In situ detection of early stages and late stages HPV infection

摘要

Embodiments of the invention provide methods, monoclonal antibodies, polyclonal antibodies, assays, and kits for detecting HPV infection and HPV related cancer diagnosis, including infection by various HPV genotypes, early and/or late stage HPV-associated or HPV-specific cancers. The anti-HPV antibodies are used in performing immunological assays on clinical samples. Various immunological assays and kits for detecting HPV infection, cervical cancer, other HPV related cancers, early stage precancerous lesions as well as late stage cancer progression are also provided.

主权项

1. A method of detecting papillomavirus infection in a human subject and determining a risk of the human subject developing a cancerous lesion, comprising:
receiving a sample obtained from the human subject, the sample comprising a population of cells susceptible to infection by a papillomavirus, applying the sample to a slide; contacting the sample with a first staining reagent comprising an anti-HPV monoclonal antibody generated against a purified recombinant papillomavirus protein, 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, andthe monoclonal antibody is capable of binding in situ to said proteins in a clinical sample; and a positive staining is indicative of the presence of a papillomavirus protein in the sample thereby indicating papillomavirus infection in the human subject; and determining a nuclear to cytoplasm ratio in size for at least one cell of the population of cells; and determining a score for the sample based on the nuclear to cytoplasm ratio in size and the positive staining wherein the score indicates a risk of the human subject developing a cancerous lesion.