High throughput cell-based HPV immunoassays for diagnosis and screening of HPV-associated cancers

  • US 9,128,094 B2
  • Filed: 12/16/2010
  • Issued: 09/08/2015
  • Est. Priority Date: 01/08/2010
  • Status: Active Grant
First Claim
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1. A method for quantifying an HPV protein expressed by a human papillomavirus (HPV) infected cell in a clinical sample, comprising the steps of:

  • receiving a clinical sample, said clinical sample comprising a population of cells susceptible to infection by an HPV protein, whereinthe population of cells are whole-cells;

    depositing said clinical sample onto a substrate without lysing said population of cells;

    contacting said clinical sample with a solution comprising a monoclonal antibody that specifically binds to the HPV protein in situ under conditions that promote specific binding of said monoclonal antibody to the HPV protein expressed by one or more cells in said population of cells from said obtained clinical sample, whereinthe monoclonal antibody specifically binds to two or more native HPV proteins from different HPV types, whereinthe two or more native HPV proteins are native E7 proteins from different HPV types or native E6 proteins from different HPV types, andthe monoclonal antibody is capable of binding in situ to said proteins in a clinical sample;

    determining, in a solution phase, the amount of said monoclonal antibody bound to said clinical sample; and

    quantifying the HPV protein in said clinical sample using the amount of said monoclonal antibody bound to said clinical sample.

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