Non-invasive biospecimen collection system

Abstract

Skin cancer is the most common form of malignancy in humans, with significant associated morbidity and cost, and steadily increasing incidence. Since it is now well established that UV-damaged epidermal keratinocytes in intact skin can harbor on the order of 5 mutations / Mb, this raises the possibility of using this mutational burden as a dosimeter of UV-induced damage and potentially skin cancer risk. In particular, sampling normal skin for biomarkers of UV exposure can lead to better understanding of the genomic alterations associated with initiation of skin cancer, which ultimately will aid in stratifying risk of skin cancer development, determination of effectiveness of current prevention methods, and better targeted therapies. Disclosed herein are devices and systems for interrogation of normal non-lesional skin to extract epidermal DNA for analysis. This approach can be generalized to any epithelial surface including in the oral cavity, gastrointestinal, or genitourinary tracts.

Description

NON-INVASIVE BIOSPECIMEN COLLECTION SYSTEMCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims benefit of U.S. Provisional Application No. 63 / 622,759, filed January 19, 2025, which is hereby incorporated herein by reference in its entirety.BACKGROUND OF THE INVENTION

[0002] Skin cancer is the most common form of malignancy in humans, with significant associated morbidity and cost, and steadily increasing incidence. Exposure to ultraviolet radiation (UVR) is thought to cause approximately 90% of keratinocyte carcinomas, causing malignant transformation and permissive alterations of the immune microenvironment. UVR initiates a complex multistage process associated with accumulation of DNA photoproducts resulting in mutations, thus facilitating carcinogenesis. Such mutations frequently abrogate function of the TP53 tumor suppressor gene among others, rendering cells resistant to UV- induced apoptosis, whereupon they can acquire a growth advantage and expand as pre- malignant clones among normal keratinocytes while undergoing further genomic changes leading to full malignancy. Furthermore, the expansion of such clones, whether under selection or not, provides an opportunity to detect mutations in otherwise normal appearing skin. Since it is now well established that UV-damaged epidermal keratinocytes in intact skin can harbor on the order of 5 mutations / Mb, this raises the possibility of using this mutational burden as a dosimeter of UV-induced damage and potentially skin cancer risk.

[0003] In particular, sampling normal skin for biomarkers of UV exposure can lead to better understanding of the genomic alterations associated with initiation of skin cancer, which ultimately will aid in stratifying risk of skin cancer development, determination of effectiveness of current prevention methods, and better targeted therapies. The interrogation of normal non- lesional skin requires non-invasive methods of sampling to extract epidermal DNA for analysis. Conventional sampling methods involve skin biopsies, which requires anesthesia and causes scarring and are there not suitable for assessing multiple sites of normal, non-lesional skin, especially in cosmetically-sensitive (and often sun-exposed) areas. Although there have been multiple other non-invasive methods, include tape stripping, and superficial scraping, reported yields appear to have been substantially lower. Therefore, needed are improved, non-invasive techniques for sampling skin and other epithelial cells.SUMMARY OF THE INVENTION

[0004] Skin cancer is the most common form of malignancy in humans, with significant associated morbidity and cost, and steadily increasing incidence. Since it is now wellestablished that UV-damaged epidermal keratinocytes in intact skin can harbor on the order of 5 mutations / Mb, this raises the possibility of using this mutational burden as a dosimeter of UV- induced damage and potentially skin cancer risk. In particular, sampling normal skin for biomarkers of UV exposure can lead to better understanding of the genomic alterations associated with initiation of skin cancer, which ultimately will aid in stratifying risk of skin cancer development, determination of effectiveness of current prevention methods, and better targeted therapies. Disclosed herein are devices and systems for interrogation of normal non-lesional skin to extract epidermal DNA for analysis.

[0005] For example, disclosed herein is a sample collection device, wherein the sample collection device comprises an abrasive element configured to abrade an epithelial surface and an absorbent material, wherein the absorbent material is deformable by at least 20% by volume, is inert, hydrophilic, and autoclavable.

[0006] Also disclosed is a biospecimen collection system comprising the sample disclosed collection device; an aqueous solvent; and a sample reservoir comprising an embedded collection insert.

[0007] Also disclosed is a method for collecting a biospecimen from an epidermis of a subject comprising loading the absorbent material of the sample collection device of any one of claims 1 to 18 with an aqueous solvent; abrading the epidermis of the subject with the abrasive element of the sample collection device while deforming the absorbent material; and inserting the sample collection device into a conical sample reservoir comprising an embedded collection insert, thereby deforming the absorbent material and releasing the biospecimen into the conical sample reservoir.

[0008] The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF FIGURES

[0009] FIG. 1 shows example devices in a biospecimen collection system disclosed herein that includes a sample collection wand with an abrasive post and absorbent material, a container of cell lysis buffer, and a sample reservoir with an embedded collection insert.

[0010] FIG. 2 illustrates a process for using a biospecimen collection system disclosed herein.

[0011] FIG. 3 is a perspective view of a sample collection wand for use in the disclosed DNA collection system without the absorbent material.

[0012] FIG. 4 is a side view of a sample collection wand for use in the disclosed biospecimen collection system.

[0013] FIG. 5 is a perspective view of a collection insert that can be embedded in a sample reservoir, such as a conical centrifuge tube.

[0014] FIG. 6 is a top-down view of a collection insert that can be embedded in a sample reservoir, such as a conical centrifuge tube.

[0015] FIG. 7 is a perspective view of the distal end of the collection wand with dimensions shown for inner diameter of the absorbent material and outer diameter of the abrasive post.DETAILED DESCRIPTION

[0016] Before the present disclosure is described in greater detail, it is to be understood that this disclosure is not limited to particular embodiments described, and as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present disclosure will be limited only by the appended claims.

[0017] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the disclosure. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges and are also encompassed within the disclosure, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the disclosure.

[0018] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present disclosure, the preferred methods and materials are now described.

[0019] All publications and patents cited in this specification are herein incorporated by reference as if each individual publication or patent were specifically and individually indicated to be incorporated by reference and are incorporated herein by reference to disclose and describe the methods and / or materials in connection with which the publications are cited. The citation of any publication is for its disclosure prior to the filing date and should not be construed as an admission that the present disclosure is not entitled to antedate such publication by virtueof prior disclosure. Further, the dates of publication provided could be different from the actual publication dates that may need to be independently confirmed.

[0020] As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present disclosure. Any recited method can be carried out in the order of events recited or in any other order that is logically possible.

[0021] Embodiments of the present disclosure will employ, unless otherwise indicated, techniques of chemistry, biology, and the like, which are within the skill of the art.

[0022] The following examples are put forth so as to provide those of ordinary skill in the art with a complete disclosure and description of how to perform the methods and use the probes disclosed and claimed herein. Efforts have been made to ensure accuracy with respect to numbers (e.g., amounts, temperature, etc.), but some errors and deviations should be accounted for. Unless indicated otherwise, parts are parts by weight, temperature is in °C, and pressure is at or near atmospheric. Standard temperature and pressure are defined as 20 °C and 1 atmosphere.

[0023] Before the embodiments of the present disclosure are described in detail, it is to be understood that, unless otherwise indicated, the present disclosure is not limited to particular materials, reagents, reaction materials, manufacturing processes, or the like, as such can vary. It is also to be understood that the terminology used herein is for purposes of describing particular embodiments only, and is not intended to be limiting. It is also possible in the present disclosure that steps can be executed in different sequence where this is logically possible.

[0024] It must be noted that, as used in the specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise.Biospecimen Collection System

[0025] FIG. 1 shows example devices in a biospecimen collection system 10 that includes a sample collection device 200 with a post 230 and absorbent material 220, a solvent container 100 containing aqueous solvent 120, and a conical sample reservoir 300 with an embedded collection insert 320. In some embodiments, the sample collection device 200 comprises handle 210 having a proximal and distal end, wherein the post 230 and the absorbent material 220 are at the distal end. In some embodiments, the post 230 comprises a distal tip having an abrasive element,

[0026] In some embodiments, the absorbent material 220 comprises has a proximal and distal end with an aperture 221 through the center of the absorbent material 220 from the proximal to distal end,

[0027] In some embodiments, the post 230 is disposed within the aperture 221 in the absorbent material 220 such that the distal end of the absorbent material 220 is distally aligned with the distal tip of the post 230 when the absorbent material 220 is not compressed.

[0028] In some embodiments, the absorbent material 220 is cylindrical with an outer diameter matching the diameter of the distal end of the sample collection device 200 just proximal to the post 230.

[0029] FIG. 3 is a perspective view of a sample collection device device for use in the disclosed biospecimen collection system 10 without the absorbent material 220. As shown in FIG. 3, in some embodiments, the post 230 further comprises one or more barbs 250 configured to adhere to the absorbent material 220 within the aperture 221.

[0030] In some embodiments, both the post 230 and the aperture 221 through the center of the absorbent material 220 are cylindrical, and wherein an outer diameter 232 of the post 230 matches an inner diameter 222 of the aperture 221. For example, in some embodiments, the outer diameter 232 of the post 230 and the inner diameter 222 of the aperture 221 through the center of the absorbent material 220 each are each approximately 1.5 mm to 4.0 mm. The aperture can have a distal length 223 identical to or longer than the distal length 233 of the post 230 such that the distal tip 231 of the post 230 is exposed either when the absorbent material 220 is relaxed or is partially deformed, thereby releasing solvent 120. For example, in some embodiments, the post 230 and absorbent material 220 have a distal lengths 223 / 233 of at least 8.0 mm.

[0031] In some embodiments the post is disposed within the aperture in the absorbent material such that the distal end of the absorbent material is distally aligned within 1 mm with the distal tip of the post when the absorbent material is not compressed. For example, in some embodiments, the distal tip of the post is flush with the distal end of the absorbent material. In In some embodiments, the distal tip of the post can extend 0 to 1 mm past the distal end of the absorbent material. In other embodiments, the absorbent material extends 0 to 1 mm past the distal tip of the post.

[0032] In some embodiments, the sample reservoir 300 is a conical centrifuge tube with a 17 mm diameter. For example, in some embodiments, the sample reservoir 300 is a 15 ml conical centrifuge tube.

[0033] As shown in FIGs. 5 and 6, in some embodiments, the collection insert 320 has a polygonal shape and comprises a top surface 324, a bottom surface 325, edges having an upper portion insert 323 and a lower portion insert 322, a thickness 327 from the top surface to the bottom surface, and an outer diameter 326.

[0034] As shown in FIG. 8, in some embodiments, the conical sample reservoir 300 has an inner diameter 330 and a tapered bottom 340. In some embodiments, the collection insert 320 comprises a tapered hole 321 from the top surface 324 to the bottom surface 325 that matches an outer diameter 232 of the post 230. As shown in FIGs. 6 and 8, the outer diameter 326 of the collection insert 320 can match the inner diameter 330 of the conical sample reservoir, and the lower portion 322 of the edge of the collection insert 320 is chamfered at an angle to match the tapered bottom 340 of the conical sample reservoir 300.

[0035] As shown in FIGs. 5 and 6, the collection insert can have a triangular shape to provide 3 large gaps (fluid channels) 328 between insert and inner wall of conical sample reservoir 300 for lysate fluid 121 channeling during compression of the absorbent material 220.

[0036] The absorbent material can in some embodiments be made from any natural or synthetic absorbent material that is suitable for DNA, RNA, and / or protein collection. In some embodiments, the absorbent material is non-reactive (inert), deformable by at least 20% by volume (e.g. 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 80%), hydrophilic, and sterilizable / autoclavable. For example, in some embodiments, the absorbent material is melamine.

[0037] The sample collection device handle 210 and post 230 can be made from any rigid, non-hygroscopic metal or polymer capable of being sterilized. In some embodiments, the handle is made from material with low protein binding. Therefore, in some embodiments, the handle is not made from polystyrene.

[0038] The sample collection device handle 240 can have any length, width, and shape suitable for griping. Therefore, while wand-shaped handles are demonstrated in the figures, it is understood that any handle shape can be used. In simple embodiments, the handle 240 is smooth and / or un-contoured. However, in some embodiments, the handle 240 has contoured grip area. In some embodiments, the handle 240 has a textured or geometric design that increases gripping. For example, as shown in FIG. 3, the handle 240 of the sample collection wand 200 can have a polygonal profile.

[0039] In some embodiments the abrasive element comprises a plurality of diamond, aluminum oxide, sand, silicon carbide, and / or silicon oxide particles, crystals, and / or grit. In some embodiments, the abrasive element comprises a plurality of features having a radius ofcurvature on at least one exposed edge, corner, or point less than 25 pm, 20 pm, 10 pm, 5 pm, 1 , 0.5, or 0.1 pm. The abrasive features can be either incorporated into or disposed onto the distal tip of the post 230.

[0040] FIG. 2 illustrates a method for collecting DNA from epidermal cells of a subject. The method first involves (step 1) inserting a distal end of a sample collection device 200 comprising an abrasive post 230 and absorbent material 220 into a container 100 comprising cell lysis buffer 120 to absorb the aqueous solvent 120 into the absorbent material 220.

[0041] The method next involves (step 2) abrading the epidermal cells of the subject (e.g. skin cells) with the abrasive post 230 and aqueous solvent 120 to collect a biospecimen 121 (e.g. cells released from an epithelium) absorbed by the absorbent material 220.

[0042] The method next involves (step 3) inserting the sample collection device 200 into a sample reservoir 300 which has an embedded collection insert 320, thereby compressing the absorbent material 220 and releasing the biospecimen 121 into the sample reservoir 300.

[0043] In some embodiments, the sample collection device comprises handle having a proximal and distal end, wherein the abrasive post and absorbent material are at the distal end, wherein the abrasive post comprises an abrasive surface at a distal tip, wherein the absorbent material comprises has a proximal and distal end with an aperture through the center of the material from the proximal to distal end, and wherein the post is disposed within the hole in the absorbent material such that the distal end of the absorbent material is distally aligned with the distal tip of the post when the absorbent material is not compressed.Embodiments

[0044] Embodiment 1. A sample collection device, wherein the sample collection device comprises an abrasive element configured to abrade an epithelial surface and an absorbent material, wherein the absorbent material is deformable by at least 20% by volume, is inert, hydrophilic, and autoclavable.

[0045] Embodiment 2. The device of embodiment 1 , wherein the epithelial surface is an epidermal or mucosal surface.

[0046] Embodiment 3. The device of embodiment 2, wherein the epithelial surface is skin epidermis.

[0047] Embodiment 4. The device of any one of embodiments 1 to 3, wherein the abrasive element comprises a plurality of diamond, aluminum oxide, sand, silicon carbide, and / or silicon oxide particles, crystals, and / or grit.

[0048] Embodiment 5. The device of any one of embodiments 1 to 4, wherein the abrasive element comprises a plurality of features having a radius of curvature on at least one exposed edge less than 25 pm.

[0049] Embodiment 6. The device of any one of embodiments 1 to 10, wherein the absorbent material is a synthetic or natural foam with a pore size of from 50 to 500, such as 50 to 100, 50 to 200, 50 to 300, 50 to 400, 100 to 200, 100 to 300, 100 to 400, or 100 to 500.

[0050] Embodiment 7. The device of embodiment 11 , wherein the absorbent material comprises melamine.

[0051] Embodiment 8. The device of any one of embodiments 1 to 7, wherein the sample collection device comprises handle having a proximal and distal end, wherein the distal end of the handle comprises a post having a distal tip, wherein the abrasive element is located on the distal tip of the post, wherein the absorbent material comprises has a proximal and distal end with an aperture through the center of the absorbent material from the proximal to distal end, and wherein the post is disposed within the aperture in the absorbent material such that the distal end of the absorbent material is distally aligned within 1 mm with the distal tip of the post when the absorbent material is not compressed.

[0052] Embodiment 9. The device of embodiment 8, wherein the absorbent material is cylindrical with an outer diameter matching the diameter of the distal end of the sample collection device just proximal to the post.

[0053] Embodiment 10. The device of embodiment 8 or 9, wherein the post further comprises one or more barbs configured to adhere to the absorbent material within the aperture.

[0054] Embodiment 11. The device of any one of embodiments 8 to 10, comprising 2 or more posts each disposed with an aperture of the absorbent material.

[0055] Embodiment 12. The device of any one of embodiments 8 to 11 , wherein both the post and the aperture through the center of the absorbent material are cylindrical, and wherein an outer diameter of the post matches an inner diameter of the aperture.

[0056] Embodiment 13. The device of any one of embodiments 8 to 12, wherein the sample collection device handle is made from a rigid, non-hygroscopic metal or polymer that can be sterilized.

[0057] Embodiment 14. The device of any one of embodiments 8 to 13, wherein the sample collection device handle comprises a contoured grip area.

[0058] Embodiment 15. The device of embodiment 14, wherein the contoured grip device has a polygonal profile.

[0059] Embodiment 16. The device of any one of embodiments 8 to 15, wherein the abrasive surface of the distal tip is rounded.

[0060] Embodiment 17. The device of any one of embodiments 8 to 16 wherein the outer diameter of the post and the inner diameter of the aperture through the center of the absorbent material each are 1.5 mm to 4.0 mm.

[0061] Embodiment 18. The device of any one of embodiments 8 to 17, wherein the post has distal length of from 4.0 mm to 8.0 mm.

[0062] Embodiment 19. A biospecimen collection system, comprising the sample collection device of any one of embodiments 1 to 18; an aqueous solvent; and a sample reservoir comprising an embedded collection insert,

[0063] Embodiment 20. The biospecimen collection system of embodiment 19, wherein the collection insert has a polygonal shape and comprises a top surface, a bottom surface, edges having an upper portion and a lower portion, a thickness from the top surface to the bottom surface, and an outer diameter, wherein the conical sample reservoir has an inner diameter and a tapered bottom, wherein the collection insert comprises a tapered hole from the top surface to the bottom surface that matches an outer diameter of the post, wherein the outer diameter of the collection insert matches the inner diameter of the conical sample reservoir, and wherein the lower portion of the edge of the collection insert is chamfered at an angle to match the tapered bottom of the conical sample reservoir.

[0064] Embodiment 21. The biospecimen collection system of embodiment 20, wherein the collection insert has a triangular shape.

[0065] Embodiment 22. The biospecimen collection system of embodiment 20 or 21 , wherein the sample reservoir is a conical centrifuge tube with a 17 mm diameter.

[0066] Embodiment 23. The biospecimen collection system of embodiment 22, wherein the sample reservoir is a 15 ml conical centrifuge tube.

[0067] Embodiment 24. The biospecimen collection system of any one of embodiments 20 to 23, wherein the aqueous solvent comprises a surfactant mixture configured to disrupt and release cells from an epithelium.

[0068] Embodiment 25. The biospecimen collection system of embodiment 24, wherein the surfactant is BRIJ-30 and N-decyl-N,N-dimethyl-3-ammonio-1-propanesulfonate (DPS) or 3- (N,N-dimethyl myristyl ammonio) propanesulfonate (TPS) and BRIT-C10.

[0069] Embodiment 25. A method for collecting a biospecimen from an epidermis of a subject comprising: loading the absorbent material of the sample collection device of any one of claims 1 to 18 with an aqueous solvent; abrading the epidermis of the subject with the abrasiveelement of the sample collection device while deforming the absorbent material; and inserting the sample collection device into a conical sample reservoir comprising an embedded collection insert, thereby deforming the absorbent material and releasing the biospecimen into the conical sample reservoir.

[0070] A number of embodiments of the invention have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the invention. Accordingly, other embodiments are within the scope of the following claims.

[0071] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of skill in the art to which the disclosed invention belongs. Publications cited herein and the materials for which they are cited are specifically incorporated by reference.

[0072] Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein. Such equivalents are intended to be encompassed by the following claims.

Claims

CLAIMS1. A sample collection device, wherein the sample collection device comprises an abrasive element configured to abrade an epithelial surface and an absorbent material, wherein the absorbent material is deformable by at least 20% by volume, is inert, hydrophilic, and autoclavable.

2. The device of claim 1 , wherein the epithelial surface is an epidermal or mucosal surface.

3. The device of claim 2, wherein the epithelial surface is skin epidermis.

4. The device of claim 1 , wherein the abrasive element comprises a plurality of diamond, aluminum oxide, sand, silicon carbide, and / or silicon oxide particles, crystals, and / or grit.

5. The device of claim 1 , wherein the abrasive element comprises a plurality of features having a radius of curvature on at least one exposed edge less than 25 pm.

6. The device of claim 1 , wherein the absorbent material comprises melamine.

7. The device of claim 1 , wherein the sample collection device comprises handle having a proximal and distal end, wherein the distal end of the handle comprises a post having a distal tip, wherein the abrasive element is located on the distal tip of the post, wherein the absorbent material comprises has a proximal and distal end with an aperture through the center of the absorbent material from the proximal to distal end, wherein the post is disposed within the aperture in the absorbent material such that the distal end of the absorbent material is distally aligned within 1 mm with the distal tip of the post when the absorbent material is not compressed.

8. The device of claim 7, wherein the absorbent material is cylindrical with an outer diameter matching the diameter of the distal end of the sample collection device just proximal to the post.

9. The device of claim 7, wherein the post further comprises one or more barbs configured to adhere to the absorbent material within the aperture.

10. The device of claim 7, comprising 2 or more posts each disposed with an aperture of the absorbent material.

11. The device of claim 7, wherein both the post and the aperture through the center of the absorbent material are cylindrical, and wherein an outer diameter of the post matches an inner diameter of the aperture.

12. The device of claim 7, wherein the sample collection device handle is made from a rigid, non-hygroscopic metal or polymer that can be sterilized.

13. The device of claim 7, wherein the sample collection device handle comprises a contoured grip area.

14. The device of claim 13, wherein the contoured grip device has a polygonal profile.

15. The device of claim 7, wherein the abrasive surface of the distal tip is rounded.

16. The device of claim 7, wherein the outer diameter of the post and the inner diameter of the aperture through the center of the absorbent material each are 1 .5 mm to 4.0 mm.

17. The device of claim 7, wherein the post has distal length of from 4.0 mm to 8.0 mm.

18. A biospecimen collection system, comprising(i) the sample collection device of claim 1 ;(ii) an aqueous solvent; and(iii) a sample reservoir comprising an embedded collection insert,19. The biospecimen collection system of claim 18, wherein the collection insert has a polygonal shape and comprises a top surface, a bottom surface, edges having an upper portion and a lower portion, a thickness from the top surface to the bottom surface, and an outer diameter, wherein the conical sample reservoir has an inner diameter and a tapered bottom, wherein the collection insert comprises a tapered hole from the top surface to the bottom surface that matches an outer diameter of the post, wherein the outer diameter of the collection insert matches the inner diameter of the conical sample reservoir, and wherein the lower portion of the edge of the collection insert is chamfered at an angle to match the tapered bottom of the conical sample reservoir.

20. The biospecimen collection system of claim 19, wherein the collection insert has a triangular shape.

21. The biospecimen collection system of claim 19, wherein the sample reservoir is a conical centrifuge tube with a 17 mm diameter.

22. The biospecimen collection system of claim 21 , wherein the sample reservoir is a 15 ml conical centrifuge tube.

23. The biospecimen collection system of claim 19, wherein the aqueous solvent comprises a surfactant mixture configured to disrupt and release cells from an epithelium.

24. A method for collecting a biospecimen from an epidermis of a subject comprising:(a) loading the absorbent material of the sample collection device of claim 20 with an aqueous solvent;(b) abrading the epidermis of the subject with the abrasive element of the sample collection device while deforming the absorbent material; and(c) inserting the sample collection device into a conical sample reservoir comprising an embedded collection insert, thereby deforming the absorbent material and releasing the biospecimen into the conical sample reservoir.

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