Devices for biological sample collection and analysis and methods of use thereof

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.

What is being claimed is: 
     
         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. 
   
     
     
         2 ) The device of  claim 1 , wherein the analyte is  Streptococcus  Group A Carbohydrate Antigen. 
     
     
         3 ) The device of  claim 1 , wherein the extraction reagent is a nitrite salt. 
     
     
         4 ) The device of  claim 1 , wherein the extraction reagent is 0.2-5M nitrite salt solution. 
     
     
         5 ) The device of  claim 1 , wherein the non-volatile reagent is acidic. 
     
     
         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. 
     
     
         7 ) The device of  claim 1 , wherein the stem may be solid, porous, or any combination thereof. 
     
     
         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.   
     
     
         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. 
     
     
         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.   
     
     
         11 ) The device of  claim 5 , wherein the amount of the acidic non-volatile reagent is between 2 and 800 micromoles. 
     
     
         12 ) The device of  claim 5 , wherein the acidic non-volatile reagent is soluble in the extraction reagent. 
     
     
         13 ) The device of  claim 5 , wherein the acidic non-volatile reagent is insoluble in the extraction reagent. 
     
     
         14 ) The device of  claim 13 , wherein the acidic non-volatile reagent is configured to exchange protons with the extraction reagent. 
     
     
         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.   
     
     
         16 ) The device of  claim 5 , wherein the acidic non-volatile reagent is organic. 
     
     
         17 ) The device of  claim 5 , wherein the acidic non-volatile reagent is inorganic. 
     
     
         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.   
     
     
         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. 
   
     
     
         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.