WO2022192295A1 - Kits and methods for collecting and transporting a pathogen - Google Patents
Kits and methods for collecting and transporting a pathogen Download PDFInfo
- Publication number
- WO2022192295A1 WO2022192295A1 PCT/US2022/019399 US2022019399W WO2022192295A1 WO 2022192295 A1 WO2022192295 A1 WO 2022192295A1 US 2022019399 W US2022019399 W US 2022019399W WO 2022192295 A1 WO2022192295 A1 WO 2022192295A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- substrate
- sample
- hygroscopic polymer
- stabilizing
- collection
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims abstract description 28
- 244000052769 pathogen Species 0.000 title description 3
- 230000001717 pathogenic effect Effects 0.000 title description 3
- 230000000087 stabilizing effect Effects 0.000 claims abstract description 33
- 239000012472 biological sample Substances 0.000 claims abstract description 11
- 239000000523 sample Substances 0.000 claims description 97
- 239000000758 substrate Substances 0.000 claims description 76
- 229920000642 polymer Polymers 0.000 claims description 23
- 229920000307 polymer substrate Polymers 0.000 claims description 15
- -1 polyethylene terephthalate Polymers 0.000 claims description 12
- 239000004372 Polyvinyl alcohol Substances 0.000 claims description 10
- 229920002451 polyvinyl alcohol Polymers 0.000 claims description 10
- 239000000443 aerosol Substances 0.000 claims description 9
- 239000012149 elution buffer Substances 0.000 claims description 7
- 239000004677 Nylon Substances 0.000 claims description 6
- NIXOWILDQLNWCW-UHFFFAOYSA-N acrylic acid group Chemical group C(C=C)(=O)O NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims description 6
- XECAHXYUAAWDEL-UHFFFAOYSA-N acrylonitrile butadiene styrene Chemical compound C=CC=C.C=CC#N.C=CC1=CC=CC=C1 XECAHXYUAAWDEL-UHFFFAOYSA-N 0.000 claims description 6
- 239000004676 acrylonitrile butadiene styrene Substances 0.000 claims description 6
- 229920000122 acrylonitrile butadiene styrene Polymers 0.000 claims description 6
- 229920001778 nylon Polymers 0.000 claims description 6
- 229920001707 polybutylene terephthalate Polymers 0.000 claims description 6
- 229920000515 polycarbonate Polymers 0.000 claims description 6
- 239000004417 polycarbonate Substances 0.000 claims description 6
- 229920000139 polyethylene terephthalate Polymers 0.000 claims description 6
- 239000005020 polyethylene terephthalate Substances 0.000 claims description 6
- 229920002635 polyurethane Polymers 0.000 claims description 6
- 239000004814 polyurethane Substances 0.000 claims description 6
- 239000011118 polyvinyl acetate Substances 0.000 claims description 6
- 230000003612 virological effect Effects 0.000 claims description 6
- 102000004169 proteins and genes Human genes 0.000 claims description 5
- 108090000623 proteins and genes Proteins 0.000 claims description 5
- 229920002689 polyvinyl acetate Polymers 0.000 claims description 4
- 210000003296 saliva Anatomy 0.000 claims description 4
- 206010036790 Productive cough Diseases 0.000 claims description 3
- 240000004808 Saccharomyces cerevisiae Species 0.000 claims description 3
- 230000001580 bacterial effect Effects 0.000 claims description 3
- 210000004369 blood Anatomy 0.000 claims description 3
- 239000008280 blood Substances 0.000 claims description 3
- 239000000872 buffer Substances 0.000 claims description 3
- 210000001175 cerebrospinal fluid Anatomy 0.000 claims description 3
- 239000006174 pH buffer Substances 0.000 claims description 3
- 210000002381 plasma Anatomy 0.000 claims description 3
- 210000002966 serum Anatomy 0.000 claims description 3
- 210000003802 sputum Anatomy 0.000 claims description 3
- 208000024794 sputum Diseases 0.000 claims description 3
- 210000002700 urine Anatomy 0.000 claims description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 3
- 102000039446 nucleic acids Human genes 0.000 claims description 2
- 108020004707 nucleic acids Proteins 0.000 claims description 2
- 150000007523 nucleic acids Chemical class 0.000 claims description 2
- 150000003839 salts Chemical class 0.000 claims description 2
- 239000011148 porous material Substances 0.000 description 6
- 239000002245 particle Substances 0.000 description 4
- 229940075065 polyvinyl acetate Drugs 0.000 description 4
- 241000894006 Bacteria Species 0.000 description 3
- 230000015556 catabolic process Effects 0.000 description 3
- 239000003153 chemical reaction reagent Substances 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 241000700605 Viruses Species 0.000 description 2
- 238000004458 analytical method Methods 0.000 description 2
- 238000006731 degradation reaction Methods 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- 239000012528 membrane Substances 0.000 description 2
- 238000010146 3D printing Methods 0.000 description 1
- 241001678559 COVID-19 virus Species 0.000 description 1
- 206010011224 Cough Diseases 0.000 description 1
- 239000012491 analyte Substances 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 238000007664 blowing Methods 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 230000008878 coupling Effects 0.000 description 1
- 238000010168 coupling process Methods 0.000 description 1
- 238000005859 coupling reaction Methods 0.000 description 1
- 230000000593 degrading effect Effects 0.000 description 1
- 239000012153 distilled water Substances 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000001523 electrospinning Methods 0.000 description 1
- 239000003112 inhibitor Substances 0.000 description 1
- 230000005764 inhibitory process Effects 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 238000005057 refrigeration Methods 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 239000006163 transport media Substances 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/0096—Casings for storing test samples
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/0045—Devices for taking samples of body liquids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B2010/0083—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements for taking gas samples
- A61B2010/0087—Breath samples
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B2010/0216—Sampling brushes
Definitions
- 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.
- 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.
- a reagent is added to the sample following collection of the sample.
- Typical reagents include preservatives, inhibitors, pH buffers, transport media, and the like.
- 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.
- 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.
- the present disclosure is generally related to kits and methods for stabilizing, collecting, transporting and storing biological samples.
- 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.
- 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.
- kits and methods of collecting a sample are 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.
- 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.
- Suitable sample collection devices include swabs, wipes, scrapers, collection substrates (e.g., membrane substrates), collection vials, bio-aerosol collection devices, and the like.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- stabilizing 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.
- 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.
- 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.
- a subject 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.
- the hygroscopic polymer substrate is dissolved to release the sample from the hygroscopic polymer substrate. The sample is then recovered and analyzed.
- 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.
- the method is particularly suitable for collecting a pathogen such as a virus.
- 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.
- a bio-aerosol sample oral and/or nasal air sample
- 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.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medical Informatics (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Pathology (AREA)
- Molecular Biology (AREA)
- Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Sampling And Sample Adjustment (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
The present disclosure relates to kits and methods for stabilizing, collecting, storing, and transporting biological samples.
Description
KITS AND METHODS FOR COLLECTING AND TRANSPORTING A PATHOGEN
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.
Claims
1. 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.
2. The kit of claim 1 , wherein the sample collection device is selected from the group consisting of a swab, a wipe, a scraper, a collection substrate, a collection vial, an air sample collection device, and combinations thereof.
3. The kit of claim 1, wherein the sample elution buffer is selected from the group consisting of water, a pH buffer, a salt buffer, and combinations thereof.
4. The kit of claim 1 , wherein the hygroscopic polymer substrate comprises a polyvinyl alcohol substrate, a polyvinyl alcohol substrate, a polyvinyl 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.
5. The kit of claim 1, wherein the hygroscopic polymer substrate comprises a polyvinyl alcohol substrate.
6. The kit of claim 1 , wherein the biological sample is selected from the group consisting of saliva, expired breath, sputum, whole blood, plasma, serum, stool, urine, cerebrospinal fluid, a viral sample, a bacterial sample, a yeast sample, and combinations thereof.
7. A method for stabilizing a biological sample, the method comprising: 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.
8. The method of claim 7, wherein the sample is eluted from a collection substrate by contacting the collection substrate with an elution buffer.
9. The method of claim 7, wherein the eluted sample is transferred to the hygroscopic polymer stabilizing substrate by contacting the sample eluted from the collection substrate with the hygroscopic polymer stabilizing substrate and capturing the sample on hygroscopic stabilizing substrate.
10. The method of claim 7, further comprising dissolving the hygroscopic polymer stabilizing substrate to release the sample from the hygroscopic polymer substrate.
11. The method of claim 10, further comprising analyzing the sample.
12. The method of claim 7, wherein the hygroscopic polymer substrate is selected from the group consisting of a polyvinyl alcohol substrate, a polyvinyl 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.
13. The method of claim 7, wherein the hygroscopic polymer substrate comprises a polyvinyl alcohol substrate.
14. The method of claim 7, wherein the sample is collected using a sample collection device.
15. The method of claim 14, wherein the sample collection device is selected from the group consisting of a swab, a wipe, a scraper, a collection substrate, a collection vial, a bioaerosol sample collection device, and combinations thereof.
16. The method of claim 7, wherein the sample is selected from the group consisting of saliva, bio-aerosol, sputum, whole blood, plasma, serum, stool, urine, cerebrospinal fluid, a viral sample, a bacterial sample, a yeast sample, a protein, a nucleic acid, and combinations thereof.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US202163158153P | 2021-03-08 | 2021-03-08 | |
US63/158,153 | 2021-03-08 |
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WO2022192295A1 true WO2022192295A1 (en) | 2022-09-15 |
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US20140065689A1 (en) * | 2004-05-24 | 2014-03-06 | Integenx Inc. | Stable Protein Storage and Stable Nucleic Acid Storage in Recoverable Form |
US20150118683A1 (en) * | 2013-10-31 | 2015-04-30 | General Electric Company | Substrates and associated methods for elution of nucleic acids |
US20160274100A1 (en) * | 2015-03-19 | 2016-09-22 | Rie Kobayashi | Testing device, a transfer member, a method of the testing device, and a testing kit |
US20170067803A1 (en) * | 2015-09-09 | 2017-03-09 | Drawbridge Health, Inc. | Systems, Methods, and Devices for Sample Collection, Stabilization and Preservation |
WO2020023906A2 (en) * | 2018-07-27 | 2020-01-30 | Vaxess Technologies, Inc. | Polymer-based biospecimen collection devices and uses thereof |
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2022
- 2022-03-08 WO PCT/US2022/019399 patent/WO2022192295A1/en active Application Filing
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
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US20140065689A1 (en) * | 2004-05-24 | 2014-03-06 | Integenx Inc. | Stable Protein Storage and Stable Nucleic Acid Storage in Recoverable Form |
US20150118683A1 (en) * | 2013-10-31 | 2015-04-30 | General Electric Company | Substrates and associated methods for elution of nucleic acids |
US20160274100A1 (en) * | 2015-03-19 | 2016-09-22 | Rie Kobayashi | Testing device, a transfer member, a method of the testing device, and a testing kit |
US20170067803A1 (en) * | 2015-09-09 | 2017-03-09 | Drawbridge Health, Inc. | Systems, Methods, and Devices for Sample Collection, Stabilization and Preservation |
WO2020023906A2 (en) * | 2018-07-27 | 2020-01-30 | Vaxess Technologies, Inc. | Polymer-based biospecimen collection devices and uses thereof |
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