Device and methods for sensitive biological sample storage

Abstract

Provided herein are sample storage devices, kits, and methods for storing a biological sample. A sample storage device provided herein includes an external housing defining a sample chamber. The sample chamber is configured hold a biological sample. The sample storage device also includes a deliquescent layer including one or more deliquescent materials. The sample storage device also includes a sample membrane wherein the deliquescent material is associated with said sample membrane so as to absorb moisture therefrom.

Description

DEVICE AND METHODS FOR SENSITIVE BIOLOGICAL SAMPLE STORAGECROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application depends from and claims priority to U.S. Provisional Application No. 63 / 538,628 filed September 15, 2023, the entire contents of which are incorporated herein by reference.TECHNICAL FIELD

[0002] The present disclosure generally concerns devices and methods for storing a biological sample.BACKGROUND

[0003] Obtaining of biological samples from a wide variety of individuals is often complicated by the location of the subject relative to the facilities needed to analyze the samples. This often requires a subject to travel to a testing facility to provide a sample for analysis, which can be cumbersome depending on the required distance for travel or capability of the subject to make the trip. Moreover, it is common that subjects are located at sites whereby testing facilities are absent or not practical to utilize and may be in relatively inhospitable environments for sample collection and storage.

[0004] Obtaining samples from subjects at remote sites is confounded by an inability to effectively store a sample. Shipping and environmental conditions lead to degradation of the sample prior to its arriving at a testing facility. Accordingly, a need persists for alternative devices and methods of storing samples without significant sample degradation such as for subsequent transport to a remote testing facility.SUMMARY

[0005] Provided herein are devices, kits, and methods for collecting and storing biological samples without the need for freezing or cold storage.

[0006] In one embodiment, the present disclosure provides a sample storage device having an external housing defining a sample chamber, said sample chamber configured to hold a biological sample, a deliquescent layer including one or more deliquescent materials, and a sample membrane wherein the deliquescent material is associated with said sample membrane so as to absorb moisture therefrom. In some embodiments, the deliquescent material is associated with said sample membrane by direct contact and / or by fluid communication.

[0007] In some embodiments, the external housing comprises a base and a lid, optionally linked by a hinge and / or a sealing mechanism configured to seal the base and the lid. Optionally, the sealing mechanism is an adhesive tape. In some embodiments, the sample storage device includes a cap and / or a sample collection surface. In some embodiments the sample collection surface is coupled to the cap.

[0008] Optionally, the deliquescent material is selected from the group consisting of calcium chloride, magnesium chloride, sodium hydroxide, zinc chloride, ferric chloride, potassium carbonate, potassium phosphate, ferric ammonium citrate, ammonium nitrate, potassium hydroxide, copper sulfate, ammonium persulfate, potassium carbonate, and combinations thereof. In some embodiments, the deliquescent material is calcium chloride. In some embodiments the sample membrane is a woven material, a spun material, a foam material a plurality of capillary channels, or a material with a configuration capable of promoting capillary action of a fluid. Optionally, the sample membrane includes one or more components of a vitrification medium, optionally wherein said one or more components are vitrified within said sample membrane. In some embodiments, the sample membrane comprises trehalose, glycerol, or a combination thereof. In some embodiments, the sample storage device includes a polymeric layer comprising a vapor-permeable material.

[0009] In another embodiment, the present disclosure provides a sampling kit including a sample storage device and a sample collection device. In some embodiments, the sampling kit includes a vial containing a vitrification medium.

[0010] In another embodiment, the present disclosure provides a method of storing a sample. The method involves inserting a sample into or onto the sample membrane of the device and optionally closing the sample storage device. Optionally, the deliquescent materialabsorbs moisture from the sample. In some embodiments, the deliquescent material vitrifies the biological sample to generate a storage-stable sample. In some embodiments, the sample is desiccated to a moisture residual ratio (MRR) of 0.01 to 0.4, optionally from about 0.01 to about 0.2, or from about 0.09 to about 0.15. In some embodiments, the sample is collected at a site remote from a testing facility. Optionally, the method includes transporting the device to the testing facility. In some embodiments, the method includes reconstituting the sample to form a reconstituted sample. Optionally, the method includes subjecting the reconstituted sample to testing for the presence or absence of an analyte within the sample, optionally a biological analyte, optionally a cell, bacteria, virus, yeast, protein, antibody, nucleic acid, hormone, fatty acid, steroid, or a combination thereof.. In some embodiments, the presence of the analyte within said sample is quantified.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The drawings are not necessarily to scale; some features may be exaggerated or minimized to show details of particular components. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for teaching one skilled in the art to variously employ the present disclosure. Exemplary aspects will become more fully understood from the detailed description and the accompanying drawings, wherein:

[0012] FIG. 1A schematically depicts a sample storage device according to one or more embodiments described herein.

[0013] FIG. IB depicts the sample storage of the device of FIG. 1A in a folded configuration, according to one or more embodiments described herein.

[0014] FIG. 1C is a cross-sectional view of the device of FIG. 1 A according to one or more embodiments described herein.

[0015] FIG. ID is a cross-sectional view of the folded configuration of FIG. IB according to one or more embodiments described herein.

[0016] FIG. 2A schematically depicts a sample storage device according to one or more embodiments described herein.

[0017] FIG. 2B is a cross-sectional view of the device of FIG. 2A according to one or more embodiments described herein.

[0018] FIG. 2C is a cross-sectional view of the device of FIG. 2A including a sample collection surface according to one or more embodiments described herein.

[0019] FIG. 2D is a schematic illustration of alternative sample collection surface in the device of FIG. 2A according to one or more embodiments described herein.

[0020] FIG. 2E depicts a kit including the sample storage device of FIGS. 2A-2D and a method of use according to one or more embodiments described herein.

[0021] FIG. 3 depicts a kit including the sample storage device of FIGS. 1A-1D and a method of use according to one or more embodiments described herein.

[0022] FIG. 4 depicts a method of using the sample storage device of FIGS. 1A-1D according to one or more embodiments described herein.

[0023] FIG. 5A graphically depicts the concentration of RNA (ng / pL) in cultured cells compared to cells stored with calcium chloride.

[0024] FIG. 5B graphically depicts the RNA integrity number, demonstrating the quality of the isolated RNA in cultured cells compared to cells stored with calcium chloride.

[0025] FIG. 5C graphically depicts the comparative percentages of small RNA molecules.

[0026] FIG. 5D graphically depicts the comparative percentages of large RNA molecules.

[0027] FIG. 5E depicts the results of the RNA integrity analysis using gel electrophoresis.

[0028] FIG. 6 graphically depicts the percent recovery of freshly collected luciferase compared to luciferase vitrified to the sample membrane according to one or more embodiments described herein.DETAILED DESCRIPTION

[0029] Provided are highly advantageous devices and methods for collecting and optionally storing a biological sample that does not require cold-chain storage mechanisms, can be deployed in remote locations, is shippable, and / or is useable at a site remote from any sample testing facility or device. The provided storage devices are configured to maintain and / or enhance the diagnostic value of the sample during transport or storage at a variety of temperatures and humidities. The devices and methods as provided herein utilize a sample membrane into or onto which a sample may be effectively vitrified directly within the device by the use of one or more deliquescent materials to produce a storage stable sample. The device can then be transported to a remote testing facility while maintaining the quality of the sample obtained. These and other advantages of the present disclosure will become clearer from the following description.

[0030] The following terms or phrases used herein have the exemplary meanings listed below in connection with at least one embodiment described herein.

[0031] 0 VitrificationO , as used herein, is a process of converting a material into an amorphous material. The amorphous material may be free of any crystalline structure.

[0032] 0 Vitrification mixtureO as used herein, means a heterogeneous mixture of biological material(s) and a vitrification medium containing one or more vitrification agents and optionally other materials.

[0033] 0 Vitrification agentO , as used herein, is a material that forms an amorphous structure, or that suppress the formation of crystals as the mixture of the vitrification agent and other material(s) desiccates. The vitrification agent(s) may also provide osmotic protection or otherwise enable cell survival during dehydration. In some aspects, the vitrification agent(s) may be any water soluble solution that yields a suitable amorphous structure for storage ofbiological materials. In other aspects, the vitrification agent may be imbibed within a cell, tissue, or organ.

[0034] A 0 sample, 0 as used herein, refers to a material that may contain one or more analytes of interest, an organism or portion of an organism of interest, any biologically derived agent, or a pharmaceutical. The biological sample may be any sample potentially harboring the agent or organism of interest. In some embodiments, such as the storage of biological samples, a volume of the biological sample may be placed directly into a sampling chamber. A sample may be any sample capable of flowing through the matrices described herein and potentially harboring the agent or organism of interest. In some embodiments, the biological sample comprises saliva, blood, serum, plasma, urine, bronchoalveolar lavage fluid, sputum, nasal fluid, skin secretions, or combinations thereof. In other embodiments, the biological sample is collected from a surface. As used herein, the terms 0 surfaceO or 0 environmental surfaceO generally refer to any surface from which a sample can be collected. Exemplary, non-limiting examples of surfaces include walls, doors, floors, ceilings, drains, appliances, furniture, refrigeration systems, ducts, vents, toilet seats, handles, doorknobs, handrails, bedrails, countertops, tabletops, eating surfaces, working surfaces, equipment surfaces, clothing, etc.

[0035] Referring now to the drawings, FIGS. 1A-1D schematically depict an exemplary embodiment of a sample storage device 100 in accordance with the present disclosure.

[0036] It is noted that positional terms such as 0 upper, 0 0 lower, 0 0 proximal, 0 distal, 0 0 top,0 and 0 bottomO are used herein to assist in describing an embodiment of the present disclosure but are not limiting. The sample storage device 100 may be inverted or positioned differently than shown.

[0037] The sample storage device 100 generally includes an exterior housing 102. The exterior housing 102 is or is substantially impermeable to water and water vapor. Optionally, an exterior housing 102 is or is substantially impermeable to gas, optionally air or light. The exterior housing 102 may be formed from any suitable material, including but not limited to, polyethylene, polyvinyl chloride, polyvinyl fluoride, polypropylene, polyurethane, fluoropolymers, metals, other impermeable materials, or combinations thereof, and the like. The exterior housing 102 optionally defines a sample chamber 104. The sample chamber 104is optionally sized and shaped to house a sample membrane 106 and one or more additional layers that function to support the storage and / or transport of the sample. Exemplary functions of the additional layers include deliquescence, absorption, support, vapor permeability, combinations thereof, and the like.

[0038] The exterior housing 102 optionally includes a base 108 and a lid 110. In some embodiments, the base 108 and the lid 110 are configured to fold together, such that the two portions form a pouch around the sample chamber 104, as shown in FIG. IB. For example, and without being bound by theory, the exterior housing 102 may be formed with a hinge, fold point, or equivalent, by which the base 108 and the lid 110 may be folded together. Optionally, base 108 and lid 110 are configured to seal the sample storage device 100 around the sample chamber 104. As shown in FIG. IB, the sealing mechanism 112 may be disposed on the base 108 and / or lid 110 surrounding the sample chamber 104. Any suitable sealing mechanism is contemplated and possible. Exemplary seals can be formed from adhesive tapes including heat- activated adhesives, pressure-sensitive adhesives, gaskets, and the like.

[0039] The sample storage device 100 may include a sample membrane 106. The sample membrane 106 is optionally attached to the sample storage device 100. Alternatively, the sample membrane 106 is a separate component configured to be inserted into the sample storage device 100. In such embodiments, the sample membrane 106 may be included within a kit 300, described in further detail below.

[0040] The sample membrane 106 may be a membrane, scaffold, plurality of capillary channels, a woven material, a spun material, a foam material or any other structure operable to contain or support vitrification of a biological sample therein or thereto. Optionally, the sample membrane 106 is present in the form of a fibrous random or ordered mesh that defines channels or other continuous or discontinuous routes of access for a fluid or a biological sample. Optionally, the sample membrane 106 is in the form of a non-woven fibrous mesh optionally with high porosity (e.g. greater than 50% by volume). In some embodiments, the sample membrane 106 is a foam material, such as polyethersulfone (PES), polyurethane (PU), polyethylene (PE), polypropylene (PP), polystyrene, and the like. Illustrative examples of suitable substrates can be found in U.S. Patent Application Publication No. US 2023 / 0082652, International Patent Application Publication No. WO 2020 / 086812, International PatentApplication No. PCT / US2022 / 035892, and International Patent Application No. PCT / US2021 / 060164, also teaching methods of vitrifying or incorporating molecules into a matrix or substrate, the contents of each of which are incorporated by reference in their entirety.

[0041] In some embodiments, the sample membrane 106 is formed from one or more materials into or onto which one or more vitrified components may be associated at one or more locations. Illustrative examples of materials for the sample membrane 106 include, but are not limited to, collagen, elastin, hyaluronic acid and derivatives, sodium alginate and derivatives, chitosan and derivatives, gelatin, starch, cellulose polymers (for example, nitrocellulose (e.g. Sartorius CN95), methylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, carboxymethylcellulose, cellulose acetate phthalate, cellulose acetate succinate, hydroxypropylmethylcellulose phthalate), poly(diol citrate) (e.g., poly(octanediol citrate), etc.), casein, dextran and derivatives, poly(caprolactone), poly(hydroxyl acids), poly(L-lactide) poly(D,L lactide), poly(D,L-lactide-co-glycolide), poly(L-lactide-co-glycolide), copolymers of lactic acid and glycolic acid, copolymers of 8- caprolactone and lactide, copolymers of glycolide and s-caprolactone, copolymers of lactide and l,4-dioxane-2-one, polymers and copolymers that include one or more of the residue units of the monomers D-lactide, L-lactide, D,L-lactide, glycolide, s-caprolactone, trimethylene carbonate, l,4-dioxane-2-one or l,5-dioxepan-2-one, poly(glycolide), poly(hydroxybutyrate), poly(alkylcarbonate) and poly(orthoesters), polyesters, poly(hydroxyvaleric acid), polydioxanone, poly(ethylene terephthalate), poly(malic acid), poly(tartronic acid), polyanhydrides, polyphosphazenes, poly(amino acids), and copolymers of the above polymers as well as blends and combinations of the above polymers. Illustratively such polymers are as described in U.S. Patent Application Publication No. 2018 / 0125990 and references as cited therein including Polymers in Controlled Drug Delivery (Ilium, L. & Davids, S. S., eds., Wright, Bristol 1987); Arshady, J. Controlled Release 17:1-22 (1991); Pitt, Int. J. Phar. 59:173- 96 (1990); Holland et al., J. Controlled Release 4: 155-80 (1986).

[0042] Materials that may be used in the sample membrane 106 herein optionally can be formed into a porous mesh, such as in the form of a filter, symmetric mesh, or other such porous sheet- like material. Illustratively, the sample membrane 106 material is formed into a fibrous network. Any suitable method of forming the fibrous network is contemplated and possible. For example, and not by limitation, in some embodiments, the sample membrane 106 is formedby electrospinning. In electrospinning, desired materials are placed in a desired solvent (e.g. 2,2,2-trifluoroethanol (TFE) or hexafluoroisopropanol (HFIP)) and subjected to electrospinning processes so as to form a fiber of desired cross-sectional dimension and length and arranged in a desired orientation (optionally random) so as to have a resulting pore size (average distance between strands) to allow materials, analytes, active agents, etc. to pass through or be retained within or by the network. Optionally, the sample membrane 106 includes 2 or more layers of material, optionally 3, 4, 5, 6, or more layers of material.

[0043] In some embodiments, the sample membrane 106 defines one or more pores. Optionally, the pore size is suitable for controlling sample flow or regulating the size of molecules that may pass through the sample membrane 106. It will be appreciated that, in some embodiments, the pore size may be adjusted based on the desired molecule size or sample flow. In some aspects, the pore size within the sample membrane 106 ranges from about 5 micrometers (pm) to about 500 pm, or any value or range therebetween. In some aspects, the pores may be of an average opening of from about 20 pm to about 0.1 pm, including about 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1.0, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3, and 0.2 pm. In some aspects, the pore size of the sample membrane 106 is selected to permit the flow of a liquid and / or any reporters or target analytes of interest present in the sample. In multi-layer embodiments, different layers of the sample membrane 106 may define pores with different pore sizes.

[0044] In some embodiments, the sample membrane 106 defines a capillary channel. A capillary channel may have a length optionally defined by the thickness of a sample membrane 106 that forms the channels or by one or a plurality of individual channels themselves. A capillary channel length is optionally about one millimeter or less, but is not to be interpreted as limited to such dimensions. Optionally, a capillary channel length is of about 0.1 microns to about 1000 microns, or any value or range therebetween. Optionally, a capillary channel length is of about 5 to about 100 microns, optionally of about 1 to about 200 microns, and / or optionally of about 1 to about 100 microns. A capillary channel length is optionally about 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100 microns. In some aspects, the length of the capillary channels varies throughout a plurality of capillary channels, optionally in a non-uniform variation.

[0045] The cross-sectional area of the capillary channel(s) may be of about 2000 pm2or less. Optionally a cross-sectional area is of about 0.01 pm2to about 2000 pm2, optionally of about 100 pm2to about 2000 pm2, or any value or range therebetween. Optionally, a cross- sectional area of the capillary channel(s) is of about 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, or 2000 pm2or less.

[0046] In some aspects, the sample membrane 106 is or includes a hydrophilic material. In other aspects, the sample membrane 106 is or includes a hydrophobic material. In some embodiments, the sample membrane 106 may be treated to be hydrophilic or more hydrophilic in nature, such as through exposure to a plasma.

[0047] In some embodiments, the sample membrane 106 is or includes polycaprolactone (PCL), collagen, or combinations thereof. It will be appreciated that such water-stable polymers is are able to form networks or fibers such that one or more components may be vitrified thereon or therein. Thus, in some embodiments, the sample membrane 106 has sufficient stability in an aqueous environment so as to serve as a suitable surface for vitrification of an aqueous vitrification medium containing one or more desired molecules such as sample agents and / or detection agents.

[0048] In some embodiments, such as shown in FIG. 1C, the sample chamber 104 is subdivided into one or more additional layers. Each of the additional layers may be in direct contact with another layer and / or may be separated from the other layers by an air gap. Optionally, the sample storage device 100 includes a polymeric layer 114 for supporting the sample membrane 106. Optionally, the polymeric layer 114 is formed of a vapor-permeable material, such as spunbound polyethylene polymeric sheets (i.e., TYVEK®). Other exemplary, non-limiting vapor-permeable materials include expanded polytetrafluoroethylene (GORETEX®), microporous polypropylene films, hydrophilic polyether-ester block copolymers (e.g., SYMPATEX®), spunbound polypropylene, combinations of spunbound polypropylene and meltblown polypropylene, combinations thereof, and the like, though any suitable vapor- permeable material is contemplated and possible.

[0049] The sample storage device 100 generally includes a deliquescent layer 116. In some embodiments, the deliquescent layer 116 is in fluid communication, optionally vaporcommunication, with the sample membrane 106. In some embodiments, the deliquescent layer 116 directly contacts the sample membrane 106. In some embodiments, the deliquescent layer 116 is separated from the sample membrane 106 by a gap, optionally a gap that is configured to fluidly (optionally via vapor) contact the sample membrane and the deliquescent layer 116.

[0050] In some embodiments, vitrification is accomplished by removing moisture from the sample membrane 106 to the deliquescent material until the sample enters into a glassy state, described in greater detail herein. Optionally, the deliquescent layer 116 aids in vitrifying the sample by drawing water through the polymeric layer 114 and absorbing the water. In other embodiments, vitrification of the sample is achieved through additional methods, such as those disclosed in U.S. Patent Application Publication No. US 2023 / 0082652, International Patent Application Publication No. WO 2020 / 086812, International Patent Application No. PCT / US2022 / 035892, and International Patent Application No: PCT / US2021 / 060164. In other embodiments, complete vitrification of the sample is not achieved, but rather the sample is sufficiently vitrified so as to be protected from degradation for a time frame merely equal to or greater than any necessary storage time frame, optionally 1 to 10 days, optionally less than 10 days, optionally 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 days.

[0051] The deliquescent layer 116 generally includes one or more deliquescent materials. As used herein, 0 deliquescent or 0 deliquescenceO refers to the phenomenon in which a substance absorbs moisture from the surroundings, wherein in the presence of sufficient moisture the substance undergoes a phase change from a solid or crystalline material to a liquid. In some aspects, a material irreversibly (under standard temperature and pressure) undergoes such phase change thereby capturing fluid and not allowing such fluid to be reexpelled. It is appreciated, however, that a deliquescent material need not undergo a full phase change to promote sufficient vitrification of a sample. For example, the amount of deliquescent material is optionally sufficient or other mechanisms are provided such that the amount of fluid removed from the sample and into the deliquescent material is sufficient to fully or partially vitrify the sample, but need not fully create a complete phase change of the entirety of the deliquescent material. The deliquescent material, however, optionally captures the water from the sample and does not allow such water to be retransmitted to the sample thereby maintaining the levelof vitrification achieved in the sample and promoting stable storage of the vitrified sample in the device until a desired time such as a time for analysis or the like.

[0052] Exemplary non-limiting deliquescent materials that may be used in the device and methods as provide herein include but are not limited to calcium chloride, magnesium chloride, sodium hydroxide, zinc chloride, ferric chloride, potassium carbonate, potassium phosphate, ferric ammonium citrate, ammonium nitrate, potassium hydroxide, copper sulfate, ammonium persulfate, potassium carbonate, and combinations thereof. In some embodiments, the deliquescent material is calcium chloride.

[0053] Many sample types including but not limited to biological and pharmaceutical samples need to be protected from moisture to prevent degradation, extend shelf life, and protect against bacterial and mold growth. Deliquescent materials absorb moisture effectively. These deliquescent materials can attract several times their own weight in water, and with sufficient water present these materials will dissolve into a liquid brine if the air is humid enough and the temperature is high enough. The liquid brine is optionally either trapped inside a collector or mixed with a modified starch and thereby formed as a gel inside its packaging. Further, deliquescent materials are self-limiting, allowing for protection without exhaustion during peaks in humidity. Additionally, deliquescent materials are environmentally safe and can be disposed of without hazardous protocols. The deliquescent material is optionally capable of absorbing greater amounts of moisture when the relative humidity of the surrounding air is higher. For example, and without being bound by theory, calcium chlorideOs moisture absorption is 150 percent its weight in water at 50 percent relative humidity. As relative humidity rises, the absorption also increases. For example, at 85 percent relative humidity, the moisture absorption of calcium chloride is 600 percent its weight.

[0054] The devices provided herein also protect against re-evaporation of absorbed moisture. Still referring to FIG. 1C, the sample storage device 100 optionally includes an absorbent layer 118. As the deliquescent material absorbs water, it forms a liquid solution. The absorbent layer 118 may capture this liquid solution, thereby further preventing moisture from re-evaporating and potentially damaging the sample. In some embodiments, the absorbent layer 118 comprises a desiccant, a hydrogel, a sponge, non-woven materials, cotton, superabsorbentpolymers, or the like. In some embodiments, the absorbent layer 118 comprises a desiccant, such as silica gels, clay desiccants, and the like.

[0055] In some embodiments, the base 108 and the lid 110 each contain a plurality of additional layers. Optionally, the base 108 and the lid 110 each contain a polymeric layer 114, a deliquescent layer 116, and an absorbent layer 118.

[0056] Referring now to FIGS. 2A-2D, another embodiment of a sample storage device 200 is schematically illustrated. In embodiments, the sample storage device 200 comprises an exterior housing 202 defining a sample chamber 204. The sample storage device 200 also includes a cap 208. The sample storage device 200 includes a sample collection surface 206. The sample collection surface 206 is optionally formed from the same materials described herein above with respect to the sample membrane 106.

[0057] The sample collection surface 206 is optionally associated with an elongate shaft 254. The elongate shaft 254 may be constructed from a variety of materials, such as plastic, metal, wood, or combinations thereof. In some embodiments, the elongate shaft 254 is flexible such that it can reach sampling sites that would otherwise be inaccessible. In other embodiments, the elongate shaft 254 can be relatively rigid, so that force can be applied to the elongate shaft 254 to collect a sample.

[0058] The sample collection surface 206 is optionally in the form of a swab or device used to contact a sampling site to collect a sample. Generally speaking, the collection surface 206 is adapted for receiving a sample. In embodiments, the collection surface 206 is formed from one or more liquid permeable materials, such as cotton, fibers, sponges, foams, non-woven fabrics, bamboo, hydrophilic or hydrophobic polymers, and the like. In embodiments, the collection surface 206 is sterile to prevent contamination of the sample or inaccurate results.

[0059] The collection surface 206 may be coupled to the elongate shaft 254 using any suitable mechanism, including, but not limited to fasteners, adhesives, heat sealing, thermal bonding, and the like. In some embodiments, the collection surface 206 is coupled to the elongate shaft 254 by entanglement of the liquid permeable material on and / or around the elongate shaft 254. In some embodiments, the collection surface 206 is coupled to the elongate shaft 254 by one or more threaded fasteners.

[0060] The sample collection surface 206 may be sized and shaped to be placed fully or partially into the sample chamber 204 after the sample is collected. In some embodiments, such as shown in FIG. 2D the sample collection surface 206 is coupled to a cap 208. In such embodiments, after the sample is collected, the swab is screwed or otherwise inserted back to the tube for storage. In other embodiments, such as shown in FIG. 2C, the sample collection surface 206 is separate from the sample storage device 200. For example, in some embodiments, the sample collection surface 206 is part of a sample collection device 252, provided as part of a kit, described in greater detail herein.

[0061] In some embodiments, a collection surface 206 may be or serve as a sample membrane 106 or is coupled thereto such that fluid may be transferred from the collection surface 206 to the sample membrane 106. Optionally, the sample membrane 106 is coupled to the elongate shaft 254. In some embodiments, the sample membrane 106 is disposed on a proximal surface of the collection surface 206. In some embodiments, the sample membrane 106 is disposed at least partially between the elongate shaft 254 and the collection surface 206. Optionally, the sample membrane 106 is a layer disposed underneath the collection surface 206. In some embodiments, the collection surface 206 partially or completely covers the sample membrane 106.

[0062] Still referring to FIGS. 2A-2D, the sample storage device 200 generally includes a polymeric layer 214, separating the sample chamber 204 from the exterior housing 202 and the deliquescent layer 216. Optionally, the polymeric layer 214 is formed of a vapor-permeable material, such as spun-bonded polyolefin polymeric sheets, illustratively but not limited to those sold as TYVEK®.

[0063] The sample storage device 200 generally includes one or more deliquescent layers 216. The deliquescent layer 216 includes one or more deliquescent materials. The deliquescent materials in deliquescent layer 216 may be formed the same materials described herein above with respect to the deliquescent layer 116. In some embodiments, the deliquescent material in deliquescent layer 216 is calcium chloride.

[0064] In some embodiments, a sample storage device 200 is provided as part of a kit 250. As shown in FIG. 2E, a kit 250 generally includes the sample storage device 200 and a sample collection device 252.

[0065] The sample collection device 252 generally includes an elongate shaft 254 and a sample collection surface 206 coupled to the elongate shaft 254. Generally speaking, the collection surface 206 may be adapted for receiving a biological sample. In some embodiments, the collection surface 206 is formed from one or more liquid permeable materials, such as cotton, fibers, sponges, foams, non-woven fabrics, bamboo, hydrophilic polymers, and the like. Optionally, the collection surface 206 is sterile to prevent contamination of the sample or inaccurate results.

[0066] In operation, the sample collection device 252 is used to contact a sample. The sample may be collected by contacting the collection surface 206 to the sampling site. After the sample is collected, the sample collection device 252 may be inserted into the tube. The elongate shaft 254 is optionally broken off to ensure the sample collection device 252 can be placed into the sample storage device 200. The cap 208 may then be placed thereby sealing the sample chamber 204 from the environment and promoting vitrification of the sample within or on the sample membrane 106 by action of the deliquescent material within the device.

[0067] In some embodiments, a sample storage device 100 is provided as part of a kit 300. As shown in FIG. 3, a kit 300 generally includes the sample storage device 100 and a sample collection device 302. It will be appreciated that the elements are numbered in the first panel FIG. 3, however, for clarity and to avoid redundancy, the element numbers have been omitted in subsequent panels, as the elements are visually identifiable from the context of the figure.

[0068] The sample collection device 302 generally includes an elongate shaft 304 and a sample collection surface 306 coupled to the elongate shaft 304. Generally speaking, the collection surface 306 is adapted for receiving a sample. Optionally, the collection surface 306 is formed from one or more liquid permeable materials, such as cotton, fibers, sponges, foams, non-woven fabrics, bamboo, hydrophilic polymers, and the like. In embodiments, the collection surface 306 is sterile to prevent contamination of the sample or inaccurate results.

[0069] In operation, the sample collection device 302 is used to contact a sample. The sample may be collected by contacting the collection surface 306 to the sample, optionally by swabbing a subject or portion thereof, dropping a sample material on the collection device or other. For example, the collection surface 306 is gently rubbed or rotated over the sampling site wherein the collection surface 306 will absorb or collect the sample. Exemplary sampling sites include but are not limited to skin, nails, mucous membranes, wounds, environmental surfaces, and the like.

[0070] In some embodiments, the sample is mixed with a vitrification medium prior to or simultaneous with contact to a sample membrane 106. In some embodiments, such as shown in FIG. 3, the kit 300 includes one or more vials 308 comprising the vitrification medium. The vitrification medium can be provided in liquid or dried form. In some embodiments, the sample is mixed with the vitrification medium to form a vitrification solution. If the biological sample is a liquid biological sample, the vitrification medium can be dissolved in the liquid sample. Briefly, a vitrification medium including one or more sample agents to be vitrified into a substrate, such as a sample membrane 106, are combined and placed into or onto the sample membrane 106.

[0071] A vitrification medium may include at least one vitrification agent. Illustrative examples of a vitrification agent include, but are not limited to, dimethylsulfoxide, glycerol, sugars (e.g. trehalose, etc.), polyalcohols, methylamines, betines, antifreeze proteins, synthetic anti-nucleating agents, polyvinyl alcohol, cyclohexanetriols, cyclohexanediols, inorganic salts, organic salts, ionic liquids, or combinations thereof. In aspects, 1, 2, 3, 4, or more vitrification agents are included in the vitrification medium.

[0072] The vitrification agent is included in the vitrification medium at a concentration that is dependent on the identity of the vitrification agent. In some aspects, the concentration of the vitrification agent is below that which would be toxic to the biological sample being vitrified. As used herein, O toxicO means that functional or biological viability is not achieved upon subsequent sample use, or the biological sample is not suitable for subsequent analyses. In various aspects, the concentration of the vitrification agent is greater than or equal to 500 micromolar (|1M) and less than or equal to 6 molar (M), or any value or range therebetween.As one example, trehalose is included in various aspects in a concentration of greater than or equal to 1 millimolar (mM) and less than or equal to 6 M, optionally greater than or equal to 150 mM and less than or equal to 6 M. In some aspects, the total concentration of all vitrification agents when combined is greater than or equal to 1 mM and less than or equal to 6 M, optionally greater than or equal to 1 mM and less than or equal to 6 M.

[0073] It is contemplated that, in some aspects, the vitrification medium may further include other components, such as, by way of example and not limitation, water or other solvents, a buffering agent, one or more salts, RNase or DNAse inhibitors, or combinations thereof. A buffering agent is any agent with a pKa of 6 to 8.5 at 25 °C. Illustrative examples of buffering agents include choline, betaine, HEPES, TRIS, PIPES, MOPS, among others. In some aspects, the buffering agent is a buffering agent that contains large organic ions (greater than 120 kDa), such as choline, betaine, or HEPES. In embodiments including a buffering agent, the buffering agent is provided at a concentration suitable to stabilize the pH of the vitrification medium to a desired level.

[0074] Salts can include, by way of example and not limitation, magnesium salts, sodium salts, potassium salts, chloride salts, or combinations thereof. When included in the vitrification medium, the salts can be provided at a concentration of from greater than or equal to 1 millimolar (mM) to less than or equal to 500 mM.

[0075] A vitrification medium optionally includes a sugar (e.g. trehalose) and that further includes a combination of divalent metal ions and a chelator. Illustrative examples of divalent metal ions includes salts of Ca, Mg, Co, Fe, Zn, Mn, among others. Illustrative salts include chloride, sulfate, acetate, etc. Chelators include polyols, ethylenediaminetetraacetic acid (EDTA), egtazic acid (EGTA), among others. The molar ratio of divalent metal salt to the chelator in the vitrification solution may be 10:90 to 90:10, optionally 50:50.

[0076] A material used in a vitrification medium, detection agent, reporter, buffering agent or any other desired material may optionally be vitrified into or onto a particular device or portion thereof, optionally a collection surface, a sample membrane, or other, optionally according to the teachings of U.S. Patent No. 10,433,540. Upon contact with a fluid sample, the fluid in the sample reconstitutes the vitrification agent(s) to form a vitrification solution.This vitrification solution is then placed into a device as provided herein whereby the vitrification solution is then vitrified partially or fully by the action of the deliquescent material.

[0077] The sample alone or combined with a vitrification solution the vitrification medium is applied to the sample membrane 106. The sample storage device 100 is then closed forming a seal and stored or transported prior to analysis.

[0078] In other embodiments, a sample storage device 100 accepts a sample via a fluid coupling. As shown in FIG. 4, in some embodiments, a biological sample is collected from a patient. For example, and without being bound by theory, a sample can be collected into a collection tube 402. The collection tube 402 can then be fluidly coupled to the sample storage device 100. The sample can then be transferred to the sample storage device 100 and sealed. Optionally, the sample storage device 100 is under vacuum, such that when the sample storage device 100 is coupled with the collection tube 402, the sample is drawn into the sample storage device and contacted with the sample membrane. In other aspects, a sample storage device 100 is used to directly collect the sample by vacuum action to move the sample from the subject or surface into the sample storage device 100. It is appreciated that the sample storage device in FIG. 4 is illustrated as configured in FIG. 1, but such is not limiting. The sample storage device is optionally in a tube form similar to FIG. 2B and couplable to a system or device that is then contacted with the patient. The sample membrane 106 may be layered onto the polymeric layer 214 such that when the sample enters the sample storage device, it contacts the sample membrane and is then vitrified for eventual storage and subsequent use.

[0079] A sample storage device 100, 200 is optionally used to store a sample or portion thereof in a fully or partially vitrified form such that the sample remains sufficiently stable for the desired time until detection of an analyte is performed. Also provided herein are methods of detecting one or more sample agents in a sample. A method includes, but is not limited to inserting a sample into or onto the sample membrane of the device or kit as described herein, and optionally closing the sample storage device. Optionally, a sample storage device is penetrated by a collection device such that the sample is transferred into the sample storage device for contact with a sample membrane as provided herein. The sample storage device including the deliquescent material then absorbs moisture from the sample such that in the presence of the one or more vitrification agents, the sample analyte(s) is then partially or fullyvitrified. The deliquescent material vitrifies the sample to generate a storage-stable sample. A storage stable sample, as defined herein is one that will degrade (physically or functionally) by 10% or less over a storage period, optionally 1-10 days as otherwise described herein.

[0080] A method includes generating a storage- stable sample that has a residual water content. A storage- stable sample is one that degrades functionally by equal to or less than 10 activity percent per gram analyte over the course of no more than 10 days. Activity is based on the desired activity of the analyte. For example, activity for an antibody may be ability to bind a target. Activity for an enzyme may be ability to act on a substrate.

[0081] Residual water content is optionally quantified as a moisture residual ratio (MRR) defined the actual weight of the dried membrane following vitrification (xa) minus the weight of the dry components of the vitrification buffer (e.g. trehalose, glycerol, BSA) including the analyte (xt) and divided by xa. Thus, MRR is (xa-xt) / xa. MRR is a ratio and is unitless. An MRR of the material is optionally from 0.001 to 0.4, or any value or range therebetween. Optionally, MRR is 0.005 to 0.2. Optionally, an MRR is 0.01 to 0.08. Optionally, an MRR is 0.01 to 0.15. Optionally, and MRR is 0.08 to 0.15. Optionally, and MRR is 0.09 to 0.2. Optionally, an MRR is 0.09 to 0.15.

[0082] Optionally, a method includes collecting a sample at a remote site. A remote site is one that does not include the proper reagents or devices for analysis of the sample and thereby necessitating shipping or transporting the sample storage device from the remote site to a testing facility for subsequent analysis of the sample.

[0083] At a testing facility, a method as provided herein optionally includes subject the sample to one or more analysis methods to detect and / or quantify the presence of one or more analytes in the sample. A method optionally includes reconstituting a sample by contacting the storage- stable sample with one or more elution liquids. An elution liquid is optionally any liquid suitable for dissolving the vitrified material in the substrate. Optionally, an elution liquid is water or aqueous material. Optionally, an elution liquid is or includes one or more organics solvents. Optionally, and elution liquid includes one or more buffering agents.

[0084] Illustrative examples of elution buffer agents include but are not limited to choline, betaine, HEPES, TRIS, PIPES, MOPS, among others. Optionally, the elution buffer can include, by way of example and not limitation, magnesium salts, sodium salts, potassium salts, chloride salts, or combinations thereof. When included in the elution buffer, the salts can be provided at a concentration of from greater than or equal to 1 millimolar (mM) to less than or equal to 500 mM. Optionally, the components of the elution buffer may be provided at a concentration suitable to stabilize the pH of the elution buffer to a desired level.

[0085] A reconstituted sample is optionally subjected to testing by one or more analysis techniques. An analysis technique may be, but is not limited to luminescence, mass spectrometry, PCR, western blot, Southern blot, flow cytometry, enzymatic assay, spectrometry, or other, or combinations thereof.

[0086] Optionally, detection of the analyte relies on an enzyme / substrate reaction. In embodiments, the enzyme / substrate reaction emits detectable light proportional to the amount of the target analyte in the sample. Optionally, the enzyme / substrate combination is luciferase / luciferin. In some embodiments, the emitted light is measured. Optionally, the emitted light is measured using a luminometer. The measured values may then be compared to a standard curve to quantify the amount of the analyte in the biological sample.

[0087] The device and methods herein may be used to detect the presence or absence of one or more agents within a sample. An agent is optionally a biological agent that includes, but is not limited to proteins (e.g. antibodies, blood proteins, intracellular proteins, membrane proteins, etc.), RNA, DNA, lipid, or other. Optionally, a material to be detected is an organism or portion thereof, optionally a bacteria, virus, fungi, or other organism. In some embodiments, the organism is a bacteria.

[0088] Various aspects of the present disclosure are illustrated by the following nonlimiting examples. The examples are for illustrative purposes and are not a limitation on any practice of the present disclosure. It will be understood that variations and modifications can be made without departing from the spirit and scope of the disclosure.EXAMPLES

[0089] The following Examples are offered by way of illustration and are presented in a manner such that one skilled in the art should recognize are not meant to be limiting to the present disclosure as a whole or to the appended claims.Example 1:

[0090] In a first set of experiments, the use of the sample storage device for the isolation and detection of RNA after storage in the device is demonstrated. A testing sample device is created by sandwiching a sample between two sample membranes each coupled with a deliquescent layer. A sample Jurkat cells containing 5xl06cells are incubated with 200 pL of vitrification medium containing 600 mM trehalose, 5% glycerol and 1% Triton X-100. The solution was added to the devices. The devices containing the samples were stored at 24°C overnight.

[0091] The stored sample is then subjected to thermogravimetric analysis during RNA isolation using the spin-column method, compared to freshly cultured cells. Results from 5 samples were averaged and the percent weight loss was calculated. The results are illustrated in Table 1.Table 1

[0092] Comparative results are illustrated in FIGS. 5A-5E. After isolating the RNA, the samples were subjected to DNase treatment, and the amount of RNA was quantified using a Bio Tek Take3 plate (AGILENT, Santa Clara, CA) and analyzed by absorbance ratio at 260nm / 280 nm. Results are illustrated in FIG. 5A. The concentration of RNA isolated from cultured cells was 248.83 ng / pL, while the concentration of RNA isolated from cells stored with CaCh as a deliquescent was 129.49. The percent recovery of RNA for CaCh-vitrified cells was 51% (± 4.4%) of the RNA isolated from cultured cells.

[0093] RNA quality was assessed by fluorimetry using the QUIBIT RNA kit from Thermo Fisher Scientific (Waltham, MA) to assess the degradation of the samples. The comparative percentages of small RNA molecules are depicted in FIG. 5C, while the percentages of large RNA molecules are depicted in FIG. 5D. The RNA integrity number of each are illustrated in FIG. 5B. As shown, the RNA isolated from the cultured cells has an RNA integrity number of 9.4, while the RNA isolated from the CaCh-vitrified cells was 9.53. The results demonstrate that the quality of the RNA is virtually identical between RNA vitrified and stored as described herein or freshly obtained. The high-quality RNA isolated from the vitrified cells demonstrates excellent storage- stable samples using the deliquescent systems as described herein.

[0094] The RNA quality was confirmed by gel electrophoresis. 0.5 pg purified RNA obtained either freshly or vitrified in a device as provided herein was loaded per well. Results are illustrated in FIG. 5E. The device provides nearly identical RNA quality in RNA integrity number, percentage of small RNA, and percentage of large RNA compared with the control.Example 2

[0095] In a second set of experiments, vitrification of the vitrification medium onto the sample membrane was achieved without direct contact between the sample membrane and the deliquescent material.

[0096] A 24 mm Ahlstrom sample membrane was loaded with a volume of vitrification medium (and stored in a cassette. The cassette was placed in a mylar bag with a CaCh desiccant. Four loading volumes (17pl, 70pl, 120pl, and 175pl) were each tested across three time points (1 day, 2 days, and 3 days). Desiccant weights were recorded prior to storage and post storage. Three replicates were tested per time point.

[0097] The residual moisture was calculated using thermogravimetric analysis. The total volatiles at loading, combined with the absorbed moisture at measurement, equals the sum of the desiccant weight gain from the scaffold, the residual moisture on the scaffold, and the desiccant weight gain from the storage environment. These results are demonstrated in Table 2.Table 2

[0098] As shown, each of the residual moisture values are relatively low and appear to have maximum values at approximately 24 hours. However, these residual moisture values are based on several assumptions. First, it is assumed that the amount of solution loaded onto the sample membrane fully occupies the calculated surface area of the membrane. Second, it is presumed that the thermogravimetric analysis sample punched out for testing is exclusively taken from the portion of the membrane where the solution has been loaded. However, in reality, this is not strictly the case, as the sample may include areas of the membrane without loaded solution. This discrepancy contributes to the observed lower residual moisture values, particularly when working with low loading volumes, as areas without loaded solution do not contribute to the moisture content, skewing the results downward.

[0099] Thermogravimetric analysis was performed at multiple time points (4 hours, 8 hours, 12 hours, 16 hours, and 20 hours) using a 175 pL loading volume to determine sufficient dryingtime using the desiccant. These results are depicted in Table 3, demonstrating the 12 hours or more is a sufficient time for vitrification to occur.

[0100] The 24 hour desiccant vitrification was repeated with 175 pL of vitrification medium (9.2% BSA, 600mM Trehalose, 5% Glycerol in PBS) and 84 pg of luciferase on a 24 mm Ahlstrom membrane with CaCh desiccant. 175 pL of vitrification medium (9.2% BSA, 600mM Trehalose, 5% Glycerol in PBS) and 84 pg of luciferase were added to a 24 mm Ahlstrom membrane without vitrification for a control.

[0101] The samples were subjected to a 1-week stress test at 55 °C to simulate accelerated aging conditions. The samples were measured pre-test and post-test. The luciferase control samples gained 6 mg while the vitrified samples gained 150 mg. This results in a 108.0 % recovery for the control samples and a 108.3 % recovery for the vitrified studies, demonstrating that the deliquescent systems described herein provide excellent storage- stable samples with similar results to fresh samples.Items Listing:

[0102] In a first item, alone or in combination with any other item herein, the present disclosure relates to a sample storage device comprising: an external housing defining a sample chamber, said sample chamber configured to hold a biological sample; a deliquescent layer comprising one or more deliquescent materials; and a sample membrane; wherein: the deliquescent material is associated with said sample membrane so as to absorb moisture therefrom, optionally by direct contact and / or by fluid communication.

[0103] In a second item, alone or in combination with any other item herein, the present disclosure relates to a sample storage device wherein the deliquescent material is selected from the group consisting of calcium chloride, magnesium chloride, sodium hydroxide, zinc chloride, ferric chloride, potassium carbonate, potassium phosphate, ferric ammonium citrate, ammonium nitrate, potassium hydroxide, copper sulfate, ammonium persulfate, potassium carbonate, and combinations thereof.

[0104] In a third item, alone or in combination with any other item herein, the present disclosure relates to a sample storage device wherein the deliquescent material is calcium chloride.

[0105] In a fourth item, alone or in combination with any other item herein, the present disclosure relates to a sample storage device wherein the sample membrane is a woven material, a spun material, a foam material, a plurality of capillary channels, or a material with a configuration capable of promoting capillary action of a fluid.

[0106] In a fifth item, alone or in combination with any other item herein, the present disclosure relates to a sample storage device wherein the sample membrane comprises one or more components of a vitrification medium, optionally wherein said one or more components are vitrified within said sample membrane.

[0107] In a sixth item, alone or in combination with any other item herein, the present disclosure relates to a sample storage device wherein the sample membrane comprises trehalose, glycerol, or a combination thereof.

[0108] In a seventh item, alone or in combination with any other item herein, the present disclosure relates to a sample storage device further comprising a polymeric layer comprising a vapor-permeable material.

[0109] In an eighth item, alone or in combination with any other item herein, the present disclosure relates to a sample storage device wherein the external housing further comprises a base and a lid.

[0110] In a ninth item, alone or in combination with any other item herein, the present disclosure relates to a sample storage device wherein the external housing further comprises hinge linking the base and the lid.

[0111] In a tenth item, alone or in combination with any other item herein, the present disclosure relates to a sample storage device further comprising a sealing mechanism configured to seal the base and the lid.

[0112] In an eleventh item, alone or in combination with any other item herein, the present disclosure relates to a sample storage device wherein the sealing mechanism is an adhesive tape.

[0113] In a twelfth item, alone or in combination with any other item herein, the present disclosure relates to a sample storage device further comprising a cap.

[0114] In a thirteenth item, alone or in combination with any other item herein, the present disclosure relates to a sample storage device further comprising a sample collection surface.

[0115] In a fourteenth item, alone or in combination with any other item herein, the present disclosure relates to a sample storage device wherein the sample collection surface is coupled to the cap.

[0116] In a fifteenth item, alone or in combination with any other item herein, the present disclosure relates to a sampling kit comprising: a sample storage device according to any of the preceding items; and a sample collection device.

[0117] In a sixteenth item, alone or in combination with any other item herein, the present disclosure relates to a sampling kit further comprising a vial, said vial comprising a vitrification medium.

[0118] In a seventeenth item, alone or in combination with any other item herein, the present disclosure relates to a method of storing a sample comprising: inserting a sample into or ontothe sample membrane of the device or kit of any one of claims 1-16; and optionally closing the sample storage device.

[0119] In an eighteenth item, alone or in combination with any other item herein, the present disclosure relates to a method of storing a sample wherein the deliquescent material absorbs moisture from the sample.

[0120] In a nineteenth item, alone or in combination with any other item herein, the present disclosure relates to a method of storing a sample wherein the deliquescent material vitrifies the biological sample to generate a storage- stable sample.

[0121] In a twentieth item, alone or in combination with any other item herein, the present disclosure relates to a method of storing a sample wherein said sample is desiccated to a moisture residual ratio (MRR) of 0.01 to 0.4.

[0122] In a twenty- first item, alone or in combination with any other item herein, the present disclosure relates to a method of storing a sample wherein the MRR is from 0.01 to 0.2, or 0.09 to 0.15.

[0123] In a twenty-second item, alone or in combination with any other item herein, the present disclosure relates to a method of storing a sample wherein said sample is collected at a site remote from a testing facility.

[0124] In a twenty-third item, alone or in combination with any other item herein, the present disclosure relates to a method of storing a sample further comprising transporting said device to said testing facility.

[0125] In a twenty-fourth item, alone or in combination with any other item herein, the present disclosure relates to a method of storing a sample further comprising reconstituting said sample to form a reconstituted sample.

[0126] In a twenty- fifth item, alone or in combination with any other item herein, the present disclosure relates to a method of storing a sample further comprising subjecting said reconstituted sample to testing for the presence or absence of an analyte within said sample.

[0127] In a twenty- sixth item, alone or in combination with any other item herein, the present disclosure relates to a method of storing a sample further comprising quantifying the presence of an analyte within said sample.

[0128] In a twenty- seventh item, alone or in combination with any other item herein, the present disclosure relates to a method of storing a sample wherein said analyte is a biological analyte.

[0129] In a twenty-eighth item, alone or in combination with any other item herein, the present disclosure relates to a method of storing a sample wherein said biological analyte is a cell, bacteria, virus, yeast, protein, antibody, nucleic acid, hormone, fatty acid, steroid, or a combination thereof.

[0130] It is noted that the terms 0 substantiallyO and 0 aboutO may be utilized herein to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. These terms are also utilized herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue. The term 0 substantiallyO is used herein also to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue. Thus, it is used to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation, referring to an arrangement of elements or features that, while in theory would be expected to exhibit exact correspondence or behavior, may in practice embody something less than exact.

[0131] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention belongs. The terminology used in the description herein is for describing particular embodiments only and is not intended to be limiting. As used in the specification and appendedclaims, the singular forms 0 a,0 0 an,0 and 0 theO are intended to include the plural forms as well, unless the context clearly indicates otherwise.

[0132] As used herein, the terms 0 horizontal and 0 vertical are relative terms only, are indicative of a general relative orientation only, and do not necessarily indicate perpendicularity. These terms also may be used for convenience to refer to orientations used in the figures, which orientations are used as a matter of convention only and are not intended as characteristic of the devices shown. The present invention and the embodiments thereof to be described herein may be used in any desired orientation. Moreover, horizontal and vertical walls need generally only be intersecting walls, and need not be perpendicular.

[0133] It is noted that one or more of the following claims utilize the term 0 whereinO as a transitional phrase. For the purposes of defining the present technology, it is noted that this term is introduced in the claims as an open-ended transitional phrase that is used to introduce a recitation of a series of characteristics of the structure and should be interpreted in like manner as the more commonly used open-ended preamble term 0 comprising.O

[0134] It should be understood that where a first component is described as 0 comprisingO or 0 includingO a second component, it is contemplated that, in some embodiments, the first component 0 consistsO or 0 consists essentially ofD the second component. Additionally, the term 0 consisting essentially offl is used in this disclosure to refer to quantitative values that do not materially affect the basic and novel characteristic(s) of the disclosure.

[0135] It should be understood that any two quantitative values assigned to a property or measurement may constitute a range of that property or measurement, and all combinations of ranges formed from all stated quantitative values of a given property or measurement are contemplated in this disclosure.

[0136] Various modifications of the present invention, in addition to those shown and described herein, will be apparent to those skilled in the art of the above description. Such modifications are also intended to fall within the scope of the appended claims.

[0137] Patents, publications, and applications mentioned in the specification are indicative of the levels of those skilled in the art to which the invention pertains. These patents,publications, and applications are incorporated herein by reference to the same extent as if each individual patent, publication, or application was specifically and individually incorporated herein by reference.

[0138] While particular embodiments have been illustrated and described herein, it should be understood that various other changes and modifications may be made without departing from scope of the claimed subject matter. Moreover, although various aspects of the claimed subject matter have been described herein, such aspects need not be utilized in combination. It is therefore intended that the appended claims cover all such changes and modifications that are within the scope of the claimed subject matter.

Claims

CLAIMSWhat is claimed is:

1. A sample storage device comprising: an external housing defining a sample chamber, said sample chamber configured to hold a biological sample; a deliquescent layer comprising one or more deliquescent materials; and a sample membrane; wherein: the deliquescent material is associated with said sample membrane so as to be capable of absorbing moisture therefrom.

2. The sample storage device of claim 1, wherein the deliquescent material is selected from the group consisting of calcium chloride, magnesium chloride, sodium hydroxide, zinc chloride, ferric chloride, potassium carbonate, potassium phosphate, ferric ammonium citrate, ammonium nitrate, potassium hydroxide, copper sulfate, ammonium persulfate, potassium carbonate, and combinations thereof.

3. The sample storage device of claim 1, wherein the deliquescent material is calcium chloride.

4. The sample storage device of claim 1, wherein the sample membrane is a woven material, a spun material, a foam material, a plurality of capillary channels, or a material with a configuration capable of promoting capillary action of a fluid.

5. The sample storage device of any of claims 1-4, wherein the sample membrane comprises one or more components of a vitrification medium, optionally wherein said one or more components are vitrified within said sample membrane.

6. The sample storage device of claim 5, wherein the sample membrane comprises bovine serum albumin, trehalose, glycerol, or a combination thereof.

7. The sample storage device of any of claims 1-4, further comprising a polymeric layer comprising a vapor-permeable material.

8. The sample storage device of any of claims 1-4, wherein the external housing further comprises a base and a lid.

9. The sample storage device of claim 8, wherein the external housing further comprises hinge linking the base and the lid.

10. The sample storage device of claim 8, further comprising a sealing mechanism configured to seal the base and the lid.

11. The sample storage device of claim 10, wherein the sealing mechanism is an adhesive tape.

12. The sample storage device of any of claims 1-4, further comprising a cap.

13. The sample storage of device of claim 12, further comprising a sample collection surface.

14. The sample storage of device of claim 13, wherein the sample collection surface is coupled to the cap.

15. The sample storage device of any of claims 1-4, wherein the deliquescent material is associated with said sample membrane by direct contact and / or by fluid communication.

16. A sampling kit comprising: the sample storage device according to any of claims 1-4; and a sample collection device.

17. The sampling kit of claim 16, further comprising a vial, said vial comprising a vitrification medium.

18. A method of storing a sample comprising:inserting a sample into or onto the sample membrane of the sample storage device of any of claims 1-4; and optionally closing the sample storage device.

19. The method of storing a sample according to claim 18, wherein the deliquescent material absorbs moisture from the sample.

20. The method of storing a sample according to claim 18, wherein the deliquescent material vitrifies the biological sample to generate a storage- stable sample.

21. The method of storing a sample according to claim 18, wherein said sample is desiccated to a moisture residual ratio (MRR) of 0.01 to 0.4.

22. The method of storing a sample according to claim 21, wherein the MRR is from 0.01 to 0.2, or 0.09 to 0.15.

23. The method of claim 18, wherein said sample is collected at a site remote from a testing facility.

24. The method of claim 23 further comprising transporting said sample storage device to said testing facility.

25. The method of claim 24 further comprising reconstituting said sample to form a reconstituted sample.

26. The method of claim 25 further comprising subjecting said reconstituted sample to testing for the presence or absence of an analyte within said sample.

27. The method of claim 26 further comprising quantifying the presence of an analyte within said sample.

28. The method of claim 26 wherein said analyte is a biological analyte.

29. The method of claim 28 wherein said biological analyte is a cell, bacteria, virus, yeast, protein, antibody, nucleic acid, hormone, fatty acid, steroid, or a combination thereof.

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