×

HCV antigen-antibody combination assay and methods and compositions for use therein

  • US 9,841,427 B2
  • Filed: 09/11/2015
  • Issued: 12/12/2017
  • Est. Priority Date: 03/14/2013
  • Status: Active Grant
First Claim
Patent Images

1. A method for the combined detection of an HCV antigen and an HCV antibody in a test sample, the method comprising:

  • a) providing the following components;

    i. a solid phase comprising a tagged anti-HCV core monoclonal antibody and a first tagged HCV capture antigen bound thereto, wherein the anti-HCV core monoclonal antibody binds an HCV core antigen in the test sample and the first HCV capture antigen binds a first anti-HCV antibody in the test sample, and wherein the first HCV capture antigen consisting of the amino acid sequence of SEQ ID NO;

    97, 98, 99, 100, 102, 103, 104, 105, or 106; and

    ii. a first detectably labeled HCV detection antigen for binding to the first anti-HCV antibody captured by the first HCV capture antigen;

    b) incubating the components of step (a) under conditions whereby;

    i. the tagged anti-HCV core monoclonal antibody specifically binds to the HCV core antigen present in the test sample to produce an anti-HCV core monoclonal antibody-HCV core antigen complex captured on the solid phase;

    ii. the first tagged HCV capture antigen specifically binds to the first anti-HCV antibody present in the test sample to produce a first HCV capture antigen-first anti-HCV antibody complex captured on the solid phase; and

    iii. the first detectably labeled HCV detection antigen specifically binds to the anti-HCV antibody of the first HCV capture antigen-first anti-HCV antibody complex captured on the solid phase;

    c) isolating the solid phase comprising the captured HCV antigen and the first captured anti-HCV antibody from unreacted test sample and reagents;

    d) contacting the isolated solid phase with a detectably labeled conjugate antibody that binds to the HCV core antigen of the anti-HCV core monoclonal antibody-HCV core antigen complex; and

    e) detecting;

    i. a first signal generated from the detectably labeled conjugate antibody, wherein presence of the first signal indicates presence of the HCV core antigen in the test sample; and

    ii. a second signal generated from the first detectably labeled HCV detection antigen, wherein presence of the second signal indicates presence of the first anti-HCV antibody in the test sample.

View all claims
  • 2 Assignments
Timeline View
Assignment View
    ×
    ×