the volume of the sampler head interior void.

[0086] 38. The device of embodiment 37, wherein a ratio (v:v) of the interior void of the sampler head to the secondary remaining volume of the interior void of the collection tube is at least about 1:2, preferably between about 1:2 and 1:300, preferably between about 1:2 and 1:100, preferably between about 1:2 and 1:75, 1:50, 1:40, 1:30, 1:20, 1:10, or 1:5.

[0087] 39. A composition comprising the device of any one of embodiments 1 to 38, wherein the device comprises a stool sample.

[0088] 40. The composition of embodiment 39, wherein the stool sample is from a human subject.

[0089] 41. A method of collecting a sample of material, comprising:

[0090] a) providing a device according to any one of embodiments 1 to 40; b) collecting an amount of the material within the interior void of the sampler head; and

[0091] c) inserting the sampler wand into the collection tube and forming a sealed device.

[0092] 42. The method of embodiment 41, wherein in the sealed device, the displacing member of the collection tube is positioned within the sampler head, whereby at least a portion of the amount of material collected in the sampler head interior void is expelled from the sampler head interior void through a port in the sampler head and into the collection tube.

[0093] 43. The method of embodiment 41, wherein the amount of material contained in the sampler head interior void is a metered sample of the material.PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214

[0094] 44. The method of embodiment 41, wherein the amount of material expelled from the sampler head interior void is a metered sample of the material.

[0095] 45. The method of any one of embodiments 41 to 44, wherein, when the sampler wand and the collection tube form a sealed device, the displacing member of the collection tube fdls at least 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90% 95%, 96%, 97%, 98%, 99% of the interior volume of the sampler head interior void.

[0096] 46. The method of embodiment 45, wherein the displacing member of the collection tube fills substantially all of the sampler head interior void.

[0097] 47. The method of any one of embodiments 41 to 46, wherein the device comprises a collection tube having an interior void bounded by the tube wall, the bottom wall, and a plane defined by the top edge, the tube interior void having a maximum volume of at least 5 mL, preferably between about 5 mL and 250 mL, including any intermediate number of mL or fractions thereof, preferably between about 10 mL and 100 mL, including 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, and 99.999 mL, including any intermediate fractions thereof.

[0098] 48. The method of any one of embodiments 41 to 47, wherein the device further comprises a volume of solution contained in the collection tube.

[0099] 49. The method of embodiment 48, wherein a ratio of the volume of the collected sample to the volume of solution in the collection tube (v:v), or a ratio of a mass of collected sample to the volume of solution in the collection tube (w:v) is at least about 1:2, preferablyPATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 between 1:2 and 1:300 , preferably between 1:2 and 1:100, preferably between 1:2 and 1:75, 1:50, 1:40, 1:30, 1:20, 1:10, or 1:5.

[0100] 50. The method of embodiment 48 or embodiment 49, wherein the solution comprises one or more reagents selected from the group consisting of:

[0101] i) a buffer;

[0102] ii) a salt;

[0103] iii) a preservative;

[0104] iv) a detergent;

[0105] v) a sugar or polysaccharide;

[0106] vi) a protoporphyrin;

[0107] vii) a polyvalent cation;

[0108] viii) an osmolyte;

[0109] ix) a horse radish peroxidase (HRP) stabilization component; x) a surfactant;

[0110] xi) a nuclease inhibitor;

[0111] xii) a protease inhibitor;

[0112] xiii) a chelator;

[0113] xiv) a chaotropic salt;

[0114] xv) a protein;

[0115] xvi) a nucleic acid;

[0116] xvii) an inhibitor binding agent; and

[0117] xviii) silica particles.

[0118] 51. A kit for collecting a sample of material, comprising:

[0119] i) a device of any one of embodiments 1 to 40; and

[0120] ii) an agent selected from:

[0121] - a solution, and

[0122] a dried agent.PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 52. The kit of embodiment 51, wherein the device contains the agent.

[0123] 53. The kit of embodiment 52, wherein the agent comprises a solution.

[0124] 54. The kit of embodiment 52, wherein the agent comprises a dried agent.

[0125] 55. The kit of embodiment 51, wherein the device does not contain the agent.

[0126] 56. The kit of any one of embodiments 51 to 53, wherein the agent is a solution comprising one or more reagents from the group consisting of

[0127] i) a buffer;

[0128] ii) a salt;

[0129] iii) a preservative;

[0130] iv) a detergent;

[0131] v) a sugar or polysaccharide;

[0132] vi) a protoporphyrin;

[0133] vii) a polyvalent cation;

[0134] viii) an osmolyte;

[0135] ix) a horse radish peroxidase (HRP) stabilization component; x) a surfactant;

[0136] xi) a nuclease inhibitor;

[0137] xii) a protease inhibitor;

[0138] xiii) a chelator;

[0139] xiv) a chaotropic salt;

[0140] xv) a protein;

[0141] xvi) a nucleic acid;

[0142] xvii) an inhibitor binding agent; and

[0143] xviii) silica particles.PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 57. The kit of embodiment 54, wherein the agent is a dried agent comprising one or more reagents from the group consisting of:

[0144] i) a buffer;

[0145] ii) a salt;

[0146] iii) a preservative;

[0147] iv) a detergent;

[0148] v) a sugar or polysaccharide;

[0149] vi) a protoporphyrin;

[0150] vii) a polyvalent cation;

[0151] viii) an osmolyte;

[0152] ix) a horse radish peroxidase (HRP) stabilization component; x) a surfactant;

[0153] xi) a nuclease inhibitor;

[0154] xii) a protease inhibitor;

[0155] xiii) a chelator;

[0156] xiv) a chaotropic salt;

[0157] xv) a protein;

[0158] xvi) a nucleic acid;

[0159] xvii) an inhibitor binding agent;

[0160] xviii) a desiccant; and

[0161] xvix) silica particles.

[0162] 58. The kit of any one of embodiments 51 to 57, further comprising one or more of:

[0163] a) packaging for shipping, storage, or mailing the device;

[0164] b) printed instructions for collecting a sample using the device;

[0165] c) a catchment device or container for receiving a specimen deposited on or in the catchment device during defecation and holding the specimen during collection of a sample;PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 d) a holder for holding an unsealed device during collection of a sample from a specimen; and

[0166] e) a holder for securing a sealed device in a shipping container.

[0167] 59. A method of processing a stool sample, the method comprising,

[0168] a) obtaining a stool sample by the method of any one of embodiments 41 to 50; and

[0169] b) testing the stool sample for an amount and / or presence of one or more analytes, wherein the analytes comprise one or more of the following: i) a nucleic acid;

[0170] ii) a protein;

[0171] iii) a lipid ;

[0172] iv) a carbohydrate; and

[0173] v) a metabolite.

[0174] 60. The method of embodiment 59, wherein the nucleic acid comprises DNA and / or RNA.

[0175] DEFINITIONS

[0176] To facilitate an understanding of the present technology, a number of terms and phrases are defined below. Additional definitions are set forth throughout the detailed description.

[0177] As used herein, “a” or “an” or “the” can mean one or more than one. For example, “a” widget can mean one widget or a plurality of widgets.

[0178] As used herein, the term “metered” means having an expected quantity that is reproducible with an acceptable range of variation.

[0179] As used herein, the term “analyte” is to be construed broadly as any compound, molecule, element, ion, or other substance of interest to be detected, identified, or characterized. Non-limiting examples of analytes include biomolecules, e.g., nucleic acids, proteins, carbohydrates, lipids, metabolites, organic and inorganic compounds; eukaryoticPATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 cells, such as human cells or cell components (e.g., tumor-associated cells, tissue cells, blood cells, etc.), bacterial cells or cell components; fungal cells or cell components; including, for each of the aforementioned cells and cell types: whole cells, nucleic acids, organelles, membranes, proteins, small molecules, metabolites, and any molecule, substance, or material produced in or associated with a cell or cell component. In some embodiments, an analyte is a marker or a biomarker.

[0180] As used herein, the terms “biomarker” and “marker” are used interchangeably, and refer to a biological material (e.g., a nucleic acid, or a region of a nucleic acid, or a protein) that may be used to distinguish non-normal cells (e.g, cancer cells) from normal cells, e.g., based on presence, absence, or status (e.g., methylation state or mutation) of the marker substance. Examples of biological materials include, without limitation, nucleic acids, polypeptides, carbohydrates, fatty acids, cellular components (e.g., cell membranes and mitochondria), and whole cells. In some instances, markers are particular nucleic acid regions (e.g., genes, intragenic regions, specific loci, etcf Regions of nucleic acid or protein that are biomarkers may be referred to, e.g., as “marker genes,” “marker regions,” “marker sequences,” “marker loci,” etc.

[0181] As used herein, the terms “subject” and “patient” refer to an animal, preferably a human, from which a stool specimen is collected. In some instances, the subject is also a “user” (and thus the user is also the subject or patient). In some embodiments, the subject is both the person who deposits a stool specimen, e.g., onto surface or in a container, and the person that removes a portion of the deposited stool to make a stool sample. In some embodiments, the subject is the person who produces a stool by defecation, and a different person removes a portion of the deposited stool as a stool sample. The term “subject” includes animals, preferably mammals, including humans. In a preferred embodiment, the subject is a primate. In an even more preferred embodiment, the subject is a human.

[0182] As used herein, the transitional phrase “consisting essentially of’ as used in reference to compositions, steps, or other features is to be read as “consisting of’ the specified materials, steps, or features, plus only unavoidable additional elements that do not materiallyPATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 affect the basic and novel character! stic(s) of the materials, methods, steps, etc., e.g., unavoidable contaminants, unavoidable steps.

[0183] As used herein, the term “comprising” is used interchangeably with “including,” and “containing,” “having,” and “characterized by,” and is inclusive or open-ended and does not exclude additional, unrecited elements, features, or method steps. The term “comprising” means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.

[0184] The transitional phrase "consisting essentially of limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention.

[0185] The transitional phrase "consisting of excludes any element, step, or ingredient not specified in the claim.

[0186] As used herein, the term “stool sample” or “fecal sample” are used interchangeably and refer to a sample comprising fecal matter. A stool sample may comprise cells (e.g., colorectal cells, colonocytes, bacterial cells), exosomes, blood, stool (e.g., fecal matter), components thereof (e.g., components of cells; components of stool, such as stool proteins, stool nucleic acids, etc., - components of blood, such as blood proteins, blood nucleic acids, organic compounds, such as phenolic compounds, etc.). or a combination thereof. A stool sample may be a solid, semi-solid, or a liquid stool sample. A stool sample may additionally comprise urine.

[0187] As used herein, the terms “deposited stool” and “stool specimen” are used interchangeably and refer to stool material deposited by a user, e.g., a subject or patient, preferably on a surface or in a container, during defecation, including but not limited to the entirety of stool material produced by a subject during an act of defecation, or a portion of stool material remaining after removal of a portion or sample therefrom.

[0188] As used herein, the term “soft matter composition” is used without limitation to refer to any material or specimen of soft composition, that is preferably non-liquid, andPATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 encompasses, e.g., soft solids and semisolids, such as stool, pastes, gels, greases, butters, foams, sludges, clays, tissues, etc.

[0189] As used herein, the term “non-liquid” as used in reference to a consistency of a soft matter composition or material to be sampled, refers to a soft material that does not exhibit the characteristics of a liquid, e.g., the characteristic readiness to flow and conform its shape to the shape of a container, and lacking the ability to maintain a fixed shape in the absence of a container.

[0190] As used herein in reference to stool, the term “removed portion” refers to stool material removed from a deposited stool, e.g., by scraping, poking, coring, cutting, scooping, brushing, etc.

[0191] The term “stabilizing reagent” refers to a reagent suitable for stabilizing one or more components, preferably macromolecular components, e.g., protein, cells, nucleic acid, carbohydrate, blood components, and other components, of a stool sample. The term “stabilizing solution” and “stabilizing buffer” are used interchangeably herein in reference to a fluid matrix comprising the stabilizing reagent. A stabilizing reagent may be mixed with a suitable fluid to form the stabilizing solution, or a stabilizing solution may be provided for immediate use of the stabilizing solution without need for addition of a fluid. Stabilizing reagents include but are not limited to reagents selected to stabilize one or more of proteins (e.g., hemoglobin), nucleic acids e.g., DNA or RNA), cells (e.g., bacterial or eukaryotic cells), or any other molecules or material in a sample, e.g., a stool sample.

[0192] As used herein, the term “metered sample” refers to a sample having an expected quantity that is reproducible with an acceptable range of variation, e.g., within a range of variation that is acceptable for a purpose for which the metered sample is produced. For example, for a sampler head (8) configured to collect a target sample having size of about 0.1, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 or more grams of sample, including any intermediate fraction thereof, e.g., 0.1 grams, 0.01 grams, 0.001 grams or multiples thereof, acceptable variation may range from plus or minus (±) 0.01, 0.1, 0.2, 0.3., 0.4, 0.5, 0.6, 0.7, 0.8, 0.9. 1.0, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14,PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, or 100 percent, including any intermediate fraction thereof, of the target sample size.

[0193] As used herein, the term “integral” as used in describing a part or feature of a component refers to a feature or part that is formed from the same material, as part of the process of forming the component (e.g., by molding, carving, or machining). A feature formed as an integral part of a component is distinguished, for example, from a feature that is added to the component after it is formed, e.g., by use of a fastener or adhesive.

[0194] As used herein, the term “port” refers to an opening or hole through an element or feature of the device, preferably a hole through a sampler head side wall (10) whereby material (e.g., air, fluid, sample material) that is within sampler head (8) is exposed to an environment outside the sampler head (8), and whereby such material within sampler head (8) may pass between the sampler head interior void (9) to the environment outside the sampler head (8), and vice versa.

[0195] As used herein, the term “engagement feature” refers to a feature of a first element of the device (1) configured to interact with a feature of a second element of the device, e.g., to reversibly or irreversibly attach the first element to the second element. For example, in some embodiments, engagement features of a cap and a collection tube are configured to interact with each other to seal the device (1). In some embodiments, an engagement feature of a sampler head (8) is configured to interact with an engagement feature of a collection tube (3), e.g., on the bottom wall (20) and / or displacing member (21) of the collection tube (3), so that the sampler head (8) may be reversibly or irreversibly attached to the collection tube (3), e.g., upon sealing of the device. In some embodiments, one part, e.g., a cap (5) has an engagement feature and another part, e.g., a collection tube (3) has a mated engagement feature selected for effective engagement with the engagement feature of the cap. For example, in some embodiments, cap (5) and collection tube (3) have thread features, such that cap (5) is engaged with collection tube (3) by rotation, i.e., by “screwing” the cap onto the collection tube. Other engagement features include but are not limited to bayonet mount elements, snap closure parts, or parts forming a friction seal.PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 As used herein, a “sealed device” refers to a device (1) having a cap (5) and collection tube (3) in which engagement features on the cap and collection tube are engaged to an extent necessary that a sealing joint (27) prevents passage of fluid, e.g., from inside sealed device (1) to the outside of device (1).

[0196] As used herein, the term “substantially” as used in reference to a quality or quantity of a component or feature refers to a quality or quantity in which some degree of variation is permissible, wherein the variation does not materially affect the basic and novel characteristic(s) of the component or feature, or of the claimed embodiment.

[0197] As used herein, the term “kit” refers to any delivery system for delivering materials. In the context of the systems provided herein, a kit may allow for the storage, transport, delivery, or use of the systems disclosed herein, and / or for processing samples, e.g., stool samples, obtained with the systems provided herein or collected according to the methods provided herein e.g., sample collection devices, sample stabilizing reagents; sample processing reagents such as particles, buffers, denaturants, oligonucleotides, filters, assay reaction components, etc., in the appropriate containers), and / or supporting materials (e.g., sample processing or sample storage vessels, written instructions for performing a procedure, such as any of the methods provided herein, etc.), and / or materials for transporting the kit from one location to another. For example, in some embodiments kits include one or more enclosures (e.g., boxes) containing the components of the system, e.g., one or more sampling devices, reagents, a set of instructions, etc. As used herein, the term “fragmented kit” refers to a delivery system comprising two or more separate containers that each contains a subportion of the total kit components. The containers may be delivered to the intended recipient together or separately. For example, a first container may contain materials for sample collection and a buffer. For instance, a first container may contain materials for sample collection and a cell stabilization buffer. A second container may contain reagents for detection of the one or more biomarkers. For example, a second container may contain capture oligonucleotides and denaturant. The term “fragmented kit” is intended to encompass kits containing analyte specific reagents (ASR's) regulated under section 520(e) of the Federal Food, Drug, and Cosmetic Act, but are not limited thereto. Indeed, any delivery system comprising two or more separate containers that each contains a subportion of thePATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 total kit components are included in the term “fragmented kit.” For example, a fragmented kit may contain analyte-specific reagents, reagents for nucleic acid extraction, and / or nucleic acid modification reagents. Alternatively, a fragmented kit comprising analyte specific reagents may be used in conjunction with a commercially available kit for analyte extraction, e.g., of nucleic acid, protein, fat, carbohydrate, intact cells, etc. In such embodiments, the kit may comprise reagents for sample collection and a cell stabilization buffer, and may be used in conjunction with a suitable kit for analyte extraction to isolate the analyte from the sample prior to detecting one or more biomarkers, such as biomarkers described herein. In contrast, a “combined kit” refers to a delivery system containing all of the components for sample collection and processing, or sample collection, processing, and assaying, in a single container (e.g., in a single box housing each of the desired components). The term “kit” includes both fragmented and combined kits. In preferred embodiments, kits according to the technology are configured to be used, stored, and / or shipped (e.g., to a user or from a user to a medical facility) at ambient temperature, i.e., at the temperature of the environment around the kit (e.g., in a room, truck, aircraft hold, etc.), without use of means for temperature control (e.g., dry ice or wet ice, cooling packs, heating means, etc.). In other embodiments, kits according to the technology are used, stored, and / or shipped under controlled temperatures, e.g., with refrigeration.

[0198] The term “system” as used herein refers to a collection of articles for use for a particular purpose, e.g., a collection of devices, agents, reagents, and instruments for collecting a sample (e.g., in preparation for analyzing the sample), or for collecting, processing, and / or analyzing a sample for a particular purpose. In some embodiments, the articles of a system comprise instructions for use, as information supplied on, e.g., an article, on paper, on recordable media (e.g., DVD, flash drive, etc.). In some embodiments, instructions direct a user to an online location, e.g., a website for viewing, hearing, and / or downloading instructions. In some embodiments, instructions or other information are provided as an application (“app”) for a mobile device.

[0199] As used herein, the term “central axis,” as used in reference to a device or component of a device, refers to an axis about which the device has at least one element having rotational symmetry. For example, in device (1) depicted in Figs. 1 and 2, central axis (23) is indicated byPATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 a dashed line, and is defined by the line between the point at the center of the bottom of the collection tube (3) and the point at the center of the top of the cap (5), when the cap is engaged with the collection tube. In the depicted embodiment, when the device is not assembled, the central axis of sampler wand (2) is defined by the point at the center of the sampler head opening (14) and the center of the top of cap (5), while the central axis of the collection tube (3) is defined by the line between the point at the center of the tube opening (19) and the point at the center of the bottom wall (20) of collection tube (3) and / or a point at the center of the displacing member (21). In embodiments in which the collection tube comprises an alignment element (33), e.g., in an indent (26) in the bottom wall (20), the alignment element (33) may comprise a protrusion or spike that has a central axis collinear with the collection tube central axis (see, e.g., Figs. 15 and 18).

[0200] Embodiments may comprise an asymmetrical feature, e.g., a sampler wand stem (4) or sampler head (8) comprising one or more ridges, bumps, dimples, grooves or other protruding or indenting elements that differ from each other, e.g., in size, shape, and / or distribution such that they are not symmetrical. In such embodiments, a basic or underlying shape of a device component, e.g., a sampler wand stem (4) or sampler head (8) (or other component of a sampler wand or collection tube), may be considered separately from such features. For example, a basic conical or tubular shape of a stem (4) or a bell shape of a sampler head (8), such as those in the embodiments depicted in Figs. 1 and 7A, respectively, may define a central axis, even if such stems and / or sampler heads further comprise elements that are not symmetrical, e.g., with respect to the central axis.

[0201] As used herein in reference to the device (1) or a portion thereof, a “clocking element” refers to a feature, including but not limited to a detectable marking, ridge, groove, dot, etc., for determining a rotational position of the device, e.g., with respect to the central axis of the device, and / or for determining and / or setting an orientation of a component of the device (1), e.g., such as a label on a collection tube (3), e.g., to facilitate scanning.

[0202] As used herein, the term “alignment element” refers to a feature, including but not limited to a detectable marking, ridge, groove, dot, etc., for determining a position of a first component of the device (1), e.g., a sampler wand (2), with respect to a second component ofPATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 the device (1), e.g., a collection tube (3), e.g., as an aid in determining when the device (1) is sealed or not sealed.

[0203] As used herein, the term “anti -rotation element” refers to an element, including but not limited to a ridge, groove, bulge, button, indent, etc., that may be engaged, e.g., by a holder or a robotic device, that, when engaged, restricts or prevents rotation of device (1), e.g., around the device central axis (23) with respect to the holder, and / or restricts rotation of the sampler wand (2) with respect to the collection tube (3) around the device central axis (23).

[0204] As used herein, the term “click element” refers to a feature, e.g., of a collection tube (3) and / or of a sampler wand (2) that provides tactile and / or audible indicator, e.g., a click, signaling the position of the component having the click element. By way of example, in some embodiments, the collection tube (3) and / or the cap (5) of the sampling wand (2) comprise one or more click elements, e.g., one or more tube click elements (32) and / or one or more wand click elements (37) (see, e.g., Figs. 17A and 17B), that indicate when the device (1) is sealed or unsealed by rotation of the sampling wand (2) with respect to the collection tube (3). In preferred embodiments, click elements provide a tactile indication when alignment markings (33) on the sampler wand (2) and the collection tube (3) are brought into alignment, and / or when they are rotated out of alignment.

[0205] As used herein, the term “agent” refers to an element, e.g., a composition, component, material, etc., for example for use with, in, on, and / or within a device such as device (1) or a component thereof, to provide a property or effect, e.g., on the device or component thereof, and / or on a composition or sample contacted with the device.

[0206] As used herein, the term “reagent” refers to reactive or non-reactive ingredient or material, e.g., organic and inorganic chemicals, solvents, acids, bases, biological molecules, polymers, salts, ions, buffers, chemical elements, inert and reactive particles or beads, mixtures thereof, and products produced by interaction or reaction by or among reagents in a reagent mixture.PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 BRIEF DESCRIPTION OF THE DRAWINGS

[0207] Fig. l is a view of an embodiment of the device provided herein, showing a sampler wand (2) and a collection tube (3), with the sampler wand disengaged from the collection tube. The central axis (23) of the device is indicated by a dashed line. A displacing member (21) is shown in the bottom wall (20) of the collection tube (3), and comprises an alignment element (33).

[0208] Fig. 2 is a side view of an embodiment of the device provided herein, showing device (1) in a sealed state in which cap (5) of sampler wand (2) is secured to collection tube (3), and has raised features (16), e.g., for enhancing gripping, and an alignment marking (5b). The stem (4) and sampler head (8) are visible within collection tube (3). The central axis (23) of the device is indicated by a dashed line. The sampler head (8) of sampling wand (2) covers the displacing member (21) of the collection tube (3).

[0209] Fig. 3A and 3B show side views of a sampler wand (2) (Fig. 3A) and a collection tube (3) (Fig. 3B) of an embodiment of the device provided herein, with exemplary dimensions shown in inches.

[0210] Fig. 4A shows a side view and a sectional view of an embodiment of the device provided herein, in which cap (5) is engaged with collection tube (3) to provide a sealed device. The embodiment shown comprises a gasket (25) that provides a seal between cap (5) and the top edge (18) of the collection tube (3).

[0211] Fig. 4B shows an embodiment in which the cap (5) makes direct contact with the top edge (18) of the collection tube (3) forming a sealed joint (27) between the cap (5) and the collection tube (3) when the device is closed. In some embodiments, the cap (5) or the collection tube (3) comprises a raised groove at the sealed joint (27) to facilitate uniform contact between components. Uniform contact between the cap (5) and the top edge (18) of the collection tube (3) thus forms the sealed joint (27) between the cap (5) and the top edge (18) of the collection tube (3) without requiring a gasket. This gasket-less seal may prevent over-tightening of the cap (e.g., by the user).PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 Fig. 4C shows an exploded diagram of an embodiment of sampler wand (2), comprising a cover (6), grip ring (5a), stem (4) with attached sampler head (8), and gasket (25).

[0212] Fig. 5A shows a top view of an embodiment of the device (1).

[0213] Fig. 5B shows a side view of an embodiment of the device (1), showing exemplary dimensions (in inches).

[0214] Fig. 5C shows a bottom view of an embodiment of the device (1), showing indent (26) in bottom wall (20) of collection tube (3).

[0215] Fig. 5D shows a cross-sectional view of the device of Fig. 5 A at position A-A.

[0216] Fig. 5E shows a side view of an embodiment of the device (1), showing exemplary dimensions (in millimeters).

[0217] Figs. 6A-6C show examples of internal volumes of an embodiment of the device: A) the maximum volume of the interior void (22) of collection tube (3) when empty; B) the primary remaining volume of the interior void (22) of collection tube (3) upon displacement by the stem (4) with sampler head (8); C) the volume of interior void (9) of sampler head (8).

[0218] Fig. 7A shows embodiments of the device having different arrangements, patterns and distances of raised or indented features (16) (e.g., bumps, ridges, grooves, dimples, etc.) on the exteriors of exemplary caps. The top panel shows 4 sealed devices comprising sampler wands and collection tubes and the bottom panel shows 4 exemplary sampler wands alone. Different embodiments of caps and different embodiments of sampler heads are shown.

[0219] Fig. 7B illustrates different embodiments of stems (4) shown as dashed lines indicating exemplary silhouettes of 3-dimensional stems of different shapes and dimensions. Embodiments of the technology are not limited to any particular stem shape or size. Stems may be round in cross-section, or the cross-section may have a different shape, e.g., an oval or ellipse shape, a regular or irregular polygon (e.g., square, rectangle, triangle, hexagon, preferably a convex polygon), etc. Different parts of a single stem may have different cross-sectional shapes. Stems may comprise one or more ridges, bumps, dimples, grooves or otherPATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 protruding or indenting elements, and may comprise one or more holes or ports therethrough, as illustrated schematically by the two smaller ovals in embodiment VI in Fig. 7B.

[0220] Fig. 8A shows different embodiments of sampler heads.

[0221] Fig. 8B shows an embodiment of a sampler head (8) comprising breaks (12a) between teeth (13).

[0222] Fig. 9A and 9B (detail view of 9A) illustrate positioning of a sampling tip (e.g., of a pipetting device) with respect to the displacing member (21) in collection tube (3), e.g., such that the displacing member does not impede access by the sampling tip to the bottom of the collection tube.

[0223] Fig. 10 illustrates an embodiment of a sealed device in a vertical orientation (with the cap at the top) and containing different volumes of fluid (40, 45, or 50 mb). Arrows indicate the fluid level covering sampler head (8).

[0224] Fig. 11 illustrates an embodiment of a sealed device in a horizontal orientation and containing different volumes of fluid (40, 45, or 50 mL). Arrows indicate the fluid level partially or completely covering sampler head (8)

[0225] Fig. 12A shows a detail illustration of the joint between a flange portion (4a) of stem (4) (see Fig. 4C) of sampler wand (2) and the top edge (18) of collection tube (3), as sealed by gasket (25), when cap threads (7) are engaged with tube threads (24).

[0226] Fig. 12B shows a detail illustration of the sealed joint (27) between a flange portion (4a) of stem (4) (see Fig. 4C) of sampler wand (2) and the top edge (18) of collection tube (3), as sealed without a gasket.

[0227] Fig. 12C shows a detail sectional view illustration of a sealed joint (27) between a sealing lip (28) on cap (5) and a sealing surface (29) on an inner side wall (30) of collection tube (3), as sealed without a gasket. In some embodiments, sealing lip (28) is molded as an integral part of cap (5).

[0228] Fig. 13 shows several embodiments of device (1) having cap alignment markings (5b) and tube alignment markings (3a). The markings are not limited to any particular orientation being indicative of, e.g., a state of engagement of the cap (5) with the collection tube (3). InPATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 the embodiments shown, the markings (5b, 3a) are proximal to each other, and are either aligned center to center (e.g., with arrowheads aligned tip to tip), or with an arrowhead tip aligned with one edge of a rectangular alignment marking. Embodiments of the device may have one pair of alignment markings or several pairs of alignment markings, e.g., 2, 3, 4, etc., distributed around the cap (5) and / or collection tube (3).

[0229] Fig. 14 illustrates an embodiment of the device (1) in a sealed configuration, with sampler wand (2) engaged with collection tube (3), and in an open configuration, with sampler wand (2) separated from collection tube (3).

[0230] Fig. 15 shows a side view and a section view of an embodiment of the collection tube (3), showing indent (26) in bottom wall (20) and having an indent opening (35), and having an indent void space (36). Indent (26) includes an alignment element (33) extending into the indent void space (36).

[0231] Fig. 16 shows an embodiment of the collection tube (3) comprising tube click elements (32), with a detail view of a tube click element (32).

[0232] Fig. 17A shows a bottom view of an embodiment of the collection tube (3) comprising tube click elements (32), with a detail view of a tube click element (32). An alignment element (33) and a clocking element (34) are also shown.

[0233] Fig. 17B shows a bottom perspective view of an embodiment of the sampling wand (2) comprising wand click elements (37), with detail views of two wand click elements (37).

[0234] Fig. 17C shows a bottom perspective view of an embodiment of the device (1) showing wand click elements (37), with detail views of two wand click elements (37), a tube click element (32), and tube and wand alignment markings (3a, 5b).

[0235] Fig. 18 shows a bottom side perspective view and a bottom view of an embodiment of the collection tube (3) comprising an alignment element (33) and a clocking element (34) in the indent (26) in the bottom wall (20) of the collection tube (3).

[0236] Fig. 19 is a front view of an embodiment of the device.

[0237] Fig. 20 is a left side view of an embodiment of the device.PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 Fig, 21 is a back view of an embodiment of the device.

[0238] Fig. 22 is a right side view of an embodiment of the device.

[0239] Fig. 23 is a bottom side perspective view of an embodiment of the device.

[0240] Fig. 24 is a bottom perspective view of an embodiment of the device.

[0241] Fig. 25 is a bottom view of an embodiment of the device.

[0242] Fig. 26 is a top view of an embodiment of the device.

[0243] Fig. 27. is an exploded view of an embodiment of the device.

[0244] Fig. 28 is a front view of an embodiment of the collection tube.

[0245] Fig. 29 is a left side view of an embodiment of the collection tube.

[0246] Fig, 30 is a back view of an embodiment of the collection tube.

[0247] Fig. 31 is a right side view of an embodiment of the collection tube.

[0248] Fig. 32 is a top perspective view of an embodiment of the collection tube.

[0249] Fig. 33 is a bottom perspective view of an embodiment of the collection tube.

[0250] Fig. 34 is a bottom side perspective view of an embodiment of the collection tube. Fig. 35 is a bottom view of an embodiment of the collection tube.

[0251] Fig. 36 is a top view of an embodiment of the collection tube.

[0252] Fig. 37 is a front view of an embodiment of the sample wand.

[0253] Fig. 38 is a left side view of an embodiment of the sample wand.

[0254] Fig, 39 is a back view of an embodiment of the sample wand.

[0255] Fig. 40 is a right side view of an embodiment of the sample wand.

[0256] Fig. 41 is a top perspective view of an embodiment of the sample wand.

[0257] Fig. 42 is a bottom perspective view of an embodiment of the sample wand.

[0258] Fig. 43 is a bottom side perspective view of an embodiment of the sample wand. Fig. 44 is a bottom view of an embodiment of the sample wand.PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 Fig. 45 is a top view of an embodiment of the sample wand.

[0259] Fig. 46 is a front view of an embodiment of the collection tube.

[0260] Fig. 47 is a left side view of an embodiment of the collection tube.

[0261] Fig, 48 is a back view of an embodiment of the collection tube.

[0262] Fig. 49 is a right side view of an embodiment of the collection tube.

[0263] Fig. 50 is a top perspective view of an embodiment of the collection tube.

[0264] Fig. 51 is a bottom perspective view of an embodiment of the collection tube.

[0265] Fig. 52 is a bottom side perspective view of an embodiment of the collection tube. Fig. 53 is a bottom view of an embodiment of the collection tube.

[0266] Fig. 54 is a top view of an embodiment of the collection tube.

[0267] Fig. 55 is an exploded view of an embodiment of the device.

[0268] DETAILED DESCRIPTION OF THE INVENTION

[0269] Embodiments of the invention are described in this Detailed Description of the Invention, and in the Summary above, which is incorporated here by reference. Although the invention has been described in connection with specific embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Those skilled in the art who review this disclosure will readily appreciate that many modifications are possible (e.g., variations in sizes, dimensions, structures, shapes and proportions of the various elements, values of parameters, mounting arrangements, use of materials, orientations, etc.) without materially departing from the novel teachings and advantages of the subject matter of the technology. Accordingly, all such modifications are intended to be included within the scope of the present invention as defined in the appended claims. In particular, although features of the technology are described herein by reference to stool samples in particular, the technology is not limited to stool samples and may be applied to any soft matter composition from which a sample may be taken.PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 Provided herein are sampling devices that find use in collecting samples, e.g., stool samples, that are of suitably reproducible size, in sample amounts that are suitable for detecting or otherwise assaying analytes (e.g., of human nucleic acids, proteins, etc.) in the sample. The device finds particular use in collecting metered samples for disease screening, e.g., nucleic acid-based or protein-based screening for digestive system inflammation and / or cancer, e.g., colorectal cancer, in a subject.

[0270] In addition to facilitating collection by a subject of a sample having a reproducible volume or mass, the device provided herein actively expels collected sample material into a stabilizing buffer within the device, enhancing the stabilizing of analytes within the sample material (cells, proteins, nucleic acids, e.g.) by mixing of the sample with stabilizing buffer, and / or reducing loss of sample material, e.g., by reducing or preventing adhesion of collected sample to the device.

[0271] Provided herein are embodiments of a collection device (1) adapted to comprise one or more of the following features:

[0272] 1. Collect samples, preferably metered samples, from soft specimens, e.g., stool specimens of varying consistencies;

[0273] 2. Collect samples, preferably metered samples, that include sample material from the outer and inner regions of the stool specimen, and optionally from multiple locations in the specimen, e.g., to maximize chances of collecting analytes associated with a condition such as inflammation, cancers, e.g., analytes such as cells, nucleic acids, proteins, lipids, carbohydrates etc., if present;

[0274] 3. Collect enough sample material to yield nucleic acid quantities sufficient for nucleic acid analysis (e.g., methylation assays, gene expression assays, sequencing assays);

[0275] 4. Actively disperse a collected sample into stabilizing buffer within the device; 5. To contain buffer prior to collection of the collected sample, such that the user does not need to transfer buffer to the device from a separate container; and 6. Contain sufficient buffer to cover a collected sample, whether the device is vertical or on its side.PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214

[0276] The device of the technology can capture sufficient amounts of sample material, in particular stool sample material, for analysis of multiple target analytes, e.g., protein analytes and nucleic acid analytes, and provide for analysis of many different analytes, e.g., different proteins and different nucleic acids, e.g., human nucleic acids. Preferably, the device of the technology collects at least 1 gram, preferably at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 grams, or any intermediate fraction thereof. In preferred embodiments, the device of the technology provides sufficient sample for at least two independent measurements of analytes or panels of analytes, e.g., of target nucleic acids or panels of target nucleic acids. In contrast to whole-stool bucket-type at-home collection devices, the technology provides sample collection devices that use substantially less material to manufacture, are substantially less cumbersome to package, ship, and process, and produce a substantially smaller amount of downstream waste, including hazardous medical waste, for disposal.

[0277] Device

[0278] As shown by Figs. 1-55, the device (1) comprises as principal components a sampler wand (2) and a collection tube (3). Embodiments of the device, particularly in reference to the interactions of these and other components, are described below.

[0279] Sampler wand

[0280] The device comprises as a first component a sampler wand (2). In the embodiment illustrated in Fig. 1, sampler wand (2) comprises a proximal portion adapted for contact with and manipulation by a user and a distal portion that is adapted to capture a sample, e.g., a metered sample.

[0281] In the embodiment illustrated in Fig. 1, sampler wand (2) comprises a stem (4) between the proximal and distal portions of the wand. In the illustrated embodiment, stem (4) connects cap (5) on the proximal portion to sampler head (8) on the distal portion. In some embodiments, sampler wand (2) comprises a cap, while in some embodiments, sampler wand (2) does not comprise a cap. In some embodiments, for example, the stem (4) of the sampler wand (2) may be grasped directly, or may be attached to a handle that is not a cap.PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 Cap

[0282] In the embodiment illustrated in Fig. 1, cap (5) is provided. Cap (5) provides a component for gripping or manipulating the sampler wand (2), e.g., by a user or robotic device. Cap (5) further preferably comprises a cap engagement feature, e.g., cap threads (7), configured to engage with a mated engagement feature, e.g., tube threads (24) on a collection tube, wherein when the cap engagement feature is engaged with the mated engagement feature, the cap and tube form a sealed device. In some embodiments, the cap (5) comprises raised or textured features, e.g., bumps and / or ridges as illustrated in Fig. 7A, e.g., useful in gripping and manipulating the sampler wand (2) by the user.

[0283] In some embodiments, the cap (5) comprises one or more click elements that interact with one or more corresponding click elements on the collection tube (3) to produce an audible indicator ( .g., a click sound) indicating proper closure of the device. For example, in some embodiments the cap (5) comprises one or more ridges that interact with one or more corresponding tabs on the collection tube (5) to produce an audible indication that the cap has been rotated to a sufficient degree to close the device. In some embodiments, the cap (5) comprises a single click element. In some embodiments, the cap (5) comprises more than one click element (e.g., 2, 3, 4, etc.). For example, in some embodiments the cap (5) comprises two click elements spaced 180 degrees apart. In some embodiments, the collection tube (3) comprises an equal or a different number of click elements as the cap (5). In some embodiments, the one or more click elements on the cap (5) and / or one or more click elements on the collection tube (3) are formed integrally with the cap (5) and / or collection tube (3), respectively. For example, in some embodiments the cap (5) comprises one or more click elements that are an integral part of the cap. In some embodiments, the collection tube (3) comprises one or more click elements that are an integral part of the collection tube (3).

[0284] In preferred embodiments, the cap further comprises one or more alignment markings (5b) e.g., to indicate a rotational position of the cap with respect to the collection tube. For example, Fig. 13 shows examples of alignment markings (5b) on caps (5), in alignment with tube alignment markings (3a) on collection tubes (3). Alignment markings on the caps and collection tubes may be the same or different, e.g., the same or different shapes, textures,PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 orientations of shapes, etc. The alignment of the cap with the collection tube may be indicated by any suitable position of the alignment markings with respect to each other. For example, in some embodiments alignment is indicated by the alignment marking (5b) on the cap (5) being in line with an outer edge of the alignment marking (3a) on the collection tube (3), as shown in Fig 13, indicating that the cap has been tightened to or past a suitable point to ensure sealing of the device. In alternative embodiments, alignment of the cap with the collection tube may be indicated by the alignment marking (5b) on the cap (5) being centered with a midline of the alignment marking (3a) on the collection tube (3). In some embodiments, each of the alignment marking (5b) of the cap (5) and the alignment marking (3b) of the collection tube (3) contain left and right boundaries, and the left and right boundary of each marking is in line with the left and right boundary of the other marking.

[0285] In some embodiments, the cap (5) and the collection tube (3) each comprise one or more click elements and one or more alignment markings that provide both an audible and visual indicator that the device is properly sealed.

[0286] Sampler head

[0287] The distal portion of sampler wand (2) comprises a sampler head (8) adapted to capture a sample, preferably a metered sample. For example, in the embodiment illustrated in Fig. 1, sampler head (8) comprises a side wall (10) that defines a sampler head opening (14) at the distal end of sampler wand (2). In certain preferred embodiments, side wall (10) comprises a distal edge (12) at the distal end of the sampler wand (2). In some embodiments, the distal edge (12) comprises a plurality of teeth (13). The teeth (13) on distal edge (12) are not limited to any particular shape or edge profile. For example, the teeth (13) may be sharp or pointed, as illustrated in Fig. 8, or the edge profile of the teeth may be squared off, blunted, and / or rounded, e.g., as illustrated in Figs. 1 and 3, or combinations thereof. The distal edge may comprise 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, or more teeth. In some embodiments teeth (13) are the same length and in some embodiments, some teeth are longer or shorter than neighboring teeth. In some embodiments, teeth (13) on a sampler head (8) are all substantially the same width, while in some embodiments, one or more teeth are wider or narrower than other teeth on the same sampler head (8). Additionally,PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 in some embodiments, a plurality of teeth (13) are evenly distributed such that they are each equidistant from neighboring teeth, while in some embodiments, at least some of the teeth are unevenly arrayed, such that not all teeth are equidistant from neighboring teeth. In some embodiments, the distal edge (12) does not comprise teeth. For example, in some embodiments all points around the distal edge (12) are coplanar and define a continuous circle.

[0288] In preferred embodiments, the sampler head opening (14) is circumferentially defined by sampler head side wall (10), such that the sampler head opening (14) is circular. In the embodiment illustrated in Fig. 1, the sampler head (8) comprises a closed end (15), at an end of the sampler head attached to stem (4). The sampler head (8) comprises an interior void (9) bounded by side wall (10), closed end (15), and a plane defined by the distal edge (12) of sampler head (8). In embodiments in which the distal edge (12) comprises a plurality of teeth (13), the plane defined by distal edge (12) is defined by points on the ends of 3 or more of teeth, preferably the longest teeth, if the teeth are not all of the same length. In preferred embodiments, the plane of the distal edge (12) is perpendicular to central axis (23). In some embodiments, sampler head side wall (10) defines a sampler head opening (14) that is not circular, but is a different shape, e.g., an oval or ellipse shape, or a regular or irregular polygon (e.g., square, rectangle, triangle, hexagon, preferably a convex polygon), etc.

[0289] Sampler head side wall (10) of sampler head (8) comprises at least one port (11), preferably a plurality of ports (11) providing connection between the interior void (9) with the exterior of sampler head (8). In preferred embodiments, sampler head side wall (10) comprises a plurality of ports that are preferably distributed to different positions on the sampler head (8), e.g., the plurality of ports in some embodiments are radially distributed around a central axis of sampler head (8). Additional examples of suitable arrangements of ports (11) on sampler heads are provided in Fig. 8. In other embodiments, sampler head (8) comprises a plurality of ports (11) that are irregularly or asymmetrically arranged on the sampler head (8). The ports (11) are not restricted to any particular shape, and may, for example, comprise circular, oval, rectangular, or irregular or other suitable shapes, in any combination or arrangement. As illustrated in Fig. 8B, in some embodiments, the teeth (13) of sampler head (8) are not connected to each other around the circumference of the samplerPATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 head side wall (10). For example, in some embodiments, sampler head side wall (10) comprises a break (12a) between at least one pair of teeth (13), e.g., connecting a port (11) and distal edge (12) or between a plurality of pairs of teeth (13) or between all teeth (13). In some embodiments, neighboring teeth touch at break (12a), while in some embodiments, break (12a) provides a gap between neighboring teeth.

[0290] Stem

[0291] In preferred embodiments, sampler head (8) is attached to cap (5) by a stem (4). In some embodiments, stem (4) varies in diameter along its length. In some embodiments, stem (4) is tapered along its length. For example, in the embodiment illustrated in Fig. 1, stem (4) has a large diameter at its proximal end and progressively narrows between the proximal portion and the distal portion of the sampler wand (2), presenting as a truncated cone.

[0292] In some embodiments, the shape of stem (4) is selected to provide a particular ratio between the collection tube (3) interior volume and the volume of the sampler head interior void (9), or a particular ratio between a solution and a sample when device (1) is in use. In some embodiments, e.g., the shape of stem (4) is selected to maximize the amount of the collection tube interior volume it displaces in a sealed device (1), such that e.g., less solution is required to fdl the remaining interior volume of collection tube (3) and / or cover sampler head (8). For example, tapered stem (4) illustrated in Figs. 1 and 2 displaces more of the interior volume of the collection tube (3) than a slim cylindrical stem, e.g., as shown in the embodiments illustrated in Fig. 7A. Stem (4) may be larger than these exemplary embodiments. For example, stem (4) may be further thickened between cap (5) and sampler head (8), e.g., may have convexly curved or bulging sides.

[0293] Stem (4) of the device is not limited to any particular shape. As illustrated in Fig. 7B showing exemplary silhouettes of embodiments of stem (4), any number of shapes may be used in embodiments of the device, so long as the stem positions sampler head (8) at a desired position withing collection tube (3).

[0294] As discussed in more detail below, in certain embodiments, use of the device (1) comprises expelling the collected sample from the interior void (9) of the sampler head (8)PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 through the ports (11) during closure of the device, e.g., when cap (5) is screwed on or otherwise sealed to collection tube (3). Thus, in some embodiments, the shape(s) of and / or distribution of ports (11) on sampler head (8) are generally selected to suit a range of expected textural or plastic properties (e.g., firmness, hardness, stickiness, etc.) of a material to be sampled using the device. For example, it may be preferable to use larger ports if a type of collected sample is very firm, as pressing such a sample through very small ports may require an unacceptable amount of pressure. Alternatively, if the material is very soft, it may be preferable to use smaller ports, e.g., to improve containment of the collected sample, and / or to reduce or prevent leakage or loss of the collected sample through the ports before the sampler wand (2) can be inserted into the collection tube (3).

[0295] In some embodiments, e.g., for preparing a sample from a stool sample, e.g., a metered sample, the interior void (9) of a sampler head (8) is sized to collect a suitable amount of sample based on the needs of the test(s) to be conducted, preferably to conduct the needed tests at least twice. As a non-limiting example, for human DNA testing, a collected sample of between about 1 gram and 15 grams finds use. For testing stool for more or different analytes, or for testing other materials (e.g., foods, environmental samples, industrial samples, e.g.) it may be preferable to collect either smaller or larger amounts of a specimen. The volume of the interior void (9) of a sampler head (8) of the instant technology is not limited to any particular size, and may be sized to contain 0.1, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 or more grams of sample, including any intermediate fraction thereof, e.g., 0.1 grams, 0.01 grams, 0.001 grams or multiples thereof.

[0296] In preferred embodiments, the collected sample is expelled from the sampler head (8) into a volume of solution in collection tube (3), preferably a stabilizing solution. The volume of solution used for a volume collected sample is preferably selected to be large enough to sufficiently stabilize the collected sample, but to be small enough to avoid excessively diluting the collected sample. In some embodiments, the volume of solution in the collection tube (3) is at least 5 mL, preferably between about 5 mL and 300 mb, including any intermediate number of mL or fractions thereof, preferably between about 5 mL and 300 mL,PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 preferably between about 10 mb and 100 mL, including 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, and 99.999 mL, including any intermediate fractions thereof.

[0297] In preferred embodiments, the ratio of the volume of the collected sample to the volume of solution (volume:volume, or “v:v”) e.g., in a collection tube, or the ratio of the mass of the collected sample to the volume of solution (mass or weight volume, or “w:v”) is at least about 1:2, preferably between 1:2 and 1:300 , preferably between 1:2 and 1:100, preferably between 1:2 and 1:75, 1:50, 1:40, 1:30, 1:20, 1:10, or 1:5. In embodiments of the technology, the volume of solution in the collection tube is provided in pre-mixed form, as a solution, while in some embodiments, a volume of solution is provided as a dried agent to be dissolved or resuspended, e.g., by a user of the device, for example, by the addition of a measured amount of water,

[0298] In some embodiments, the cap (5) and sampler head (8) are essentially circular in cross section. In preferred embodiments, the stem (4) is also circular in cross section for at least a portion of its length, and the centers of the circular cross-sections of the cap (5), stem (4), and sampler head (8) are aligned on the central axis (23) of the device (1), as illustrated in Fig. 1. In some embodiments, the stem (4) and / or sampler head (8) have a central axis that is not the same as the central axis (23) of the device (1) as a whole.

[0299] In preferred embodiments, cap (5) is adapted to mate with and seal collection tube (3) (discussed below), at a top edge (18) of the collection tube (3). In preferred embodiments, mated threads on the cap (5) and collection tube (3) engage with each other, e.g., by rotating the cap with respect to the collection tube, thereby sealing the device (1). In some embodiments, as shown in Fig. 4B, the cap (5) makes direct contact with the top edge (18) of the collection tube (3) forming a sealed joint (27) between the cap (5) and the collection tube (3). In some contemplated embodiments, the device (1) is sealed by engagement of the cap and collection tube using one or more of a snap closure, bayonet closure, or friction seal, orPATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 by any other closure mechanism by which a cap securely closes a vessel to seal contents inside the vessel. In preferred embodiments, mated threads on the cap (5) and collection tube (3) provide for securing the sampler wand (2) with a half-turn screw fit to the collection tube (3). As illustrated, e.g., in Figs. 4, and 12A, in some embodiments, device (1) comprises a gasket (25) to seal the junction between cap (5) and collection tube (3).

[0300] In some embodiments, device (1) is configured to allow a user to separate sampler head (8) from cap (5), e.g., after a sampler wand (2) containing a collected sample is engaged with collection tube (3) to seal the device. For example, in some embodiments, sample wand (2) is configured to have disengagement feature, such that manipulation of sample wand (2) or of the sealed device (1) detaches a detachable sampler head (8) from the sampler wand (2). For example, in some embodiments, stem (4) comprises a break point or detachment point wherein separation occurs, e.g., when cap (5) is loosened from or further rotated with respect to collection tube (3). In some embodiments, all or part of stem (4) remains attached to detached sampler head (8), while in some embodiments, all or part of stem (4) detaches from detached sampler head (8). In some embodiments, an engagement feature of a sampler head (8) is configured to interact with an engagement feature of collection tube (3), e.g., on the bottom wall (20) and / or on displacing member (21) of the collection tube (3), so that the sampler head (8) may be reversibly or irreversibly attached to collection tube (3), e.g., upon sealing of the device. Engagement of the sampler head (8) with the collection tube (3) may be configured to facilitate separation of the sampler head (8) from the cap (5), e.g., by facilitating breakage or disengagement of the sampler head (8) from cap (5).

[0301] In some embodiments, the device further comprises an ejector movably attached to or incorporated into sampler wand (2), e.g., in the cap (5), wherein manipulation of the ejector (e.g., pressing or sliding a button, pulling a tab, rotating a portion of the cap, etc.) detaches sampler head (8) from cap (5).

[0302] As illustrated in Figs. 12B and 12C, in some embodiments, device (1) comprises a gasket-less seal at the junction between cap (5) and collection tube (3). For example, precision molding processes may be used so that contact between surfaces on cap (5) and collection tube (3) come into direct contact to make a sealing joint (27) between the cap andPATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 collection tube. Fig. 12B shows a detail illustration of an embodiment in which the sealed joint (27) is made by contact between a flange portion (4a) of stem (4) of sampler wand (2) and the top edge (18) of collection tube (3), and Fig. 12C shows an embodiment in which the sealed joint (27) is made by contact between a sealing lip (28) on cap (5) and a sealing surface (29) on an inner side wall (30) of collection tube (3). In preferred embodiments, sealing lip (28) is an integral part of cap (5), e.g., it is formed during the molding process to produce a part of sampler wand (2), e.g., the molding of cap (5) or stem (4).

[0303] Collection tube

[0304] The technology provides a device (1) comprising a collection tube (3). In some embodiments, collection tube (3) has an overall tubular or cylindrical shape. However, the collection tube may have a non-circular cross-section, e.g., oval, hexagon, square, etc. In preferred embodiments, a collection tube (3) that uses a threaded closure, e.g., as illustrated in Fig. 1, is circular in cross-section on at least the portion of the collection tube that comprises tube threads (24). In preferred embodiments, the collection tube (3) comprises a displacing member (21), which is typically a protrusion from the bottom wall (20) of the collection tube (3) into the interior void (22) of the collection tube (3). See, e.g., Figs. 1 and 3B. The displacing member (21) may be hollow or solid, may be formed of the same material as collection tube (3), and may be formed at the time the tube is formed, or may be added to a flat bottom wall (20) of a collection tube after the body of the collection tube is separately formed. In preferred embodiments, the displacing member (21) is formed as an integral part of collection tube (3), formed at the same time and from the same material as collection tube (3). For example, Fig. 4A provides a cross sectional view of device (1), showing displacing member (21) formed by an indent (26) formed in bottom wall (20) of collection tube (3), wherein the collection tube side wall (17), bottom wall (20) and displacing member (21) are formed as a continuous piece of, for example, plastic. In some embodiments, indent (26) is used as a way of engaging the collection tube (3), e.g., to engage the collection tube (with or without the other components of device (1)) with a holder, rack, conveyor, mixer, gripper, rotator, etc. In some embodiments, the collection tube (3) comprises an alignment element (33), e.g., for engagement with a holder, rack, conveyor, mixer, gripper, rotator, etc.PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 Preferably, the indent (26) is formed in the bottom wall (20) of the collection tube (3) and has an indent opening (35) at an exterior surface of the bottom wall (20), the indent defining an indent void space (36) bounded by the indent opening (35) in the bottom wall (20), as illustrated in Fig. 15. The indent (26) preferably comprises an alignment element (33). See, e.g., Figs. 15 and 18.

[0305] An alignment element (33) in the indent (26) preferably has central axis that is preferably coaxial with the central axis (23) of the collection tube (3), and preferably has rotational symmetry around the central axis (23). In preferred embodiments, the alignment element (33) has 2, 3, 4, 5, 6, 7, 8, 9, or 10-fold rotational symmetry, preferably 3-fold rotational symmetry, e.g., as in the embodiment illustrated in Figs. 17, 18, 25, 35, and 54. In preferred embodiments, an alignment element having / / -fold (e.g., 2 to 10-fold) rotational symmetry is configured to engage with another component, e.g., a holder, rack, conveyor, mixer, gripper, rotator, in any one of n different rotational positions about the tube central axis (23). An alignment element may be composed of the same material as the collection tube (3) or may comprise or be composed of different material(s).

[0306] In some embodiments, as described above the collection tube (3) comprises one or more click elements that interact with corresponding click elements on the cap (5) to provide an audible indicator of proper closure of the device. In some embodiments, as described above the collection tube (3) comprises one or more alignment markings that provide a visual indicator of proper closure of the device when aligned with one or more corresponding alignment markings on the cap (5).

[0307] One or more clocking elements (34) may be used, e.g., to determine a precise rotational position of the device (1), sampling wand (2) and / or the collection tube (3) with respect to the tube central axis (23). A clocking element may be useful in robotic or mechanical handling, e.g., for determining the position of the device by determining the position of the clocking element (34), or for orienting a component of the device (1), e.g., to facilitate scanning of a label on the device (1). In preferred embodiments, the one or more clocking elements (34) define a unique rotational position, e.g., the pattern or distribution of clocking elements on a collection tube (3) does not have rotational symmetry. In preferredPATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 embodiments, a single clocking element (34) is used, e.g., as in the embodiment illustrated in Figs. 17, 18, 25, 35, and 54. In some embodiments, the clocking element (34) is substantially within the indent (26), offset from the central axis (23) of the collection tube (3). In preferred embodiments, a clocking element is configured to engage with another component, e.g., a holder, rack, conveyor, mixer, gripper, rotator, in a unique rotational position with respect to the tube central axis (23), or such that another component can interact with the clocking element to put the device, sampling wand, or collection tube in a preferred rotational position. A clocking element (34) may be composed of the same material as the collection tube (3) or may comprise or be composed of different material(s). In preferred embodiments, the clocking element (34) comprises a ridge.

[0308] In some embodiments, displacing member (21) is essentially circular in cross section and is preferably centered on a central axis of collection tube (3). In preferred embodiments, the central axis of displacing member (21) in device (1) in a closed or sealed state, e.g., as illustrated in Fig. 2, is aligned with the centers of cap (5), stem (4), and sampler head (8) on the central axis (23) of the device (1), as illustrated in Figs. 1 and 2.

[0309] An object of the displacing member (21) is to occupy some or all of the interior void (9) of sampler head (8) of the sampler wand (2). Thus, in preferred embodiments, displacing member (21) is dimensioned to match the interior dimensions of the sampler head (8), as shown in Fig. 4A. Further, the displacing member (21) is positioned inside the bottom of collection tube (3) such that when the sampler wand (2) is fully inserted into collection tube (3) (e.g., when a cap (5) on sampler wand (2) is screwed into place to seal collection tube (3), displacing member (21) fills most or all of the interior void (9) of the sampler head (8). Thus, during use in collecting a metered stool sample, material within sampler head (4) is expelled from the sampler head through one or more ports (11) as the displacing member (21) displaces the material. The displacing member need not expel all of the sample material from the sampler head and the amount expelled may be determined by how much, e.g., what percentage, of the volume of the sampler head (8) interior void (9) is filled by displacing member (21) when the device is sealed. In preferred embodiments, the displacing member of the collection tube fills at least 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90% 95%, 96%, 97%, 98%, 99% of the interior volume of the sampler head. In some embodiments,PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 collection tube (3) comprises a movable displacing member (21), e.g., that may be positioned in a fully or partially withdrawn position with respect to a sampler head (8) when sampler wand (2) is fully inserted into collection tube (3), and that may be moved into position, e.g., extended into the interior void (9) of the sampler head (8), thereby displacing some or all of the material in the sampler head.

[0310] As illustrated in Fig. 6A, the collection tube (3) has a maximum volume of an interior void (22) of collection tube (3) when empty. As used herein in reference to the maximum volume of the collection tube, the terms “mL” (milliliters) and “cc” (cubic centimeters) are used interchangeably, and 1 cc is equivalent to 1 mL. In preferred embodiments, the maximum volume of collection tube (3) is at least 5 mL, preferably between about 5 mL and 300 mL, including any intermediate number of mL or fractions thereof (e.g., .1 mL, .01 mL, .001 mL or multiples thereof). In preferred embodiments, a collection tube (3) has a maximum volume of between about 10 mL and 100 mL, including 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 560, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, and 99.999 mL, including any intermediate fractions thereof (e.g., 0.1 mL, 0.01 mL, 0.001 mL or multiples thereof).

[0311] As illustrated in Fig. 6B, the primary remaining volume of the interior void (22) of collection tube (3) is the maximum volume, less the volume of displacement by the stem (4) with sampler head (8). Fig. 6C illustrates the volume of interior void (9) of sampler head (8). In preferred embodiments, a secondary remaining volume of interior void (22) upon insertion of the stem and sampler head (8) is the maximum volume, less the volume of displacement by the stem (4) with sampler head (8), less the volume of the interior void (9) of sampler head (8). The secondary remaining volume is preferably at least 2 times (2X) the volume of the interior void (9) of sampler head (8), preferably at least 3X, preferably at least 4X, preferably at least 5, 6, 7, 8, 9, or 10X the volume of the interior void (9) of sampler head (8), or any intermediate fractions thereof (e.g., 4. IX, 4.2X, 4.3X, 4.4X, etc.). In other embodiments, the secondary remaining volume of the interior void (22) is the same as, or is less than, the interior void (9) of sampler head (8).PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 As illustrated in Figs. 10 and 11, in preferred embodiments, the remaining interior volume is preferably large enough to hold a volume of solution, e.g., a stabilizing solution or buffer, that at least partially covers sampler head (8), preferably covering most of the sampler head (8), more preferably completely covers sampler head (8). Preferably, sampler head (8) is partially or completely covered when the sealed device containing the collected sample is horizontal, e.g., laying on its side as shown in Fig. 11. Preferably, the ratio of the volume of interior void (9) of the sampler head (8) to the volume of solution in the collection tube, whether provided as a pre-filled solution or as a solution reconstituted from dried reagents, is at least about 1:2 (v:v), preferably between 1:2 and 1:300 (v:v), preferably between 1:2 and 1:100 (v:v), preferably between 1:2 and 1:75, 1:50, 1:40, 1:30, 1:20, 1:10, or 1:5 (v:v).

[0312] In preferred embodiments, during use, some or all of the material in sampler head (8) is expelled into a surrounding fluid, e.g., a stabilizing buffer, in collection tube (3), when the sampler wand (2) is inserted into collection tube (3), e.g., when cap (5) engages to collection tube (3) to form a sealed device.

[0313] Filling of the sampler head (8) with a material such as stool, e.g., using a twisting, coring, plunging, or scraping action provides a sample having a volume or mass that is largely determined by the volume of the interior void of the sampler head (8). Expulsion of the sample through multiple ports (11) breaks up the sample and disperses it into the buffer, enhancing the stabilizing effect of the buffer.

[0314] Preferably, the tube opening (19) and the sampler head (8) are configured such that a user may insert the sampler head (8) with sampled material into the tube opening (19) of the collection tube (3) with ease, e.g., with sufficient clearance that inadvertent contact between the sample material with, e.g., the exterior of the collection tube (3) and / or the top edge (18) of the collection tube (3) is readily avoidable. In some embodiments, the tube opening (19) of the collection tube has an inner diameter of about 1 to 2 inches. In some embodiments, the tube opening (19) of the collection tube has an inner diameter of 1.1 to 2 inches, 1.2 to 1.9 inches, 1.3 to 1.8 inches, or 1.4 to 1.7 inches, or any fraction therebetween. In some embodiments, the tube opening (19) of the collection tube has an inner diameter of 1.4 to 1.5 inches (e.g., 1.4, 1.42, 1.44, 1.46, 1.48, or 1.5 inches, or any fraction therebetween). In somePATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 embodiments, the tube opening (19) of the collection tube has an inner diameter of 1.5 to 1.7 inches (e.g., 1.5, 1.6, 1.62, 1.64, 1.66, 1.68, or 1.7 inches, or any fraction therebetween). The “inner diameter” refers to the diameter of the opening of the collection tube measured from inside of the tube, excluding, for example, the thickness of the walls of the collection tube.

[0315] In some embodiments, the widest point of the sampler head (8) is at the sampler head opening (14). In some embodiments, the sampler head opening (14) is essentially circular, e.g., without teeth, or with teeth that are arranged in a circle, the circle having an outer diameter measured from the outside of the sampler head side wall (10) and including the thickness of the side wall. In certain embodiments, the sampler head opening (14) has an outer diameter of about 0.25 inches to 1 inch, preferably 0.5 inches to 1 inch, preferably 0.7 inches to 1 inch, or any fraction therebetween. In some embodiments, the sampler head opening (14) has an outer diameter of 0.7 inches to 0.95 inches. In some embodiments, the sampler head opening (14) has an outer diameter of 0.8 inches to 0.9 inches.

[0316] In some embodiments, the inner diameter of the tube opening (19) is at least 50% larger than the outer diameter of the sampler head opening (14). In some embodiments, the inner diameter of the tube opening (19) is at least 50%, 55%, 60%, 65%, 70%, 75%, or 80% larger than the outer diameter of the sampler head opening (14). In some preferred embodiments, the tube opening (19) has an inner diameter of about 1.3 to 1.8 inches and the sampler head opening (14) is circular and has an outer diameter of about 0.7 to 0.95 inches.PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 Materials

[0317] Some embodiments find advantages in constructing the device from various types of materials, e.g., disposable materials, recyclable materials, reusable materials, sterilizable materials, autoclavable materials, chemically inert materials, biodegradable materials, etc. The members of device (1) may be made from any material that provides structural soundness to the device as used for its intended purpose, and that is chemically and biochemically compatible with collected samples and solutions, e.g., stabilizing buffers, which may contact the device. In some embodiments, members of the device (1) are made from a material that can be frozen.

[0318] Members of the device may all be composed of the same material, or different members may be composed of different materials. For example, in preferred embodiments, members of device (1) that are exposed to the collected sample are typically selected to minimize or prevent binding of analytes (e.g., nucleic acids, proteins, cells) to the surfaces of these members during use, which may result in loss of the bound material. Materials are also typically selected to minimize or prevent alteration of the sample components, e.g., degradation of molecules, alteration in viability or stability of human cells, bacteria, or viruses, etc. For example, materials may be selected to avoid altering the composition of the sample components, by releasing, leaching, and / or transferring materials, such as plasticizers, coatings, or byproducts of manufacture (e.g., bisphenol A (BP A), phthalates, per- and polyfluoroalkyl substances (PFAS), fine particulates such as talcum powder, surfactants, dyes, etc.), to the sample.

[0319] In some embodiments, one or more elements of the device are made from plastics such as, e.g., polypropylene, polyethylene, polystyrene, and polytetrafluoroethylene. In some embodiments, the collection tube (3) is made from a transparent plastic, e.g., polypropylene (PP) or polyethylene (PE), while in some embodiments, a collection tube may comprise or be composed of a material that is not transparent, e.g., to limit light exposure to a contained sample. Different materials may be suitable for different applications and sample types. Embodiments of the device may comprise, for example, one or more of silicone, glass, ceramic and / or crystalline materials (e.g., alumina, hydroxyapatite, zirconia, diamond, graphite), metal materials (e.g., platinum, gold, cobalt-chromium alloy, stainless steel,PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 titanium & titanium alloys, etc.), and / or polymers (e.g., acetal (ACL), cyclic olefin copolymer (COC), ethylene chlorotrifluoroethylene (ECTFE), ethylene propylene diene monomer rubber (EPDM) ethylene propylene rubber (EPR), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), fluorinated high-density polyethylene (FLPE), high-density polyethylene (HDPE), high impact polystyrene (HIPS), low density polyethylene (LDPE), polycarbonate (PC), pothetherimide (PEI), polyethylene terephthalate (PET), polyethylene terephthalate copolymer (PETG), polymethylmethacrylate (PMMA), polymethylpentene (PMP), polypropylene (PP), polypropylene copolymer (PPCO), modified polyphenylene ether (PPE), polystyrene (PS), poly sulfone (PSF), poly vinylidenedifluoride (PVDF), tetrafluoroethylene (PTFE / TFE), thermoplastic elastomer (TPE),

[0320] trimethyl carbonate (TMC), TMC NAD-lactide, etc.). In some embodiments, components of sampler wand (2) and collection tube (3) are made from the same material. For example, in certain embodiments, the same material, e.g., polypropylene polyethylene, or one of the polymers discussed above, is used for multiple parts but one or more parts are differently colored or have a different level of transparency. For example, in some embodiments, a collection tube (3) is made of clear polypropylene and parts of sampler wand (2) (e.g., the cap (5), stem (4) and / or sampler head (8)) are composed of opaque polypropylene, e.g., white polypropylene.

[0321] In some embodiments, components of sampler wand (2) and collection tube (3) are made from different materials. For example, in some embodiments, a collection tube (3) is made of clear polypropylene and parts of sampler wand (2) (e.g., the cap (5), stem (4) and / or sampler head (8)) are composed of opaque polyethylene, e.g., white polyethylene, while in some embodiments, a collection tube (3) is made of opaque material, e.g., white, amber, brown, or black polyethylene or polypropylene, e.g., to shield contents of the collection tube (3) from view or from light, and parts of sampler wand (2) (e.g., the cap (5), stem (4) and / or sampler head (8)) are composed of clear material, e.g., clear polypropylene, polymethylpentene, or polycarbonate.

[0322] In some embodiments, sampler wand (2) comprises a mixture of different materials. For example, in some embodiments, the cap (5) is made of one material, and stem (4) and / or sampler head (8) are made from one or more different materials.PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 The materials that find use in the device (1) are not limited to any particular selection or combination of suitable materials used for the parts of the device. In some embodiments, the materials and compositions are chosen to provide a shelf-life for the device of at least 2 years. In some embodiments, materials for the device are selected to block light and / or ultraviolet radiation. For example, amber or opaque materials may be selected. In some embodiments, materials may be selected to allow inspection of samples contained therein, e. ., optically, or under different lighting conditions. Thus, in some embodiments, materials may be selected for their optical properties, e.g., degree of transparency under different lighting conditions, e.g., in light within the daylight spectrum, and / or under UV lighting. For example, in some embodiments, materials may be selected to fluoresce or to lack fluorescence under UV light.

[0323] As illustrated, e.g., in Figs. 4, and 12A, in some embodiments, device (1) comprises a gasket (25) to seal the junction between cap (5) and collection tube (3). Any suitable material, typically a polymeric material may be used. In some embodiments, the gasket comprises low density polyethylene (LDPE), silicone, nitrile, EPDM (ethylene propylene diene monomer) rubber, vinylidene fluoride diene rubber (VITON), etc. In certain preferred embodiments, the gasket comprises multiple plies. For example, in some embodiments, a gasket is a three-ply co-extruded material consisting of a foamed LDPE core sandwiched between two layers of solid LDPE, e.g., TRISEAL F-217® (Tri-Seal, Blauvelt, NY).

[0324] In some embodiments, the sampler head (8) material may be selected to provide a particular degree of friction with respect to a sample, e.g., to retain sample material such as stool during the sampling process. In some embodiments, the interior surface of the sampler head (8) provides friction to retain the collected sample, e.g., during removal of the collected sample from the stool specimen. For example, in some embodiments, the number and arrangement of ports (11) are selected to enhance retention of a very soft sample, e.g., a semiliquid sample, within the interior sampler head (8).

[0325] In some embodiments, one or more materials or surface on materials in device (1) may be selected to provide a smooth surface, e.g., to enhance release of sample material fromPATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 the sampler head (8), collection tube (3), and / or stem (4). In some embodiments, one or more of the device surfaces comprise a non-stick or hydrophobic layer or coating.

[0326] In some embodiments, materials of cap (5) may be selected for enhanced gripping. For example, in some embodiments, members of cap (5) may comprise a thermoplastic vulcanizate (TPV), e.g., Santoprene™ TPV (Celanese Corp.) to have a rubber-like grip and feel. Santoprene™ TPV is fully dynamically vulcanized EPDM (ethylene propylene diene monomer) rubber in a thermoplastic matrix of polypropylene (PP). In preferred embodiments, raised features (16) of cap (5), e. ., as shown in Fig. 2, are fully or partially formed from a TPV.

[0327] In some embodiments, cap (5) and / or collection tube (3) are configured to facilitate automated processing, e.g., opening, closing, and / or transferring the device by mechanical or robotic means. For example, in some embodiments, cap (5) comprises one or more features configured to engage with a cap driver device, e.g., raised ridges or grooves on the sides of cap (5) and / or collection tube (3); raised element(s) and / or indented feature(s) (e.g., ridge, blade, cross, hexagon, square, or star-shaped elements, etc.) on the top of cap (5), e.g., for automatically or robotically rotating cap (5) with respect to the collection tube (3) using, e.g., a cap driver.

[0328] Solutions and dried reagents

[0329] In some embodiments, the device comprises an agent, e.g., a solution or a dried agent in the collection tube (3), or provided for addition to the collection tube b a user. In some embodiments, the agent comprises a form of reagent, e.g., one or more reagents dried, e.g., as a powder, cake, or coating, or as an encapsulated composition that can be dissolved, suspended, or otherwise disrupted with a fluid to provide a solution in the collection tube (3). In some embodiments, the device or a system or kit of the technology comprises one or more preservatives, e.g., a preservative solution or one or more components for preparation of a solution, for example dried reagents, e.g., as a powder, cake, or coating, or as an encapsulated composition that can be dissolved, suspended, or otherwise disrupted with a fluid to provide a solution. In some embodiments, a solution (provided as a solution or asPATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 dried material to form a solution) is a stabilizing buffer. Preferably, a stabilizing buffer may comprise a buffer for providing a controlled pH, and optionally one or more salts, e.g., sodium chloride. In certain embodiments, the stabilizing solution comprises Tris buffer and EDTA, e.g., 500 mM Tris, pH 9.0, 150 mMEDTA, and 10 mMNaCl. In some embodiments, a stabilizing solution comprises a HEPES buffer. In some embodiments, a stabilizing solution comprises an antimicrobial agent, e.g., sodium azide, gentamicin, aPROCLIN preservative (a mixture of 5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl-4-isothiazolin-3-one), etc. In some embodiments, other salts may be used, e.g., Hanks Balanced Salt Solution (HBSS). In some embodiments, a stabilizing solution may comprise reagents selected from a protoporphyrin; a polyvalent cation; a sugar or polysaccharide and, optionally, a polyvalent cation; an osmolyte; and a horse radish peroxidase (HRP) stabilization component and, optionally, a polyvalent cation, e.g., as described in U.S. Pat. No. 11,385,243, which is incorporated herein by reference for all purposes. For example, one such exemplary solution may comprise a buffer and a protoporphyrin complexed with Cr3+or Co3+, wherein the concentration of the protoporphyrin complexed with Cr3is 1.25-5 pM and the concentration of the protoporphyrin complexed with Co3+is 2.5-10 pM.

[0330] In some embodiments, reagents may comprise adsorbant or other binding agents, including but not limited to polyvinylpyrrolidone (PVP), soluble or insoluble polyvinylpolypyrrolidone (PVPP), INHIBITEX® buffer or tablets (Qiagen N.V.), silica particles, activated charcoal, coated activated charcoal (see, e.g., Icenhour, U.S.

[0331] 2011 / 0201085), and carbohydrate adsorption matrices (see, e.g., Muller, U.S. Pat. No.

[0332] 6,992,182), the Icenhour and Muller publications being incorporated herein by reference in their entireties.

[0333] In some embodiments, stabilizing reagents may comprise one or more of a surfactant (e.g., Tween-20) a nuclease inhibitor (e.g., RNase inhibitor, proteinase K, a chelator), and / or a protein, e.g., bovine serum albumin (BSA) or casein, and nucleic acid (e.g.,. bulk fish DNA, tRNA, synthetic polynucleotides, etc.). In some embodiments, the solution or dried agent comprises one or more of sarkosyl and a chaotropic salt (e.g., guanidine thiocyanate).PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 Preferably, a solution in a sealable container, e.g., a stabilizing buffer, comprises components to break up, solubilize, and / or suspend a collected stool sample such that a portion of the mixture provides an aliquot suitable for analysis. Preferably, the solution comprises components to stabilize, preserve, and / or protect the resulting suspension so that the analytes to be tested (e.g., cells, RNA, DNA, proteins) do not degrade or become damaged between the time the sample is acquired and the time the sample is tested. The solution thus helps to ensure that the analysis of a sample accurately reflects the analytes (e.g., RNA, DNA, proteins) present in the sample when the sample was acquired. The solution or the dried agents may also comprise components to neutralize or bind to substances that may inhibit downstream assays, e.g., polyvinylpyrrolidone and / or polyvinylpolypyrrolidone which bind to phenolic substances. In some embodiments, one or more of the reagents, e.g., polyvinylpolypyrrolidone, are provided in a form that is not soluble in the solution. In some embodiments, preferably in embodiments wherein a stool collection device contains dried reagents, the stool collection device contains a desiccant. The technology contemplates any solution useful to preserve or prepare at least a portion of a stool sample, e.g., for a particular type of analysis.

[0334] In some embodiments, a chelating agent, e.g., EDTA, is included. In some embodiments, a stabilizing buffer comprises a protein stabilizing buffer. Embodiments of the technology may comprise stabilizing buffers as described, e.g., in U.S. Pat. Nos. 9,211,112 and 11,385,243; or a nucleic acid stabilizing buffer as described, e.g., in U.S. Pat Nos.

[0335] 6,551,777; 8,722,330, 10,064,404; 9,376,709; 9,657,227; 9,926,590; and 10,144,955, and PCT / US2023 / 077955, each of which is incorporated herein by reference in its entirety.

[0336] Use of the device

[0337] The device is designed to provide an easy way to collect and produce fecal samples for analysis. Accordingly, it is designed for use by both the sample provider and the sample tester. The sample provider may be, in some uses of the device, a person who does not have medical or clinical training, and thus the device is easy to use for such lay users in acquiring the sample. The device is therefore particularly suitable for use remotely, e.g., in the home or residential facility, or anywhere outside a medical clinic or laboratory, or for use in the field,PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 e.g., for collecting environmental or industrial samples. Thus, in some embodiments the collection tube (3) is composed of opaque material, or is covered, e.g., with a label, such that the interior components e.g., the stem and sampler head of the sampler wand) are substantially blocked from view of a user, e.g., to avoid confusion regarding the proper use of the device.

[0338] At the same time, the device is designed within the appropriate tolerances and with a design that allows for precise and accurate analysis of the sample by a human or machine tester. Generally, the device will be provided to the sample provider in an assembled form -e.g., the collection tube (3) is pre-filled with a volume of solution, and the cap (5) of the sampler wand (2) is secured to the collection tube such that the device (1) is sealed.

[0339] Upon producing a stool, the sample provider removes the sampler wand (2) from the collection tube (3) and places the distal edge (12) of the sampler head (8) at a site on the stool specimen. Using a twisting action, the sample provider cuts the distal edge (12) of the sampler head (8) into the specimen, preferably to capture a roughly cylindrical portion of the specimen within the interior void (9) of the sampler head (8), in a “coring” fashion.

[0340] Preferably, the sample provider collects sufficient stool material to fill the interior void (9) of sampler head (8), either at a single locus on the specimen, or by successive coring at multiple different loci on the specimen. In some embodiments, teeth (13) on the sampler head (8) may also be used to loosen sample material and / or to collect sample material by scraping, e.g., scraping across a specimen to obtain a sample from multiple locations. In preferred embodiments, removing the sampler head from the specimen with a twisting action results in release of the sampler head (8) from the specimen with a minimum of excess stool material on the exterior of the sampler head (8).

[0341] The sampler wand (2) is then re-inserted into the collection tube (3), cap threads (7) are engaged with the tube threads (24) and the cap (5) is rotated with respect to the collection tube (3) until it can no longer be turned, such that the device (1) is completely sealed, and fluid cannot escape. In some embodiments, the device (1) is completely sealed by application of at least about 15 in-lbf torque. In some embodiments, the device (1) is completely sealed by application of about 10 in-lbf to about 25 in-lbf torque. As such, thePATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 device is configured for ease of use by subjects, including subjects with poor hand and / or arm strength, by simple manual manipulation (e.g., rotation) of the cap with respect to the collection tube.

[0342] As the cap (5) is replaced on and secured to the collection tube (3), displacing member (21) is aligned with the sampler head (8) and is forced into sampler head (8) through sampler head opening (14). The displacing member (21) then presses stool material out of the sampler head (8) through ports (11), into a solution, e.g., a buffer contained in the collection tube (3). Forcing sample material through the ports serves to break up and reduce the particle size of the sample, and the solution then acts to further break up, solubilize, and / or suspend the collected sample. In addition, the solution typically comprises components to stabilize, preserve, and / or protect the suspension. In some embodiments, the sample provider further mixes the solution and the collected sample, e.g., by shaking, rotating, or otherwise agitating the sealed device. The sample provider then returns the sealed device (1) containing the collected sample to a laboratory, clinic, or other location for analysis. In some embodiments, the device is designed to be appropriate for return by mail or shipping service.

[0343] Next, the testing facility retrieves all or a portion of the stool suspension for analysis. In some embodiments, the sealed container is shaken, rotated, or vortexed to ensure that the collected sample is completely dispersed or homogenized in the solution. A user or machine withdraws a portion of the suspension (e.g., by a syringe needle or a pipette tip) to collect an aliquot of the suspension for further processing and testing. As illustrated in Fig. 9, the sampler wand (2) is removed from the collection tube (3) to access the mixture of buffer and stool in the collection tube (3). As shown, embodiments of the collection tube (3) are configured to allow a pipet tip to reach the bottom of the collection tube unimpeded, facilitating withdrawal of an aliquot of or essentially all of the suspended material. In some embodiments, a suspension is removed from collection tube (3) without removal of sampler wand (2). For example, in some embodiments, cap (5) or collection tube (3) comprises an openable port that provides access to fluid or suspension contained in the device. In some embodiments, a device may be punctured, e.g., with a needle or canula, for access to fluid or suspension contained in the device. In some embodiments, device (1) comprises a penetrable seal through which a portion of the suspension is obtained. Some embodiments provide thatPATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 the seal is made from foil. However, other materials are appropriate for the device provided the material seals the sample collection chamber while also being penetrable (e.g., by a pipette tip or by a syringe needle) such that a human or machine obtains a portion of the contents sealed within device (1). Some non-limiting examples of materials provided in various embodiments include foil paper, rubber, wax, and plastic, and combinations thereof, e.g., in layered or laminated forms.

[0344] In some embodiments, a cap having an attached sampler wand is replaced by a different cap, e.g., after expulsion of the sample from the sampler head into a solution in the collection tube. Such a replacement cap is preferably one that engages with the collection tube (3) to form a sealed container, but that does not have a sampler wand attached, thereby facilitating or simplifying additional processing steps, e.g., centrifugation and supernatant or pelleted sample acquisition, using the original collection tube (3).

[0345] In some embodiments, some or all of the suspension is poured from the collection tube (3) to a different container or device for further processing steps. After the required aliquot of the suspension is withdrawn, the device may be resealed and any remaining stool sample suspension may then be stored (e.g., heated, ambient, refrigerated, or frozen storage) or used in another process, or discarded, as appropriate.

[0346] While use of the device for stool sample collection is described as one embodiment, the device (1) finds application in sampling any type of similar soft materials, e.g., foods, environmental samples (e.g., soil or biological materials), waste or industrial materials, etc.

[0347] Systems and kits

[0348] The technology finds use in kits comprising embodiments of the devices described and, in some embodiments, optional components such as, e.g., an instruction for use (e.g., providing the steps of a related method) and related packaging for storage, shipping, and the like. Embodiments of the kits may comprise one or more solutions, e.g., comprising a stabilizing reagent, a buffer, a salt, or a preservative for using with (e.g., for treating, homogenizing, preserving, or storing) the collected sample and the analytes it contains.PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 Kits may also comprise other components useful for catching a stool specimen, such as a collection system for use with a commode or toilet for conveniently securing a stool specimen produced by a subject during defecation, such that the collected sample may be collected from the specimen using the technology. Many different suitable commode specimen collectors, e.g., paper or plastic bowls, slings, webs, bags, or other receptacles that fit to a commode or toilet, are available through medical suppliers, pharmacies, and scientific supply companies, or directly from manufacturers, e.g., Therepak Corp., Zymo Research; Alpha Labs; Excretas, HyStool; Abexx; Ability Building Community; or Takahashi Keisei Corp. The stool specimen container of US Pat. No. 10,265,054 is also suitable for use.

[0349] Kits may also provide other items to facilitate use of the device, or shipping and handling of the device before or after use. For example, kits may provide a holder or rack, to hold the device during use (e.g., to stably hold the collection tube in a vertical position, to avoid spillage when the device is not sealed) and / or to secure the sealed device in a shipping container.

[0350] Aspects of the technology are illustrated in U.S. Provisional Application Serial No.

[0351] 63 / 381,031, fded October 26, 2022, U.S. Design Application Ser. No., 29 / 867,482 filed October 26, 2022, Industrial Design Application Ser. No. WTPO132201 / 970181898, filed April 26, 2023, now International Registration No. DM / 231747, and WO 2024 / 092157A1, filed Oct. 26, 2023, each of which is incorporated herein by reference in its entirety, for all purposes.

[0352] As discussed above, technology herein is directed to overcoming the challenge of providing a sample collection device that can be reliably used by any subject in a diverse population of subjects to collect a sample of material, e.g., stool, in a stabilized manner that is suitable for transport, e.g., from a subject’s home or other residence or location, a physician’s office, a clinic, etc., to a medical laboratory using standard commercial shipping methods or public mail. Exemplary embodiments of the device of the technology are shown in Figures 1-55.PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 All literature and similar materials cited in this application, including but not limited to, patents, patent applications, articles, books, treatises, manufacturer publications and product literature, and internet web pages are expressly incorporated by reference in their entirety for any purpose. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of ordinary skill in the art to which the various embodiments described herein belong. When definitions of terms in incorporated references appear to differ from the definitions provided in the present teachings, the definition provided in the present teachings shall control.

[0353] The scope of the present disclosure is not intended to be limited by the specific disclosures of preferred embodiments in this section or elsewhere in this specification, and may be defined by claims as presented in this section or elsewhere in this specification or as presented in the future. The language of the claims is to be interpreted broadly based on the language employed in the claims and not limited to the examples described in the present specification or during the prosecution of the application, which examples are to be construed as non-exclusive.

[0354] Features, materials, characteristics, or groups described in conjunction with a particular aspect, embodiment, or example are to be understood to be applicable to any other aspect, embodiment or example described in this section or elsewhere in this specification unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and / or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and / or steps are mutually exclusive. The protection is not restricted to the details of any foregoing embodiments. The protection extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

[0355] Furthermore, certain features that are described in this disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a singlePATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations, one or more features from a claimed combination can, in some cases, be excised from the combination, and the combination may be claimed as a subcombination or variation of a subcombination.

Claims

PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214CLAIMSWhat is claimed is:

1. A device for collecting and containing a sample, the device comprising a sampler wand comprising a sampler head and a collection tube, wherein the sampler head comprises:i) a sampler head side wall comprising a plurality of ports therethrough;ii) a sampler head closed end; andiii) a sampler head opening bounded by a distal edge;wherein the sampler head side wall, sampler head closed end and sampler head opening define and contain a sampler head interior void having an interior volume,wherein the collection tube comprises a bottom wall joined around a circumference to a tube wall, a top edge of the tube wall defining a tube opening, the collection tube comprising a tube interior void bounded by the tube wall, the tube opening, and the bottom wall, wherein the collection tube comprises:a) a displacing member projecting from the bottom wall into the tube interior void toward the tube opening,b) an alignment element; and / orc) a clocking element.

2. The device of claim 1, wherein the displacing member is formed by an indent formed in the bottom wall of the collection tube and having an indent opening at an exterior surface of the bottom wall, the indent defining an indent void space bounded by the indent opening in the bottom wall.

3. The device of claim 2, wherein the collection tube has a central axis defined by center points of the collection tube opening, the displacing member and the indent opening.

4. The device of claim 3, wherein the alignment element and / or the clocking element are within the indent and project into the indent void space.PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.442145. The device of claim 4, wherein the alignment element comprises anti -rotation elements, preferably a spike comprising anti-rotation elements.

6. The device of claim 5, wherein the spike has a spike central axis that is collinear with the collection tube central axis.

7. The device of any one of claims 4 to 6, wherein the indent comprises a side having a radial distance from the collection tube central axis, wherein the clocking element projects from the side of the indent into the indent void space, wherein the clocking element identifies a rotational position of the device with respect to the tube central axis.

8. The device of any one of claims 1 to 7, wherein the displacing member is formed as an integral part of the collection tube.

9. The device of any one of claims 1 to 8, wherein the alignment element is formed as an integral part of the collection tube.

10. The device of any one of claims 1 to 9, wherein the clocking element is formed as an integral part of the collection tube.

11. The device of any one of claims 1 to 10, wherein the sampler head opening is on a plane defined by the distal edge.

12. The device of any one of claims 1 to 11, wherein the sampler head has a sampler head central axis, wherein the sampler head opening has a center point on the sampler head central axis.

13. The device of any one of claims 1 to 12, wherein the sampler wand comprises a cap.PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.4421414. The device of claim 13, wherein the cap is attached to the sampler head, preferably to the sampler head closed end, by a stem.

15. The device of claim 13 or claim 14, wherein the cap has a center point on a cap central axis, and wherein the sampler wand has a wand central axis defined by the center point of the cap and the center point of the sampler head opening.

16. The device of any one of claims 1 to 15, wherein the distal edge of the sampler head comprises one or more teeth.

17. The device of any one of claims 1 to 16, wherein the sampler head interior void is sized to contain from about 0.1 grams to about 50 grams of sample material, preferably stool sample material.

18. The device of claim 17, wherein the sampler head interior void is sized to contain about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, or 50 grams, including any intermediate fractions thereof, of sample material, preferably stool sample material.

19. The device of claim 18, wherein the sampler head interior void is sized to contain about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 grams, including any intermediate fractions thereof, of sample material, preferably stool sample material.

20. The device of any one of claims 13 to 19, wherein the cap comprises a cap engagement portion and the collection tube comprises a mated engagement portion.

21. The device of claim 20, wherein the cap engagement portion comprises cap threads and wherein the mated engagement portion comprises tube threads.PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.4421422. The device of claim 20 or claim 21, wherein when the cap engagement portion and the mated engagement portion are engaged, the sampler wand and the collection tube form a sealed device.

23. The device of claim 22, wherein the cap comprises a cap click feature and / or the collection tube comprises a tube click feature, wherein, when the cap engagement portion and the mated engagement portion are engaged, the cap click feature and / or the collection tube click feature produce a tactile or audible click that indicate when the sample wand and the collection tube have formed a sealed device.

24. The device of claim 23, wherein the cap click feature interacts with the collection tube click feature to produce the tactile or audible click.

25. The device of claim 22, wherein the cap comprises a cap alignment marking and the collection tube comprises a tube alignment marking, wherein, when the cap engagement portion and the mated engagement portion are engaged, positions of the cap alignment marking and the tube alignment marking indicate when the sample wand and the collection tube have formed a sealed device.

26. The device of any one of claims Ito 25, wherein the collection tube has an interior void bounded by the tube wall, the bottom wall, and a plane defined by the top edge, the tube interior void having an interior void maximum volume of at least 5 mb, preferably between about 5 mb and 250 mb, including any intermediate number of mb or fractions thereof, preferably between about 10 mb and 100 mb, including 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, and 99.999 mb, including any intermediate fractions thereof.PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 27. The device of any one of claims 1 to 26, wherein, when the sampler wand and the collection tube form a sealed device, the displacing member of the collection tube is positioned within the sampler head and fills at least a portion of the sampler head interior void.

28. The device of claim 27, wherein, when the sampler wand and the collection tube form a sealed device, the displacing member of the collection tube fills at least 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90% 95%, 96%, 97%, 98%, 99% of the interior volume of the sampler head interior void.

29. The device of claim 28, wherein the displacing member of the collection tube fills substantially all of the sampler head interior void.

30. The device of any one of claims 26 to 29, wherein the device has a primary remaining volume of the interior void of the collection tube that equals the interior void maximum volume less the interior void volume displaced by a sampler head and sampler stem.

31. The device of claim 30, wherein a ratio (v:v) of the interior void of the sampler head to the primary remaining volume of the interior void of the collection tube is at least about 1:2, preferably between about 1:2 and 1:300, preferably between about 1:2 and 1:100, preferably between about 1:2 and 1:75, 1:50, 1:40, 1:30, 1:20, 1:10, or 1:5.

32. The device of any one of claims 1 to 31, wherein the device further comprises a volume of solution contained in the collection tube.

33. The device of claim 32, wherein a ratio (v:v) of the volume of the interior void of the sampler head to the volume of solution in the collection tube is at least about 1:2, preferably between 1:2 and 1:300 , preferably between 1:2 and 1:100, preferably between 1:2 and 1:75, 1:50, 1:40, 1:30, 1:20, 1:10, or 1:5.PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 34. The device of claim 32 or claim 33, wherein the solution comprises one or more reagents selected from the group consisting of:i) a buffer;ii) a salt;iii) a preservative;iv) a detergent;v) a sugar or polysaccharide;vi) a protoporphyrin;vii) a polyvalent cation;viii) an osmolyte;ix) a horse radish peroxidase (HRP) stabilization component;x) a surfactant;xi) a nuclease inhibitor;xii) a protease inhibitor;xiii) a chelator;xiv) a chaotropic salt;xv) a protein;xvi) a nucleic acid;xvii) an inhibitor binding agent; andxviii) silica particles.

35. The device of any one of claims 1 to 31, wherein the device further comprises at least one dried agent contained in the collection tube.

36. The device of claim 35, wherein the at least one dried agent comprises one or more reagents selected from the group consisting of:i) a buffer;ii) a salt;iii) a preservative;iv) a detergent;PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 v) a sugar or polysaccharide;vi) a protoporphyrin;vii) a polyvalent cation;viii) an osmolyte;ix) a horse radish peroxidase (HRP) stabilization component;x) a surfactant;xi) a nuclease inhibitor;xii) a protease inhibitor;xiii) a chelator;xiv) a chaotropic salt;xv) a protein;xvi) a nucleic acid;xvii) an inhibitor binding agent;xviii) a desiccant; andxvix) silica particles.

37. The device of any one of claims 30 to 36, wherein the device has a secondary remaining volume of the interior void of the collection tube that equals the interior void maximum volume less the volume displaced by a sampler head and sampler stem, less the volume of the sampler head interior void.

38. The device of claim 37, wherein a ratio (v:v) of the interior void of the sampler head to the secondary remaining volume of the interior void of the collection tube is at least about 1:2, preferably between about 1:2 and 1:300, preferably between about 1:2 and 1:100, preferably between about 1:2 and 1:75, 1:50, 1:40, 1:30, 1:20, 1:10, or 1:5.

39. A composition comprising the device of any one of claims 1 to 38, wherein the device comprises a stool sample.

40. The composition of claim 39, wherein the stool sample is from a human subject.PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.4421441. A method of collecting a sample of material, comprising:a) providing a device according to any one of claims 1 to 40;b) collecting an amount of the material within the interior void of the sampler head; andc) inserting the sampler wand into the collection tube and forming a sealed device.

42. The method of claim 41, wherein in the sealed device, the displacing member of the collection tube is positioned within the sampler head, whereby at least a portion of the amount of material collected in the sampler head interior void is expelled from the sampler head interior void through a port in the sampler head and into the collection tube.

43. The method of claim 41, wherein the amount of material contained in the sampler head interior void is a metered sample of the material.

44. The method of claim 41, wherein the amount of material expelled from the sampler head interior void is a metered sample of the material.

45. The method of any one of claims 41 to 44, wherein, when the sampler wand and the collection tube form a sealed device, the displacing member of the collection tube fills at least 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90% 95%, 96%, 97%, 98%, 99% of the interior volume of the sampler head interior void.

46. The method of claim 45, wherein the displacing member of the collection tube fills substantially all of the sampler head interior void.

47. The method of any one of claims 41 to 46, wherein the device comprises a collection tube having an interior void bounded by the tube wall, the bottom wall, and a plane defined by the top edge, the tube interior void having a maximum volume of at least 5 mb,PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 preferably between about 5 mb and 250 mb, including any intermediate number of mb or fractions thereof, preferably between about 10 mb and 100 mL, including 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, and 99.999 mL, including any intermediate fractions thereof.

48. The method of any one of claims 41 to 47, wherein the device further comprises a volume of solution contained in the collection tube.

49. The method of claim 48, wherein a ratio of the volume of the collected sample to the volume of solution in the collection tube (v:v), or a ratio of a mass of collected sample to the volume of solution in the collection tube (w:v) is at least about 1 :2, preferably between 1 :2 and 1:300 , preferably between 1:2 and 1:100, preferably between 1:2 and 1:75, 1:50, 1:40, 1:30, 1:20, 1:10, or 1:5.

50. The method of claim 48 or claim 49, wherein the solution comprises one or more reagents selected from the group consisting of:i) a buffer;ii) a salt;iii) a preservative;iv) a detergent;v) a sugar or polysaccharide;vi) a protoporphyrin;vii) a polyvalent cation;viii) an osmolyte;ix) a horse radish peroxidase (HRP) stabilization component;x) a surfactant;xi) a nuclease inhibitor;xii) a protease inhibitor;PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 xiii) a chelator;xiv) a chaotropic salt;xv) a protein;xvi) a nucleic acid;xvii) an inhibitor binding agent; andxviii) silica particles.

51. A kit for collecting a sample of material, comprising:i) a device of any one of claims 1 to 40; andii) an agent selected from:- a solution, and- a dried agent.

52. The kit of claim 51, wherein the device contains the agent.

53. The kit of claim 52, wherein the agent comprises a solution.

54. The kit of claim 52, wherein the agent comprises a dried agent.

55. The kit of claim 51, wherein the device does not contain the agent.

56. The kit of any one of claims 51 to 53, wherein the agent is a solution comprising one or more reagents from the group consisting of:i) a buffer;ii) a salt;iii) a preservative;iv) a detergent;v) a sugar or polysaccharide;vi) a protoporphyrin;vii) a polyvalent cation;PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214 viii) an osmolyte;ix) a horse radish peroxidase (HRP) stabilization component;x) a surfactant;xi) a nuclease inhibitor;xii) a protease inhibitor;xiii) a chelator;xiv) a chaotropic salt;xv) a protein;xvi) a nucleic acid;xvii) an inhibitor binding agent; andxviii) silica particles.

57. The kit of claim 54, wherein the agent is a dried agent comprising one or more reagents from the group consisting of:i) a buffer;ii) a salt;iii) a preservative;iv) a detergent;v) a sugar or polysaccharide;vi) a protoporphyrin;vii) a polyvalent cation;viii) an osmolyte;ix) a horse radish peroxidase (HRP) stabilization component;x) a surfactant;xi) a nuclease inhibitor;xii) a protease inhibitor;xiii) a chelator;xiv) a chaotropic salt;xv) a protein;xvi) a nucleic acid;PATENT Attorney Docket No. EXCT-44214.601 Applicant Reference No. EXCT-022PCT.44214xvii) an inhibitor binding agent;xviii) a desiccant; andxvix) silica particles.

58. The kit of any one of claims 51 to 57, further comprising one or more of:a) packaging for shipping, storage, or mailing the device;b) printed instructions for collecting a sample using the device;c) a catchment device or container for receiving a specimen deposited on or in the catchment device during defecation and holding the specimen during collection of a sample;d) a holder for holding an unsealed device during collection of a sample from a specimen; ande) a holder for securing a sealed device in a shipping container.

59. A method of processing a stool sample, the method comprising,a) obtaining a stool sample by the method of any one of claims 41 to 50; and b) testing the stool sample for an amount and / or presence of one or more analytes, wherein the analytes comprise one or more of the following:i) a nucleic acid;ii) a protein;iii) a lipid ;iv) a carbohydrate; andv) a metabolite.

60. The method of claim 59, wherein the nucleic acid comprises DNA and / or RNA.

Images