WO2021216780A1

WO2021216780A1 - Collection devices for biological samples and methods of use thereof

Info

Publication number: WO2021216780A1
Application number: PCT/US2021/028491
Authority: WO
Inventors: Elisabeth LADERMAN
Original assignee: Biomerica, Inc.
Priority date: 2020-04-21
Filing date: 2021-04-21
Publication date: 2021-10-28

Abstract

The present disclosure provides a device for collecting a biological sample from a subject suspected or having a viral infection, the device comprising: a sample collection portion, comprising an absorbent pad capable of receiving a biological sample, a flexible card flap that is dimensionally suited to completely seal the sample collection portion, and a non-absorbent solid support, wherein the device is suitable for maintaining the stability of the sample.

Description

COLLECTION DEVICES FOR BIOLOGICAL SAMPLES AND METHODS OF USE

THEREOF

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority to U.S. Provisional Application No. 63/013,521, filed on April 21, 2020 and U.S. Provisional Application No. 63/015,192, filed on April 24, 2020. The entire contents of the foregoing applications are hereby incorporated herein by reference.

BACKGROUND OF THE INVENTION

The disclosure relates to containers, devices, processes, kits and methods for collecting, storing and stably transporting biological samples obtained from a subject (e.g., a human subject) that may contain, viral particles (such as coronavirus) or antibodies capable of binding thereto. The containers, devices, kits and methods described herein are particularly designed for maintaining the stability of a biological sample(s) collected from a subject (e.g., a human subject) during storage and transport to a laboratory setting, such that the biological sample(s) is suitable for subsequent laboratory analysis.

The covid-19 pandemic has caused significant impact not only to individuals, families and communities, but also on companies, governments and global supply chains worldwide. As the social and economic repercussions of the pandemic place additional pressure on the healthcare system, it is becoming necessary to collect and store biological samples obtained from individuals suspected of having covid-19 in non-laboratory settings (e.g., an individual’s home, a place of business or clinical setting) for subsequent transport to an appropriate laboratory for analysis and/or confirmation of the presence or absence of SARS-CoV-2 (or antibodies capable of binding thereto) in the biological sample. However, liquid sample collection, handling, transport, and storage, which is the conventional approach, has numerous problems including, but not limited to (1) container breakage or leakage, which causes loss of sample and increases risk of infection; (2) sample instability during shipment and storage; (3) refusal of transport carriers to accept liquid containing biohazardous material; and (4) collection of quantities of sample greater than that necessary for testing in order to ensure quantities compatible with common laboratory methods of serum or plasma preparation and subsequent analysis. To overcome these problems, the present disclosure provides containers, devices, processes, kits and methods for collecting a biological sample, e.g., a drop of whole blood, plasma, serum or a sample obtained from a nasal or oral swab, with an appropriate absorbent material, which, in a particular embodiment, is dried prior to (or during) transport. In some embodiments, dried biological samples have the advantage of helping to preserve certain components of the biological sample for later analysis. In other embodiments, the biological sample is treated prior to transport (e.g., the biological sample is denatured and/or the biological sample is exposed to ultraviolet irradiation) to ensure the biological sample is preserved and/or is not hazardous for transport and/or subsequent laboratory analysis.

Accordingly, there is currently a need for a container, a device, a process, or a kit for the collection, storage and transport of a biological sample (e.g., a dried blood sample or a dried sample obtained from a nasal or oral swab) suspected of containing a coronavirus (e.g., SARS-CoV-2), or antibodies capable of binding thereto, wherein the biological sample is further capable of efficient extraction / dehydration for subsequent analysis in a laboratory setting where more sophisticated equipment, highly trained personnel, and professional quality controls, can perform appropriate analyses.

SUMMARY OF THE INVENTION

In one aspect the present disclosure provides a device for collecting a biological sample from a subject suspected or having a viral infection, the device comprising: a sample collection portion, comprising an absorbent pad capable of receiving a biological sample, a flexible card flap that is dimensionally suited to completely seal the sample collection portion, and a non-absorbent solid support, wherein the device is suitable for maintaining the stability of the sample.

In some embodiments, the absorbent pad is capable of absorbing at least about 10 μl of the sample. In other embodiments, the absorbent pad is capable of absorbing at least about 20 μl of the sample. In another embodiment, the absorbent pad is capable of absorbing at least about 30 μl of the sample. In another embodiment, the absorbent pad is capable of absorbing between 15-30 μl of the sample. In another embodiment, the absorbent pad is capable of absorbing between 15-20 μl of the sample. In yet another embodiment, the absorbent pad is capable of absorbing 20 μl of the sample.

In some embodiments, the absorbent pad is composed of at least one material selected from the group consisting of a glass fiber, a nitrocellulose, a nitrocellulose blend with polyester, a nitrocellulose blend with cellulose, a paper, and an acrylonitrile copolymer. In one embodiment, the absorbent pad comprises paper. In another embodiment, absorbent pad comprises glass.

In some embodiments, the non-absorbent solid support comprises at least one material selected from the group consisting of a glass fiber, a nitrocellulose, a nitrocellulose blend with polyester, a nitrocellulose blend with cellulose, a paper, and an acrylonitrile copolymer. In some embodiments, the flexible card flap comprises at least one material selected from the group consisting of a glass fiber, a nitrocellulose, a nitrocellulose blend with polyester, a nitrocellulose blend with cellulose, a paper, and an acrylonitrile copolymer.

In some embodiments, the absorbent pad comprises the biological sample applied thereon. In some embodiments, the absorbent pad comprising the biological sample is sufficiently dried prior to closure of the flexible card flap. In some embodiments, the closure of the flexible card flap occurs at least 10 minutes after the biological sample is applied to the absorbent pad. In other embodiments, the closure of the flexible card flap occurs at least 20 minutes after the biological sample is applied to the absorbent pad. In other embodiments, the closure of the flexible card flap occurs at least 30 minutes after the biological sample is applied to the absorbent pad. In other embodiments, the closure of the flexible card flap occurs at least 40 minutes after the biological sample is applied to the absorbent pad. In other embodiments, the closure of the flexible card flap occurs at least 50 minutes after the biological sample is applied to the absorbent pad. In other embodiments, the closure of the flexible card flap occurs at least 60 minutes after the biological sample is applied to the absorbent pad.

In some embodiments, the absorbent pad further remains sealed for at least 5 hours at a temperature between 2-25°C. In some embodiments, the absorbent pad further remains sealed for at least 10 hours at a temperature between 2-25°C. In some embodiments, the absorbent pad further remains sealed for at least 15 hours at a temperature between 2-25°C. In some embodiments, the absorbent pad further remains sealed for at least 20 hours at a temperature between 2-25°C. In some embodiments, the absorbent pad further remains sealed for at least 24 hours at a temperature between 2-25°C. In some embodiments, the absorbent pad further remains sealed for about 7 days at a temperature between 2-8°C. In some embodiments, the absorbent pad further remains sealed for about 14 days at a temperature of 25°C.

In one embodiment, the the device is packaged in a sterile container. In some embodiments, the device further comprises at least one or more agents selected from a group consisting of a fixative agent, an anti-coagulant, a capture agent, a diagnostic reagent and a buffer, a reference standard. In some embodiments, the one or more agents are exposed to the biological sample after collection from the subject, and wherein the one or more agents maintain or enhance the stability of the sample. In one embodiment, the agent is the anti-coagulant. In one embodiment, the anti-coagulant agent is EDTA or heparin. In one embodiment, the the anti-coagulant is K2 EDTA.

In some embodiments, the biological sample is selected from the group consisting of whole blood, blood plasma, blood serum, amniotic fluid, breast milk, vaginal secretions, semen, seminal fluid, urine, amniotic fluid, cerebrospinal fluid, bronchoalveolar lavage fluid, tears, saliva, mucous, tissue, tissue homogenate, cellular extract, a nasal sample, an oral sample, and spinal fluid. In one embodiment, the sample is whole blood.

In some embodiments, the viral infection is caused by a virus selected from the group consisting of 229E, NL63, OC43, HKU1, MERS-CoV, SARS-CoV, SARS-CoV-2, influenzavirus A, influenzavirus B, influenzavirus C, and influenzavirus D. In some embodiments, the biological sample is pretreated under conditions effective to inactivate the at least one virus prior to transport. In some embodiments, the conditions effective to inactivate the at least one virus comprises denaturing the biological sample. In some embodiments, the conditions effective to inactivate the at least one virus comprises incubating the biological sample for at least 1 minute at a temperature, wherein the temperature is at least 45°C, at least 50°C, or is at least 55°C, or is at least 60°C, or is at least 65°C, or is at least 70°C, or is at least 75°C, or is at least 80°C, or is at least 85°C, or is at least 90°C. In some embodiments, the conditions effective to inactivate the at least one virus comprises exposing the biological sample to an effective amount of ultraviolet irradiation.

In some embodiments, the device is used to transport the biological sample from a non-laboratory setting.

In another aspect, the present disclosure provides a method for detecting a target analyte in a biological sample from a subject infected with or suspected of being infected with a viral infection. The method comprises the steps of collecting the biological sample from the subject, contacting the sample with an absorbent pad of a device capable of receiving the sample. The device comprises a sample collection portion comprising the absorbent pad capable of receiving the sample, a flexible card flap that is dimensionally suited to completely seal the sample collection portion, and a non-absorbent solid support, drying the biological sample applied to the absorbent pad, wherein the drying produces a dried sample spot in the absorbent pad, eluting the sample from the dried sample spot and testing the eluted sample using an immunoassay that detects the target analyte. In one embodiment, the absorbent pad is capable of absorbing between 10-50 µl of the sample applied thereupon. In some embodiments, the drying comprises maintaining the absorbent pad at room temperature for at least 10 minutes prior to sealing the absorbent pad with the flexible card flap. In some embodiments, the drying comprises maintaining the absorbent pad at room temperature for at least 20 minutes prior to sealing the absorbent pad with the flexible card flap. In some embodiments, the drying comprises maintaining the absorbent pad at room temperature for at least 30 minutes prior to sealing the absorbent pad with the flexible card flap. In some embodiments, the method further comprises maintaining the absorbent pad at a temperature between 2-25°C for at least 5 hours. In some embodiments, the method further comprises maintaining the absorbent pad at a temperature between 2-25°C for at least 5 hours. In some embodiments, the method further comprises maintaining the absorbent pad at a temperature between 2-25°C for at least 10 hours. In some embodiments, the method further comprises maintaining the absorbent pad at a temperature between 2-25°C for at least 15 hours. In some embodiments, the method further comprises maintaining the absorbent pad at a temperature between 2-25°C for at least 20 hours. In some embodiments, the method further comprises maintaining the absorbent pad at a temperature between 2-25°C for at least 24 hours. In some embodiments, eluting comprises adding at least about 1.0 mL, at least about 1.2 mL, at least about 1.4 mL, or at least about 1.8 mL of sample diluent to the dried sample spot. In one embodiment, eluting comprises adding about 1.4 mL of sample diluent to the dried sample spot. In some embodiments, the method further comprises incubating at room temperature for at least 12 hours, for at least 24 hours or for at least 36 hours, after adding the sample diluent. In one embodiment, the method further comprises incubating at room temperature for 24 hours after adding the sample diluent. In some embodiments, the biological sample is selected from the group consisting of whole blood, blood plasma, blood serum, amniotic fluid, breast milk, vaginal secretions, semen, seminal fluid, urine, amniotic fluid, cerebrospinal fluid, bronchoalveolar lavage fluid, tears, saliva, mucous, tissue, tissue homogenate, cellular extract, a nasal sample, an oral sample, and spinal fluid. In one embodiment, the sample is whole blood. In some embodiments, collecting the whole blood sample is obtained from the subject via finger prick using a lancet. In some embodiments of the method, the absorbent pad is capable of absorbing at least about 10 µl of the sample. In other embodiments of the method, the absorbent pad is capable of absorbing at least about 20 µl of the sample. In other embodiments of the method, the absorbent pad is capable of absorbing at least about 30 µl of the sample. In other embodiments of the method, the absorbent pad is capable of absorbing between 15-30 µl of the sample. In other embodiments of the method, the absorbent pad is capable of absorbing between 15-20 µl of the sample. In yet another embodiment of the method, the absorbent pad is capable of absorbing 20 µl of the sample. In some embodiments, the contacting step of the method further comprises at least one or more agents selected from a group consisting of a fixative agent, an anti-coagulant, a capture agent, a diagnostic reagent and a buffer, a reference standard. In some embodiments, the one or more agents are exposed to the biological sample after collection from the subject, and wherein the one or more agents maintain or enhance the stability of the sample. In one embodiment, the agent is the anti-coagulant. In one embodiment, the anti-coagulant agent is EDTA or heparin. In one embodiment, the the anti-coagulant is K2 EDTA. In some embodiments, the method further comprises a step of transporting the biological sample in a packaged sterile container, and the transporting step is after the drying step but before the eluting step of the method described herein. In one embodiment of the method, the transporting is from a non-laboratory setting. In some embodiments, the viral infection of the subject described in the method is caused by a virus selected from the group consisting of 229E, NL63, OC43, HKU1, MERS- CoV, SARS-CoV, SARS-CoV-2, influenzavirus A, influenzavirus B, influenzavirus C, and influenzavirus D. In one embodiment, the viral infection of the subject described in the method is caused by SARS-CoV-2. In one embodiment of the method, the target analyte comprises antibodies that bind specifically to SARS-CoV-2. In one embodiment of the method, the immunoassay detects IgG antibodies against SARS-CoV-2. In another aspect the present disclosure provides a kit for testing a sample for a target analyte from subject infected with or suspected of being infected with a viral infection. The kit comprises an instrument for collecting the sample, a device for storing the sample, a sample diluent, wherein the sample diluent elutes the sample from the absorbent pad; and components for performing an ELISA to test the sample for the presence of a predetermined or an undetermined target. In some embodiments, the kit includes a device comprising a lancet as a device for obtaining the sample from the subject via finger prick. In some embodiments, the kit includes a device comprising a sample collection portion, comprising an absorbent pad capable of receiving a sample, a flexible card flap that is dimensionally suited to completely seal the sample collection portion after the sample is collected on the absorbent pad, and a non-absorbent solid support.

In some embodiments of the kit, the absorbent pad is capable of absorbing at least about 10 μl of the sample. In other embodiments of the kit, the absorbent pad is capable of absorbing at least about 20 mΐ of the sample. In other embodiments of the kit, the absorbent pad is capable of absorbing at least about 30 mΐ of the sample. In other embodiments of the kit, the absorbent pad is capable of absorbing between 15-30 mΐ of the sample. In other embodiments of the kit, the absorbent pad is capable of absorbing between 15-20 mΐ of the sample. In yet another embodiment of the kit, the absorbent pad is capable of absorbing 20 mΐ of the sample.

In some embodiments, the kit further comprises at least one or more agents selected from a group consisting of a fixative agent, an anti-coagulant, a capture agent, a diagnostic reagent and a buffer, a reference standard. In some embodiments, the one or more agents are exposed to the biological sample after collection from the subject, and wherein the one or more agents maintain or enhance the stability of the sample. In one embodiment, the agent is the anti-coagulant. In one embodiment, the anti-coagulant agent is EDTA or heparin. In one embodiment, the the anti-coagulant is K2 EDTA.

In some embodiments of the kit, the viral infection of the subject is caused by a virus selected from the group consisting of 229E, NL63, OC43, HKU1, MERS-CoV, SARS-CoV, SARS-CoV-2, influenzavirus A, influenzavirus B, influenzavirus C, and influenzavirus D. In one embodiment, the viral infection is caused by SARS-CoV-2. In one embodiment, the target analyte comprises antibodies that bind specifically to SARS-CoV-2. In one embodiment, the ELISA kit components detect IgG antibodies against SARS-CoV-2. In some embodiments, the ELISA kit components comprise microwells, a wash buffer, a negative control, a positive control, a secondary antibody conjugate, a 3,3',5,5'-Tetramethylbenzidine substrate and a stop solution. In one embodiment, the ELISA kit components are components of COVID-19 IgG ELISA kit from Biomerica with a catalog number 7086.

In another aspect, the present disclosure provides a process for preparing a sample for analysis of a target analyte in a biological sample from a subject infected with or suspected of being infected with a viral infection. The process comprises the steps of collecting the biological sample from the subject, contacting the sample with a device comprising a sample collection portion, comprising an absorbent pad capable of receiving the sample, a flexible card flap that is dimensionally suited to completely seal the sample collection portion, and a non-absorbent solid support and drying the biological sample applied to the absorbent pad, wherein the drying produces a dried sample spot in the absorbent pad.

In some embodiments, drying comprises maintaining the absorbent pad with the sample applied thereon at room temperature for at least 10 minutes, at least 20 minutes, at least 30 minutes, at least 40 minutes, at least 60 minutes, or at least 60 minutes prior to sealing the absorbent pad. In one embodiment, the process further comprises maintaining the absorbent pad with the sample applied thereon at room temperature to dry the sample for at least 10 minutes prior to sealing the absorbent pad with the flexible card flap. In another embodiment, the process further comprises maintaining the absorbent pad with the sample applied thereon at room temperature to dry the sample for at least 20 minutes prior to sealing the absorbent pad with the flexible card flap. In yet another embodiment, the process further comprises maintaining the absorbent pad with the sample applied thereon at room temperature to dry the sample for at least 30 minutes prior to sealing the absorbent pad with the flexible card flap.

In some embodiments, the process further comprises maintaining the sealed absorbent pad with the dried sample at a temperature between 2-25°C for at least 5 hours. In another embodiment, the process further comprises maintaining the sealed absorbent pad with the dried sample at a temperature between 2-25°C for at least 10 hours. In another embodiment, the process further comprises maintaining the sealed absorbent pad with the dried sample at a temperature between 2-25°C for at least 15 hours. In another embodiment, the process further comprises maintaining the sealed absorbent pad with the dried sample at a temperature between 2-25°C for at least 20 hours. In yet another embodiment, the process further comprises maintaining the sealed absorbent pad with the dried sample at a temperature between 2-25°C for at least 24 hours. In some embodiments, the process further comprises unsealing the sealed absorbent pad and eluting the biological sample by adding at least about 1.0 mL, at least about 1.2 mL, at least about 1.4 mL, or at least about 1.8 mL of biological sample diluent to the sample. In one embodiment, the process further comprises unsealing the sealed absorbent pad and eluting the biological sample by adding about 1.4 mL, or at least about 1.8 mL of sample diluent to the sample. In some embodiments, the process further comprises incubating the biological sample at room temperature for at least 12 hours, for at least 24 hours or for at least 36 hours, after adding the sample diluent. In one embodiment, the process further comprises incubating the biological sample at room temperature for 24 hours after adding the sample diluent. In some embodiments of the process described herein, the biological sample is selected from the group consisting of whole blood, blood plasma, blood serum, amniotic fluid, breast milk, vaginal secretions, semen, seminal fluid, urine, amniotic fluid, cerebrospinal fluid, bronchoalveolar lavage fluid, tears, saliva, mucous, tissue, tissue homogenate, cellular extract, and spinal fluid. In one embodiment of the process provided herein, the sample is whole blood. In some embodiments of the process, the whole blood sample is obtained from the subject via finger prick using a lancet. In some embodiments of the process provided herein, the absorbent pad is capable of absorbing at least about 10 µl of the sample. In other embodiments of the process, the absorbent pad is capable of absorbing at least about 20 µl of the sample. In other embodiments of the process, the absorbent pad is capable of absorbing at least about 30 µl of the sample. In other embodiments of the process, the absorbent pad is capable of absorbing between 15-30 µl of the sample. In other embodiments of the process, the absorbent pad is capable of absorbing between 15-20 µl of the sample. In yet another embodiment of the process, the absorbent pad is capable of absorbing 20 µl of the sample. In some embodiments, the contacting step of the process further comprises contacting the absorbent pad with at least one or more agents selected from a group consisting of a fixative agent, an anti-coagulant, a capture agent, a diagnostic reagent and a buffer, a reference standard, wherein the one or more agents are exposed to the biological sample after collection from the subject, and wherein the one or more agents maintain or enhance the stability of the sample. In some embodiments, the agent is an anti-coagulant. In some embodiments, the anti-coagulant is is EDTA or heparin. In some embodiments, the anti- coagulant is K2 or K3 EDTA. In another embodiment, the contacting step of the process further comprises contacting the absorbent pad with K2 EDTA.

In one embodiment of the process, the biological sample from a subject suspected or having a viral infection is caused by a virus selected from the group consisting of 229E,

NL63, OC43, HKU1, MERS-CoV, SARS-CoV, SARS-CoV-2, influenzavirus A, influenzavirus B, influenzavirus C, and influenzavirus D. In one embodiment of the process, the biological sample from a subject suspected or having a viral infection is caused by SARS- CoV-2. In one embodiment of the process, the target analyte comprises antibodies that bind specifically to SARS-CoV-2. In one embodiment of the process, the target analyte comprises a SARS-CoV-2 antigen (e.g., Spike (s) protein from SARS-CoV-2) that is a pathogenic determinant of a SARS-CoV-2 infection. In one embodiment of the process, target analyte comprises a S protein from SARS-CoV-2.

BRIEF DESCRIPTION OF THE FIGURES

Fig. 1 shows an image of an exemplary whole blood collection card. The whole blood collection card includes a paper card solid support with a single sample collection portion housing an absorbent pad located within the solid support. In this particular embodiment, the sample collection portion houses a 7 x 20 mm absorbent pad.

Fig. 2 shows a schematic overview of an exemplary whole blood collection card workflow starting from sample collection, transport, lab storage, recovery of sample from the card and testing/analysis.

Fig. 3 shows a scatter plot depicting absorbance (at 480 nm) as a function of elution time in comparison to a serum control. The plot is obtained by measuring the blood card response against the index value for each negative patient across all elution time points. The elution was carried out in 1.1 mL of buffer for different elution time points of 0, 2, 3, 5, 16,

20, 24 hours.

Fig. 4 shows a zoomed in view of a dot plot for the negative samples when a 1.4 correction factor is applied in the whole blood collection card data to the results obtained in experiments to assess the matrix equivalence between serum, plasma, and whole blood. Results show no significant upward bias in the negative samples when the correction factor is applied.

Fig. 5 shows a zoomed in view of a dot plot for the negative samples when a 1.3 correction factor is applied in the whole blood collection card data to the results obtained in experiments to assess the matrix equivalence between serum, plasma, and whole blood. Results show no significant upward bias in the negative samples when the correction factor is applied.

Fig. 6 shows a zoomed in view of a dot plot for the negative samples when a 1.2 correction factor is applied in the whole blood collection card data to the results obtained in experiments to assess the matrix equivalence between serum, plasma, and whole blood. Results show no significant upward bias in the negative samples when the correction factor is applied.

Fig. 7 shows a zoomed in view of a dot plots for the negative samples when no correction factor is applied in the whole blood collection card data to the results obtained in experiments to assess the matrix equivalence between serum, plasma, and whole blood.

DETAILED DESCRIPTION

The present invention provides devices, methods, processes and kits for testing biological samples obtained from a subject (e.g., a human) infected with or suspected of being infected with a viral infection (e.g., a SARS CoV-2 infection). The containers, devices, and kits disclosed herein may be transported from a non-laboratory setting such as an individual’ s home, a place of business or a point-of care facility, where a biological sample is collected and stored, to a second location (e.g., a laboratory capable of performing an analysis) without the need for refrigeration or expedited delivery times. In some embodiments, the methods described herein include collecting a biological sample using containers, devices, processes and kits as described herein, thereby maintaining the stability of the collected biological samples during storage and transport such that the biological samples are suitable for subsequent laboratory analysis, while at the same time, eliminating the need for conditions or expenses associated with the transport of a biological sample. In some embodiments, the biological sample is then provided to an appropriate laboratory that can extract and/or rehydrate the biological sample for analysis. In other embodiments, the biological sample is then provided to an appropriate laboratory that can extract the biological sample without the need to rehydrate the biological sample for analysis.

The containers, devices, processes, kits and methods described herein allow for efficient and safe collection and storage of a biological sample for transport to a laboratory setting.

I. Definitions

The term “about”, as used herein, refers to a value that is within 10% above or below the value being described. The term “sample”, as used herein, refers to any medium (e.g., a fluid) suspected of containing a target analyte such as an antibody (e.g., an antibody capable of binding to SARS- CoV-2 antibody) or an antigen of interest (e.g., a SARS-CoV-2 antigen). The phrase “contacting the sample”, “sample application” or “sample is applied” are used interchangeably and refer to the application of a sample (e.g., a biological sample) to a device as described herein, such as a whole blood collection card having at least one sample collection portion housing an absorbent pad such that the sample is capable being stably retained within the absorbent pad for a period of time sufficient for transport and subsequent recovery using an appropriate elution buffers and procedures as described herein. The term “stability of a biological sample,” as used herein refers the capability of a biological sample to retain its initial characteristics (e.g., characteristics at the time of collection from a subject) over a period of time. Non-limiting exemplary initial characteristics include concentration of the components within the sample, ionic strength, state of the components in the sample such as complexed or aggregated. The stability of the biological sample is mainly affected by storage time and also by other factors (e.g., contact with air, diffusion, evaporation, exposure to light) that alter the metabolism of the components of a biological sample (e.g., cells) or cause the initial property to disappear. The term “maintaining the stability of the biological sample,” as used herein is the ability of the biological sample to retain the initial property for a period of time within specified limits when the sample is stored under defined conditions. Non-limiting example of maintaining the stability of the sample could include addition of anticoagulants such as EDTA to prevent coagulation of a blood sample, storing the blood sample at room temperature in a sealed container to prevent oxidative damage to the cells mediated by exposure to air. The term “sample collection portion,” as used herein refers to the three-dimensional region where an absorbent pad is located or housed. In an exemplary embodiment, a device described herein may comprises at least one sample collection portion housing a single absorbent pad spatially disposed in or attached to a non-absorbent solid support. The term “target analyte” or “antigen,” as used herein, refers to any analyte of interest in a sample, which is capable of binding to a capture agent (e.g., an anti-SARS-CoV-2 antibody or a SARS-CoV-2 antigen). II. Device for collecting a biological sample

In one aspect, the present disclosure provides a device comprising a sample collection portion that may be employed in a process for liquid sample collection, storage, transport and/or delivery to a suitable laboratory for subsequent testing/analysis.

The sample collection portion is located or configured in the device to allow for a sample to be applied (e.g., a blood sample from a human subject), in some embodiments, the device contains one or more sample collection portions for receipt of one or more liquid samples. For embodiments of devices with more than one sample collection portion (i.e., a plurality of sample collection portions), each sample portion is capable of having applied to it a single sample from a human subject, or a single sample from more than one human subject. In one embodiment, the sample collection portion (or an absorbent pad housed therein) may be later removed for subsequent processing and analysis of a sample contained in this sample collection portion. In another embodiment, the entire sample collection portion may be removed from the device for subsequent processing and analysis of the sample contained therein. In certain embodiments, the perimeter of the sample collection portion may be configured for easy removal from the device.

In some embodiments, the devices provided herein are made of cellulose and are suitable for collecting samples (e.g., blood samples). In other embodiments, exemplary devices are made of materials including, but not limited to, cardboard, paper (e.g., filter paper), plastic or a composite material. Exemplary sample collection portions can be made of Whatman cards such as DMPK-A, DMPK-B and DMPK-C cards, and cardboard. The regions of the card, other than the sample collection portion, can include, but are not limited to, a card flap, and/or the base of the card, which can comprise materials which may be the same as or different from the sample collection portion. These regions of the card, other than the sample collection portion, may be made of plastic, paper, cardboard, glass, and transparent or nontransparent solid plastic. The devices described herein provide a reliable, fast and stable means for sample collection, storage, transport and subsequent analysis. The device of the present disclosure is described in detail below. i. Composition of the Device

The disclosure provided herein is directed to a device for collecting a sample (e.g., a biological sample) from a subject (e.g., a human subject) suspected or having a viral infection (e.g., SARS-CoV-2). in one embodiment, the device comprises a sample collection portion that comprises an absorbent pad capable of receiving the sample, a flexible card flap that is dimensionally suited to completely seal the sample collection portion comprising the absorbent pad, and a non-absorbent solid support. The device provided herein is suitable for maintaining the stability of the sample (e.g., a biological sample). For example, in certain embodiments, maintaining the stability of the sample may include the addition of an anticoagulant(s), such as EDTA, in the absorbent pad to prevent coagulation of a blood sample. In another embodiment, maintaining the stability of the sample may include storing the sample (e.g., a biological sample) at room temperature in a sealed container to prevent oxidative damage to cells (e.g., blood cells) in the sample mediated by exposure to air. One non-limiting example of a device as disclosed herein is a whole blood collection card (WBCC) comprising a paper card with a single sample collection portion comprising a single absorbent pad in the center of the whole blood collection card, such as that shown in FIG.1. The device, the sample collection portion, and the absorbent pad may be any shape including circular, oblong, polygonal, triangular, trapezoidal, rectangular or square-shaped. The regions of the card other than the sample collection portion, such as the flexible card flap and the non-absorbent solid support, can comprise materials made of plastic, paper, cardboard, glass, and transparent or non-transparent solid plastic. ii.Sample Collection Portion & the Absorbent Pad In some embodiments, the device as described herein comprises a sample collection portion comprising an absorbent pad capable of receiving the biological sample The absorbent pad is located or housed within a three dimensional space generally referred to as the “sample collection portion”. In some embodiments, the sample collection portion may include an area apart from the absorbent pad to collect excess sample, store buffers or other agents (e.g., stabilizers) that may be used to process the sample. In some embodiments, the absorbent pad is capable of retaining fluid sample by, e.g., capillary action or absorption. In one particular embodiment, a biological sample may be applied onto the absorbent pad described herein by applying the biological sample onto the absorbent pad and allowing the biological sample to migrate into the pad by capillary action or gravity. In various embodiments described herein, the sample collection portion comprises a single absorbent pad may be any shape including circular, oblong, polygonal, triangular, trapezoidal, rectangular or square-shaped. In other embodiments described herein, the device comprises more than one (i.e., a plurality of) absorbent pads. In some embodiments, the absorbent pad may be a natural fibrous material or a synthetic fibrous material and may be selected from a variety of materials including, but not limited to, plastic, paper (e.g., filter paper, such as Whatman filter paper), jute, rubber, cellulose, cardboard, glass, and transparent or non- transparent solid plastics such as polyethylene. In some embodiments, the absorbent pad can be made of cellulose. In a particular embodiment, the absorbent pad can be made of porous cellulose matrix. In other embodiments, the absorbent pad can be made of Whatman cards such as DMPK-A, DMPK-B and DMPK-C cards. In other embodiments, the absorbent pad may also comprise hydrophilic polymers, such as polyvinyl alcohol (PVA), polyethylene glycol (PEG) or polyvinylpyrrolidone (PVP). Polyethylenes (PE), which may be employed, include, but are not limited to, high density polyethylene (HDPE), low density polyethylene (LDPE), or ultra high molecular weight polyethylene (UHMWPE), or a blend thereof. In some embodiments, the absorbent pad is made up of paper, e.g., including but not limited to Whatman 903 filter paper, Whatman DMPK filter paper or Whatman FTA filter paper Ahlstrom Grade 226 filter paper and/or Munktell TFN filter paper. In another embodiment, the absorbent pad is composed of at least one material selected from the group consisting of a glass fiber, a nitrocellulose, a nitrocellulose blend with polyester, a nitrocellulose blend with cellulose, a paper, and an acrylonitrile copolymer. In one embodiment, the absorbent pad is composed of a cellulose-based paper material. In another embodiment, the absorbent pad is made of porous glass. In certain other embodiments, suitable components of an absorbent pad may include, but are not limited to, hydrophilic polyethylene materials or pads, acrylic fiber, glass fiber, filter paper or pads, desiccated paper, paper pulp, fabric, and the like. In one particular embodiment, an absorbent pad may comprise material such as a non-woven spunlaced acrylic fiber, nonwoven polyethylene treated to improve the hydrophobic property of the material. In one embodiment, the absorbent pad is configured as a strip, with some, most, or all, of the strip comprising the absorbent material, thereby generating a strip-based collection device. In another embodiment, the absorbent pad is configured into a circular shape or a square-shape rather than a strip. In some embodiments, a biological sample may be applied as a drop (e.g., a blood drop from a finger prick) and allowed to migrate radially through the absorbent pad, thereby generating a “sample spot.” In some embodiments, a marking, such as a circle, may be incorporated onto the absorbent pad indicating a target location where the sample (e.g., a biological sample) should be applied and the approximate amount of sample to be applied (by, for example, instructing the user to fill most or all of the marked location). In other embodiments described herein, the absorbent pad retains the biological sample applied thereon. In some embodiments, the absorbent pad comprises a biological sample is sufficiently dried prior to closure of the flexible card flap as described below. In some embodiments, the absorbent pad comprises a porous matrix. In some embodiments, the porous matrix has a porosity from about 20% to about 80%, from about 25% to about 70%, from about 30% to about 60%, or from about 30% to about 50%. In some embodiments, the porous matrix has a pore size of from about 1 μm to about 200 μm, from about 10 μm to about 100 μm, or from about 20 μm to about 60 μm. In some embodiments, the absorbent pad has a thickness of from about 100 microns (μm) to about 5 mm, or from about 200 μm to about 3 mm, or from about 0.5 mm to about 2 mm. In one embodiment, the absorbent pad has dimensions of about 7 x 20 mm. In other embodiments, the absorbent pad has dimensions of about 5 x 20 mm, about 10 x 20 mm, about 15 x 20 mm, about 20 x 20 mm, about 5 x 30 mm, about 10 x 30 mm, about 15 x 30 mm, about 20 x 30 mm, about 25 x 30 mm, and about 30 x 30 mm. An absorbent pad may be composed of a hydrophobic or hydrophilic material, and this property is chosen depending on the sample to be applied to the sample collection portion. In one embodiment, the absorbent pad is hydrophilic so that hydrophilic samples may be absorbed into the pad. Hydrophilic absorbent pads are preferred for use with blood samples. In another embodiment, the absorbent pad is hydrophobic so that hydrophobic samples may be absorbed into the pad. Hydrophobic absorbent pads may be desirable if the sample contains surfactants. In some embodiments, the amount of absorbed sample in the absorbent pad is controlled by the cross sectional area, thickness and pore volume of the pad. In one embodiment, the sample is absorbed into the absorbent pad by capillary force. In another embodiment, the sample is absorbed into the absorbent pad by gravity. In yet another embodiment, the sample is absorbed into the absorbent pad by a combination of capillary and gravitational forces. The sample capacity of the absorbent pad may be from about 0.1 μl to about 500 μl, from about 1 μl to about 250 μl, from about 2 μl to about 225 μl, from about 3 μl to about 200 μl, from about 5 μl to about 150 μl, from about 10 μl to about 100 μl, from about 5 μl to about 50 μl, from about 10 μl to about 40 μl, or from about 10 μl to about 30 μl. The pore volume of the absorbent pad may be greater than about 1 μl or less than about 1000 μl, or any value between about 1 μl and about 1000 μl, or from about 0.1 μl to about 500 μl, from about 1 μl to about 250 μl, from about 2 μl to about 225 μl, from about 3 μl to about 200 μl, from about 5 μl to about 150 μl, from about 10 μl to about 100 μl, from about 5 μl to about 50 μl, from about 10 μl to about 40 μl, or from about 10 μl to about 30 μl. In some embodiment, the absorbent pad has a capacity to absorb at least about 30 µl, from about 10 μl to about 50 μl, from about 15 μl to about 35 μl, from about 15 μl to about 30 μl, from about 15 μl to about 20 μl, or about 20 μl of whole blood sample obtained from a patient. In one embodiment, the absorbent pad has a capacity to absorb about 20 μl of whole blood sample obtained from a patient. iii.Flexible Card Flap In certain embodiment described herein, the device comprises a flexible card flap that is dimensionally suited to completely seal the sample collection portion. In one embodiment, the flexible card flap is intended to facilitate collection of a sample and prevent any contamination with other samples or agents post sample collection. In mother embodiment, the flexible card flap is intended to facilitate collection of a sample and prevent any moisture from collecting in the absorbent pad housed within the sample collection portion, post sample collection The flexible card flap may be made from glass fiber, a nitrocellulose, a nitrocellulose blend with polyester, a nitrocellulose blend with cellulose, a paper, an acrylonitrile copolymer or combinations therefrom. In one embodiment, the flexible card flap is made from paper. In preferred embodiments of the device described herein, the flexible card flap is dimensionally suited to completely seal the absorbent pad. In certain embodiments of the disclosure, the absorbent pad comprising the biological sample is sufficiently dried prior to closure of the flexible card flap. In one embodiment, the absorbent pad is sealed with the flexible card flap after a period of time upon contacting the biological sample from the subject. The period of time when the absorbent pad, after contacting the biological sample, is sealed with the flexible card flap ranges from about 5 minutes to about 120 minutes, from about 10 minutes to about 60 minutes, from about 15 minutes to about 45 minutes, from 20 minutes to about 40 minutes, from 25 minutes to about 35 minutes, from about 30 minutes to about 40 minutes or from about 30 minutes to about 60 minutes. The sample in the absorbent pad has typically dried during this period of time. In one embodiment, closure of the flexible card flap occurs at least 10 minutes after the biological sample is applied to the absorbent pad. In one embodiment, closure of the flexible card flap occurs at least 10 minutes after the biological sample is applied to the absorbent pad. In another embodiment, closure of the flexible card flap occurs at least 20 minutes after the biological sample is applied to the absorbent pad. In another embodiment, closure of the flexible card flap occurs at least 30 minutes after the biological sample is applied to the absorbent pad. In another embodiment, closure of the flexible card flap occurs at least 40 minutes after the biological sample is applied to the absorbent pad. In yet another embodiment, closure of the flexible card flap occurs at least 60 minutes after the biological sample is applied to the absorbent pad. In all of the embodiments provided herein, the sample in the absorbent pad has typically dried prior to the closure of the flexible card flap. iv.Non-absorbent Solid Support In some embodiments, the absorbent pad is configured to be connected to, housed in or embedded within a non-absorbent solid support. In one embodiment, the absorbent pad is connected to a non-absorbent solid support through any suitable means including, but not limited to, an adhesive. In one embodiment, the non-absorbent solid support is comprised of a non-absorbent plastic. In some embodiments, the non-absorbent solid support comprises a glass fiber, a nitrocellulose, a nitrocellulose blend with polyester, a nitrocellulose blend with cellulose, a paper, an acrylonitrile copolymer or combinations therefrom. In one embodiment, the non-absorbent solid support is made from paper. In certain other embodiments of the devices described herein, the device may be used without an additional housing. In such embodiments, the non-absorbent solid support has sufficient mechanical strength and rigidity, and in addition, facilitates the use of the device without additional housing. In some embodiments of the device provided here, a print can be applied to the non-absorbent solid support to act as a unique identifier. In some embodiments, the unique identifier can be a company logo. In other embodiments, the unique identifier can be a label that identifies the sample. In yet another embodiment, the unique identifier can be a barcode and/or a quick response (QR) code that can be also directly printed onto the card. In some embodiments, the unique identifier may also comprise a magnetic strip for information storage. In some embodiments, the non-absorbent solid support can be laminated materials, such as cardboard or a plastic sheet using techniques familiar to one of ordinary skill in the art. In some embodiments, the non-absorbent solid support can also be inserted into a frame sheet using techniques familiar to one of ordinary skill in the art. In other embodiments, the device is used to transport a biological sample from a non- laboratory setting such as a point of care testing location, a near patient setting for collection of blood, a patient’s home, an employer’s place of business, a school, etc., to an appropriate laboratory setting, e.g., a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory, for subsequent analysis. In some embodiments, the device may be configured with an additional housing such as a sealed container. In some embodiments, the sealed container is a sterile container. In some embodiments, the sealed container may be made from metal, glass, a nitrocellulose, a nitrocellulose blend with polyester, a nitrocellulose blend with cellulose, a paper, an acrylonitrile copolymer or combinations therefrom. In various embodiments, the containers, devices, and kits described herein allow a subject to obtain a biological sample at home, at a place of business or at a clinical setting in a manner that provides a reliably stable biological sample that can be transported to an appropriate laboratory for accurate assessment of viral infection status. Notably, in some embodiments, the containers, devices, and kits described herein facilitate the collection of small sample amounts (e.g., one or a few drops of blood, such as about 10 μl to 200 μl, or about 20 μl to about 100 μL, or about 30 μl to about 70 μl, and in certain embodiments, about 50 μl, or about 25 μl), which may then be dried and/or fixed, stored, and transported in a manner that permits accurate assessments of the viral infection status, e.g., at a later time and/or different location.

In some embodiments, the device may be stored in sufficiently appropriate storage conditions until the operator at a laboratory performs the analysis. In many embodiments, the absorbent pad further remains sealed for at least 5 hours, at least 10 hours, at least 15 hours, at least 20 hours, or at least 24 hours at a temperature between 2-25°C after the flexible card flap is sealed, thereby enclosing the absorbent pad within the sample collection portion prior to transportation. In some embodiments, the absorbent pad remains sealed for about 7 days, about 14 days or about 21 days at a temperature between 2-8°C after the flexible card flap is sealed, thereby enclosing the absorbent pad within the sample collection portion prior to transportation. In some embodiments, the absorbent pad remains sealed for at least 20 hours at a temperature between 2°C -25°C after the flexible card flap is sealed, thereby enclosing the absorbent pad within the sample collection portion prior to transportation. In some embodiments, the absorbent pad remains sealed for about 7 days at a temperature between 2- 8°C after the flexible card flap is sealed, thereby enclosing the absorbent pad within the sample collection portion prior to transportation. In other embodiments, the absorbent pad remains sealed for about 14 days at a temperature of 25°C after the flexible card flap is sealed, thereby enclosing the absorbent pad within the sample collection portion prior to transportation.

In various embodiments, the biological sample is treated prior to transport in order to preserve the biological sample and/or ensure the biological sample is safe (i.e., not hazardous) for transport and/or subsequent laboratory analysis. In certain embodiments, the biological sample is pretreated under conditions effective to inactivate a virus in the biological sample prior to transport. For example, in some embodiments, the biological sample described herein is allowed to dry under various conditions of time and temperature. Thus, in some embodiments, drying may occur by allowing the device containing the biological sample to remain at room temperature for several hours, or may occur in an accelerated manner through the use of a drying device that employs mechanisms such as fans or heaters. However, in other embodiments, the biological sample is treated by heating prior to transport. Thus, in such embodiments, the biological sample is incubated at a temperature sufficient to inactivate a virus, wherein the temperature is at least 40°C, at least 45°C, at least 50°C, or is at least 55°C, or is at least 60°C, or is at least 65°C, or is at least 70°C, or is at least 75°C, or is at least 80°C, or is at least 85°C, or is at least 90°C. Yet, in other embodiments, the biological sample is treated by exposing the biological sample to an effective amount of ultraviolet irradiation sufficient to inactivate a virus prior to transport.

In another embodiment, the conditions effective to inactivate the at least one virus comprises exposing the biological sample to an effective amount of ultraviolet irradiation. v. Functional Additives

In some embodiments, the absorbent pad may contain functional additives. In some embodiments, the functional additives help maintain the stability of the sample applied to the absorbent pad. In some embodiments, functional additives include, but are not limited to, chelating agents, such as ethylene diamine tetraacetic acid (EDTA), surfactants, such as anionic surfactant, cationic surfactant or non-ionic surfactant, DNA stabilizing agents, such as uric acid or urate salt, or a weak acid, such as Tris(hydroxymethyl)aminomethane (TRIS). In other embodiments, the functional additives include, but are not limited to, the following: polyelectrolytes, C-18, C-8 or C-4 modified silica, silica gel, ion exchange material, controlled porous glass (CPG), solid phase extraction (SPE) media, cell lysis reagents, protein denaturing additives, chemicals that denature or de-activate proteins and/or lyse cells, anti oxidants, chemicals that preserve the analyte to be measured in the sample, enzyme inhibitors, antimicrobials, and color change indicators, chaotropic agent, such as urea, thiourea, guanidinium chloride, or lithium perchlorate, etc. In some embodiments, the absorbent pads may also contain an anti-coagulant, such as heparin, citrate, EDTA and/or chelating agents. In some embodiments, the absorbent pads contain K2 or K3 EDTA. In one embodiment, the absorbent pads contain K2 EDTA. In some embodiments, the device may optionally contain a storage stabilizing agent, such as a desiccant or an oxygen scavenger. In some embodiments, the device may optionally be stored with a storage stabilizing agent, such as a desiccant or an oxygen scavenger. vi. Samples

A sample, as disclosed herein, may include, but are not limited to, biological and non- biological fluids. Biological fluids include, but are not limited to, bodily fluids such as whole blood, blood plasma, blood serum, amniotic fluid, breast milk, vaginal secretions, semen, seminal fluid, urine, amniotic fluid, cerebrospinal fluid, bronchoalveolar lavage fluid, tears, saliva, mucous, tissue, tissue homogenate, cellular extract, and spinal fluid. Other biological fluids include but are not limited to culture medium such as cell or tissue culture medium. Non-biological fluids include water samples including fresh water, sea water, and wastewater samples, organic solution samples, inorganic solution samples, samples from the petrochemical industry such as samples from oil fields, environmental samples and food samples. In some embodiments, biological and non-biological samples may contain cells, viral particles and other pathogenic determinants such as antibodies to a viral antigen. In one embodiment, when the biological sample is blood, the absorbent pad may contain K2 EDTA. Samples also include, but are not limited to, tissues, animal or plant cells, microorganisms (for example, bacteria, viruses, mold, and fungi), and plasmids. Cells include, but are not limited to, cultured cells, epithelial cells, mesothelial cells, endothelial cells and stem cells or other progenitor cells. Cells may be obtained from tissues, organs and biological fluids using techniques known to one of ordinary skill in the art.

In some embodiments, a biological sample, as described herein, is any material obtained from a subject, e.g., a human subject suspected of having a viral infection. For example, a biological sample can be a sample of a bodily fluid, a cell sample, or a tissue sample from a biopsy. Bodily fluid samples can include, but are not limited to blood, urine, sputum, semen, feces, saliva, bile, cerebral fluid, nasal swab, urogenital swab, nasal aspirate, spinal fluid, etc. Biological samples can also include any sample derived from a sample taken directly from a subject, e.g., human. For example, a biological sample can be the plasma fraction of a blood sample, serum, protein or nucleic acid extraction of the collected cells or tissues or from a specimen that has been treated in a way to improve the detectability of the specimen, for example, a lysis buffer containing a mucolytic agent that breaks down the mucus in a nasal specimen significantly reducing the viscosity of the specimen and a detergent to lyse the virus thereby releasing antigens and making them available for detection by the assay.

In other embodiments, the biological sample described herein can be derived from any source, such as a physiological fluid, including blood, serum, plasma, saliva or oral fluid, sputum, ocular lens fluid, nasal fluid, nasopharyngeal or nasal pharyngeal swab or aspirate, sweat, urine, milk, ascites fluid, mucous, synovial fluid, peritoneal fluid, transdermal exudates, pharyngeal exudates, bronchoalveolar lavage, tracheal aspirations, cerebrospinal fluid, semen, cervical mucus, vaginal or urethral secretions, amniotic fluid, and the like. Herein, fluid homogenates of cellular tissues such as, for example, hair, skin and nail scrapings are also considered biological samples.

In other embodiments of the device, methods and the kits described herein, samples contain a target(s) analyte including, but not limited to, nucleic acid (DNA, RNA), carbohydrates, lipids, proteins, peptides, hormones, antibodies, metabolites, neurotransmitters, immunomodulators, drugs, drug metabolites, alcohol, ions, or electrolytes. In some embodiments of the disclosure, the sample contains at least one target analyte, such as an antibody that specifically binds to an antigen(s) from one or more viruses selected from the group consisting of 229E, NL63, OC43, HKU1, MERS-CoV, SARS-CoV, SARS-CoV-2, influenzavirus A, influenzavirus B, influenzavirus C, and influenzavirus D. In one embodiment, the biological sample from a subject suspected or having a viral infection is caused by a virus selected from the group consisting of 229E, NL63, OC43, HKU1, MERS- CoV, SARS-CoV, SARS-CoV-2, influenzavirus A, influenzavirus B, influenzavirus C, and influenzavirus D. In some other embodiments of the disclosure, the sample contains at least one target analyte, such as an antigen that is a pathogenic determinant from one or more viruses selected from the group consisting of 229E, NL63, OC43, HKU1, MERS-CoV, SARS-CoV, SARS-CoV-2, influenzavirus A, influenzavirus B, influenzavirus C, and influenzavirus D.

In some embodiments, the biological sample is pretreated under a condition effective to inactivate the one or more virus prior to transport. In some embodiments, the condition effective to inactivate the at least one virus comprises denaturing the biological sample. In one embodiment, the condition effective to inactivate the at least one virus comprises incubating the biological sample for at least 1 minute at a temperature, wherein the temperature is at least 50°C. In another embodiment, the condition effective to inactivate the at least one virus comprises exposing the biological sample to an effective amount of ultraviolet irradiation.

III. Method for detecting a target analyte in a biological sample

In another aspect, the present disclosure provides a method for detecting a target analyte in a biological sample from a subject infected with or suspected of being infected with a viral infection. The method comprises the steps of collecting the biological sample from the subject, contacting the sample with an absorbent pad of a device capable of receiving the sample. The device comprises a sample collection portion comprising the absorbent pad capable of receiving the sample, a flexible card flap that is dimensionally suited to completely seal the sample collection portion, and a non-absorbent solid support, drying the biological sample applied to the absorbent pad, wherein the drying produces a dried sample spot in the absorbent pad, eluting the sample from the dried sample spot and testing the eluted sample using an immunoassay that detects the target analyte. In some embodiments, drying comprises maintaining the absorbent pad at room temperature for at least 10 minutes, at least 20 minutes, at least 30 minutes, at least 40 minutes, at least 60 minutes, or at least 60 minutes prior to sealing the absorbent pad. In many embodiments of the methods provided herein, the absorbent pad further remains sealed for at least 5 hours, at least 10 hours, at least 15 hours, at least 20 hours, or at least 24 hours at a temperature between 2-25°C after the sample in the absorbent pad has dried. In some embodiments, eluting comprises adding at least about 1.0 mL, at least about 1.2 mL, at least about 1.4 mL, or at least about 1.8 mL of sample diluent to the absorbent pad (e.g., to the dried sample spot on the absorbent pad). In one embodiment, eluting comprises adding about 1.4 mL of sample diluent to the dried sample spot on the absorbent pad. In some embodiments, the method further comprises incubating the absorbent pad at room temperature for at least 12 hours, for at least 24 hours or for at least 36 hours, after adding the sample diluent. In one embodiment, the method further comprises incubating the absorbent pad at room temperature for 24 hours after adding the sample diluent. In some embodiments, the sample used in the methods described herein include, but are not limited to, biological and non-biological fluids. Biological fluids include, but are not limited to, bodily fluids such as whole blood, blood plasma, blood serum, amniotic fluid, breast milk, vaginal secretions, semen, seminal fluid, urine, amniotic fluid, cerebrospinal fluid, bronchoalveolar lavage fluid, tears, saliva, mucous, tissue, tissue homogenate, cellular extract, and spinal fluid. Other biological fluids include but are not limited to culture medium such as cell or tissue culture medium. In one embodiment of the process provided herein, the sample is whole blood. In some embodiments of the methods provided herein, collecting the whole blood sample is obtained from the subject via finger prick using a lancet. In some embodiments of the method, the absorbent pad has a capacity to absorb at least about 30 µl, from about 10 μl to about 50 μl, from about 15 μl to about 35 μl, from about 15 μl to about 30 μl, from about 15 μl to about 20 μl, or about 20 m! of whole blood sample obtained from a patient. In one embodiment of the method, the absorbent pad has a capacity to absorb about 20 μl of whole blood sample obtained from a patient.

In one embodiment, a whole blood sample is applied to the absorbent pad of the device described herein. In one embodiment, the blood sample is maintained in a liquid state and the device is stored in a moist environment for subsequent use or transport, such as mailing. In another embodiment, the blood sample is permitted to dry before transport. In one embodiment of the process described here, the absorbent pad is sealed with the flexible card flap after a period of time after contacting the blood sample from the patient with the absorbent pad. The period of time when the absorbent pad, after contacting the biological sample, is sealed with the flexible card flap ranges from about 5 minutes to about 120 minutes, from about 10 minutes to about 60 minutes, from about 15 minutes to about 45 minutes, from 20 minutes to about 40 minutes, from 25 minutes to about 35 minutes, or from about 30 minutes to about 40 minutes. The sample in the absorbent pad has typically dried during this period of time. In one embodiment, the period of time when the absorbent pad, after contacting the biological sample, is sealed with the flexible card flap is 30 minutes. In one embodiment, the device with a dried blood sample may then be stored for subsequent use or transport, such as mailing. In another embodiment, upon sufficient sample drying, the absorbent pad is sealed with the flexible card flap and stored until the appropriate time to perform a test on the sample contained therein. In one embodiment, upon sufficient sample drying, the device may be placed in the appropriate storage conditions until an operator (e.g., appropriate laboratory personnel) performs an analysis of the sample.

In some embodiments of the method, the device may be placed in sufficiently appropriate storage conditions until the operator at a laboratory performs the analysis. In many embodiments, the absorbent pad further remains sealed for at least 5 hours, at least 10 hours, at least 15 hours, at least 20 hours, or at least 24 hours at a temperature between 2- 25 °C after the flexible card flap is sealed, thereby enclosing the absorbent pad within the sample collection portion prior to transportation. In some embodiments, the absorbent pad remains sealed for about 7 days, about 14 days or about 21 days at a temperature between 2- 8°C after the flexible card flap is sealed, thereby enclosing the absorbent pad within the sample collection portion prior to transportation. In some embodiments, the absorbent pad remains sealed for at least 20 hours at a temperature between 2-25 °C after the flexible card flap is sealed, thereby enclosing the absorbent pad within the sample collection portion prior to transportation. In some embodiments, the absorbent pad remains sealed for about 7 days at a temperature between 2-8°C after the flexible card flap is sealed, thereby enclosing the absorbent pad within the sample collection portion prior to transportation. In other embodiments, the absorbent pad remains sealed for about 14 days at a temperature of 25°C after the flexible card flap is sealed, thereby enclosing the absorbent pad within the sample collection portion prior to transportation. In some embodiments, after the blood sample dries in the absorbent pad, the device may be processed immediately to perform a desired test to detect a selected target analyte.

In some embodiments of the method described herein, the sample contains at least one target analyte, such as an antibody that bind specifically to the antigens from one or more viruses selected from the group consisting of 229E, NL63, OC43, HKU1, MERS-CoV, SARS-CoV, SARS-CoV-2, influenzavirus A, influenzavirus B, influenzavirus C, and influenzavirus D. In some other embodiments of the process, the sample contains at least one target analyte, such as an antigen that is a pathogenic determinant from one or more viruses selected from the group consisting of 229E, NL63, OC43, HKU1, MERS-CoV, SARS-CoV, SARS-CoV-2, influenzavirus A, influenzavirus B, influenzavirus C, and influenzavirus D. In one embodiment of the method, the biological sample from a subject suspected or having a viral infection is caused by a virus selected from the group consisting of 229E, NL63, OC43, HKU1, MERS-CoV, SARS-CoV, SARS-CoV-2, influenzavirus A, influenzavirus B, influenzavirus C, and influenzavirus D. In one embodiment of the method, the biological sample from a subject suspected or having a viral infection is caused by SARS-CoV-2. In one embodiment of the method, the target analyte comprises antibodies that bind specifically to SARS-CoV-2. In one embodiment of the method, the immunoassay of the method detects IgG antibodies against SARS-CoV-2.

In some embodiments, the disclosure further comprises a means for converting a dried sample (contained on the sealed absorbent described herein) into a liquid extract suitable for one or more analyses, e.g., in an appropriate laboratory setting. In some embodiments, after the sample dries, a portion of the absorbent pad containing the dried blood sample may be obtained by cutting the absorbent pad with a knife, scissors, a sharp punch of desired shape at the cutting surface, or another tool or instrument known to one of ordinary skill in the art. In another embodiment, a “sample spot” in the absorbent pad may be punched away from the absorbent pad by application of force to a spot, especially in embodiments wherein the perimeter of the spot is somewhat thinner or weaker than the paper material on either side. In one embodiment, the biological sample containing portion of the absorbent pad is placed into a suitable container (tube, microwell, vial etc.) and a defined volume of extraction fluid (i.e., an eluent used interchangeably with sample diluent or diluent) is added so that the biological sample-containing portion of the absorbent material becomes submerged into the extraction fluid. In such embodiments, several options are available. In one embodiment, the excised portion of the absorbent pad with the sample spot may be covered and stored until the appropriate time to perform a test on the sample contained therein. In other embodiments, the excised portion of the absorbent pad with the sample spot may be processed immediately to perform a desired test to detect a target sample. In other embodiments, the process described comprises the step of incubating the excised portion at room temperature for at least 24 hours after adding the eluent to elute the sample. In one embodiment, the process described comprises the step of incubating the excised portion at room temperature for at least 24 hours after adding about 1.4 ml of the eluent to elute the sample. In some embodiments of the process described herein, the absorbent pad with the dried blood sample may be cut or punched into a receptacle based on the card design and requirement. Such receptacles may also contain reagents useful in performing an assay of one or more analytes in the sample. Appropriate reagents are known to one of ordinary skill in the art and are chosen based on the target analyte to be measured. For example, analyte-specific antigens, optionally in addition to a colorimetric indicator may be used to bind to a target antibody (e.g., SARS CoV2- antibody) and develop a color. In one embodiment of the process, the dried blood sample is eluted into a receptacle such as a test tube, centrifuge tube or assay tube, by adding an eluent or a diluent such as the ELISA (7086), Whole Blood Card Elution buffer (e.g., phosphate-buffered saline). In some embodiments, at least about 5 ml, at least about 4 ml, at least about 3 ml, at least about 2 ml, or at least about 1 ml of the eluent is added to the absorbent pad with the sample spot. The examples describe the optimization of various parameters of the process including the volume of eluent used to extract the sample from the absorbent pad. In one embodiment, at least about 1.4 ml of the eluent is added to the absorbent pad with the sample spot. In another embodiment, 1.4 ml of the eluent is added to the absorbent pad with the sample spot. In some embodiments, the biological sample containing portion of the absorbent pad is first separated from the non-absorbent solid support and placed into an extraction container. In some embodiments, the extraction container is then subjected to a physical agitation process (e.g. shaking, vortexing, sonicating) allowing for the components of the dried sample to become dissolved into the eluent. In another embodiment, the extraction container is placed into a sonicator bath and subjected to sonication. After a sufficient period of time undergoing sonication, a sample extract is generated. In some embodiments, the biological sample extract is further processed, such as by filtration, centrifugation and/or solid-phase extraction, to remove insoluble matter, concentrate target analytes and/or otherwise render the extract more suitable for analysis. In some embodiments, the sample may contain a protein or a peptide and the elution of the protein or the peptide from the absorbent pad makes the protein (e.g., a SARS CoV2- antibody) or peptide (e.g., a SARS CoV2- spike (S) protein) available for measurement with an enzyme linked immunoabsorbent assay (ELISA) or radioimmunoassay (RIA). In another embodiment, the sample may contain another type of biological molecule, such as a lipid, a nucleic acid (for example DNA or RNA), or a neurotransmitter (such as catecholamines, indoleamines, acetylcholine) or metabolites thereof. In one embodiment, the blood sample containing SARS CoV2-antibody is subjected to the process described herein such that the absorbent pad with the sample spot is eluted with 1.4 ml of the eluent after incubating at room temperature for at least 24 hours and subjected to an ELISA (e.g., COVID-19 IgG ELISA 7086) to detect SARS CoV2-antibody. The COVID-19 IgG ELISA 7086 is an enzyme immunoassay which detects IgG antibodies to SARS-CoV-2. Recombinant SARS-CoV-2 spike proteins are immobilized onto microtiter wells. The antigen is allowed to react with specific IgG antibodies (or IgA or IgM antibodies) present in the patient’s serum or plasma. Unbound sample is removed by the wash step. Enzyme labeled antibody conjugate is allowed to react with the antigen-antibody complex. A color is developed by the addition of a substrate that reacts with the coupled enzyme. The color intensity is measured and is directly proportional to the concentration of IgG antibody specific to SARS-CoV-2. Fig.2 shows an exemplary workflow of the process described herein starting from sample collection, transport, lab storage, recovery from the card and testing. In some embodiments, the blood is collected by finger prick of the patient using lancet, before applying to the absorbent pad. In some embodiments, the transport involves packaging and shipping the whole blood collection card to laboratory for testing. in some embodiments, the laboratory receives the whole blood collection card and stores it until testing/analysis. Prior to testing/analyzing, the dried sample from the absorbent pad is eluted in sample diluent (Code 9523). In some embodiments, the extracted sample is tested in the 7086 ELISA. IV. Kits

In certain aspects, the instant disclosure provides kits for testing a sample for a target analyte from subject (e.g., a human subject) infected with or suspected of being infected with a viral infection. The kits comprise an instrument for obtaining the sample, a device for storing the sample, a sample diluent, wherein the sample diluent elutes the sample from the absorbent pad; and components for performing an ELISA to test the sample for the presence of a predetermined or an undetermined target. In some embodiments, the kits include a device comprising a lancet as a device for obtaining the sample from the subject via finger prick. In some embodiments, the kits include a device comprising a sample collection portion, comprising an absorbent pad capable of receiving a sample, a flexible card flap that is dimensionally suited to completely seal the sample collection portion after the sample is collected on the absorbent pad, and a non-absorbent solid support.

In some embodiments, the kits described herein include instructions for use, e.g., instructions for collecting the sample, transporting the sample, recovering the sample and testing the recovered sample. The kits may optionally further comprise means for collecting the sample from the patient (e.g., a lancet, for pricking the subject's finger). In certain embodiments, kits may include alcohol swabs to sterilize and disinfect the site of collection, lancets to puncture the skin, and capillaries to collect and measure the biological sample (e.g., blood) volume. In some embodiments, the kits can, optionally, contain instructions describing how to collect a biological sample, or multiple samples, e.g., over a period of days into collection tube(s) provided in the kit. In some embodiments, the kit further comprises a return envelope and instructions regarding transport to the provider (e.g., a laboratory) for analysis. Table 1 provides the components of an exemplary COVID-19 IgG ELISA (7086) kit used in the testing for the presence of SARS CoV2- antibody in the patient sample. All reagent components except the whole blood card shown in Table 1 are part of the COVID-19 IgG ELISA kit.

Table 1: Kit Reagent List

In one embodiment, the kits described herein comprise adequate stabilizers to preserve a biological sample at ambient temperature through the transport process.

In another embodiment, the kits comprise packaging that is capable of neutralizing any active virus that may be deposited during use or transport.

In some embodiments, the kits include a fixation solution, e.g., a mixture of chemicals in aqueous solution designed to immediately halt biological activity in living cells of the collected samples, disrupt and halt enzymatic activities within the sample, (i.e. kinase activity and phosphatase activity); preserve the blood cell structures in a manner amenable to shipping through commercial carriers (e.g., FedEx), and/or make biological sample compatible with downstream procedures.

In some embodiments, the absorbent pads of the kits may also contain an anti coagulant, such as heparin, citrate and/or chelating agents. In some embodiments, the absorbent pads contain K2 or K3 EDTA. In one non-limiting embodiment, the kits described herein may contain up to about 10 mM up to about 100 mM, preferably about 50 mM EDTA, 1-10% paraformaldehyde and a buffer (e.g., phosphate buffered saline, e.g., about pH 7 to about pH 8, typically about pH 7.4) among other components. In another embodiment, the kit comprises K2 EDTA. In certain embodiments, other agents such as methanol, ethanol, acetone, urea, and the like may be used. In some embodiments, the samples used in the kits described herein include, but are not limited to, biological and non-biological fluids. Biological fluids include, but are not limited to, bodily fluids such as whole blood, blood plasma, blood serum, amniotic fluid, breast milk, vaginal secretions, semen, seminal fluid, urine, amniotic fluid, cerebrospinal fluid, bronchoalveolar lavage fluid, tears, saliva, mucous, tissue, tissue homogenate, cellular extract, and spinal fluid. In one embodiment, the sample is whole blood. In some embodiments, collection of the whole blood sample is performed by a lancet provided in the kit to prick the patient’s finger. In some embodiments of the method, the absorbent pad has a capacity to absorb at least about 30 µl, from about 10 μl to about 50 μl, from about 15 μl to about 35 μl, from about 15 μl to about 30 μl, from about 15 μl to about 20 μl, or about 20 μl of whole blood sample obtained from a patient. In one embodiment of the method, the absorbent pad has a capacity to absorb about 20 μl of whole blood sample obtained from a patient. A variety of target analyte may be analyzed or tested utilizing the kits described herein. For example, analytes could include virus, viral particles, viral antigens and fragments thereof or any combination thereof. The samples collected from the subject can comprise analytes from a coronavirus (e.g., 229E, NL63, OC43, HKU1, MERS-CoV, SARS-CoV and SARS-CoV-2), an influenza virus (e.g., influenza A, influenza B, influenza A subtypes); a hepatitis virus, and many others. In some embodiments of the disclosure, the sample contains at least one target analyte, such as an antibody that bind specifically to the antigens from one or more viruses selected from the group consisting of 229E, NL63, OC43, HKU1, MERS- CoV, SARS-CoV, SARS-CoV-2, influenzavirus A, influenzavirus B, influenzavirus C, and influenzavirus D. In one embodiment, the sample from the patient contains at least one target analyte, such as an antibody that bind specifically to SARS-CoV-2. In some other embodiments of the disclosure, the sample from the patient contains at least one target analyte, such as an antigen that is a pathogenic determinant from one or more viruses selected from the group consisting of 229E, NL63, OC43, HKU1, MERS-CoV, SARS-CoV, SARS- CoV-2, influenzavirus A, influenzavirus B, influenzavirus C, and influenzavirus D. In one embodiment, the sample from the patient contains at least one target analyte, such as an antigen that is a pathogenic determinant (e.g., spike protein of SARS-CoV-2) of SARS-CoV- 2. In one embodiment, the biological sample from a subject suspected or having a viral infection is caused by a virus selected from the group consisting of 229E, NL63, OC43, HKU1, MERS-CoV, SARS-CoV, SARS-CoV-2, influenzavirus A, influenzavirus B, influenzavirus C, and influenzavirus D. In one embodiment, the biological sample from a subject suspected or having a viral infection is caused by SARS-CoV-2. In one embodiment, the target analyte comprises antibodies that bind specifically to SARS-CoV-2. In one embodiment of the method, the immunoassay of the method detects IgG antibodies against SARS-CoV-2. Numerous analytical devices known to those of skill in the art may be adapted in accordance with the present invention, to detect multiple target analytes. By way of example, dipstick, lateral flow and flow-through devices, particularly those that are immunoassays, may be modified in order to detect and distinguish multiple target analytes. In certain embodiments the individual components of the kit may be provided in one container. Alternatively, it may be desirable to provide the components of the kit separately in two or more containers, e.g., one container for the device, and at least another for the components of the ELISA. The kit may be packaged in a number of different configurations such as one or more containers in a single box. The different components can be combined, e.g., according to instructions provided with the kit. The kit can also include a delivery device. V. Process for Preparing a Sample for Analysis of a Target Analyte In another aspect, the present disclosure provides a process for preparing a sample for analysis of a target analyte in a biological sample from a subject infected with or suspected of being infected with a viral infection. The process comprises the steps of collecting the biological sample from the subject, contacting the sample with a device comprising a sample collection portion, comprising an absorbent pad capable of receiving the sample, a flexible card flap that is dimensionally suited to completely seal the sample collection portion, and a non-absorbent solid support and drying the biological sample applied to the absorbent pad, wherein the drying produces a dried sample spot in the absorbent pad. In some embodiments, drying comprises maintaining the absorbent pad at room temperature for at least 10 minutes, at least 20 minutes, at least 30 minutes, at least 40 minutes, at least 50 minutes, or at least 60 minutes or more prior to sealing the absorbent pad. In one embodiment, the process further comprises maintaining the absorbent pad of step (b) at room temperature to dry the sample for at least 10 minutes prior to sealing the absorbent pad with the flexible card flap. In another embodiment, the process further comprises maintaining the absorbent pad of step (b) at room temperature to dry the sample for at least 20 minutes prior to sealing the absorbent pad with the flexible card flap. In yet another embodiment, the process further comprises maintaining the absorbent pad of step (b) at room temperature to dry the sample for at least 30 minutes prior to sealing the absorbent pad with the flexible card flap. In many embodiments of the process provided herein, the absorbent pad further remains sealed for at least 5 hours, at least 10 hours, at least 15 hours, at least 20 hours, or at least 24 hours at a temperature between 2-25°C after the sample in the absorbent pad has dried. In some embodiments, the process further comprises maintaining the sealed absorbent pad of step (c) at a temperature between 2-25°C for at least 5 hours. In another embodiment, the process further comprises maintaining the sealed absorbent pad of step (c) at a temperature between 2-25°C for at least 10 hours. In another embodiment, the process further comprises maintaining the sealed absorbent pad of step (c) at a temperature between 2-25°C for at least 15 hours. In another embodiment, the process further comprises maintaining the sealed absorbent pad of step (c) at a temperature between 2-25°C for at least 20 hours. In yet another embodiment, the process further comprises maintaining the sealed absorbent pad of step (c) at a temperature between 2-25°C for at least 24 hours. In some embodiments, eluting comprises adding at least about 1.0 mL, at least about 1.2 mL, at least about 1.4 mL, or at least about 1.8 mL of sample diluent to the absorbent pad (e.g., to the dried sample spot on the absorbent pad). In one embodiment, eluting comprises adding about 1.4 mL of sample diluent to the dried sample spot on the absorbent pad. In some embodiments, the process further comprises unsealing the sealed absorbent pad and eluting the biological sample by adding at least about 1.0 mL, at least about 1.2 mL, at least about 1.4 mL, or at least about 1.8 mL of biological sample diluent to the sample. In some other embodiments, the process further comprises unsealing the sealed absorbent pad and eluting the biological sample by adding about 1.4 mL, or at least about 1.8 mL of sample diluent to the sample. In some embodiments, the process further comprises incubating the biological sample at room temperature for at least 12 hours, for at least 24 hours or for at least 36 hours, after adding the sample diluent. In one embodiment, the process further comprises incubating the biological sample at room temperature for 24 hours after adding the sample diluent. The samples in various embodiments of the process described herein include, but are not limited to, biological and non-biological fluids. Biological fluids include, but are not limited to, bodily fluids such as whole blood, blood plasma, blood serum, amniotic fluid, breast milk, vaginal secretions, semen, seminal fluid, urine, amniotic fluid, cerebrospinal fluid, bronchoalveolar lavage fluid, tears, saliva, mucous, tissue, tissue homogenate, cellular extract, and spinal fluid. In one embodiment of the process provided herein, the sample is whole blood. In some embodiments of the process, the whole blood sample is obtained from the subject via finger prick using a lancet. In some embodiment, the absorbent pad has a capacity to absorb from about 10 μl to about 50 μl, from about 15 μl to about 35 μl, from about 15 μl to about 25 μl, 15 μl to about 20 μl, or about 20 μl of whole blood sample obtained from a patient. In one embodiment, the absorbent pad has a capacity to absorb about 20 μl of whole blood sample obtained from a patient. In one embodiment of the process, a whole blood sample is applied to the absorbent pad of the device described herein. In one embodiment, the blood sample it is maintained in a wet state and the device is stored in a moist environment for subsequent use or transport, such as mailing. In another embodiment, the blood sample is permitted to dry before transport. In one embodiment of the process described here, the absorbent pad is sealed with the flexible card flap after a period of time upon contacting the blood sample from the patient. The period of time when the absorbent pad, after contacting the biological sample, is sealed with the flexible card flap ranges from about 5 minutes to about 120 minutes, from about 10 minutes to about 60 minutes, from about 15 minutes to about 45 minutes, from 20 minutes to about 40 minutes, from 25 minutes to about 35 minutes, or from about 30 minutes to about 40 minutes. The sample in the absorbent pad has typically dried during this period of time. In one embodiment, the period of time when the absorbent pad, after contacting the biological sample, is sealed with the flexible card flap is 30 minutes. In one embodiment, the device with the dried blood sample may then be stored for subsequent use or transport, such as mailing. In another embodiment, after the sample dries in the absorbent pad it is sealed and stored until the appropriate time to perform a test on the sample contained therein. In one embodiment, after the blood sample dries in the absorbent pad, the device may be placed in the appropriate storage conditions until the operator decides to perform further tests. In some embodiments of the process described herein, the absorbent pad remains sealed for at least 20 hours at a temperature between 2-25°C after the flap card seals the absorbent pad and prior to transportation. In some embodiments, the absorbent pad remains sealed for about 7 days at a temperature between 2-8°C after the flap card seals the absorbent pad and prior to transportation. In other embodiments, the absorbent pad remains sealed for about 14 days at a temperature of 25°C after the flap card seals the absorbent pad and prior to transportation. In some embodiments, the absorbent pad remains sealed for at least 20 hours at a temperature between 2-25°C after the flap card seals the absorbent pad and after transportation. In some embodiments, the absorbent pad remains sealed for about 7 days at a temperature between 2-8°C after the flap card seals the absorbent pad and after transportation. In other embodiments, the absorbent pad remains sealed for about 14 days at a temperature of 25°C after the flap card seals the absorbent pad and after transportation. In some embodiments, after the blood sample dries in the absorbent pad, the device may be processed immediately to perform a desired test to detect a selected target. In some embodiments, the contacting step of the process further comprises contacting the absorbent pad with at least one or more agents selected from a group consisting of a fixative agent, an anti-coagulant, a capture agent, a diagnostic reagent and a buffer, a reference standard, wherein the one or more agents are exposed to the biological sample after collection from the subject, and wherein the one or more agents maintain or enhance the stability of the sample. Non-limiting example of fixation solution includes a mixture of chemicals in aqueous solution designed to immediately halt biological activity in living cells of the collected samples, disrupt and halt enzymatic activities within the sample, (i.e. kinase activity and phosphatase activity); preserve the blood cell structures in a manner amenable to shipping through commercial carriers (e.g., FedEx), and/or make biological sample compatible with downstream procedures. In some embodiments, the contacting step of the process further comprises contacting the absorbent pad with an anti-coagulant, such as heparin, citrate and/or chelating agents. In some embodiments, the anti-coagulant is K2 or K3 EDTA. In one non-limiting embodiment, the contacting step of the process further comprises contacting the absorbent pad with up to about 10 mM up to about 100 mM, preferably about 50 mM EDTA, 1-10% paraformaldehyde and a buffer (e.g., phosphate buffered saline, e.g., about pH 7 to about pH 8, typically about pH 7.4) among other components. In another embodiment, the contacting step of the process further comprises contacting the absorbent pad with K2 EDTA. In certain embodiments, other agents such as methanol, ethanol, acetone, urea, and the like may be used. In some embodiments of the process described herein, the sample contains at least one target analyte, such as an antibody that bind specifically to the antigens from one or more viruses selected from the group consisting of 229E, NL63, OC43, HKU1, MERS-CoV, SARS-CoV, SARS-CoV-2, influenzavirus A, influenzavirus B, influenzavirus C, and influenzavirus D. In some other embodiments of the process, the sample contains at least one target analyte, such as an antigen that is a pathogenic determinant from one or more viruses selected from the group consisting of 229E, NL63, OC43, HKU1, MERS-CoV, SARS-CoV, SARS-CoV-2, influenzavirus A, influenzavirus B, influenzavirus C, and influenzavirus D. In one embodiment of the process, the biological sample from a subject suspected or having a viral infection is caused by a virus selected from the group consisting of 229E, NL63, OC43, HKU1, MERS-CoV, SARS-CoV, SARS-CoV-2, influenzavirus A, influenzavirus B, influenzavirus C, and influenzavirus D. In one embodiment of the process, the biological sample from a subject suspected or having a viral infection is caused by SARS-CoV-2. In one embodiment of the process, the target analyte comprises antibodies that bind specifically to SARS-CoV-2. In one embodiment of the process, the target analyte comprises a SARS-CoV- 2 antigen (e.g., Spike (s) protein from SARS-CoV-2) that is a pathogenic determinant of a SARS-CoV-2 infection. In one embodiment of the process, target analyte comprises a S protein from SARS-CoV-2. In some embodiments, the process further comprises a means for converting a dried sample (contained on the sealed absorbent described herein) into a liquid extract suitable for one or more analyses, e.g., in an appropriate laboratory setting. In some embodiments, after the sample dries, a portion of the absorbent pad containing the dried blood sample may be obtained by cutting the pad with a knife, scissors, a sharp punch of desired shape at the cutting surface, or another tool known to one of ordinary skill in the art. In another embodiment, the “sample spot” in the absorbent pad may be punched away from by application of force to spot, especially in embodiments wherein the perimeter of the spot is somewhat thinner or weaker than the paper material on either side. In one embodiment, the biological sample containing portion of the absorbent pad is placed into a suitable container (tube, microwell, vial etc.) and a defined volume of extraction fluid (i.e., an eluent used interchangeably with sample diluent or diluent) is added so that the biological sample- containing portion of the absorbent material becomes submerged into the extraction fluid. At this point, several options exist. The cut portion of the absorbent pad with the sample spot may be covered and stored until the appropriate time to perform a test on the target contained therein. Alternatively, the cut portion of the absorbent pad with the sample spot may be processed immediately to perform a desired test to detect a target analyte. In some embodiments, the process described comprises the step of incubating at room temperature for at least 24 hours after adding the eluent to elute the sample. In one embodiment, the process described comprises the step of incubating at room temperature for at least 24 hours after adding about 1.4 ml of the eluent to elute the sample. In some embodiments of the process described herein, the absorbent pad with the dried blood sample may be cut or punched into a receptacle based on the card design and requirement. Such receptacles may also contain reagents useful in performing an assay of one or more analytes in the sample. Appropriate reagents are known to one of ordinary skill in the art and are chosen based on the target analyte to be measured. For example, analyte-specific antigens, optionally in addition to a colorimetric indicator may be used to bind to a target antibody (e.g., SARS CoV2- antibody) and develop a color. In one embodiment of the process, the dried blood sample is eluted into a receptacle such as a test tube, centrifuge tube or assay tube, by adding an eluent or a diluent such as the ELISA (7086), Whole Blood Card Elution buffer. In some embodiments, the elution buffer is phosphate-buffered saline. In some embodiments, at least about 5 ml, at least about 4 ml, at least about 3 ml, at least about 2 ml, or at least about 1 ml of the eluent is added to the absorbent pad with the sample spot. The examples describe the optimization of various parameters of the process including the volume of eluent used to extract the sample from the absorbent pad. In one embodiment, at least about 1.4 ml of the eluent is added to the absorbent pad with the sample spot. In another embodiment, 1.4 ml of the eluent is added to the absorbent pad with the sample spot. In some embodiments, the biological sample containing portion of the absorbent material is first separated from the non-absorbent solid support and placed into an extraction container. In some embodiments, the extraction container is then subjected to a physical agitation process (e.g. shaking, vortexing, sonicating) allowing for the components of the dried sample to become dissolved into the eluent. In another embodiment, the extraction container is placed into a sonicator bath and subjected to sonication. After a sufficient period of time undergoing sonication, a sample extract is generated. In some embodiments, the biological sample extract is further processed, such as by filtration, centrifugation and/or solid-phase extraction, to remove insoluble matter, concentrate target analytes and/or otherwise render the extract more suitable for analysis. In some embodiments, the sample may contain a protein or a peptide and the elution of the protein or a peptide from the absorbent pad makes the protein (e.g., SARS CoV2- antibody) or peptide (e.g., SARS CoV2- spike (S) protein) available for measurement with an enzyme linked immunoabsorbent assay (ELISA) or radioimmunoassay (RIA). In another embodiment, the sample may contain another type of biological molecule, such as a lipid, a nucleic acid (for example DNA or RNA), or a neurotransmitter (such as catecholamines, indoleamines, acetylcholine) or metabolites thereof. In one embodiment, the blood sample containing SARS CoV2- antibody is subjected to the process described herein such that the absorbent pad with the sample spot is eluted with 1.4 ml of the eluent after incubating at room temperature for at least 24 hours and subjected to an ELISA (e.g., COVID-19 IgG ELISA 7086) to detect SARS CoV2- antibody. The COVID-19 IgG ELISA 7086 is an enzyme immunoassay which detects IgG antibodies to SARS-CoV-2. Recombinant SARS-CoV-2 spike proteins are immobilized onto microtiter wells. The antigen is allowed to react with specific IgG antibodies present in the patient’s serum or plasma. Unbound sample is removed by the wash step. Enzyme labeled antibody conjugate is allowed to react with the antigen- antibody complex. A color is developed by the addition of a substrate that reacts with the coupled enzyme. The color intensity is measured and is directly proportional to the concentration of IgG antibody specific to SARS-CoV-2. Fig.2 shows an exemplary workflow of the process described herein starting from sample collection, transport, lab storage, recovery from the card and testing. In some embodiments, the blood is collected by finger prick of the patient using lancet, before applying to the absorbent pad. In some embodiments, the transport involves packaging and shipping the whole blood collection card to laboratory for testing. The laboratory receives the whole blood collection card and stores until testing. Prior to testing the dried sample from the absorbent pad is eluted in sample diluent (Code 9523). Finally, the extracted sample is tested in the 7086 ELISA. EXAMPLES The following examples are put forth so as to provide those of ordinary skill in the art with a description of how the compositions and methods described herein may be used, made, and evaluated, and are intended to be purely exemplary of the present disclosure and are not intended to limit the scope of what the inventors regard as their invention. EXAMPLE 1: Sample Collection and Addition to the Whole Blood Collection Card The sample (e.g., a blood sample) will be collected from a patient using a lancet to prick one or more of the patient’s fingers. The sample collected from the finger prick may optionally be stored in a capillary tube or optionally applied directly to a whole blood collection card, such as one described herein. In some embodiments, the card with the applied sample(s) is dried and placed in an airtight transport container which will be stored at 2-8 ºC until the sample(s) is tested. When the sample is ready to be tested/analyzed, the dried sample is eluted using an elution buffer and tested using an immunoassay such as an enzyme immunoassay which detects IgG antibodies to a predetermined target antigen (e.g., a SARS- CoV-2 antigen such as a spike (S) protein).

In an exemplary embodiment, the whole blood collection card consists of a paper card with a single absorbant pad in the center as shown in Figure 1. In an explemplary embodiment, the absorbant pad is a 7 x 20 mm absorbent pad. Table 2 lists the materials used in the manufacturing of the whole blood collection card.

Table 2: Materials used in the manufacturing of the whole blood collection card

The whole blood collection card described above was used for the detection of a SARS-CoV-2 antigen in a COVID-19 IgG ELISA immunoassay. Sample was collected in a point-of-care, near patient, or other non-laboratory setting using a finger stick capillary device where, thereafter, whole blood collected from the finger stick was placed on the absorbent pad housed within the whole blood collection card. The blood sample applied to the whole blood card was dried and then sent to a laboratory for analysis using the COVID-19 IgG ELISA 7086 immunoassay using the COVID-19 IgG ELISA kit (7086). The COVID-19 IgG ELISA is an enzyme immunoassay that detects IgG antibodies to a SARS-CoV-2 antigen. Table 2 shows the components of the COVID-19 IgG ELISA (7086) kit used in the testing. All reagent components except the whole blood collection card are a part of the COVID-19 IgG ELISA kit.

Briefly, recombinant SARS-CoV-2 spike proteins were immobilized onto microtiter wells. The antigen was allowed to react with specific IgG antibodies present in the patient’s collected serum or plasma that was applied to the whole blood collection card. Unbound sample was removed by the wash step. Enzyme labeled antibody conjugate was allowed to react with the antigen-antibody complex. A color was developed by the addition of a substrate that reacts with a coupled enzyme (e.g., horse radish peroxidase). The color intensity was measured and was directly proportional to the concentration of IgG antibody specific to SARS-CoV-2 antibodies from the patient sample.

A. Sample Dilution and Recovery Experiments

Typically, a whole blood collection card requires 50μL fingerstick whole blood added to the card where sample recovery from the card is typically performed by elution with 2.2 mL of a diluent for 45 minutes at room temperature. Conditions for use in the COVID-19 ELISA were, however, determined as described below. The experiments described below were performed using contrived whole blood samples (K2 EDTA). Testing was performed using kit components shown in Tables 1 and 2.

The typical ratio of 50μL sample to 2.2 mL diluent, which can be used in other testing applications (e.g., food testing applications), was reduced to a ratio of 20μL sample to 1.1 mL diluent. This was done because the inventors discovered that the eluent volume needed for the COVID-19 ELISA is far less than for other applications such as food ELISA. One contrived whole blood sample (K2 EDTA) was prepared by spiking in one negative whole blood specimen with PCR positive SARS-CoV-2 serum at four dilutions (0, 1:10, 1:20, 1:40, 1:50). 20μL of the contrived samples were applied onto the whole blood card and dried. After drying the strip was eluted in 1.1 mL of diluent for 45 minutes at room temperature.

The matched serum sample was spiked for direct comparison. The samples were tested in the COVID-19 ELISA. Results are shown in Table 3. Table 4 shows absorbance results for eight negative fingerstick samples tested against matched serum.

Table 3: Recovery study on Whole Blood Collection Card in the COVID-19 ELISA.

Table 4: Absorbance data- Fingerstick Blood Card Results

A bias of ~ 20% is seen between the recovery of the blood card and serum. There is also a notable increase in O.D observed for the negative (0 spike) sample when compared to serum. Based on these results, further elution experiments were carried out to reduce the background.

B. Determination of the Elution Time

Elution time was varied to select optimal elution time to reduce background in negative patients. Four unique negative whole blood (K2 EDTA) samples were tested against the matched serum. The cards were dried, followed by elution in 1.1 mL of buffer for 0, 2, 3, 5, 16, 20, 24 hours. After elution the samples were tested on the COVID-19 ELISA. Figure

3 and Table 5 show the blood card response and index value for each negative patient across all elution time points. Figure 3 show the scatter plot of elution time vs. absorbance with the serum control added for comparison.

Table 5: Elution Time Study

Results show that elution between 16 and 24 hours gives significantly less background response and is close to the matched serum results. Based on these results an elution time of 24 hours was selected as the optimized elution time.

C. Determination of the Elution Volume

With increasing the elution time to 24 hours, the elution volume was increased and varied between 1.4 and 1.5 mL. Six contrived samples were prepared from two unique negative patients by spiking the negative whole blood (EDTA K2) with a positive PCR confirmed SAR-Cov-2 patient. 20μL of the samples were applied to the card and dried. The cards were eluted in 1.4 mL and 1.5 mL at 16, 20, 24 hours at room temperature. The eluted samples were tested in the COVID-19 ELISA. Regression statistics for each of the two samples are shown in Table 6 and Table 7 respectively. Recovery for the contrived samples showed a range for elution volume to be 1.4 -1.5 mL with a slight over-recovery. Table 6: Regression Statistics for elution volume experiments described above (20-10-123A).

Table 7: Regression Statistics for elution volume experiments described above (20-10-123B).

D. Flex Studies for the Determination of Drying Time

The drying time before closing card was evaluated by applying whole blood from 4 unique specimens into the whole blood collection card (1 card/specimen matrix). A total of 4 cards were left open for 15, 30, and 60 minutes. Cards were visually inspected for dryness and no transfer of blood to the paper card envelope upon closure. Results indicate that 30 minutes is sufficient time for the card to be dry enough to close prior to transporting to the lab.

Eight contrived whole blood samples (K2 EDTA) were prepared by spiking two unique negative whole blood specimens with PCR positive SARS-CoV-2 serum at the target levels 0.75x cutoff, 1.5 x cutoff, 3.0 x cutoff. 20μL of the spiked samples were applied to the whole blood collection card, dried open for 30 minutes at 25°C, then closed and continued to dried at 25°C for the designate drying times, 4, 8, 16, 20, and 24 hours.

After drying the cards were tested in a signal run. Clinical interpretation for each sample at each dry time was evaluated. Table 8 shows the results. Dry time between 20-24 hours was selected as optimal interval for drying before shipping cards to testing laboratory.

Table 8: Drying time After Closing the Card

E. Flex Studies for Determination of Volume of Sample Added Four contrived whole blood samples (K2 EDTA) were prepared by spiking one negative whole blood specimen with PCR positive SARS-CoV-2 serum at the target levels 0.75 x Cutoff, 1.5 x Cutoff, and 3 x Cutoff. The spiked samples were applied to the whole blood collection card at the designed sample volumes 5μL, 10μL, 15μL, 20μL, 25μL, 30μL and 35µL. The cards dried at 25C° for 24 hours. After drying the cards were eluted in assay buffer for 24 hours and then tested in a signal run. Clinical interpretation for each sample at each sample volume was evaluated. Table 9 shows the results. Results show 100% agreement with expected results at sample volume between 15μL and 25μL. Table 9: Flex study on volume of sample added to the blood card

As described above, results from the experiments using contrived samples provided the following parameters for testing: 20μL Sample addition to the blood card (Flex 15-25μL), 30-minute drying time before closure of card flap, >20 hours drying time at room temperature after closure of card flap, 1.4 mL elution volume and 24-hour elution time at room temperature. Based on the above parameters a preliminary assessment of capillary whole blood samples was performed followed by an expanded study, as described below in Example 2. EXAMPLE 2: Testing Design Attributes of the Whole Blood Collection Card

A. Preliminary Assessment of Capillary Whole Blood Sample

Since the studies in Example 1 were performed using contrived samples, a preliminary assessment of the performance was done using capillary whole blood. Fingerpick capillary whole blood, PCR positive and Negative, were collected using the blood card. 20 μL of the samples were added onto the card. The cards were dried for > 20 hours and then eluted with 1.4 mL sample diluent and tested in the COVID-19 ELISA. Matching Serum and Plasma were also collected. Results are shown in Table 10. Table 10: Blood Card with Preliminary Testing with Clinical samples

The results demonstrate that that fingerpick whole blood is under recovering compared to serum and plasma. An expanded study, shown below, was done to further examine the recovery between serum and the whole blood card.

B. Assessing the Matrix Equivalence between Serum, Plasma and the Whole Blood Card

An expanded study was done to assess the matrix equivalence between serum, plasma and the whole blood card. Matching PCR negative and positive serum, plasma, and fingerstick blood card samples were run to evaluate the matrix equivalence. PCR negative and positive samples were collected under IRB -approved protocol. The samples were collected via fingerstick and applied to the whole blood collection card (WBCC). The cards were dried for at least 20 hours before testing. After drying the blood cards were eluted in 1.4 mL samples diluent for 24 hours at room temperature, then tested along with the matched serum and plasma in the COVID-19 ELISA.

A total of 77 samples were tested. When assessing the correlation between serum or plasma and the WBCC, the correlation was very good (concordance correlation coefficient = 0.9653 for plasma and 0.9403 for serum). Passing and Bablok regression of WBCC data vs. serum or plasma showed a slope of 0.77 and R-squared of 0.916. However, as with other dried blood spot tests, a systematically lower analyte recovery was seen with the WBCC results than with serum and plasma. Similar to other DBS tests, a correction factor identified and applied to convert the dried blood spot (DBS) values to comparable values from serum and plasma as described below. The correction factor was identified as follows. ROC analysis of WBCC performance was conducted using serum or plasma as the reference method. ROC analysis showed an optimal cutoff for the WBCC data from between 0.4 -0.5 index, vs. 0.6 index for serum and plasma. Correction factors of 1.2, 1.3, and 1.4 were assessed based on the ratio between the serum/plasma cutoff of 0.6 and the proposed cutoff of -0.45. When the correction factor of 1.3 (0.6/0.45 - 1.3) was applied to convert the WBCC values to values comparable to those of serum and/or plasma, the slope of the line of agreement in Passing and Bablok regression was corrected 1.00, as shown in Table 11. Table 11: Passing and Bablok Regression

The correction factor was also applied to the first preliminary assessment of nine capillary whole blood samples as shown subheading A in Example 2 (see Table 10). Table 12 shows the results when a 1.3 correction factor is applied. Table 13 shows line data from the matrix equivalence study between serum, plasma, and whole blood. A zoomed in view of the dot plots for the negative samples are shown in Figures 4-7. Results show no significant upward bias in the negative samples when the correction factor is applied. In addition, using the correction factor of 1.3 for the WBCC data, concordance for PPA and NPA was 100% for serum, as shown Table 14. Plasma showed 96.8% and 100% for PPA and NPA respectively. The missed sample in plasma was at cutoff.

Table 12: Results of Capillary whole blood using correction factor 1.3

Table 13: Line Data from Matrix Equivalence Data between Serum/Plasma/Whole Blood Card

49 WBD (US) 51976217v1

50 WBD (US) 51976217v1

Table 14: PPA and NPA Agreement

C. Repeatability of the Whole Blood Card Four contrived whole blood samples (K2 EDTA) were prepared by spiking one negative whole blood specimen with PCR positive SARS-CoV-2 serum at 0.75x, 1.5x, and 3.0x the COVID-19 ELISA Assay cutoff (Index). Unspiked negative whole blood was also run.20 µL of each of the samples was used to prepare eight replicate cards for each sample. The cards were dried and tested in a signal run (same day, same operator, same laboratory). Clinical interpretation for each sample replicate was evaluated and data is summarized in Table 15. Results show 100% agreement with expected results at all test levels. Table 15: Repeatability of the Whole Blood Card.

D. Laboratory Storage of Blood Card Eight contrived whole blood samples (K2 EDTA) were prepared by spiking two unique negative whole blood specimens with PCR positive SARS-CoV-2 serum at 0.75x, 1.5x, and 3.0x the COVID-19 ELISA Assay cutoff (Index). Unspiked negative whole blood was also run. 20 µL of each of the samples was applied to the whole blood collection card and dried. After drying the cards were placed at 2-8°C or 25°C for up to 21 days. At the end of the stability interval the blood cards were tested in a single run. Clinical interpretation for each sample was evaluated across each storage condition. Results are shown in Table 16. Data supports storage at 2-8°C for 7 days and storage at 25°C for 14 days. Table 16: Laboratory Storage of Blood Collection Card

OTHER EMBODIMENTS

All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference to the same extent as if each independent publication or patent application was specifically and individually indicated to be incorporated by reference.

While the present disclosure has been described in connection with specific embodiments thereof, it will be understood that it is capable of further modifications and this disclosure is intended to cover any variations, uses, or adaptations of the disclosure following, in general, the principles of the disclosure and including such departures from the disclosure that come within known or customary practice within the art to which the disclosure pertains and may be applied to the essential features hereinbefore set forth, and follows in the scope of the claims.

Other embodiments are within the claims.

Claims

CLAIMS 1. A device for collecting a biological sample from a subject suspected of having a viral infection, the device comprising: a sample collection portion, comprising an absorbent pad capable of receiving the biological sample, a flexible card flap that is dimensionally suited to completely seal the sample collection portion, and a non-absorbent solid support, wherein the device is suitable for maintaining the stability of the biological sample.

2. The device of claim 3, wherein the absorbent pad is capable of absorbing at least about 10 µl of the sample.

3. The device of any one of claims 1-2, wherein the absorbent pad is capable of absorbing at least about 20 µl of the sample.

4. The device of any one of claims 1-3, wherein the absorbent pad is capable of absorbing at least about 30 µl of the sample.

5. The device of any one of claims 1-4, wherein the absorbent pad is capable of absorbing between 15- 30 µl of the sample.

6. The device of any one of claims 1-5, wherein the absorbent pad is capable of absorbing between 15- 20 µl of the sample.

7. The device of any one of claims 1-6, wherein the absorbent pad is capable of absorbing 20 μl of the sample.

8. The device of any one of claims 1-7, wherein the absorbent pad is composed of at least one material selected from the group consisting of a glass fiber, a nitrocellulose, a nitrocellulose blend with polyester, a nitrocellulose blend with cellulose, a paper, and an acrylonitrile copolymer.

9. The of any one of claims 1-8, wherein the absorbent pad comprises paper.

10. The device of any one of claims 1-8, wherein the absorbent pad comprises glass fiber.

11. The device of any one of claims 1-10, wherein the non-absorbent solid support comprises at least one material selected from the group consisting of a glass fiber, a nitrocellulose, a nitrocellulose blend with polyester, a nitrocellulose blend with cellulose, a paper, and an acrylonitrile copolymer.

12. The device of any one of claims 1-10, wherein the flexible card flap comprises at least one material selected from the group consisting of a glass fiber, a nitrocellulose, a nitrocellulose blend with polyester, a nitrocellulose blend with cellulose, a paper, and an acrylonitrile copolymer.

13. The device of any one of claims 1-12, wherein the absorbent pad comprises the biological sample applied thereon.

14. The device of any one of claims 1-13, wherein the absorbent pad comprising the biological sample is sufficiently dried prior to closure of the flexible card flap.

15. . The device of claim 14, wherein closure of the flexible card flap occurs at least 10 minutes after the biological sample is applied to the absorbent pad.

16. The device of claim 14, wherein closure of the flexible card flap occurs at least 20 minutes after the biological sample is applied to the absorbent pad.

17. The device of claim 14, wherein closure of the flexible card flap occurs at least 30 minutes after the biological sample is applied to the absorbent pad.

18. The device of claim 14, wherein closure of the flexible card flap occurs 40 minutes after the biological sample is applied to the absorbent pad.

19. The device of claim 14, wherein closure of the flexible card flap occurs at least 60 minutes after the biological sample is applied to the absorbent pad.

20. The device of any one of claims 15-19, wherein the absorbent pad further remains sealed for at least 5 hours at a temperature between 2-25 °C.

21. The device of any one of claims 15-20, wherein the absorbent pad further remains sealed for at least 10 hours at a temperature between 2-25 °C.

22. The device of any one of claims 15-21, wherein the absorbent pad further remains sealed for at least 15 hours at a temperature between 2-25 °C.

23. The device of any one of claims 15-22, wherein the absorbent pad further remains sealed for at least 20 hours at a temperature between 2-25 °C.

24. The device of any one of claims 15-23, wherein the absorbent pad further remains sealed for at least 24 hours at a temperature between 2-25 °C.

25. The device of any one of claims 15-24, wherein the absorbent pad further remains sealed for about 7 days at a temperature between 2-8°C.

26. The device of any one of claims 15-25, wherein the absorbent pad further remains sealed for about 14 days at a temperature of 25°C.

27. The device of any one of claim 13-26, wherein the device is packaged in a sterile container.

28. The device of any one of claims 1-27, further comprising at least one or more agents selected from the group consisting of a fixative agent, an anti-coagulant, a capture agent, a diagnostic reagent and a buffer, a reference standard, wherein the one or more agents are exposed to the biological sample after collection from the subject, and wherein the one or more agents maintain or enhance the stability of the sample.

29. The device of claim 28, wherein the agent is the anti-coagulant.

30. The device of claim 29, wherein the anti-coagulant agent is EDTA or heparin.

31. The device of claim 30, wherein the anti-coagulant is K2 EDTA.

32. The device of any one of claims 1-31, wherein the biological sample is selected from the group consisting of whole blood, blood plasma, blood serum, amniotic fluid, breast milk, vaginal secretions, semen, seminal fluid, urine, amniotic fluid, cerebrospinal fluid, bronchoalveolar lavage fluid, tears, saliva, mucous, tissue, tissue homogenate, cellular extract, and spinal fluid.

33. The device of claim 32, wherein the sample is whole blood.

34. The device of any one of claims 1-33, wherein the viral infection is caused by a virus selected from the group consisting of 229E, NL63, OC43, HKU1, MERS-CoV, SARS-CoV, SARS-CoV-2, influenzavirus A, influenzavirus B, influenzavirus C, and influenzavirus D.

35. The device of any one of claims 1-34, wherein the biological sample is pretreated under a condition effective to inactivate the one or more virus prior to transport.

36. The device of claim 35, wherein the condition effective to inactivate the at least one virus comprises denaturing the biological sample.

37. The device of claim 35 or 36, wherein the condition effective to inactivate the at least one virus comprises incubating the biological sample for at least 1 minute at a temperature, wherein the temperature is at least 40°C.

38. The device of claim 37, wherein the temperature is at least 45°C.

39. The device of claim 37, wherein the temperature is at least 50°C.

40. The device of claim 37, wherein the temperature is at least 55°C.

41. The device of claim 37, wherein the temperature is at least 60°C.

42. The device of claim 35 or 36, wherein the condition effective to inactivate the at least one virus comprises exposing the biological sample to an effective amount of ultraviolet irradiation.

43. The device of any one of claims 1-42, wherein the device is used to transport the biological sample from a non-laboratory setting.

44. A method for detecting a target analyte in a biological sample from a subject infected with or suspected of being infected with a viral infection, the method comprising: (a) collecting the biological sample from the subject; (b) contacting the biological sample with an absorbent pad of a device, wherein the device comprises a sample collection portion comprising the absorbent pad capable of receiving the sample, a flexible card flap that is dimensionally suited to completely seal the absorbent pad, and a non-absorbent solid support, wherein the absorbent pad is capable of absorbing between 10-50 µl of the sample applied thereupon; (c) drying the biological sample applied to the absorbent pad, wherein the drying produces a dried sample spot in the absorbent pad; (d) eluting the sample from the dried sample spot of step (c); and (e) testing the eluted sample of step (e) using an immunoassay that detects the target analyte.

45. The method of claim 44, wherein drying comprises maintaining the absorbent pad at room temperature for at least 10 minutes prior to sealing the absorbent pad with the flexible card flap.

46. The method of any one of claims 44-45, wherein drying comprises maintaining the absorbent pad at room temperature for at least 20 minutes prior to sealing the absorbent pad with the flexible card flap.

47. The method of any one of claims 44-46, wherein drying comprises maintaining the absorbent pad at room temperature for at least 30 minutes prior to sealing the absorbent pad with the flexible card flap.

48. The method of any one of claims 45-47, further comprising maintaining the absorbent pad at a temperature between 2-25°C for at least 5 hours.

49. The method of any one of claims 45-48, further comprising maintaining the absorbent pad at a temperature between 2-25°C for at least 10 hours.

50. The method of any one of claims 45-49, further comprising maintaining the absorbent pad at a temperature between 2-25°C for at least 15 hours.

51. The method of any one of claims 45-50, further comprising maintaining the absorbent pad at a temperature between 2-25°C for at least 20 hours.

52. The method of any one of claims 45-51, further comprising maintaining the absorbent pad at a temperature between 2-25°C for at least 24 hours.

53. The method of any one of claims 44-53, wherein eluting comprises adding at least about 1.0 mL, at least about 1.2 mL, at least about 1.4 mL, or at least about 1.8 mL of sample diluent to the dried sample spot.

54. The method of claim 53, wherein eluting comprises adding about 1.4 mL of sample diluent to the dried sample spot.

55. The method of any one of claims 53-54, further comprising incubating at room temperature for at least 12 hours, for at least 24 hours or for at least 36 hours, after adding the sample diluent.

56. The method of claim 55, wherein the incubating at room temperature is for 24 hours after adding the sample diluent.

57. The method of any one of claims 44-56, wherein the biological sample is selected from the group consisting of whole blood, blood plasma, blood serum, amniotic fluid, breast milk, vaginal secretions, semen, seminal fluid, urine, amniotic fluid, cerebrospinal fluid, bronchoalveolar lavage fluid, tears, saliva, mucous, tissue, tissue homogenate, cellular extract, and spinal fluid.

58. The method of claim 57, wherein the biological sample is whole blood.

59. The method of claim 57 or 58, wherein collecting the whole blood sample is obtained from the subject via finger prick using a lancet.

60. The method of any one of claims 44-59, wherein the absorbent pad is capable of absorbing at least about 30 µl of the blood sample.

61. The method of any one of claims 44-60, wherein the absorbent pad is capable of absorbing between 15-30 µl of the sample.

62. The method of any one of claims 44-61, wherein the absorbent pad is capable of absorbing between 15-20 µl of the sample.

63. The method of any one of claims 44-62, wherein the absorbent pad is capable of absorbing 20 µl of the sample.

64. The method of any one of claims 44-63, wherein step (b) further comprises contacting the absorbent pad with at least one or more agents selected from a group consisting of a fixative agent, an anti- coagulant, a capture agent, a diagnostic reagent and a buffer, a reference standard, wherein the one or more agents are exposed to the biological sample after collection from the subject, and wherein the one or more agents maintain or enhance the stability of the sample.

65. The method of claim 64, wherein the agent is the anti-coagulant.

66. The method of claim 65, wherein the anti-coagulant agent is EDTA or heparin.

67. The method of claim 66, wherein the anti-coagulant is K2 EDTA.

68. The method of any one of claims 44-67, further comprising a step of transporting the biological sample in a packaged sterile container, wherein the transporting step is after step (c) and before step (d).

69. The method of claim 68, wherein the transporting is from a non-laboratory setting.

70. The method of any one of claims 44-69, wherein the viral infection is caused by a virus selected from the group consisting of 229E, NL63, OC43, HKU1, MERS-CoV, SARS-CoV, SARS-CoV-2, influenzavirus A, influenzavirus B, influenzavirus C, and influenzavirus D.

71. The method of claim 70, wherein the viral infection is caused by SARS-CoV-2.

72. The method of any one of claims 44-71, wherein the target analyte comprises antibodies that bind specifically to SARS-CoV-2.

73. The method of any one of claims 44-72, wherein the immunoassay of step (e) detects IgG antibodies against SARS-CoV-2.

74. A kit for testing a sample for a target analyte from subject infected with or suspected of being infected with a viral infection, the kit comprising: an instrument for collecting the sample; a device for storing the sample; wherein the device comprises a sample collection portion comprising an absorbent pad capable of receiving the sample, a flexible card flap that is dimensionally suited to completely seal the sample collection portion after the sample is collected on the absorbent pad, and a non-absorbent solid support; a sample diluent, wherein the sample diluent elutes the sample from the absorbent pad; and an in vitro Enzyme-Linked Immunosorbent Assay (ELISA) kit components for the testing of the sample.

75. The kit of claim 74, wherein the instrument for collecting the sample comprises a lancet; wherein the sample is obtained from the subject via finger prick using a lancet.

76. The kit of claims 74 or 75, wherein the sample is selected from the group consisting of whole blood, blood plasma, blood serum, amniotic fluid, breast milk, vaginal secretions, semen, seminal fluid, urine, amniotic fluid, cerebrospinal fluid, bronchoalveolar lavage fluid, tears, saliva, mucous, tissue, tissue homogenate, cellular extract, and spinal fluid.

77. The kit of claim 76, wherein the sample is whole blood.

78. The kit of any one of claims 74-77, wherein the absorbent pad is capable of absorbing at least about 30 μl of the blood sample.

79. The kit of any one of claims 74-78, wherein the absorbent pad is capable of absorbing between 15-30 μl of the sample.

80. The kit of any one of claims 74-79, wherein the absorbent pad is capable of absorbing between 15-20 mΐ of the sample.

81. The kit of any one of claims 74-80, wherein the absorbent pad is capable of absorbing 20 mΐ of the sample.

82. The kit of any one of claims 74-81, further comprising at least one or more agents selected from a group consisting of a fixative agent, an anti-coagulant, a capture agent, a diagnostic reagent and a buffer, a reference standard, wherein the one or more agents are exposed to the biological sample after collection from the subject, and wherein the one or more agents maintain or enhance the stability of the biological sample.

83. The kit of claim 82, wherein the agent is an anti-coagulant.

84. The kit of claim 83, wherein the anti-coagulant agent is EDTA or heparin.

85. The kit of claim 84, wherein the anti-coagulant is K2 EDTA.

86. The kit of any one of claims 47-55, wherein the viral infection is caused by a virus selected from the group consisting of 229E, NL63, OC43, HKU1, MERS-CoV, SARS-CoV, SARS-CoV-2, influenzavirus A, influenzavirus B, influenzavirus C, and influenzavirus D.

87. The kit of claim 86, wherein the viral infection is caused by SARS-CoV-2.

88. The kit of any one of claims 74-87, wherein the target analyte comprises antibodies that bind specifically to SARS-CoV-2.

89. The kit of any one of claims 74-88, wherein the ELISA kit components detect IgG antibodies against SARS-CoV-2.

90. The kit of any one of claims 74-89, wherein the ELISA kit components comprise microwells, a wash buffer, a negative control, a positive control, a secondary antibody conjugate, a 3, 3', 5,5'- Tetramethylbenzidine substrate and a stop solution.

91. The kit of claim 90, wherein the ELISA kit components are components of COVID-19 IgG ELISA kit from Biomerica with a catalog number 7086.

92. A process for preparing a sample for analysis of a target analyte in a biological sample from a subject infected with or suspected of being infected with a viral infection, comprising:

(a) collecting the biological sample from the subject;

(b) contacting the biological sample with a device comprising a sample collection portion comprising the absorbent pad capable of receiving the sample, a flexible card flap dimensionally suited to completely seal the absorbent pad, and a non-absorbent solid support, wherein the absorbent pad is capable of absorbing between 10-50 μl of the sample applied thereupon; and

(c) drying the biological sample applied to the absorbent pad, wherein the drying produces a dried sample spot in the absorbent pad; thereby preparing the sample for analysis of the target analyte in a biological sample.

93. The process of claim 92, further comprising maintaining the absorbent pad of step (b) at room temperature to dry the sample for at least 10 minutes prior to sealing the absorbent pad with the flexible card flap.

94. The process of claim 92, further comprising maintaining the absorbent pad of step (b) at room temperature to dry the sample for at least 20 minutes prior to sealing the absorbent pad with the flexible card flap.

95. The process of claim 92, further comprising maintaining the absorbent pad of step (b) at room temperature to dry the sample for at least 30 minutes prior to sealing the absorbent pad with the flexible card flap.

96. The process of any one of claims 92-95, further comprising maintaining the sealed absorbent pad of step (c) at a temperature between 2-25°C for at least 5 hours.

97. The process of any one of claims 92-95, further comprising maintaining the sealed absorbent pad of step (c) at a temperature between 2-25°C for at least 10 hours.

98. The process of any one of claims 92-95, further comprising maintaining the sealed absorbent pad of step (c) at a temperature between 2-25°C for at least 15 hours.

99. The process of any one of claims 92-95, further comprising maintaining the sealed absorbent pad of step (c) at a temperature between 2-25°C for at least 20 hours.

100. The process of any one of claims 92-95, further comprising maintaining the sealed absorbent pad of step (c) at a temperature between 2-25°C for at least 24 hours.

101. The process of any one of claims 96-100, further comprising unsealing the sealed absorbent pad and eluting the biological sample by adding at least about 1.0 mL, at least about 1.2 mL, at least about 1.4 mL, or at least about 1.8 mL of biological sample diluent to the sample.

102. The process of any one of claims 96-100, further comprising unsealing the sealed absorbent pad and eluting the biological sample by adding about 1.4 mL, or at least about 1.8 mL of sample diluent to the sample.

103. The process of claim 102, further comprising incubating the biological sample at room temperature for at least 12 hours, for at least 24 hours or for at least 36 hours, after adding the sample diluent.

104. The process of claim 102, further comprising incubating the biological sample at room temperature for about 24 hours after adding the sample diluent.

105. The process of any one of claims 92-104, wherein the biological sample is selected from the group consisting of whole blood, blood plasma, blood serum, amniotic fluid, breast milk, vaginal secretions, semen, seminal fluid, urine, amniotic fluid, cerebrospinal fluid, bronchoalveolar lavage fluid, tears, saliva, mucous, tissue, tissue homogenate, cellular extract, and spinal fluid.

106. The process of any one of claims 92-104, wherein the biological sample is a whole blood sample.

107. The process of any one of claims 92-104, wherein the whole blood sample is obtained from the subject via finger prick using a lancet.

108. The process of any one of claims 92-107, wherein the absorbent pad is capable of absorbing at least about 30 µl of the blood biological sample.

109. The process of any one of claims 92-107, wherein the absorbent pad is capable of absorbing between 15-30 µl of the biological sample.

110. The process of any one of claims 92-107, wherein the absorbent pad is capable of absorbing between 15-20 µl of the biological sample.

111. The process of any one of claims 92-107, wherein the absorbent pad is capable of absorbing 20 µl of the biological sample.

112. The process of any one of claims 92-111, wherein step (b) further comprises contacting the absorbent pad with at least one or more agents selected from a group consisting of a fixative agent, an anti-coagulant, a capture agent, a diagnostic reagent and a buffer, a reference standard, wherein the one or more agents are exposed to the biological sample after collection from the subject, and wherein the one or more agents maintain or enhance the stability of the sample.

113. The process of claim 112, wherein the agent is the anti-coagulant.

114. The process of claim 112, wherein the anti-coagulant agent is EDTA or heparin.

115. The process of claim 112, wherein the anti-coagulant agent is K2 EDTA.

116. The process of any one of claims 92-115, wherein the viral infection is caused by a virus selected from the group consisting of 229E, NL63, OC43, HKU1, MERS-CoV, SARS-CoV, SARS-CoV-2, influenzavirus A, influenzavirus B, influenzavirus C, and influenzavirus D.

117. The process of any one of claims 92-115, wherein the viral infection is caused by SARS-CoV-2.

118. The process of any one of claims 92-115, wherein the target analyte comprises antibodies that bind specifically to SARS-CoV-2.

119. The process of any one of claims 92-115, wherein the target analyte comprises SARS-CoV-2 antigen.

120. The process of claim 119, wherein the SARS-CoV-2 antigen is a spike protein.