High throughput cell-based HPV immunoassays for diagnosis and screening of HPV-associated cancers
First Claim
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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Abstract
Methods for quantifying an HPV protein expression in a clinical sample are disclosed. The quantifying methods include the process for obtaining the clinical sample. Such a clinical sample is consisted of a population of cells that are susceptible to infection by an HPV. The quantifying methods also include the process for depositing the clinical sample into a container. The clinical sample is contacted with the first antibody that specifically binds to an HPV protein which is expressed by an HPV-infected cell under a condition that promotes specific binding of the first antibody to the HPV protein expressed by the population of cells. The methods further include the process for quantifying the specific binding of the first antibody and thereby quantifying the HPV protein expression in the clinical sample. The assay provides an objective test to identify patients with high-grade precursor from cytology samples before biopsy.
96 Citations
23 Claims
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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:
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receiving a clinical sample, said clinical sample comprising a population of cells susceptible to infection by an HPV protein, wherein the 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, wherein the monoclonal antibody specifically binds to two or more native HPV proteins from different HPV types, wherein the two or more native HPV proteins are native E7 proteins from different HPV types or native E6 proteins from different HPV types, and the 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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23)
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Specification