# US 2018/0021771 A1 · Devices for biological sample collection and analysis and methods of use thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2018/0021771 A1 - Document ID: US20180021771A1 - Status: Published application - Kind: A1 - Application number: 15/548,971 - Filed: 2016-02-17 - Published: 2018-01-25 - Earliest claimed: 2015-02-17 - Assignees: Bio-Marketing-T, Ltd. (Bmt) - Applicants: Bio-Marketing-T, Ltd. (BMT) - Inventors: Idan Tamir - Web page: https://patentgrep.com/patent/US20180021771A1 ## CPC - B01L 3/5029: {using swabs} - B01L 3/5023: {with a sample being transported to, and subsequently stored in an absorbent for analysis} - C12M 1/30: Sampler being a swab - C12Q 1/14: Streptococcus; Staphylococcus - G01N 33/5302: {Apparatus specially adapted for immunological test procedures} - G01N 33/538: by sorbent column, particles or resin strip {, i.e. sorbent materials} - G01N 33/543: with an insoluble carrier for immobilising immunochemicals - G01N 33/54388: {based on lateral flow} - G01N 33/558: using diffusion or migration of antigen or antibody {(immunochromatographic test strips G01N33/54387)} - G01N 33/56944: {Streptococcus} - B01L 2300/0825: Test strips - B01L 2300/16: Surface properties and coatings - B01L 2300/161: Control and use of surface tension forces, e.g. hydrophobic, hydrophilic - B01L 2400/0406: capillary forces - B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE - C12M: APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; {APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS} - C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) ## Abstract In some embodiments, the present invention is a device, including: a swab including an absorptive component attached to a stem, an extraction chamber configured to receive the swab and position the absorptive component of the swab configured to be in fluid communication with an extraction reagent, a test strip configured to be brought in fluid communication with the extraction reagent following extraction of the analyte from the biological sample, including: a sample receiving portion configured to accept a sample, a site on the strip where the analyte-specific labeled reagent has been incorporated, such reagent configured to bind the analyte from the biological sample, a capture portion configured to receive: the analyte from the biological sample and the analyte-specific labeled reagent so as to result in displaying a positive or negative result at the completion of the assay, and an adsorbent pad attached to the test strip. ## Claims ### Claim 1 1) A device, comprising: a swab comprising an absorptive component attached to a stem, wherein the absorptive component comprises a non-volatile reagent, an extraction chamber configured to receive the swab and position the absorptive component of the swab configured to be in fluid communication with an extraction reagent, wherein the extraction chamber is filled with an extraction reagent, a test strip configured to be brought in fluid communication with the extraction reagent following extraction of an analyte from the biological sample, comprising: a sample receiving portion configured to accept a sample, wherein the sample is a liquid sample, and wherein the sample receiving portion is configured to permit the movement of an analyte in the liquid sample through the test strip by capillary action, a site on the strip where the analyte-specific labeled reagent has been incorporated, wherein the analyte-specific labeled reagent is configured to bind the analyte from the biological sample, and wherein the analyte-specific labeled regent is comprised of a molecule that binds the analyte specifically and with high affinity and is further labeled with a label that allows its detection, a capture portion configured to receive the analyte from the biological sample and the analyte-specific labeled reagent so as to result in displaying a positive or negative result at the completion of the assay, and an adsorbent pad attached to the distal end of the test strip and configured to bind to an excess extraction reagent thereby allowing flow across the test strip. ### Claim 2 (depends on 1) 2) The device of claim 1, wherein the analyte is Streptococcus Group A Carbohydrate Antigen. ### Claim 3 (depends on 1) 3) The device of claim 1, wherein the extraction reagent is a nitrite salt. ### Claim 4 (depends on 1) 4) The device of claim 1, wherein the extraction reagent is 0.2-5M nitrite salt solution. ### Claim 5 (depends on 1) 5) The device of claim 1, wherein the non-volatile reagent is acidic. ### Claim 6 (depends on 1) 6) The device of claim 1, wherein the swab and test strip are configured to be in fluid communication, so as to result in capillary flow from the absorptive component of the swab to a sample receiving portion of the test strip. ### Claim 7 (depends on 1) 7) The device of claim 1, wherein the stem may be solid, porous, or any combination thereof. ### Claim 8 (depends on 1) 8) The device of claim 1, wherein the stem is configured to provide: mechanical support for the absorptive component of the swab, and capillary flow through a porous core of the stem. ### Claim 9 (depends on 1) 9) The device of claim 1, wherein the absorptive component of the swab is composed of a fiber, foam of polymeric material, absorbent material, or any combination thereof. ### Claim 10 (depends on 5) 10) The device of claim 5, wherein the acidic non-volatile reagent is deposited at the absorptive component of the swab by: spraying, dipping, or dispersing the solvent containing the acidic non-volatile reagent onto the absorptive component of the swab, and evaporating the solvent. ### Claim 11 (depends on 5) 11) The device of claim 5, wherein the amount of the acidic non-volatile reagent is between 2 and 800 micromoles. ### Claim 12 (depends on 5) 12) The device of claim 5, wherein the acidic non-volatile reagent is soluble in the extraction reagent. ### Claim 13 (depends on 5) 13) The device of claim 5, wherein the acidic non-volatile reagent is insoluble in the extraction reagent. ### Claim 14 (depends on 13) 14) The device of claim 13, wherein the acidic non-volatile reagent is configured to exchange protons with the extraction reagent. ### Claim 15 (depends on 13) 15) The device of claim 13, wherein the insoluble acidic non-volatile reagent is deposited on the swab in a region configured to attach to the absorptive component, and wherein the insoluble acidic non-volatile reagent is deposited on the swab by coating with a membrane or film made of a polymeric material prior to the application of the absorptive component, so as to result in avoiding direct contact between the acid and the subject. ### Claim 16 (depends on 5) 16) The device of claim 5, wherein the acidic non-volatile reagent is organic. ### Claim 17 (depends on 5) 17) The device of claim 5, wherein the acidic non-volatile reagent is inorganic. ### Claim 18 (depends on 1) 18) The device of claim 1, wherein the device comprises: a first structural component configured to attach the absorptive component of the swab by the stem of the swab, a second structural component configured to house the test strip, wherein the absorptive component and a sample receiving portion of the test strip are in liquid communication when joining the first structural component and the second structural component. ### Claim 19 19) A method, comprising: (i) collecting a biological sample of a subject by use of a swab comprising a first, non-volatile reagent; (ii) transferring the swab to a chamber containing an extraction reagent, so as to allow the non-volatile reagent to react with the extraction reagent and result in generating an extraction solution; (iii) extracting an analyte from the biological sample of the subject by the extraction solution; (iv) contacting the extraction solution containing the extracted analyte with a lateral flow immunochromatographic assay device comprising a labeled analyte-specific reagent; and (v) determining a presence or absence of the extracted analyte in the biological sample of the subject, wherein the binding of the analyte to a capture reagent specifically immobilizes the labeled analyte-indicator complex on the lateral flow immunochromatographic assay device, and wherein the capture reagent is configured to specifically bind to the analyte. ### Claim 20 20) A method comprising: (i) collecting a biological sample of a subject by an absorptive component of a swab, wherein the absorptive component of the swab is configured to be in physical contact with a sample receiving portion of a lateral flow immunochromatographic assay test strip comprising a labeled analyte-specific reagent; (ii) transferring the absorptive component of the swab to a chamber containing an extraction reagent, wherein an extraction solution is formed in-situ by the reaction of the extraction reagent with the second non-volatile reagent incorporated in the absorptive component of the swab, and wherein the extraction solution is configured to extract the biological sample of the subject; (iii) extracting an analyte from the biological sample; (iv) determining the presence or absence of the extracted analyte in the biological sample of the subject by measuring a signal generated by a binding of a labeled analyte-indicator complex to a capture reagent, wherein the capture reagent is immobilized on the lateral flow immunochromatographic assay device, and wherein the capture reagent is configured to specifically bind the analyte.