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Test strip apparatus and method for determining presence of analyte in a fluid sample

  • US 6,001,658 A
  • Filed: 09/13/1996
  • Issued: 12/14/1999
  • Est. Priority Date: 09/13/1996
  • Status: Expired due to Term
First Claim
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1. A semiquantitative method for determining the presence of an analyte in a sample fluid, comprisingexposing a portion of a test strip apparatus to said sample fluid to be tested, wherein said test strip apparatus comprises:

  • a conjugate pad comprising a diffusible labelled first binding partner that binds with said analyte;

    a first area comprising an immobilized second binding partner that competes with said analyte to bind with said diffusible labelled first binding partner; and

    a second area comprising an immobilized third binding partner that binds with said diffusible labelled first binding partner,located in sequence in a capillary fluid flow direction in said test strip apparatus;

    allowing said analyte in said sample fluid to migrate up the test strip apparatus by capillary action; and

    reading a result of said test strip by comparing relative label intensities in said first area and said second area,wherein a greater relative label intensity in said second area as compared to said first area indicates the presence of said analyte in said sample fluid in an amount greater than a value determined by the amounts of said first and second binding partners and a lesser relative intensity in said second area as compared to said first area indicates the presence of said analyte in said sample fluid in an amount less than a value determined by the amounts of said first and second binding partners.

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