Foldable stool specimen collecting device

Abstract

Devices, systems, kits, and methods for stool sample collection, in particular devices that reversibly attach to a toilet to facilitate collecting, preferably at-home collecting, of a stool specimen from a subject, and for holding the specimen during sampling.

Description

[0001] PATENT Attorney Docket No.: EXCT-43060.601

[0002] FOLDABLE STOOL SPECIMEN COLLECTING DEVICE

[0003] The present application claims priority to U.S. Provisional Application Serial No. 63 / 724,775, filed November 25, 2024, and to U.S. Design application Ser. No. 29 / 974,823, filed November 25, 2024, and to WIPO 163884, filed May 24, 2025 and having International Registration No. DM / 251260, each of which is incorporated herein by reference in its entirety.

[0004] FIELD OF THE INVENTION

[0005] The present disclosure relates to devices, systems, kits, and methods for stool sample collection. In particular, the disclosure relates to devices that reversibly attach to a toilet to facilitate collection, preferably at-home collection, of a stool sample from a subject.

[0006] BACKGROUND OF THE INVENTION

[0007] Diagnostic testing often requires isolating and assaying analytes such as biomolecules from a specimen (e.g., tissue, cells, body fluid, stool) collected from a subject. Biomolecules for analysis include, e.g., nucleic acids, proteins, fats, or other molecules present in the specimen. Collection of stool samples often involves use of a device, e.g., a plastic or paperboard basket, or paper sling, collectively referred to as “catchments,” to catch and hold stool during defecation by a subject, such that a sample of the whole stool can be removed e.g., using a small spoon, paddle, brush, swab, or the like. In a medical setting, large rigid catchments, e.g., of molded cardboard or plastic, are typically used. However, these may be difficult to dispose of in a home setting. Soft paper catchments have been used, but these are often difficult to unfold, attach, and / or remove, and the use thereof can be confusing for a subject. Moreover, such paper catchments lack durability and may fail or rupture during stool sampling, especially in the presence of liquid (e.g., urine, or liquid stool). PATENT

[0008] Attorney Docket No.: EXCT-43060.601

[0009] SUMMARY OF THE INVENTION

[0010] Provided herein are devices, systems, kits, and methods for collecting or removing a portion of a deposited stool. In particular, the technology provides foldable specimen collecting devices (referred to interchangeably as catchment devices) that are foldable for compactness (e.g., take up minimal space in a packaged stool collection kit), easy to unfold and use, and that enhance sample quality by avoiding mixing of stool specimens with urine and / or toilet water. The foldable specimen collecting devices of the technology are sufficiently durable to receive a deposited stool, e.g., during defecation by a subject, and to hold the deposited stool during subsequent manipulation, e.g., scraping, poking, coring, etc., to remove one or more portions of stool therefrom, e.g., for further analyses, yet are preferably composed substantially of flushable and / or recyclable and / or biodegradable materials. Exemplary embodiments include but are not limited to:

[0011] 1. 1. A device for collecting deposited stool from a subject, the device comprising a frame comprising a specimen support surface and one or more adhesive tabs configured to reversibly affix the frame to a toilet.

[0012] 2. The device of embodiment 1, further comprising a liner covering the specimen support surface of the frame, the liner comprising a specimen contact surface.

[0013] 3. The device of embodiment 2, wherein the liner is reversibly affixed to the frame.

[0014] 4. The device of embodiment 2 or embodiment 3, wherein the liner is flushable.

[0015] 5. The device of any one of embodiments 1-4, wherein when the frame is reversibly affixed to the toilet, the specimen support surface is positioned within a central opening of a toilet seat, and below a rim of a toilet bowl.

[0016] 6. The device of any one of embodiments 1-5, wherein the frame is foldable to a 2D configuration and unfoldable to a 3D configuration. PATENT Attorney Docket No.: EXCT-43060.601

[0017] 7. The device of any one of embodiments 1-6, wherein the frame comprises paperboard.

[0018] 8. The device of embodiment 7, wherein the paperboard comprises solid bleached sulfate (SBS) board, preferably having a caliper (pt or mil) of about 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 or 28pt or any fraction therein, preferably 6pt to 28pt or any fraction therebetween, preferably lOpt to 20pt or any fraction therebetween, preferably 14pt to 18pt or any fraction therebetween, preferably 16pt.

[0019] 9. The device of embodiment 7 or embodiment 8, wherein the paperboard is water- resistant.

[0020] 10. The device of any one of embodiments 7-9, wherein the paperboard is semi-rigid.

[0021] 11. The device of any one of embodiments 1-10, wherein the frame comprises at least two side tabs.

[0022] 12. The device of any one of embodiments 1-11, wherein the frame comprises at least one back tab.

[0023] 13. The device of any of embodiments 1-12, further comprising a one-piece liner adhesive.

[0024] 14. The device of embodiment 13, wherein the one-piece liner adhesive comprises a temporary adhesive side and a permanent adhesive side.

[0025] 15. The device of any of embodiments 1-14, wherein the frame comprises a back wall, two side walls, and an open side.

[0026] 16. The device of any of embodiments 1-15, wherein the frame is water resistant on one side or both sides. PATENT Attorney Docket No.: EXCT-43060.601

[0027] 17. The device of any of embodiments 2-16, wherein the liner comprises a nonwoven fabric.

[0028] 18. The device of embodiment 17, wherein the liner is biodegradable.

[0029] 19. The device of embodiment 17 or embodiment 18, wherein the liner has an overhang over an open end of the frame.

[0030] 20. The device of any one of embodiments 1-19, wherein when the frame is affixed to a toilet, the frame of the device withstands a pressure applied to the specimen support surface of at least 2.5 kgF (kilogram force units) without rupturing or tearing.

[0031] 21. A method of collecting a stool sample, comprising: on a device of any one of embodiments 1-20, wherein the device is reversibly affixed to a toilet, producing a deposited stool on a specimen support surface of a frame of the device or on a specimen contact surface of a liner of the device.

[0032] 22. A method of collecting a stool sample, comprising: i) reversibly affixing a device of any one of embodiments 1-20 to a toilet; and ii) producing a deposited stool on the device, preferably on a specimen support surface of a frame or on a specimen contact surface of a liner of the device.

[0033] 23. A method of collecting a stool sample, comprising removing a portion of deposited stool from a device of any one of embodiments 1-20, preferably from a specimen support surface of a frame of the device or from a specimen contact surface of a liner of the device, preferably wherein the device is reversibly affixed to a toilet, wherein the removing provides a removed portion. PATENT

[0034] Attorney Docket No.: EXCT-43060.601

[0035] 24. A method of collecting a stool sample, comprising: i) reversibly affixing a device of any one of embodiments 1-20 to a toilet, wherein a subject produces a deposited stool on the device, preferably on a specimen support surface of a frame of the device or on a specimen contact surface of a liner of the device; and ii) removing a portion of deposited stool from the device to provide a removed portion.

[0036] 25. The method of embodiment 23 or embodiment 24, further comprising placing the removed portion of stool into a sealable container.

[0037] 26. The method of embodiment 25, wherein the sealable container contains a stabilization buffer.

[0038] 27. The method of embodiment 23 or embodiment 24, further comprising contacting the removed portion with a surface, preferably a slide or card surface.

[0039] 28. A kit comprising the device of any one of embodiments 1-20, further comprising instructions for use.

[0040] 29. The kit of embodiment 28, further comprising a sampling device for removing a portion of a deposited stool.

[0041] 30. The kit of embodiment 29, wherein the sampling device comprises a spoon, a swab, a FIT tube device, a sampling wand, or a sampling wand device comprising a sampling wand and a collection tube.

[0042] 31. The kit of any one of embodiments 28-30, further comprising one or more solutions. PATENT

[0043] Attorney Docket No.: EXCT-43060.601

[0044] 32. The kit of embodiment 31, wherein the one or more solutions comprise 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) an inhibitor binding agent; and xvi) an antimicrobial agent.

[0045] 33. The kit of any one of embodiments 28-32, further comprising shipping materials for shipping one or more removed samples of stool.

[0046] 34. A system comprising the device of any one of embodiments 1-20, and instructions for use.

[0047] 35. The system of embodiment 34, further comprising a sampling device for removing a portion of deposited stool.

[0048] 36. The system of embodiment 35, wherein the sampling device comprises a spoon, a swab, a FIT tube device, a sampling wand, or a sampling wand device comprising a sampling PATENT

[0049] Attorney Docket No.: EXCT-43060.601 wand and a collection tube.

[0050] 37. The system of any one of embodiments 34-36, further comprising one or more solutions.

[0051] 38. The system of embodiment 37, wherein the one or more solutions comprise 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) an inhibitor binding agent; and xvi) an antimicrobial agent.

[0052] 39. A method of manufacturing a foldable device, the method comprising: i) providing a flat assembly comprising a frame adhered to a first side of a liner adhesive and a liner adhered to a second side of the liner adhesive; ii) folding the flat assembly in one or more folding steps; iii) removing a release liner from a frame adhesive positioned on the frame at a first frame adhesive binding site; and PATENT

[0053] Attorney Docket No.: EXCT-43060.601 iv) folding a portion of the device to attach a second frame adhesive binding site to the frame adhesive; wherein the method produces the foldable device in a folded configuration; and wherein the device unfolds into a three-dimensional collecting configuration.

[0054] 40. The method of embodiment 39, wherein the first side of the liner adhesive comprises a permanent adhesive or a temporary adhesive.

[0055] 41 . The method of embodiment 39, wherein the second side of the liner adhesive comprises a permanent adhesive or a temporary adhesive.

[0056] 42. The method of embodiment 39, wherein frame comprises at least two tabs, preferably three tabs.

[0057] 43. A method of manufacturing a foldable device, the method comprising: i) folding a frame in one or more folding steps; ii) removing a release liner from a frame adhesive positioned on the frame at a first frame adhesive binding site; and iii) folding a portion of the frame to attach a second frame adhesive binding site to the frame adhesive; wherein the method produces the foldable device in a folded configuration; and wherein the device unfolds into a three-dimensional collecting configuration.

[0058] 44. The method of embodiment 43, wherein frame comprises at least two tabs, preferably three tabs. PATENT Attorney Docket No.: EXCT-43060.601

[0059] BRIEF DESCRIPTION OF THE DRAWINGS

[0060] Figs. 1A-1D illustrate steps of using an embodiment of device (1). Fig. 1A shows the device (1) in its flat or “2D” folded form, e.g., as received by a subject. Fig. IB shows the device in its unfolded form, with a semi-rigid frame (2) and with a liner (3) within the frame (2). A user peels release liner (14) from the side and back tabs (4) to expose an adhesive surface, and the tabs are reversibly affixed to the seat of a commode or toilet, as shown in Fig. 1C. After defecation of a stool onto the liner (3) and removal of one or more samples, a user releases the liner (3) from the frame (2) and deposits the liner (3) and the remaining stool material into the toilet for disposal. The frame (2) may then be removed from the toilet seat, e.g., by peeling at the points of adhesive contact of the tabs (4), for disposal or recycling.

[0061] Figs. 2A-2F illustrate a first manner of folding an embodiment of the device (1) into a flattened or “2D” form, e.g., for shipping or for packaging in a kit for sample collection. In panel A, the semi-rigid frame is in an unfolded configuration having a box-like or bowl-like structure. Creases in the sides of device (1) allow the side walls (6a, 6b) to interleave and to flatten against back wall (5) of the device (Figs. 2B-2E). Fig. 2F shows the back tab (4b) folded back against the backside of back wall (5). Unfolding the device (1), e.g., before use for stool collection, may be accomplished by performing the illustrated steps in reverse.

[0062] Figs. 2G-2L illustrate a second manner of folding an embodiment of the device (1) into a flattened or “2D” form. In panel 2G, the semi-rigid frame is in an unfolded configuration having a box-like or bowl-like structure. Panels 2H and 21 illustrate how creases in the sides of device (1) allow the back panel (5) to fold down to meet the specimen support surface (7), and for the side walls (6a, 6b) to fold on themselves and to tuck underneath the outside of the specimen support surface (7), to arrive at the flattened arrangement shown in different views in panels 2J-2L. Unfolding the device (1), e.g., before use for stool collection, may be accomplished by performing the illustrated steps in reverse.

[0063] Fig. 3 illustrates a flat section of paperboard, cut, and creased to form an embodiment of the frame (2). The dashed lines show the location of creases to facilitate folding the paperboard into the 3D structure of the frame. In the embodiment illustrated, each side wall PATENT Attorney Docket No.: EXCT-43060.601 of the 3D assembled frame (2) is formed from two portions of side wall that overlap and are joined, e.g., with adhesive. The two portions of side wall (6a) are joined to each other as indicated by the curved arrow in Fig. 3, and the two portions of side wall (6b) indicated by lines in Fig. 3 are similarly joined to each other forming a box-like or bowl-like 3D structure, e.g., as shown in Fig. 9B and 10, having a specimen support surface (7). Specimen support surface (7) has a front curve (8). In the embodiment shown, frame (2) includes corner panels (5a, 5b) that, in the assembled frame, are disposed between back wall (5) and the side walls (6a, 6b). Use of one or more corner panels between the side walls and back wall may round out the corners of the frame into a more bowl-like structure.

[0064] Fig. 4 illustrates an embodiment for forming the side walls of frame (2) using adhesive, in which adhesive binding site (10a) is adhered to adhesive binding site (10b) on the underside of frame (2) using a strip of adhesive (9). Likewise, adhesive binding site (10c) is adhered to adhesive binding site (lOd) on the underside of frame (2) using a strip of adhesive (9).

[0065] Fig. 5 illustrates exemplary locations of adhesive for reversibly affixing a liner (3) to frame (2). Liner adhesives (12a-12e), e.g., adhesive strips, positioned on frame (2) are indicated.

[0066] Figs. 6A-6B illustrate a reverse side of the frame (2) shown in Figs. 2-5, showing an embodiment of placement of adhesives (13a-l 3c) on the tabs (4a-4c). Fig. 6B is a detail view of one tab (4) having adhesive (13) covered by a release liner (14). In this embodiment, the release liner (14) extends beyond the outer edge of tab (4) for easy removal.

[0067] Fig. 7 shows an embodiment of frame (2) having tab printing (15), e.g., with instructive text on each tab (4a-4c), for positioning the device on a toilet seat, as illustrated in Fig. 1C. Other markings, e.g., tick marks (16), may optionally be included, e.g., to facilitate alignment of adhesive strips, folds, disposable liners, etc.

[0068] Fig. 8 provides an exemplary embodiment of a liner (3), for covering the specimen support surface, back wall, and at least portions of the side walls of a frame (2), e.g., as illustrated in Figs. IB and 9E. The portion of the liner (3) that covers the specimen support surface (7) of frame (2) (e.g., as shown in Fig. 3) provides a specimen contact surface (11) PATENT Attorney Docket No.: EXCT-43060.601 that receives and directly contacts a deposited stool during use. A front curve (3f) of the specimen contact surface (11) of the liner generally follows the front curve (8) of the specimen support surface (7) of the frame (2) (frame not shown here).

[0069] Figs. 9A-9E illustrate the parts of an embodiment of a device (1) as they are arranged in an assembled device. Tn the illustrated embodiment, the side walls (6a, 6b) and the back wall (5) of frame (2) shown in Fig. 9A are joined as described above to provide the box or bowl-like structure shown in Fig. 9B. In one embodiment, liner adhesive strips applied to the frame (2) affix the liner (3) to the frame (Fig. 9C), with specimen contact surface (11) of the liner (3) covering the specimen support surface (7) of frame (2) (Fig. 9D). In some embodiments, the liner is configured to tear away from the frame, e.g., for disposal of a residual portion of a stool specimen into the toilet bowl. In some embodiments, a reversible adhesive is used, and in some embodiments, the liner comprises perforations to allow tearing of a predetermined portion of the liner. See, e.g., Fig. 11, showing perforations (3b) in the liner (3). The back side of each of the three tabs (4a-4c) of the frame (2) are provided with adhesive strips (Fig. 9E), as described above in reference to Figs. 6A-6B. The partially- assembled components of Figs. 9A-9E are provided by way of illustrating relationships between different components of the embodiment of device (1), and not by way of limiting the technology, e.g., to any particular order of steps for assembling the components to form the device.

[0070] Fig. 10 shows a top perspective view of an embodiment of device (1) comprising frame (2) and liner (3). The frame (2) comprises side walls (6a, 6b) and back wall (5) separated by corner panels (5a, 5b). Side walls (6a, 6b) and back wall (5) are attached to tabs (4a, 4c, 4b), respectively. As shown, the tabs (4a, 4b, 4c) on the frame show an embodiment of a release liner (14) extending beyond the outer edge of the tab. The upper sides of each tabs (4a, 4b, 4c) include tab printing (15) with information for the user regarding positioning and adhering device (1) to a toilet seat for use. In some embodiments, tabs (4a, 4b, 4c) are formed as an integral part of the frame (2), while in some embodiments, the tabs are formed separately and attached to the frame, e.g., by adhesive. In some embodiments, the tabs are formed from adhesive material, e.g., adhesive tape, (see, e.g., Fig. 19, an exploded view of the device in which the tabs are shown as separate parts of the frame). A flushable liner (3), PATENT Attorney Docket No.: EXCT-43060.601 shown in white, is positioned within the frame (2), and provides a specimen contact surface (11) that covers the specimen support surface (7) of the frame (2). The liner (3) includes a liner tab (3a) near but not adhered to the back tab (4b), so that the liner is easily grasped for removal and disposal after use. The front of the specimen contact surface (11) of liner (3) has a curve that follows the front curve (8) of the support surface (7) of the frame (2). In the illustrated embodiment, the frame (2) includes an open side at least partially defined by the front curve (8).

[0071] Fig. 11 A shows a top perspective view of an embodiment of device (1) comprising frame (2) and liner (3). In the embodiment illustrated, the liner (3) comprises perforations (3b, 3c) so that pulling forward on liner tab (3a) causes the liner (3) to tear along the perforations such that the specimen contact surface (11) of the liner and any specimen upon it are separated from the frame (2), e.g., for easy disposal in the toilet bowl. The liner (3) preferably has a front curve (3f) that generally follows front curve (8) of the frame (2) The perforations comprise a series of holes or cuts in the liner material, e.g., to facilitate tearing and to control where tearing occurs. The spacing between the holes or cuts in the perforated liner material and / or the size of the holes or lengths of the cuts used in the perforations, may be uniform, or they may vary in different parts of the liner. For example, the cut lengths and / or spacing of perforations (3b) on the liner back panel (3d) may be the same or different as the cut lengths and / or spacing of perforations (3c) on the side panel (3e) of the liner (3). Cut perforations are not limited to any particular length or distribution, and may be, for example, 10, 20 30 or more millimeters in length. In exemplary embodiments the cut perforations are about 0.5 to 20 mm in length, preferably about 1 to 15 mm, preferably about 1 to 10 mm, preferably about 2 to 9 mm, preferably about 3 to 8 mm, or any fractional length therebetween. In some embodiments, perforation cuts on the back panel (3d) are longer than the perforation cuts on the side panels (3e) of the liner (3), or vice versa. For example, in some embodiments, perforations (3b) comprise cuts of about 6 mm, while perforations (3c) comprise cuts of about 3 mm. Dashed double-headed arrows show width (18) of the opening of the unfolded device, length (19) of a specimen support surface (7), and vertical depth (20) of the device from the top of the sides to the specimen support surface.

[0072] Fig. 1 IB shows a top perspective view of an embodiment of the device. PATENT

[0073] Attorney Docket No.: EXCT-43060.601

[0074] Fig. 11C shows a bottom perspective view of an embodiment of the device.

[0075] Fig. 12 shows a front view of an embodiment of the device.

[0076] Fig. 13 shows a back view of an embodiment of the device.

[0077] Fig. 14 shows a right side view of an embodiment of the device.

[0078] Fig. 15 shows a left side view of an embodiment of the device.

[0079] Fig. 16 shows a top view of an embodiment of the device.

[0080] Fig. 17 shows a bottom view of an embodiment of the device.

[0081] Fig. 18 shows an exploded view of an embodiment of the device.

[0082] Fig. 19 shows an exploded view of an embodiment of the device.

[0083] Fig. 20 shows a front view of an embodiment of the device wherein the foldable collecting device is in a folded configuration.

[0084] Fig. 21 shows a back view of an embodiment of the device wherein the foldable collecting device is in a folded configuration.

[0085] Fig. 22 shows a front view of an embodiment of the device wherein the foldable collecting device is in a folded configuration.

[0086] Fig. 23 shows a back view of an embodiment of the device wherein the foldable collecting device is in a folded configuration.

[0087] Fig. 24 shows a front view of an embodiment of the device wherein the foldable collecting device is in a folded configuration.

[0088] Fig. 25 shows a back view of an embodiment of the device wherein the foldable collecting device is in a folded configuration.

[0089] Figs. 26A-26D show side views of an embodiment of the device wherein the foldable collecting device is in a folded configuration.

[0090] Figs. 27A and 27B show top perspective views of an embodiment of the frame (2) of device (1). The dashed line in Fig. 27A indicates the position of a liner. PATENT

[0091] Attorney Docket No.: EXCT-43060.601

[0092] Fig 28 shows a bottom perspective view of an embodiment of a frame (2) of the device.

[0093] Fig. 29 shows a front view of an embodiment of the frame of the device.

[0094] Fig. 30 shows a back view of an embodiment of the frame of the device.

[0095] Fig. 31 shows a right side view of an embodiment of the frame of the device.

[0096] Fig. 32 shows a left side view of an embodiment of the frame of the device.

[0097] Fig. 33 shows a top view of an embodiment of the frame of the device.

[0098] Fig. 34 shows a bottom view of an embodiment of the frame of the device.

[0099] Fig. 35 shows a top perspective view of an embodiment of the device.

[0100] Fig. 36 shows a top perspective view of an embodiment of the device.

[0101] Fig. 37 shows a bottom perspective view of an embodiment of the device.

[0102] Fig. 38 shows a front view of an embodiment of the device.

[0103] Fig. 39 shows a back view of an embodiment of the device.

[0104] Fig. 40 shows a right side view of an embodiment of the device.

[0105] Fig. 41 shows a left side view of an embodiment of the device.

[0106] Fig. 42 shows a top view of an embodiment of the device.

[0107] Fig. 43 shows a bottom view of an embodiment of the device.

[0108] Fig. 44 shows an exploded view of an embodiment of the device.

[0109] Fig. 45 shows an exploded view of an embodiment of the device.

[0110] Fig. 46 shows a front view of an embodiment of the device wherein the foldable collecting device is in a folded configuration.

[0111] Fig. 47 shows a back view of an embodiment of the device wherein the foldable collecting device is in a folded configuration. PATENT

[0112] Attorney Docket No.: EXCT-43060.601

[0113] Fig. 48 shows a front view of an embodiment of the device wherein the foldable collecting device is in a folded configuration.

[0114] Fig. 49 shows a back view of an embodiment of the device wherein the foldable collecting device is in a folded configuration.

[0115] Figs. 50A-50D show side views of an embodiment of the device wherein the foldable collecting device is in a folded configuration.

[0116] Fig. 51 shows a top perspective view of an embodiment of the device.

[0117] Fig. 52 shows a front view of an embodiment of the device wherein the foldable collecting device is in a folded configuration.

[0118] Fig. 53 shows a back view of an embodiment of the device wherein the foldable collecting device is in a folded configuration.

[0119] Figs. 54A-54D show side views of an embodiment of the device wherein the foldable collecting device is in a folded configuration.

[0120] Fig. 55 shows an exploded view of an embodiment of the device.

[0121] Fig. 56 shows a top perspective view of an embodiment of the frame (2) of device (1).

[0122] Fig. 57 shows a top perspective view of an embodiment of the frame of the device, with the dashed line indicating the position of a liner.

[0123] Fig. 58 shows a top perspective view of an embodiment of the frame of the device, with the dashed lines indicating the positions of release liners that cover mounting adhesives.

[0124] Fig 59 shows a bottom perspective view of an embodiment of the frame of the device.

[0125] Fig. 60 shows a front view of an embodiment of the frame of the device.

[0126] Fig. 61 shows a back view of an embodiment of the frame of the device.

[0127] Fig. 62 shows a right side view of an embodiment of the frame of the device.

[0128] Fig. 63 shows a left side view of an embodiment of the frame of the device.

[0129] Fig. 64 shows a top view of an embodiment of the frame of the device. PATENT Attorney Docket No.: EXCT-43060.601

[0130] Fig. 65 shows a bottom view of an embodiment of the frame of the device.

[0131] Fig. 66 shows a top perspective view of an embodiment of the liner of the device, with the dashed line indicating the position of a frame.

[0132] Fig. 67 shows a top perspective view of an embodiment of the liner of the device.

[0133] Fig 68 shows a bottom perspective view of an embodiment of the liner of the device.

[0134] Fig. 69 shows a front view of an embodiment of the liner of the device.

[0135] Fig. 70 shows a back view of an embodiment of the liner of the device.

[0136] Fig. 71 shows a right side view of an embodiment of the liner of the device.

[0137] Fig. 72 shows a left side view of an embodiment of the liner of the device.

[0138] Fig. 73 shows a top view of an embodiment of the liner of the device.

[0139] Fig. 74 shows a bottom view of an embodiment of the liner of the device.

[0140] Fig. 75A shows an embodiment of the foldable device (1) during assembly, comprising a frame (2) layer and a liner (3) layer, and further comprising two side attachment tabs and one back attachment tab, each having a release liner that covers mounting adhesive on the back or underside of each attachment tab. The liner (3) is shown transparent in order to show the alignment of the one-piece liner adhesive (17) and the frame (2). Side and back tabs (4a, 4b, 4c) are shown, each with peelable release liner (14) on the underside, and frame adhesive binding sites (10a, 10c) are indicated.

[0141] Fig. 75B shows a top perspective view of the same assembly shown in Fig. 75A.

[0142] Fig. 76 shows an embodiment of the frame of the device and the liner adhesive (17). The one piece liner adhesive (17) is centered left-to right with the frame (2) and is attached to the frame on a permanent adhesive side. Frame adhesive binding sites (10) are indicated.

[0143] Fig. 77A shows an embodiment of the foldable device during assembly, comprising a frame layer and a liner layer, and further comprising two side attachment tabs and one back attachment tab, each having a release liner that covers mounting adhesive on the back or underside of each attachment tab. The liner is shown transparent in order to show the PATENT Attorney Docket No.: EXCT-43060.601 alignment of the one-piece liner adhesive (17) and the frame (1). The tabs (4a, 4b, 4c) are applied at corresponding locations and placed according to a general layout shown. The one- piece liner adhesive (17) and the liner (3) are centered (left-to-right) as viewed from Fig. 77A on the frame (2). In the illustrated embodiment, the liner (3) overhangs the frame (2) at the bottom (e.g., over the open end) by approximately 5 mm. The temporary adhesive side of the one-piece liner adhesive (17) bonds to the liner (3) and the permanent adhesive side bonds to the frame (2). Frame adhesive binding sites (10a, 10c) are indicated.

[0144] Fig. 77B is an exploded view of the foldable device of Fig. 77A, and additionally shows a strip of frame adhesive (9) to be aligned with a frame adhesive binding site (10).

[0145] Fig. 78 illustrates a bottom view of the foldable device of Fig. 77A. In the illustrated embodiments, the adhesive on the distal-most regions of the attachment tabs (4a, 4b, 4c) are deadened with a printable substrate to generate a non-stick region. In some embodiments, coloration can be added to match the overall design. After assembly, there is preferably a gap of approximately 2 mm of exposed adhesive between the peel-off portion of release liner (14) and the body of frame (2) to accommodate ease of folding. Frame adhesive binding sites (10b, lOd) are indicated.

[0146] Fig. 79 illustrates a manner of folding an embodiment of the device (1) into a flattened or “2D” form, e.g., for shipping or for packaging in a kit for sample collection. The flat assembly shown in STEP A is folded as shown in Fig. 79, and attachment of the frame adhesive binding sites to each other as depicted in Fig. 79 steps I-J, put the device in a final assembled form, with step K (tucking down the back tab) putting the device in a final folded form. Upon unfolding, the device is in the 3D form shown, e.g., in Figs. 35-43. An embodiment of the final folded form is shown in Figs. 80A-80B.

[0147] Fig. 80A shows a front view of the device illustrated in Fig. 79, wherein the foldable collecting device is in a folded configuration.

[0148] Fig. 80B shows a side view of the device illustrated in Fig. 79, wherein the foldable collecting device is in a folded configuration.

[0149] Fig. 80C shows a back view of the device illustrated in Fig. 79, wherein the foldable collecting device is in a folded configuration. PATENT

[0150] Attorney Docket No.: EXCT-43060.601

[0151] Fig. 81 is a front view of a frame (2) of the foldable collecting device of FIG. 77A.

[0152] Fig. 82 is a front view of a liner (3) of the foldable collecting device of FIG. 77A.

[0153] Fig. 83 is a front view of a one-piece liner adhesive (17) of the foldable collecting device of FIG. 77A.

[0154] Fig. 84A is a front view of attachment tab (4a) of the foldable collecting device of Fig. 77A showing release liner (14).

[0155] Fig. 84B is back view of attachment tab (4a) of the foldable collecting device of Fig. 77A showing release liner (14).

[0156] Fig. 85A is a front view of attachment tab (4b) of the foldable collecting device of Fig. 77A showing release liner (14).

[0157] Fig. 85B is back view of attachment tab (4b) of the foldable collecting device of Fig. 77A showing release liner (14).

[0158] Fig. 86A is a front view of attachment tab (4c) of the foldable collecting device of Fig. 77A showing release liner (14).

[0159] Fig. 86B is back view of attachment tab (4c) of the foldable collecting device of Fig. 77A showing release liner (14).

[0160] DEFINITIONS

[0161] 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.

[0162] Throughout the specification and claims, the following terms take the meanings explicitly associated herein, unless the context clearly dictates otherwise.

[0163] The phrase “in one embodiment” as used herein does not necessarily refer to the same embodiment, though it may. Furthermore, the phrase “in another embodiment” as used herein does not necessarily refer to a different embodiment, although it may. Thus, as described below, various embodiments of the technology may be readily combined, without departing from the scope or spirit of the technology. PATENT

[0164] Attorney Docket No.: EXCT-43060.601

[0165] In addition, as used herein, the term “or” is an inclusive “or” operator and is equivalent to the term “and / or” unless the context clearly dictates otherwise. The term “based on” is not exclusive and allows for being based on additional factors not described unless the context clearly dictates otherwise. In addition, throughout the specification, the meaning of “a,” “an,” and “the” include plural references. The meaning of “in” includes “in” and “on.”

[0166] 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.

[0167] The transitional phrase "consisting of' excludes any element, step, or ingredient not specified in the claim.

[0168] The transitional phrase “consisting essentially of’ as used in claims in the present application 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, as discussed in In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976). For example, a composition “consisting essentially of’ recited elements may contain an unrecited contaminant at a level such that, though present, the contaminant does not alter the function of the recited composition as compared to a pure composition, i.e., a composition “consisting of’ the recited components.

[0169] 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; eukaryotic 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. 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 PATENT Attorney Docket No.: EXCT-43060.601 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, etc.). 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.

[0170] The term “assaying” as used herein in reference to cell samples refers to qualitatively assessing or quantitatively measuring an aspect of a sample, e.g., assessing or measuring the presence, amount, state, or functionality of a target entity, e.g., a biomarker.

[0171] As used herein, the terms “patient” or “subject” refer to an organism from whom a stool sample is collected using the devices and methods provided herein. In some embodiments, the subject is both the person who deposits stool onto the sample surface of the device 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.

[0172] As used herein, the term “stool sample” or “fecal sample” are used interchangeably herein 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.

[0173] As used herein, the terms “deposited stool” and “stool specimen” are used interchangeably and refer to stool material deposited on a specimen contact surface (11) of a device (1) by a user (e.g., a subject or patient) during defecation, including but not limited to PATENT Attorney Docket No.: EXCT-43060.601 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 thereof.

[0174] 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.

[0175] As used herein, the term “residual stool” and “residual specimen” refer to deposited stool from which one or more portions have been removed, e.g., by scraping, poking, coring, cutting, scooping, brushing, etc.

[0176] 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.

[0177] The term “reversibly affixed” as used herein refers to attachments, preferably adhesive attachments, that attach one component to another in a manner in which the components can be separated from each other without damage (e.g, tearing, stretching), to the components, including, e.g., using clips, hooks, folds, tucks, adhesives, tapes, loops, etc.

[0178] The term “foldable” with relation to a device (1) or frame (2) indicates that any one or more areas of the device or frame can be folded into a flattened configuration, e.g., for ease of shipping, and that the same areas can be unfolded prior to use such that the device or frame can be placed onto a toilet for use, as described herein. In some embodiments, the frame (2) comprises one or more creases or junctions that facilitate folding and unfolding into the desired flattened (“2D”) and bowl-like (“3D”) configurations.

[0179] As used herein in reference to the device, the term “frame” refers to a structural component that gives shape and support to a liner. PATENT Attorney Docket No.: EXCT-43060.601

[0180] As used herein in reference to a device (1), a “liner” refers to an object or material that covers at least a portion of the frame of the device, preferably at least a portion of a specimen support surface. In preferred embodiments, a liner comprises or is composed of disposable material, preferably flushable material, e.g., a material certified as flushable and septic safe based on industry and / or regulatory standards. For example, one set of flushability standards has been jointly developed by the Association of the Nonwoven Fabrics Industry (IND A) and the European Disposables and Nonwovens Association (EDANA). A second set of more rigorous standards was developed by the International Water Services Flushability Group (IWSFG). Detailed test methods have been developed to determine whether a nonwoven material meets these flushability standards. INDA / EDANA International Standards of Flushability provides guidelines for assessing flushability (see, e.g., world wide web at edana<dot>org / docs / default-source / product-stewardship / l-guidelines-for-assessing- the-flushability-of-disposable-nonwoven-products-ed-4-ex-cop.pdf?sfvrsn=a23eca32_2 / ).

[0181] In some embodiments, a liner comprises or is composed of woven or nonwoven fabric, preferably nonwoven fabric, including cellulose-rich wet-laid dispersible nonwovens, multi-ply dispersible nonwovens, short-fiber cellulose blends having enhanced dispersibility, and nonwovens of air-laid pulp with dispersible binders. In particularly preferred embodiments, a liner comprises or is composed of plant fibers, such as wood pulp cellulose, regenerated cellulose (e.g., viscose, rayon) lyocell, natural fibers (e.g., bast, hemp, flax, bamboo) and / or biobased fibers such as polylactic acid (PLA) fibers, in, e.g., nonwoven fabric, preferably spunlace nonwoven fabric formed by hydroentanglement of fibers.

[0182] As used herein, the term “nonwoven” as used in reference to materials such as fabric used in a device (1), e.g., in a frame (2) and / or liner (3), refers to a textile or fabric that is formed from fiber without forming yam, e.g., it is composed of fibers that have been adhered or bonded to form a web without first forming threads or yarns, e.g., for knitting or weaving. Fibers may be bonded by a number of methods, including mechanically (entangling fibers physically, including e.g., needle punching to interlock fibers, and hydroentangling using, e.g., high-pressure waterjets); thermally (e.g., using heat to fuse fibers); and chemically (e.g., using adhesives or binders). Nonwoven fabrics include but are not limited to spun-bond nonwoven, spun-lace nonwoven, melt-blown nonwoven, air-laid nonwoven, wet-laid PATENT Attorney Docket No.: EXCT-43060.601 nonwoven, and stitch-bonded non-wovens. Fiber material may be natural (e. ., wool, cotton, silk, cellulose, wood pulp, bamboo, viscose, etc.) or synthetic (e.g., polyesters, polypropylene, etc.)

[0183] The term “adhesive” as used herein refers to any substance that is capable of holding materials together in a functional manner by surface attachment that resists separation.

[0184] The term “temporary adhesive” as used herein refers to an adhesive material, e.g., tape, glue, spray adhesive that provides a mild, temporary hold, between 2 or more elements, e.g., a liner (3) and frame (2) of device (1), such that the two or more elements can be easily removed or separated, preferably without damaging (e.g., stretching, tearing, etc.) the elements adhered by the temporary adhesive.

[0185] As used herein, the term “permanent adhesive” refers to an adhesive that forms a permanent attachment between 2 or more elements that are not intended to be separated, e.g., during use. In some embodiments, elements permanently attached cannot be readily removed or separated without, for example, damaging (e.g., stretching, tearing, etc.) the elements adhered by the permanent adhesive.

[0186] In some embodiments, an adhesive for liner (3), e.g., liner adhesive strips (12a, 12b, 12c, 12d, 12e) shown in Fig. 5, one-piece liner adhesive (17) shown in Fig. 76, preferably comprises one or more of pressure-sensitive adhesives (PSAs; e.g., acrylic PSAs, rubberbased PSAs, silicone PSAs, water-based PSA emulsions, etc.), hot-melt adhesives, water- dispersible / water-soluble binders and sizing (e.g., polyvinyl alcohol polymers, modified starch), and water-activated (gummed) tapes with starch adhesives.

[0187] In some embodiments, a liner (3) is reversibly attached to frame (2) by a method comprising mechanical attachment, e.g., using mechanical interlocks such as tabs, slots, or tuck-flaps formed in the paperboard that capture liner edges without adhesive; hook-and-loop or micro-hook engagement areas sized for temporary retention of a nonwoven edge; and / or crimping, stitching, and / or ultrasonic tack points, e.g., applied at limited regions to allow subsequent tearing or dispersal.

[0188] As used herein, the term “release liner” refers to a liner, e.g., a paper or plastic-based film sheet that comprises a surface, for example a treatment or coating, that provides a PATENT Attorney Docket No.: EXCT-43060.601 release effect such that the release liner can be readily removed from a tacky or adhesive surface to expose the tacky or adhesive surface, e.g., an adhesive strip, sticker, tape, etc., for adhering to another surface.

[0189] 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 (e.g., wands, scoops, spoons, and rods for removing a portion of a stool sample collected using the technology, e.g., as provided in U.S. Pat. Nos. 9,211,112 and 11,385,243, WO 2013 / 025917 and PCT / US2023 / 077955, each of which is incorporated herein by reference in its entirety, for all purposes), sample stabilizing reagents; sample processing reagents such as particles, buffers, denaturants, oligonucleotides, fdters, 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., a frame (2) with liner (3); and reagents and / or supporting materials). 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 the total kit components are included in the term “fragmented kit.” For example, a fragmented kit may contain analyte-specific reagents, reagents for nucleic acid PATENT Attorney Docket No.: EXCT-43060.601 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.

[0190] The term “system” as used herein refers to a collection of articles for use for a particular purpose, e.g, a collection of devices, 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.

[0191] DETAILED DESCRIPTION OF THE INVENTION

[0192] Diagnostic testing often requires isolating and assaying analytes such as biomolecules from a specimen (e.g, tissue, cells, body fluid, stool) collected from a subject. Biomolecules PATENT Attorney Docket No.: EXCT-43060.601 for analysis include, e.g., nucleic acids, proteins, fats, sugars or other molecules present in the specimen.

[0193] Stool samples for testing are preferably collected by a subject in the home, at the convenience of the subject. Available devices for at-home stool sample collection are designed to collect either the whole stool specimen (e.g., for nucleic acid testing), or a very small amount of stool (e.g., for detection of hemoglobin). However, an intermediate amount of stool is suitable for nucleic acid analysis, especially for analysis of human-derived nucleic acids in the sample (e.g., free nucleic acids, nucleic acids in colorectal cells from the human subject who produced the stool sample).

[0194] Large collection devices configured to collect whole stool specimens from a subject for nucleic acid testing are more costly to manufacture and to ship. Moreover, the amount of stool collected often exceeds the amount typically required for analysis, and such collections produce large amounts of hazardous waste. Typically, the entire container used to hold the stool sample must be handled and disposed of as hazardous waste.

[0195] Small collection devices designed to sample only a small fraction of a whole stool specimen with, e.g., a small spoon, paddle, brush, swab, or the like, require a secondary device to collect the whole stool specimen prior to sampling (henceforth referred to as a “catchment”). Fecal Immunochemical Test (FIT) devices used for colorectal cancer (CRC) screening collect very small amounts of stool (<50 mg) and are often accompanied by a catchment device to temporarily receive and hold deposited stool during removal of a sample using, e.g., a FIT device. Collecting small amounts of stool with such a device typically requires minimal pressure be applied to the stool, and catchments used for collecting very small samples do not require, and thus often lack, strength and durability. Disposable catchments for home use may also be difficult to unfold, attach, and / or remove, and the use thereof can be confusing for a subject.

[0196] Sampling devices designed to collect intermediate amounts of stool (approx. 1-15 grams) often require more pressure to be applied to a deposited stool specimen during, for example, scooping, scraping, coring, slicing, etc., and any accompanying catchment device must be appropriately durable. An exemplary sample collection wand for capturing a portion PATENT Attorney Docket No.: EXCT-43060.601 of stool in this size range (also referred to as a sampling wand) is described in PCT / US2023 / 077955. Catchments designed for FIT sampling may fail or rupture during sample collection with an intermediate-sized device, especially in the presence of liquid (e.g., urine, or liquid stool). Moreover, catchments designed for FIT sampling may not have a shape or dimensions that are compatible with collecting an intermediate-sized sample.

[0197] The technology herein provides devices, systems, kits, and methods to facilitate collection of intermediate-sized stool samples, e.g., in a home or medical setting. In particular, the technology provides foldable specimen collecting devices (referred to interchangeably as catchment devices and capture devices) that are foldable for compactness (e.g., take up minimal space in a packaged stool collection kit), easy to deploy and use, and that enhance sample quality by avoiding mixing of stool specimens with urine and / or toilet water. The foldable specimen collecting devices of the technology are sufficiently durable to receive a deposited stool, e.g., during defecation by a subject, and to hold the deposited stool during subsequent manipulation, e.g., scraping, poking, coring, etc., to remove one or more portions therefrom, e.g., for further analyses. Further, the multiple attachment points, e.g., the adhesive tabs (4) in Fig. 1, ensure proper front-to-back positioning and orientation of the device (1) when affixed to a toilet seat for use.

[0198] While the technology is described with respect to use with a toilet seat, the technology is not limited to use with, for example, a flush toilet. The technology also finds use with any commode or appliance using which a human subject may defecate through an opening, including but not limited to portable commodes, adaptive commodes, pit toilets, squat toilets, bedpans, etc.

[0199] In some aspects, provided herein are devices, kits, systems, and methods of use thereof, for catching a stool deposited by a subject, e.g., during defecation. In some embodiments, the device comprises: a) a frame (2) comprising a specimen support surface (7) and one or more adhesive tabs (4), preferably three adhesive tabs (4) configured to reversibly affix the frame (2) to a toilet seat.

[0200] In some embodiments, device (1) further comprises: PATENT Attorney Docket No.: EXCT-43060.601 b) a liner (3), affixed to the frame (2), and configured to cover the specimen support surface (7) with a specimen contact surface (11). The liner (3) is preferably further configured such that at least a portion of the liner is removable from the frame (2) by the user, e.g., for disposal into the toilet along with the remaining specimen, after a sample has been removed from the deposited stool.

[0201] In some embodiments, e.g., in which device (1) does not comprise a liner (3), a deposited stool principally contacts the specimen support surface (7) of frame (2).

[0202] In some embodiments, e.g., in which device (1) further comprises liner (3), a deposited stool principally contacts the liner (3), e.g., on the specimen contact surface (11), such that removal of the liner (3) after use removes most or all of the specimen and leaves a frame (2) that has made minimal contact with the deposited stool.

[0203] In some embodiments, the frame (2) comprises a foldable, water-resistant material. For example, in some embodiments the frame (2) is folded into a desired shape or size for packaging in a suitable container (e.g., box, bag, envelope, etc.). In some embodiments, the frame (2) is easily unfolded and placed on a toilet seat (e.g., the adhesive tabs (4a-4c) are reversibly affixed to the toilet seat. In preferred embodiments, the specimen support surface (7) covered by the specimen contact surface (11) of the liner (3) is positioned within the toilet bowl) prior to use.

[0204] In some embodiments, the frame (2) and the liner (3) are packaged / folded together (e.g., as one unit), such that the liner (3) is already placed on the specimen support surface of the frame (2) without further action by the user prior to use. For example, the liner (3) may be secured to the specimen support surface of the frame (2) using a suitable adhesive, such that the frame (2) can be unfolded and placed on the toilet seat with the liner (3) already secured in place. The adhesive used to secure the liner (3) to the frame (2) is preferably sufficiently strong to adhere the liner (3) to the frame during packaging, unfolding, and initial use of the system, while also avoiding tearing or rupturing of the liner (3) during collection of the stool sample. In some embodiments, the adhesive is a low tack, reversible adhesive, such that the liner (3) remains intact during removal, and the entirety of the liner (3) is removed from the frame (2) for disposal by the user (e.g., after the user has collected a stool PATENT Attorney Docket No.: EXCT-43060.601 sample). In some embodiments, the adhesive is high-tack, or permanent, and the liner (3) is configured such that only a portion will tear away from the frame (2), e.g., along a row of perforations, such that adhered portions of the liner (3) remain attached to the frame (2), while other portions, e.g., the specimen contact surface (11) and portions of the back panel (3d) and side panels (3e) of the liner (3) release from the frame (2) for disposal. The technology is not limited to a particular form of adhesive, and embodiments include high tack and low tack glue, tape, and / or sprayable adhesives.

[0205] Alternatively, the frame (2) and the liner (3) may be separate, such that the user places the liner (3) onto the frame (2) prior to use. For example, the user may place the liner (3) onto the specimen support surface prior to placing the frame (2) onto the toilet seat, or after placing the frame (2) onto the toilet seat. The liner (3) may comprise an adhesive backside such that the liner (3) remains in place on the specimen support surface during use. For example, in some embodiments the liner (3) comprises an adhesive backside covered by a removable protective layer, which the user can remove / peel away to reveal the adhesive backside prior to attaching the liner (3) to the specimen support surface. Alternatively or additionally, the liner (3) may have a substantially similar shape as the specimen support surface such that the liner (3) may rest upon the specimen support surface and remain in place without significant disruption or movement away from the collection surface during use. Still alternatively, in some embodiments the frame (2) and liner (3) are provided in a kit that further comprises a separate adhesive (e.g., tape, glue, or a sprayable adhesive). The user may apply the adhesive to the backside of the liner (3) or to the top surface of the specimen support surface, and adhere the liner (3) to the specimen support surface prior to use.

[0206] In some embodiments the frame (2) is connected to the sides of the toilet seat by one or more tabs, preferably three tabs, as shown in Figs. 1 A-1D. During use (e.g., in the unfolded configuration of the frame (2)), the one or more tabs are reversibly affixed to a toilet seat, and the side walls (6a, 6b) of the frame (2) facilitate extension of the frame (2) into the bowl of the toilet such that the specimen support surface (7) can be appropriately situated at a depth within the toilet bowl such that the subject does not sit directly upon the specimen contact surface (11) of the liner (3) during use. PATENT Attorney Docket No.: EXCT-43060.601

[0207] The frame (2) is configured to provide a specimen support surface (7) that is suspended within the toilet bowl such that the subject seated at the toilet does not inadvertently sit directly upon the specimen contact surface (11) of the liner (3) during use, and so that the underside of the specimen support surface (7) of the frame (2) does not contact the water in the toilet bowl. In some embodiments, when unfolded, the frame (2) forms a box-like structure in which the side walls (6a, 6b) and back wall (5) are substantially perpendicular to the specimen support surface (7), maximizing the distance between the specimen contact surface (11) and the subject during use of the device (1). In some embodiments, a vertical depth (20) from the top of the sides walls to the specimen support surface (7) or specimen contact surface (11), as shown by a dashed line in Fig. 11A, is at least about 3”, preferably between about 3” and 6”.

[0208] Preferably, specimen support surface (7) has a width that is no wider than the side-to- side width of a toilet seat opening, such that, for example, the sample support surface (7) of the unfolded device (1) can readily pass down through the toilet seat opening and / or be pulled up through the toilet seat opening. For example, in an embodiment of device (1) as shown in Fig.11 A, the width of specimen support surface (11) between sidewall (6a) and sidewall (6b) is preferably between about 4 and 6 inches, preferably between about 4 and 5 inches, preferably about 4.5 inches.

[0209] In some embodiments, the specimen support surface (7) has a length (19), e.g, between the center of front curve (8) and the center of back wall (5) where the back wall meets specimen support surface (7), that is similar to the width of sample support surface (11) between the side walls (6a, 6b). For example, in an embodiment of device (1) as shown in Fig.11 A, the length (19) of sample support surface (11) between the centers of front curve (8) and backwall (5) is preferably between about 4” and 6”, preferably between about 4” and 5”, preferably about 4.5”. In some embodiments, the length (19) of sample support surface (11) between the centers of front curve (8) and backwall (5) is shorter than or longer than the width of sample support surface (1 1) between the side walls (6a, 6b).

[0210] In some embodiments, when unfolded, the frame (2) forms a bowl-like structure in which the side walls (6a, 6b) and / or back wall (5) are at an angle that is >90 degrees with respect to the plane of the specimen support surface (7). In an installed configuration, e.g, PATENT Attorney Docket No.: EXCT-43060.601 when adhered to a toilet seat, a width (18) between the sides of the device (1) at the top opening, e.g., between the tabs as shown by a dashed arrow in Fig. 11 A, is greater than the width of the specimen support surface (7) at the base of side walls (6a, 6b). In preferred embodiments, the width (18) of the opening is between about 6” to about 10”.

[0211] In some embodiments, one or both corners between the side walls (6a, 6b) and the back wall (5) comprises one or more corner panels (5a, 5b), e.g., triangular or flared corner panels that provide additional expandability and flexibility in each corner, e.g., to allow the top opening of the bowl to expand to a size substantially wider than the width of the specimen support surface (7). In some embodiments the side walls (6a, 6b) are joined to the back wall (5) or to corner panels (5a, 5b) along a fully sealed corner, or along a corner comprising one or more gaps (e.g., a corner in which the side walls (6a, 6b) are joined to the back wall (5) or to corner panels (5a, 5b) in spaced intervals, e.g., with spot gluing or welds. In other embodiments, the side walls are not joined to the back wall, such that the back corners are open, and all three walls fold inwardly or outwardly independently of one another.

[0212] In folded form the device is preferably essentially flat and, as indicated by doubled headed arrows in Figs. 80A-80C, device (1) has a width (21), a height (22) and a thickness (23). In some embodiments, the width (21) is preferably from about 4” to about 8”, the height (22) is preferably from about 4” to about 7”, and the thickness (23) is preferably from about 1 / 16th“ to about 14”.

[0213] In some embodiments, the frame (2) comprises one or more creases or junctions that facilitate folding and unfolding of the frame (2) into desired configurations. In some embodiments, the location at which the tabs connect to the side walls is a foldable crease, and the location at which the side walls connect to the specimen support surface is another foldable crease. As described above, in some embodiments the frame (2) and the liner (3) are packaged together, as one unit. In such embodiments, the liner (3) is housed on the specimen support surface of the frame (2) and portions of the frame (2) fold into a flattened configuration such that the liner (3) is trapped on the specimen support surface of the frame (2). As described above, the liner (3) may be secured to the specimen support surface by a suitable adhesive, such as glue, tape, or a sprayable adhesive. Unfolding of the frame (2) PATENT Attorney Docket No.: EXCT-43060.601 prior to use reveals the liner (3) in place on the specimen support surface, and the user may place the frame (2) (e.g., already containing the liner (3) on the specimen support surface) into the toilet for use. In other embodiments, the frame (2) is folded separately from the liner (3), which is placed onto the specimen support surface of the frame (2) by the user prior to use. The technology is not limited to any particular arrangement for folding or unfolding. For example, as illustrated in Figs. 2A-2F, in one embodiment, folding of the device (1) comprises folding the sides of the foldable collecting device (1) toward the center, such that in the folded “2D” form, the folded side walls (6a, 6b) are sandwiched between the back wall (5) and the specimen support surface (7) of the frame (2). In the embodiment illustrated in Figs. 2G-2L, folding the device (1) comprises folding the back wall (5) down to meet the specimen support surface (7), and folded side walls (6a, 6b) come together and tuck together on the underside of the specimen support surface (7).

[0214] In some embodiments, the frame (2) comprises a paperboard material, e.g., SBS paperboard, coated unbleached kraft paperboard (CUK), coated recycled paperboard (CRB), clay-coated news back (CCNB), folding boxboard / bleached carton board (FBB), uncoated kraft paperboard, non-bending chipboard, molded fiber / pulp structured board, etc. In some embodiments, the paperboard material comprises a paper material and a suitable coating, e.g., a wax coating, a clay / mineral coating (e.g., kaolin), water-dispersible or water-resistant barrier sizing (starch- or PVOH-based), biopolymer coatings e.g., polylactic acid or compostable coatings), etc. In some embodiments, one or both sides of the paperboard are coated with water-resistant paint or ink, e.g., a screen-printing ink, preferably an acrylic ink that can be applied in water-soluble form but that cures to be water-resistant or water-proof upon drying. In some embodiments, the coating imparts the desired strength, durability, and water-resistance to the frame (2) and in particular to the specimen support surface such that samples can be collected and portions thereof can be removed from the frame (2) (e.g., from the specimen support surface) without rupturing, tearing, etc., even in the presence of a liquid stool sample, urine, or toilet water (e.g., from the underside) and even when a force is exerted on the specimen support surface in order to obtain the desired portion of a stool sample for downstream analyses. Screen printing can be used not only to provide a water-resistant coating, but also to provide selected color or colors, markings such as tick marks (see, e.g., PATENT Attorney Docket No.: EXCT-43060.601

[0215] Fig. 7), or text (e.g, instructive text related to manufacture, assembly, and / or use). In preferred embodiments, the paperboard material comprises solid bleached sulfate (SBS) board, preferably having a caliper (pts or mil) of about 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 or 28pt (6 to 28 mil), or any fraction thereof, preferably lOpt to 20pt, preferably 14pt to 18pt, or any fraction therebetween, preferably 16pt. As used herein in reference to paper, the caliper indicates the thickness of a single sheet, typically indicated in thousandths of an inch (e.g., 4 / 1000ths or 0.004 inches), and typically indicated in units of points (“pt” or “pts”) or mil, each of which indicate 1 / 1000thof an inch. Paper having a caliper of 16pt has a thickness of 0.016 inches, or 16 mil.

[0216] In some embodiments, one or more components of frame (2) are not rigid or semirigid. For example, in some embodiments, the frame (2) comprises a rigid or semi-rigid specimen support surface (7), while one or more of the side walls (6a, 6b) and back wall (5) are composed of non-rigid material (e.g., woven or nonwoven fabric, paper). In some embodiments, one or more non-rigid components, e.g., fabric or paper side walls, back wall, and / or specimen support surface, are caused to form a bowl-like structure by tension along seams or edges supplied by members, e.g., wires or a wire frame, that give a desired shape to the non-rigid materials. Preferably, the components of the frame (2) are made of biodegradable or recyclable materials.

[0217] In some embodiments, the frame (2) comprises at least two side tabs (e.g., for attachment to sides of a toilet seat) and at least one back tab (e.g., for attachment to the back of a toilet seat). In some embodiments, the tabs are attached to the top surface of the toilet seat. In some embodiments, the tabs comprise a reversible adhesive material that secures the tabs to the surface of the toilet seat. For example, in some embodiments the tabs comprise an adhesive glue, tape, or sprayable adhesive that secures the tabs in place on the surface of the toilet seat. In some embodiments, the backside (e.g., underside) of the tabs is adhesive, such that the backside of the tabs adheres to the top surface of the toilet seat (see Fig. 1C). In some embodiments, the tabs comprise an adhesive backside covered by a removable protective layer or release liner, such that the user can peel or remove the protective layer from the backside to reveal the adhesive and secure the tabs to the toilet seat via the adhesive backside, thereby attaching the frame (2) to the toilet seat. Preferably the adhesive is strong PATENT Attorney Docket No.: EXCT-43060.601 enough to ensure attachment of the frame (2) to the toilet seat during use, while still permitting the user to readily remove the frame (2) from the toilet seat after use. In other embodiments, the frame (2) and liner (3) are provided in a kit that further comprises a separate adhesive (e.g., tape, glue, or a sprayable adhesive). The user may apply the adhesive to the tabs prior to securing the frame (2) to the toilet seat. The technology is not limited to any mode of attaching the frame (2) to the toilet seat, and attachment may comprise using one or more of clips, hooks, folds, tucks, adhesives, tapes, ties, and elastic or inelastic loops or bands.

[0218] In some aspects, provided herein are kits. In some embodiments, provided herein is a kit comprising a foldable collecting device (1) as described herein and instructions for use. In some embodiments, the kit further comprises a collection device (or collection devices) for removing one or several portions of the stool from a deposited specimen, preferably a collection device comprising, e.g., a spoon, brush, sampling wand, scoop, tube, etc. In some embodiments, kits may comprise one or more collection devices for collecting small portions of stool, e.g., a few milligrams (e.g., a FIT tube collection device, e.g., as disclosed in U.S. Pat. Nos. 5,515,341; 9,211,112; and 11,385,243, each of which is incorporated herein by reference in its entirety for all purposes), and one or more collection devices for collecting intermediate portions of stool (e.g., 1-20 grams, more than a FIT tube collection but less than the entire specimen) from the same deposited stool specimen.

[0219] In some embodiments, the kit further comprises sample-preserving materials, e.g., one or more buffers to stabilize stool sample material, or components in stool sample material (e.g., cells, proteins, nucleic acids, etc.). Preserving materials, e.g., stabilizing buffers, may be provided in a separate container, e.g., to be added to a collected sample in a collection device, or may be provided within a sample collection device, ready to receive a collected sample from a stool specimen.

[0220] In some embodiments, the kit further comprises an adhesive (e.g., tape, glue, sprayable adhesive) which can be used to secure the liner (3) to the sample collection surface and / or secure the tabs to the toilet seat to facilitate placement of the frame (2) to a toilet. PATENT Attorney Docket No.: EXCT-43060.601

[0221] In some aspects, provided herein are methods of capturing a stool sample using a collecting device (1) provided herein. In some embodiments, provided herein is a method of capturing a stool specimen, comprising: on a collecting device (1) reversibly affixed to a toilet, producing a deposited stool on the collecting device, preferably on a specimen support surface (7) of frame (2) or a specimen contact surface (11) of a liner (3) of the collecting device (1).

[0222] In some embodiments, provided herein are methods of capturing a stool sample comprising removing a portion of deposited stool from a collection device (1), preferably from a specimen support surface (7) of frame (2) or a specimen contact surface (11) of a liner (3). Preferably, the collecting device (1) is reversibly affixed to a toilet.

[0223] In some embodiments, provided herein are methods comprising: i) reversibly affixing a collecting device (1) on a toilet; and ii) producing a deposited stool on the collecting device, preferably on a specimen support surface (7) of frame (2) or on a specimen contact surface (11) of a liner (3) of the collecting device (1).

[0224] Optionally, embodiments of the methods further comprise removing a portion of the deposited stool from the collecting device.

[0225] In some embodiments, provided herein are methods comprising: i) placing the collecting device (1) onto a toilet, wherein a subject produces a deposited stool on device (1), preferably on a specimen support surface (7) of frame (2) or a specimen contact surface (11) of a liner (3); and ii) removing a portion of deposited stool from the collecting device (1) .

[0226] In some embodiments, methods comprising removing a portion from a deposited stool further comprise placing the removed stool material in a separate receptacle, e.g., a sealable container. In some embodiments, the removed stool material is contacted with a PATENT Attorney Docket No.: EXCT-43060.601 surface, e.g., a slide, test card, paper, or other device or surface, e.g., for further analysis. In some embodiments, the stool sample is removed from the deposited stool using a spoon, tube, wand, brush, etc. An exemplary sample collection wand (also referred to as a sampling wand) is described in PCT7US2023 / 077955, the entire contents of which are incorporated herein by reference for all purposes. In some embodiments, the method further comprises contacting the removed portion of stool with a solution, preferably a buffer, more preferably a buffer comprising one or more stabilizing reagents. For example, in some embodiments, the sealable container comprises a stabilization buffer. In some embodiments, the sample collection device (e.g., wand, spoon, etc.) is used to remove a portion of the stool, and the wand or spoon is then placed in or secured into a sealable container that contains the stabilizing buffer. In some embodiments, method comprising removing a portion of deposited stool further comprises disposing of the residual stool, e.g., by removing the collecting device from the toilet for disposal. In some embodiments, frame (2) is discarded, e.g., as medical waste. In some embodiments, preferably while device (1) is attached to the toilet, at least a portion of a liner (3), preferably a portion of the liner with most or all of the residual stool, is separated from frame (2) and deposited into the toilet bowl for disposal by flushing the toilet.

[0227] In some embodiments, residual stool is not disposed of. Residual stool may be further sampled, analyzed, and may be preserved for short or long periods, e.g., by refrigeration, stabilizing buffer and / or organic preservatives, freezing with or without added stabilizing buffers or preservatives, etc. In some embodiments in which residual stool is retained, the sample is preferably collected using a device (1) without a liner (3).

[0228] In some embodiments, the collecting device (1) is provided with a liner (3) already in place to cover the specimen support surface prior to use, such that when the device (1) is placed onto the toilet (e.g. when the frame (2) is adhered to the toilet seat via the adhesive tabs), the liner (3) is in place with no further action required by the user. In other embodiments, the method comprises positioning the liner (3) in the frame (2) to cover the specimen support surface (7) prior to or after placing the frame (2) on the toilet.

[0229] In some embodiments, 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 PATENT Attorney Docket No.: EXCT-43060.601 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, the solution (provided as a solution or as 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 mM EDTA, and 10 mM NaCl. In some embodiments, a stabilizing solution comprises a EIEPES buffer. In some embodiments, a stabilizing solution comprises an antimicrobial agent, e.g., sodium azide, gentamicin, a PROCLIN 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.

[0230] In some embodiments, a stabilizing solution 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 bulk protein, e.g., bovine serum albumin (BSA) or casein. In some embodiments, the solution comprises one or more of sarkosyl, and a chaotropic salt (e.g., guanidine thiocyanate).

[0231] 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 PATENT Attorney Docket No.: EXCT-43060.601

[0232] (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.

[0233] 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; U.S. Pat Nos. 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.

[0234] With reference to Figs. 75-86B, a foldable collecting device 1 includes a frame (2), a liner (3), a one-piece liner adhesive (17), and two frame adhesive strips (9), and tabs (4a, 4b, 4c), with corresponding release liners (14) that cover the mounting adhesive on the underside of the tabs.

[0235] With reference to Fig. 78, a bottom view of the foldable device is shown with the adhesive on the distal-most regions of the attachment tabs (4a, 4b, 4c) deadened with a printable substrate to generate a non-stick region. In some embodiments, coloration can be added to match the overall design. After assembly, there is preferably a gap of approximately 2 mm of exposed adhesive between the peel-off portion of release liner (14) and the body of frame (2) to accommodate ease of folding. Frame adhesive binding sites (10b, lOd) are indicated.

[0236] Advantageously, in some embodiments the foldable collecting device includes that the flat layers are assembled in flat form, and then the flat assembly is folded as shown in Fig. 79, and attachment of the adhesives as depicted in Fig. 79 steps I-J puts the device in a final assembled form, with step K (tucking down the back tab) puts the device in final folded PATENT Attorney Docket No.: EXCT-43060.601 form. The frame, liner adhesive, and liner are assembled flat and then are folded together in the steps illustrated in Fig. 79. In steps I and J of Fig. 79, the frame adhesive strips (9) are applied or uncovered, e.g., a release liner is removed from each adhesive strips , and portions of the frame side walls 6(a) and 6(b) are folded over so that frame adhesive binding site (10a) adheres to frame adhesive binding site (10b), and frame adhesive binding site (10c) adheres to frame adhesive binding site (lOd), which completes assembly of a three-dimensional foldable device in folded form. See Fig. 4 for exemplary frame adhesive strips (9) and frame adhesive binding sites (lOa-lOd). For pairs of frame adhesive binding sites that bind to each other in the final form (e.g., 10a and 10b, 10c and lOd), the embodiment is not limited by which adhesive binding site receives an application of frame adhesive first and which is then adhered to the applied frame adhesive. For example, in the device illustrated in Figs. 77A and 78, adhesive strips covered by release liners may be applied in the flat assembly at adhesive binding sites 10a and 10c (Fig. 77A), or to lOd and 10b (Fig. 78), or a combination thereof. Step K (tucking down the back tab) puts the device in a final folded form.

[0237] Upon unfolding, the device is in the three-dimensional form shown, e.g., in Figs. 35- 43, and 51, and can be refolded into the folded form. Embodiments of the final folded form are shown in Figs. 46-50D, 52-54D, and 80A-80C.

[0238] The disclosure provides a method (e.g., as illustrated in Fig. 79) of manufacturing a foldable device. The method comprising creating a flat assembly (Step A) by attaching a liner adhesive to a frame, attaching a liner to the liner adhesive, and attaching at least one tab to the frame. The method further includes (Steps B-H) of folding the flat assembly with one or more folding steps; and (Step I) providing an exposed frame adhesive surface at a first frame adhesive binding site (e.g., by removing a backing or release liner from the frame adhesive to expose an adhesive surface, by moistening a moisture-activated adhesive, by applying an adhesive gel or liquid, e.g., liquid glue, hot glue, rubber cement, etc., or by applying an adhesive tape or strip.) The method further comprises (Step J) folding a portion of the frame of the device to bring a second frame adhesive binding site into position to bind to the exposed adhesive surface at the first frame adhesive binding site, which completes assembly of a foldable device in folded form, and Step K (tucking down the back tab) puts the device in a final folded form. PATENT Attorney Docket No.: EXCT-43060.601

[0239] Upon unfolding, the device is in the three-dimensional form shown, e.g., in Figs. 35- 43, and 51, and can be refolded into the folded form. Embodiments of the final folded form are shown in Figs. 46-50D, 52-54D, and 80A-80C.

[0240] In some embodiments, a method of manufacturing a device comprises providing a flat assembly comprising a frame adhered to a first side of a liner adhesive and a liner adhered to a second side of the liner adhesive. For example, in some embodiments, providing the flat assembly comprises creating a flat assembly by attaching a liner adhesive to a frame, attaching a liner to the liner adhesive, and attaching at least one tab to the frame. The method of manufacturing preferably further comprises folding the flat assembly in one or more folding steps; removing a backing, e.g., a release liner, from a frame adhesive positioned on the frame at a first frame adhesive binding site; and folding a portion of the device to attach a second frame adhesive binding site to the frame adhesive. The method produces the foldable device in a flat, folded configuration, wherein the device unfolds into the three-dimensional collecting configuration and can be re-folded into the folded configuration.

[0241] In some embodiments, a method of manufacturing a device comprises folding a frame with one or more folding steps; removing a release liner from a frame adhesive positioned on the frame at a first frame adhesive binding site; and folding a portion of the frame to attach a second frame adhesive binding site to the frame adhesive. The method produces the foldable device in a flat, folded configuration, wherein the device unfolds into the three-dimensional collecting configuration and can be re-folded into the folded configuration.

[0242] PATENT

[0243] Attorney Docket No.: EXCT-43060.601

[0244] EXPERIMENTAL

[0245] EXAMPLE 1

[0246] As an alternative to a whole stool collection container, a device that facilitates catching and holding a deposited stool specimen and subsequent removal or sampling of only a portion thereof was developed and tested herein. The device (1), referred to herein as a “catchment” or “collecting” device, comprises a frame (2), that can be attached to a toilet seat and used to catch a stool specimen from the subject during defecation, and provide a specimen support surface to hold the specimen, e.g., during inspection (e.g., visual inspection), and / or removal of one or more portions of the stool specimen with one or more collection devices, such as a wand. For example, the frame (2) may provide a surface for sampling a portion of the stool specimen collected thereupon using a sampling wand. An exemplary sampling wand is described in PCT / US2023 / 077955, the entire contents of which are incorporated herein by reference for all purposes. The portion of the stool sample may then be transferred to a tube containing biomarker stabilizing buffer (e.g., for stabilizing nucleic acids, proteins, etc.) and shipped to the desired location for sample processing.

[0247] The catchment device described herein is very durable, even in the presence of liquid, such that it can accommodate watery stool specimens and / or accidental urination and / or contact with the toilet water. Moreover, the catchment is easy to use, easy to dispose, and easy to package (e.g., alone or with other kit components, such as a sampling device and / or stabilizing buffer) and ship. Furthermore, the catchment can withstand significant force without rupturing / tearing, such that sufficient force can be applied to effectively scrape and / or core the stool specimen (e.g., using a sampling wand).

[0248] Commercially available stool catchment devices manufactured by various vendors were identified. A detailed description of each design tested can be found in Table 1.

[0249] Table 1. Overview of Commercially Available Devices PATENT

[0250] Attorney Docket No.: EXCT-43060.601

[0251] Prior to evaluating the commercially available catchments, a list of required and / or desirable features was generated including features related to ease of set-up, attachment strength, depth of catchment in the toilet bowl, ease of sample collection, catchment durability, ease of disposal, packaging size, cost, environmental impact, and medical approval. The commercially available catchments were all designed to accompany fecal immunochemical testing (FIT) collection devices for which minimal pressure is required during collection of a portion of a given stool sample. However, certain sample collection devices (e.g., sampling wands) require significantly more force to be applied during sample collection. More specifically, to sample the firmest of stool specimens the catchment needs to be able to withstand up to 2.5 kgF (kilogram force units) even in the presence of liquid. As such, ability to withstand force (e.g., catchment durability) was one exemplary feature evaluated, among the other features described above. PATENT Attorney Docket No.: EXCT-43060.601

[0252] Each device was assessed on a scale of 1-3 across each of the criteria, representing “poor”, “acceptable”, or “excellent” performance, respectively. While many of these performance criteria are significant for effective use (such as durability and ease of use), other criteria are desirable, such as the catchment being made from recycled material or being IVD-approved. One device was immediately ruled out based on its incompatibility with American-style toilets. The catchment had no attachment method and was designed to be placed directly inside the toilet bowl of a European-style toilet containing considerably less water than American-style toilets. When placed as directed, the device sunk below the water level and immediately began dissolving and was thus incompatible with sample collection. The remaining 12 catchments were taken through rigorous evaluation across all performance criteria.

[0253] The main conclusion from this testing was that none of the commercially available products met the requirements for a stool catchment that would be compatible with the intended use. Based on durability testing alone, all existing paper-based catchments were eliminated as they were unable to withstand the force required to collect firm stool samples in the presence of liquid. While the plastic catchments generally demonstrated adequate durability performance, there were numerous drawbacks to using these catchments related to ease of use and overall size.

[0254] Given these shortcomings of existing systems, a novel stool catchment device was developed. In one embodiment, the device (1) comprises a foldable, water-resistant paperboard frame (2) that attaches to the toilet seat using adhesive tabs. Representative drawings and photographs of an exemplary device are shown in Figs. 1-86B. In some embodiments, device (1) further comprises a liner (3) to aid in residual stool disposal.

[0255] In preferred embodiments a stool catchment device (1) of the technology comprises two main material components: i) a semi rigid water-resistant paperboard frame (2), and ii) a liner (3) that rests inside the frame (2). The device (1) can preferably be folded into a flattened form for ease of shipping, and unfolds into a 3 -dimensional (3D) structure with side and back walls. The catchment is adhered to the toilet seat using side and back attachment tabs. There are adhesive strips underneath each attachment tab with release liners that can be peeled off by the end user. Once pressed into place, the catchment sticks to the toilet seat and PATENT Attorney Docket No.: EXCT-43060.601 functions to capture a stool specimen when the user has a bowel movement. The catchment design is intentionally left open in the front to facilitate sample collection, e.g., using a sample collection wand, and to avoid a urine stream during deposit of the specimen.

[0256] Following sample collection, the liner (3) can be peeled away from the frame and disposed into the toilet along with any remaining stool. In preferred embodiments, e.g., in the embodiment shown in Fig. 10, a portion of the liner (3), e.g., liner tab (3a), is not adhered to the frame (2) so that it is easily grasped for removal of the liner (3).

[0257] The material used for the liner (3) preferably flushable, and preferably is certified as flushable and septic safe based on applicable standards, e.g., IWSFG or INDA / EDANA standards of flushability, as discussed above.

[0258] Once the liner (3) is peeled away, the paperboard frame can be easily removed from the toilet seat and thrown away. All tested commercially available paper-based catchments lacked the required durability when wet. In contrast, the catchment device described herein uses a water-resistant coating, e.g., a clay and / or ink coating on one or both sides of the paperboard used to form the frame. This allows the frame to withstand the force required to collect a firm sample even if the catchment becomes wet, e.g., with toilet water and / or urine. The design described herein is also easier to unfold, easier to place correctly on the toilet, and easier to dispose of than other on-market catchments.

[0259] Durability Data: The catchment design was constructed in 10 different paper types and force tested both under dry and wet conditions (Table 2) using a sample wand described in PCT / US2023 / 077955. The most successful paper type tested was 16pt solid bleached sulfate (SBS), which did not break even with forces of greater than 5 kgF when wet. Most other paper types tested broke with less than 2.5 kgF under wet conditions or had tearing along seams when folded which compromised the material. The 16pt SBS had an advantage over other paper types tested because it both withstood > 2.5 kgF when wet without tearing or detaching from the toilet seat and could be creased without cracking or tearing along seams, unlike the thick cardstock and chipboard. Additionally, clay coating on at least one side, preferably both sides, of the SBS provides some water resistance to accommodate accidental urination and improve catchment durability. Asterisks denote that the frame (2) PATENT

[0260] Attorney Docket No.: EXCT-43060.601 tore along the seam. “+” denotes that the force required to break the frame (2) exceeded the limits of the force gauge meter.

[0261] PATENT

[0262] Attorney Docket No.: EXCT-43060.601

[0263] Table 2. Durability Testing

[0264] Force required to break through catchment:

[0265] Force (kgF)

[0266] Device Water Volume Representation Rep 1 Rep 2ReP3

[0267] EXAMPLE 2

[0268] An exemplary catchment device was developed comprising the following components: PATENT Attorney Docket No.: EXCT-43060.601

[0269] • Component A: The catchment paperboard frame is manufactured from 16pt coated solid bleached sulfate (SBS) paperboard. The printing surface is oriented towards the inside of the catchment and requires coloration and text printing, as outlined in the Detailed Specifications below.

[0270] • Component B: The adhesive used to assemble the paperboard frame (2) into its 3- dimensional form is selected to have a secure hold, preferably a permanent hold. In preferred embodiments, the side walls (6a, 6b) are secured (e.g., as illustrated in Fig 4) using double sided adhesive, or any other strong adhesive material, including hot melt material. In some embodiments, the sidewalls are secured using a tape fastener (e.g. a “Y-tape” fastener) that comprises a double-sided adhesive portion adhering to frame adhesive binding sites (10a, 10b) and (10c, lOd), and that further comprises extensions of single-sided tape that wrap to and adhere to the inside and / or outside surfaces of side walls (6a, 6b) of the frame (2), providing extra strength. The adhesive materials used in assembly of the paperboard frame (2) are preferably placed such that no adhesive comes into contact with the liner (3) on the inside of the assembled collecting device (1) (see, e.g., Figs. 4 and 9).

[0271] • Component C: The liner is cut from dispersible, degradable non-woven fibrous material. Preferably, the liner is flushable. For example, the liner is preferably certified as flushable and safe for septic systems based on, e.g., the IWSFG and / or the INDA / EDANA standards of flushability, as discussed above.

[0272] • Component D: Liner adhesive(s) (12) are used to attach the liner (3) to the catchment frame (2), e.g., as illustrated in Fig. 5, adhesive strips 12a-12e. The liner adhesive (12) is preferably selected to have a mild, temporary hold, such that the liner (3) can be easily removed from the frame (2) by a user, without, for example, tearing the liner (3) or the frame (2), or dislodging the frame (2) from its attachment to the toilet seat. In some embodiments, the liner adhesive used is 0.5” removable, repositionable tape that is doubled-sided and differentially coated, with a polyethylene terephthalate (PET) film carrier in the center that provides dimensional stability. This repositionable tape comprises a medium-tack adhesive on its face side, which provides a permanent attachment of the tape to the frame (2), e.g., as illustrated in PATENT Attorney Docket No.: EXCT-43060.601

[0273] Fig. 5. This tape further provides a low-tack adhesive on the other side, the side that contacts to liner (3) to provide a temporary bond between the frame (2) and the liner (3).

[0274] • Component E: To reversibly affix the frame (2) to a toilet seat, the catchment device (1) includes removable, repositionable tape as mounting adhesives (13a-13c) on each of the tabs (4a-4c), as illustrated in Fig. 6A and 6B. This adhesive is applied to the back sides of tabs (4a-4c) of the frame (2). During use, this is the underside of the tabs, as shown in Fig. IB. This tape material is doubled-sided and differentially coated, having one medium-tack surface and one low-tack surface, and features a very thin tissue carrier. The medium-tack adhesive is used to form a permanent attachment to each of the tabs (4a-4c) of the frame (2), e.g., as illustrated in Fig. 6A. The low-tack adhesive side forms a temporary bond to reversibly affix the tabs (4a- 4c) of the frame (2) to a toilet seat. Prior to use, the low-tack side of the mounting adhesive (13a-13c) is covered by a release liner that prevents the adhesive from unintended contact with or sticking to other materials. As shown in Fig. 6B, the release liner (14) preferably has an overhang beyond the edge of the adhesive surface, preferably beyond the edge of the tab (4), to make removal of the release liner (14) easy for the user. In preferred embodiments, the release liner has an overhang of at least about 0.25.”

[0275] • Component F: In some embodiments, the frame (2) comprises printing (15), e.g., to provide instruction or guidance to the user, to provide guidance for positioning adhesives, e.g., for assembly of the side walls 6a and 6b, and / or for reversibly affixing the liner (2), and / or to confer additional water resistance to the frame (2). For example, as illustrated in Fig. 7, lines or tick marks (16) may be used to indicate the positions for adhesive strips for forming the side walls (6a, 6b) as shown in Fig. 4 and / or for attaching the liner (3), as shown in Fig. 5. Tab printing (15) may be provided to indicate which tabs (4) are “Side” or “Back” tabs, to orient the user when positioning the device (1) on a toilet for use, and dashed line running parallel to the crease line on each attachment tab (4), e.g., the prominent dashed lines across the tabs PATENT Attorney Docket No.: EXCT-43060.601

[0276] (4a-4c) in Fig. 7, may be provided to serve as a further guide for the end user on how to properly align the device (1) during application to a toilet seat.

[0277] All literature and similar materials cited in this application, including but not limited to, patent applications, articles, books, treatises, and internet web pages are expressly incorporated herein 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.

[0278] Various modifications and variations of the described compositions, methods, and uses of the technology will be apparent to those skilled in the art without departing from the scope and spirit of the technology as described. Although the technology has been described in connection with specific exemplary embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention that are obvious to those skilled in medical supply, paper and adhesive manufacture, medical diagnostics, biochemistry, medical science, or related fields are intended to be within the scope of the following claims.

Claims

PATENTAttorney Docket No.: EXCT-43060.601CLAIMSWhat is claimed is:

1. A device for collecting deposited stool from a subject, the device comprising a frame comprising a specimen support surface and one or more adhesive tabs configured to reversibly affix the frame to a toilet.

2. The device of claim 1, further comprising a liner covering the specimen support surface of the frame, the liner comprising a specimen contact surface.

3. The device of claim 2, wherein the liner is reversibly affixed to the frame.

4. The device of claim 2 or claim 3, wherein the liner is flushable.

5. The device of any one of claims 1-4, wherein when the frame is reversibly affixed to the toilet, the specimen support surface is positioned within a central opening of a toilet seat, and below a rim of a toilet bowl.

6. The device of any one of claims 1-5, wherein the frame is foldable to a 2D configuration and unfoldable to a 3D configuration.

7. The device of any one of claims 1-6, wherein the frame comprises paperboard.

8. The device of claim 7, wherein the paperboard comprises solid bleached sulfate (SBS) board, preferably having a caliper (pt or mil) of about 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 or 28pt or any fraction therein, preferably 6pt to 28pt or any fraction therebetween, preferably lOpt to 20pt or any fraction therebetween, preferably 14pt to 18pt or any fraction therebetween, preferably 16pt.

9. The device of claim 7 or claim 8, wherein the paperboard is water-resistant.PATENTAttorney Docket No.: EXCT-43060.60110. The device of any one of claims 7-9, wherein the paperboard is semi-rigid.

11. The device of any one of claims 1-10, wherein the frame comprises at least two side tabs.

12. The device of any one of claims 1-11, wherein the frame comprises at least one back tab.

13. The device of any of claims 1-12, further comprising a one-piece liner adhesive.

14. The device of claim 13, wherein the one-piece liner adhesive comprises a temporary adhesive side and a permanent adhesive side.

15. The device of any of claims 1-14, wherein the frame comprises a back wall, two side walls, and an open side.

16. The device of any of claims 1-15, wherein the frame is water resistant on one side or both sides.

17. The device of any of claims 2-16, wherein the liner comprises a nonwoven fabric.

18. The device of claim 17, wherein the liner is biodegradable.

19. The device of claim 17 or claim 18, wherein the liner has an overhang over an open end of the frame.

20. The device of any one of claims 1-19, wherein when the frame is affixed to a toilet, the frame of the device withstands a pressure applied to the specimen support surface of at least 2.5 kgF (kilogram force units) without rupturing or tearing.PATENTAttorney Docket No.: EXCT-43060.60121. A method of collecting a stool sample, comprising: on a device of any one of claims 1-20, wherein the device is reversibly affixed to a toilet, producing a deposited stool on a specimen support surface of a frame of the device or on a specimen contact surface of a liner of the device.

22. A method of collecting a stool sample, comprising: i) reversibly affixing a device of any one of claims 1-20 to a toilet; and ii) producing a deposited stool on the device, preferably on a specimen support surface of a frame or on a specimen contact surface of a liner of the device.

23. A method of collecting a stool sample, comprising removing a portion of deposited stool from a device of any one of claims 1-20, preferably from a specimen support surface of a frame of the device or from a specimen contact surface of a liner of the device, preferably wherein the device is reversibly affixed to a toilet, wherein the removing provides a removed portion.

24. A method of collecting a stool sample, comprising: i) reversibly affixing a device of any one of claims 1-20 to a toilet, wherein a subject produces a deposited stool on the device, preferably on a specimen support surface of a frame of the device or on a specimen contact surface of a liner of the device; and ii) removing a portion of deposited stool from the device to provide a removed portion.

25. The method of claim 23 or claim 24, further comprising placing the removed portion of stool into a sealable container.PATENTAttorney Docket No.: EXCT-43060.60126. The method of claim 25, wherein the sealable container contains a stabilization buffer.

27. The method of claim 23 or claim 24, further comprising contacting the removed portion with a surface, preferably a slide or card surface.

28. A kit comprising the device of any one of claims 1-20, further comprising instructions for use.

29. The kit of claim 28, further comprising a sampling device for removing a portion of a deposited stool.

30. The kit of claim 29, wherein the sampling device comprises a spoon, a swab, a FIT tube device, a sampling wand, or a sampling wand device comprising a sampling wand and a collection tube.

31. The kit of any one of claims 28-30, further comprising one or more solutions.

32. The kit of claim 31, wherein the one or more solutions comprise 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;PATENTAttorney Docket No.: EXCT-43060.601 xii) a protease inhibitor; xiii) a chelator; xiv) a chaotropic salt; xv) an inhibitor binding agent; and xvi) an antimicrobial agent.

33. The kit of any one of claims 28-32, further comprising shipping materials for shipping one or more removed samples of stool.

34. A system comprising the device of any one of claims 1-20, and instructions for use.

35. The system of claim 34, further comprising a sampling device for removing a portion of deposited stool.

36. The system of claim 35, wherein the sampling device comprises a spoon, a swab, a FIT tube device, a sampling wand, or a sampling wand device comprising a sampling wand and a collection tube.

37. The system of any one of claims 34-36, further comprising one or more solutions.

38. The system of claim 37, wherein the one or more solutions comprise 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;PATENTAttorney Docket No.: EXCT-43060.601X) a surfactant; xi) a nuclease inhibitor; xii) a protease inhibitor; xiii) a chelator; xiv) a chaotropic salt; xv) an inhibitor binding agent; and xvi) an antimicrobial agent.

39. A method of manufacturing a foldable device, the method comprising: i) providing a flat assembly comprising a frame adhered to a first side of a liner adhesive and a liner adhered to a second side of the liner adhesive; ii) folding the flat assembly in one or more folding steps; iii) removing a release liner from a frame adhesive positioned on the frame at a first frame adhesive binding site; and iv) folding a portion of the device to attach a second frame adhesive binding site to the frame adhesive; wherein the method produces the foldable device in a folded configuration; and wherein the device unfolds into a three-dimensional collecting configuration.

40. The method of claim 39, wherein the first side of the liner adhesive comprises a permanent adhesive or a temporary adhesive.

41. The method of claim 39, wherein the second side of the liner adhesive comprises a permanent adhesive or a temporary adhesive.

42. The method of claim 39, wherein frame comprises at least two tabs, preferably three tabs.PATENTAttorney Docket No.: EXCT-43060.60143. A method of manufacturing a foldable device, the method comprising: i) folding a frame in one or more folding steps; ii) removing a release liner from a frame adhesive positioned on the frame at a first frame adhesive binding site; and iii) folding a portion of the frame to attach a second frame adhesive binding site to the frame adhesive; wherein the method produces the foldable device in a folded configuration; and wherein the device unfolds into a three-dimensional collecting configuration.

44. The method of claim 43, wherein frame comprises at least two tabs, preferably three tabs.

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