Patent ID: 6818455
Filing Date: 2004-11-16
Classification: G01N,Y10S

Abstract:
An analytical test device for detecting an analyte suspected of being present in a liquid biological sample and requiring solely the application thereto of said liquid biological sample to enable a test to be performed and a test result to be provided, said device comprising:a hollow casing constructed of moisture impervious solid material; a test strip comprising a dry porous earner disposed in said casing, said dry porous carrier comprising a test result zone and a control zone; and a labeled reagent capable of specifically binding with said analyte to form a first complex of said labeled reagent and said analyte, said labeled reagent comprising a particulate direct label and being positioned within said casing as part of said test strip prior to use, said casing including sample application aperture through which liquid biological sample can be supplied directly or indirectly to said carrier, said labeled reagent being located upstream from said test result zone prior to use and being released into mobile form by contact with said liquid biological sample, said carrier including, immobilized in said test result zone, a second reagent for specifically binding said first complex, wherein migration of said liquid biological sample through said dry porous carrier by capillarity conveying said first complex to said test result zone where said second reagent binds to said first complex thereby to form a second complex and to thereby indicate the presence of said analyte in said liquid biological sample, said casing further comprising a test result observation aperture spaced apart from said sample application aperture, said test result zone being visible through said test result observation aperture, wherein the test result observation aperture is substantially shielded to prevent accidental application of sample liquid directly to a portion of said test strip downstream from the location of said labeled reagent through the test result observation aperture, and said control zone includes a material for indicating that said liquid biological sample has been conveyed thereto by capillarity along said carder irrespective of the presence or absence of said analyte in said liquid biological sample.