US2016123977A1PendingUtilityA1

Assay Device With Shared Zones

Assignee: SPD SWISS PREC DIAGNOSTICS GMBHPriority: Sep 1, 2007Filed: Jan 13, 2016Published: May 5, 2016
Est. expirySep 1, 2027(~1.1 yrs left)· nominal 20-yr term from priority
Y10S436/805G01N 2201/12G01N 33/76G01N 2021/6439G01N 33/54366G01N 33/545G01N 2458/00G01N 21/76G01N 2201/062G01N 21/8483G01N 21/6428Y10S435/808G01N 33/558G01N 33/54389
45
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Claims

Abstract

Disclosed is an assay device for determining the presence and/or extent of one or more analytes in liquid sample containing a) first and second assays each comprising a flow-path having a detection zone for immobilising a labelled binding reagent, wherein detection of a labelled binding reagent at one or both detection zones is indicative of the presence and/or extent of one or more analytes; b) a shared reference zone; c) one or more light sources to illuminate the detection zones and the reference zone; d) one or more photodetectors to detect light from the detection zones and the reference zone, which photodetector/s generate a signal, the magnitude of which signal is related to the amount of light detected; and e) signal processing means for processing signals from the photodetector/s.

Claims

exact text as granted — not AI-modified
1 . An assay device for determining the presence and/or extent of one or more analytes in a liquid sample comprising:
 a) a first and second flow-path, each flow-path having a detection zone for immobilizing a labeled binding reagent, wherein detection of a labeled binding reagent at one or both detection zones is indicative of the presence and/or extent of one or more analytes;   b) a common sample application zone which fluidically connects the first and second flow-paths;   c) a shared reference zone;   d) one or more light sources to illuminate the detection zones and the shared reference zone;   e) one or more photodetectors to detect light from the detection zones and the shared reference zone, which photodetector generates a signal, the magnitude of which signal is related to the amount of light detected; and   f) signal processing means for processing signals from the photodetector.   
     
     
         2 . The assay device according to  claim 1 , wherein the first and or second flow-paths comprise a labeled binding reagent for an analyte or analyte analogue provided in a mobilizable form upstream from the detection zone in a dry state prior to use of the device. 
     
     
         3 . The assay device according to  claim 1 , wherein the first and/or second flow-path comprises a binding reagent for an analyte or a labeled binding reagent provided in an immobilized form at the detection zone. 
     
     
         4 . The assay device according to  claim 1 , further comprising a shared control zone. 
     
     
         5 . The assay device according to  claim 1 , wherein the shared reference zone is comprised as part of either the first or second assay. 
     
     
         6 . The assay device according to  claim 4 , wherein the control zone is comprised as part of either the first or second flow-path. 
     
     
         7 . The assay device according to  claim 4 , wherein the control zone is comprised as part of one flow-path and the shared reference zone is comprised as part of the other flow-path. 
     
     
         8 . The assay device according to  claim 1 , wherein the first and second flow-paths are capable of detecting the presence of an analyte in different concentration ranges. 
     
     
         9 . The assay device according to  claim 1 , wherein the first and second flow-paths each comprise a porous carriers. 
     
     
         10 . The assay device according to  claim 9 , wherein the porous carrier comprises nitrocellulose. 
     
     
         11 . The assay device according to  claim 1 , comprising a single porous sample receiver provided upstream from the first and second flow-paths. 
     
     
         12 . The assay device according to  claim 1 , further comprising a sink provided at the distal end of the flow-paths. 
     
     
         13 . The assay device according to  claim 1 , wherein the first and second flowpaths each comprise different amounts of labeled binding reagent. 
     
     
         14 . The assay device according to  claim 1 , comprising a first flow-path for the detection of an analyte in a lower range and a second flow-path for the detection of analyte in a higher range. 
     
     
         15 . The assay device according to  claim 14  wherein the second assay flow-path has a greater amount of labeled binding reagent than the first flow-path. 
     
     
         16 . The assay device according to  claim 1 , wherein the first flow-path comprises a labeled binding reagent for the analyte provided upstream from a detection zone and the second flow-path comprises a labeled binding reagent for the analyte and a second binding reagent for the analyte provided upstream from the detection zone. 
     
     
         17 . The assay device according to  claim 16 , wherein the first flow-path comprises a shared reference zone and the second flow-path comprises a shared control zone. 
     
     
         18 . The assay device according to  claim 17 , wherein the reference zone is provided downstream from the detection zone. 
     
     
         19 . The assay device according to  claim 17 , wherein the control zone is provided downstream from the detection zone. 
     
     
         20 . The assay device according to  claim 1 , wherein a photodetector detects light from a plurality of zones. 
     
     
         21 . The assay device according to  claim 20 , comprising a single photodetector to detect light from the two detection zones, the reference zone and the control zone. 
     
     
         22 . The assay device according to  claim 21 , comprising four light sources to illuminate the two detection zones, the reference zone and the control zone. 
     
     
         23 . The assay device according to  claim 20 , wherein the amount of light detected by the photodetector from the detection zones and the reference zone is measured prior to addition of sample to the assay device and again after addition of sample to the assay device, and a ratio of the two measurements calculated for each zone. 
     
     
         24 . The assay device according to  claim 20 , wherein a normalised percentage relative attenuation (% A) is calculated for the detection and/or control zones wherein: 
       
         
           
             
               
                   
               
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         25 . The assay device according to  claim 1 , wherein the light source comprises one or more LEDs. 
     
     
         26 . The assay device according to  claim 1 , wherein the analyte to be determined is hCG. 
     
     
         27 . the assay device according to  claim 1 , wherein the liquid sample is urine. 
     
     
         28 - 29 . (canceled)

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