US2014295472A1PendingUtilityA1

Paper Based Diagnostic Test

37
Individually held — no corporate assignee on recordPriority: Nov 10, 2011Filed: Nov 13, 2012Published: Oct 2, 2014
Est. expiryNov 10, 2031(~5.3 yrs left)· nominal 20-yr term from priority
Inventors:Sergey S. ShevkoplyasXiaoxi YangJulie Kanter WashkoNathaniel Zane Piety
G01N 33/526G01N 33/52G01N 33/66G01N 30/02G01N 30/92G01N 33/00G01N 2333/805G01N 30/90G01N 33/86G01N 33/523G01N 33/49G01N 33/80
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Claims

Abstract

A device utilizing agglutination and its method of use to diagnose diseases or conditions. The diagnostic device may comprise a substrate having pores, an agglutination zone, and a test readout zone wherein said agglutination zone is functionalized with an agglutinating agent to cause agglutination of the sample.

Claims

exact text as granted — not AI-modified
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         17 . A diagnostic device comprising:
 a substrate having pores, wherein said substrate further comprises an agglutination zone; and a sample deposited on said agglutination zone, wherein said sample is comprised of a mixture of whole blood and an agglutinating agent.   
     
     
         18 . The diagnostic device of  claim 17  where said substrate is capable of transporting laterally outwards soluble forms of Hb. 
     
     
         19 . The diagnostic device of  claim 18  wherein said agglutinating agent is a solution of a Hb solubility assay. 
     
     
         20 . The diagnostic device of  claim 19  wherein said Hb solubility assay is SickleDex™. 
     
     
         21 . The diagnostic device of  claim 20  wherein said sample is comprised of a volume of whole blood and a volume of SickleDex™ mixed, respectively, in a 1:20 ratio by volume. 
     
     
         22 . The diagnostic device of  claim 19  wherein said diagnostic device is capable of testing for sickle cell disease. 
     
     
         23 . The diagnostic device of  claim 17  further comprising a hydrophobic barrier surrounding said substrate. 
     
     
         24 . The diagnostic device of  claim 23  wherein said hydrophobic barrier is wax. 
     
     
         25 . The diagnostic device of  claim 24  wherein said substrate is chromatography paper. 
     
     
         26 . The diagnostic device of  claim 25  wherein said pores of said substrate are in the range of about 2-200 μm in diameter. 
     
     
         27 . A method of diagnosing a disease or condition comprising the steps of:
 providing a diagnostic device comprising: a substrate having pores, wherein said substrate further comprises an agglutination zone and a test readout zone; wherein said agglutination zone is functionalized with an agglutinating agent and said test readout zone is functionalized with an assay reagent;   depositing a blood sample onto said agglutination zone;   allowing said blood sample to develop; and   observing said test readout zone.   
     
     
         28 . The method of  claim 27  wherein said blood sample is approximately 7 μL in volume. 
     
     
         29 . The method of  claim 28  wherein said test readout zone is capable of changing color. 
     
     
         30 . The method of  claim 29  further comprising the steps of: using an optical image capture device to capture an image of said test readout zone after said processing step, and analyzing said image using computer software. 
     
     
         31 . The method of  claim 30  wherein said computer software is capable of converting said image into a quantified value and wherein said quantified value correlates to said diagnosis of said disease or condition. 
     
     
         32 . A method of diagnosing a disease or condition comprising the steps of:
 providing a diagnostic device comprising a substrate having pores, wherein said substrate further comprises an agglutination zone;   mixing a volume of whole blood with a volume of agglutinating agent;   depositing a droplet of said mixture onto said agglutination zone;   allowing said droplet to develop and create a blood stain pattern on said substrate; and   observing said blood stain pattern.   
     
     
         33 . The method of  claim 32  wherein said substrate is chromatography paper. 
     
     
         34 . The method of  claim 33  wherein said pores of said substrate are 2-200 μm in diameter. 
     
     
         35 . The method of  claim 34  wherein said agglutinating agent is a solution of a Hb solubility assay. 
     
     
         36 . The method of  claim 35  wherein said Hb solublity assay is SickleDex™. 
     
     
         37 . The method of  claim 36  wherein the sample is comprised of a volume of whole blood and a volume of SickleDex™ mixed, respectively, in a 1:20 ratio by volume. 
     
     
         38 . The method of  claim 37  further comprising the steps of: using an optical image capture device to capture an image of said blood stain pattern after said developing step, and analyzing said image using computer software. 
     
     
         39 . The method of  claim 38  wherein said computer software is capable of converting image into a quantified value and wherein said quantified value correlates to said diagnosis of said disease or condition. 
     
     
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