CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to United States Provisional Patent Application Ser. No. 63/158,153, filed on March 8, 2021, the disclosure of which is hereby expressly incorporated by reference in its entirety.

BACKGROUND OF THE DISCLOSURE

[0002] The present disclosure relates generally to research and medicine. More particularly, the present disclosure relates to kits and methods for collecting and transporting biological samples.

[0003] Transporting samples for long periods of time requires stabilizing the sample to prevent the degradation of the sample between the time the sample is collected and the time an assay is conducted to detect an analyte of interest suspected to be contained in the sample. Some methods provide a sample collection device such as a swab that is placed in a container or pouch that is sealed and transported. Typically, a reagent is added to the sample following collection of the sample. Typical reagents include preservatives, inhibitors, pH buffers, transport media, and the like. Alternatively or additionally, a sample is kept at very low temperatures using refrigeration, for example. These reagents prevent DNA, RNA, protein, cells, viral particles, and tissues from degrading before the sample is analyzed.

[0004] Once the sample is collected, it must be transported to the location where the sample is then analyzed. Sample stability is problematic when the sample must be transported long distances and/or if the sample must be stored for a period of time before analysis is conducted.

[0005] Accordingly, a need exists for materials and methods for collecting and stabilizing a sample for transport and/or long-term storage of the collected sample.

BRIEF DESCRIPTION OF THE DISCLOSURE

[0006] The present disclosure is generally related to kits and methods for stabilizing, collecting, transporting and storing biological samples. [0007] In one aspect, the present disclosure is directed to a kit for stabilizing a biological sample. The kit includes a hygroscopic stabilizing substrate and at least one of a sample collection device, a sample elution buffer, and instructions for using the kit.

[0008] In one aspect, the present disclosure is directed to a method for stabilizing a biological sample. The method includes collecting a sample using a sample collection device, eluting the sample from the sample collection device, and transferring the eluted sample to a hygroscopic polymer stabilizing substrate, wherein transferring the eluted sample to the hygroscopic polymer stabilizing substrate stabilizes the sample.

DETAILED DESCRIPTION

[0009] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the disclosure belongs. Although any methods and materials similar to or equivalent to those described herein can be used in the practice or testing of the present disclosure, the preferred methods and materials are described below.

[0010] The present disclosure is directed to kits and methods of collecting a sample. The kits and methods allow for long-term storage and stabilization of the sample during storage and transport of the sample before analysis is conducted on the sample.

[0011] In one aspect, the present disclosure is directed to a kit for stabilizing a biological sample comprising: a hygroscopic polymer stabilizing substrate, and at least one of a sample collection device, a sample elution buffer, and instructions for using the kit to stabilize the biological sample.

[0012] Suitable sample collection devices include swabs, wipes, scrapers, collection substrates (e.g., membrane substrates), collection vials, bio-aerosol collection devices, and the like.

[0013] Suitable elution buffers include water, pH buffers, salt buffers, and combinations thereof, that are useful for eluting the sample obtained using the sample collection device.

[0014] Suitable hygroscopic polymer stabilizing substrates include polyvinyl alcohol, polyvinyl acetate, nylon, acrylonitrile butadiene styrene, acrylic, polyethylene terephthalate, polybutylene terephthalate, polyurethane, polycarbonate and combinations thereof. Suitable hygroscopic polymer substrates include a poly-vinyl acetate substrate, a nylon substrate, an acrylonitrile butadiene styrene substrate, an acrylic substrate, a polyethylene terephthalate substrate, a polybutylene terephthalate substrate, a polyurethane substrate, a polycarbonate substrate, and combinations thereof. A particularly suitable hygroscopic polymer substrate includes polyvinyl alcohol substrates.

[0015] The hygroscopic polymer stabilizing substrate is prepared by dissolving the hygroscopic polymer in distilled water to prepare a hygroscopic polymer solution. The hygroscopic polymer solution is then deposited on a collection substrate to form the hygroscopic polymer stabilizing substrate. The hygroscopic polymer solution is deposited using methods such as electrospinning and 3D printing.

[0016] The hygroscopic polymer stabilizing substrate can range from about 10 mm to about 50 mm in thickness, including a range from about 15 mm to about 25 mm. The pore size of the hygroscopic polymer stabilizing substrate can range from about 1 nm to about 3 pm, including from about 10 nm to about 3 pm, from about 20 nm to about 3 pm, from about 50 nm to about 3 pm, from about 100 nm to about 3 pm, from about 0.15 pm to about 3 pm, from about 0.3 pm to about 3 pm, from about 0.4 pm to about 3 pm, from about 0.45 pm to about 3 pm, from about 0.5 pm to about 3 pm, and from about 1 pm to about 3 pm. The pore size can be varied depending on the size of the sample to be collected. For example, the size of SARS-CoV- 2 viral particle ranges from about 0.07 pm to about 0.09 pm, and thus, the pore size can be designed to be less than about 0.07 pm to collect a SARS-CoV-2 viral particle sample. The average size of bacteria ranges from about 0.2 pm to about 2 pm, and thus, the pore size can be designed to be less than 0.2 pm to collect a bacterial sample. The pore size can be designed to range from about 10 nm to about 2 pm to collect viral particles and bacteria in the same sample. Protein molecules range from about 3 nm to about 6 nm, and thus, the pore size can be from about 1 nm to about 10 nm to collect a protein sample.

[0017] In another aspect, the present disclosure is directed to a method of stabilizing a sample. The method includes collecting a sample using a sample collection device, eluting the sample from the sample collection device, and transferring the eluted sample to a hygroscopic polymer stabilizing substrate, wherein transferring the eluted sample to the hygroscopic polymer stabilizing substrate stabilizes the sample. [0018] As used herein, "stabilizing" the sample means the reduction, prevention, and/or inhibition of the breakdown and/or degradation of the sample such that little or no change of the sample occurs between the time the sample is collected and when the sample is analyzed.

[0019] Suitable hygroscopic stabilizing substrates include polyvinyl alcohol, polyvinyl acetate, nylon, acrylonitrile butadiene styrene, acrylic, polyethylene terephthalate, polybutylene terephthalate, polyurethane, polycarbonate and combinations thereof. Suitable hygroscopic polymer substrates include a poly-vinyl acetate substrate, a nylon substrate, an acrylonitrile butadiene styrene substrate, an acrylic substrate, a polyethylene terephthalate substrate, a polybutylene terephthalate substrate, a polyurethane substrate, a polycarbonate substrate, and combinations thereof. A particularly suitable hygroscopic polymer substrates include polyvinyl alcohol substrates.

[0020] Suitable sample collection devices include swabs, wipes, scrapers, collection substrates (e.g., membrane substrates), collection vials, bio-aerosol collection devices with a collection substrate for bio-aerosol collection, and the like.

[0021] A subject (or patient) first collects the intended sample with either swab, saliva or bio-aerosol collection. An elution buffer is then applied to the collected the sample, which elutes the sample from the collection substrate. The eluted sample is then contacted with the hygroscopic polymer stabilizing substrate. Contacting the eluted sample with the hygroscopic polymer stabilizing substrate results in sample interacting with the hygroscopic polymer stabilizing substrate by coupling, attaching, being trapped, captured, etc. by the hygroscopic polymer substrate. Interaction with the hygroscopic polymer substrate stabilizes the sample allowing the sample to be stored and/or transported until the sample is ready to be analyzed. Once the sample has arrived at a testing facility such as a laboratory, the hygroscopic polymer substrate is dissolved to release the sample from the hygroscopic polymer substrate. The sample is then recovered and analyzed.

[0022] Suitable samples include saliva, expired breath (bio-aerosol samples, e.g., oral and nasal breath samples), sputum, blood, plasma, serum, stool, urine, cerebrospinal fluid, viruses, bacteria, yeast, proteins, nucleic acids, and other combinations thereof.

[0023] The method is particularly suitable for collecting a pathogen such as a virus. [0024] In one embodiment, the subject expires breath through the mouth and/or nose by blowing, coughing, humming, singing, speaking, etc. air into a bio-aerosol collection device with a collection substrate. After the subject directs the bio-aerosol sample (oral and/or nasal air sample) into the bio-aerosol collection device, a non-extracting buffer is applied to the collection substrate, which then elutes the sample to hygroscopic polymer substrate such as a polyvinyl alcohol substrate. The hygroscopic polymer substrate can then be transported at room temperature for long periods of time.