The primary objective of this effort is to provide a methodology for assay of human papillomavirus infection in human cells by utilizing monoclonal antibody technology in the development of an immunocytologic assay. Since human papillomavirus infection has been strongly associated with cervical cancer, as well as precancerous lesions; is considered to be a major healt problem in this country and worldwide; and is easily treatable following early diagnosis, the clinical need and usefulness of an objective assay used as an adjunct to Papanicolaou smears, is apparent.The Phase I effort consists of the preparation of bovine papillomavirus proteins as immunogen and the production and initial characterization of monoclonal antibodies to the genus-specific capsid protein of Papillomaviruses from the hyperimmunization of mice. Complete characterization of the monoclonal antibodies and incorporation of them into an objective immunocytochemical assay for the detection of papillomavirus infection in humans is planned for Phase II. The uniquenes of the product derives from the anticipated improvement in sensitivity, specificity, and cost over existing methodologies, and the high likelihood of commercial success is assured by a substantial existing market for earl diagnostic techniques for cervical cancer which will grow with increasing public awareness and a better test.
Thesaurus Terms:Animals, Chordates, Mammals, Rodents, Myomorpha, Mice (Laboratory) Biological Preparations And Standardization, Natural Products Productionby Chemical Synthesis, Design And Production, Proteins And Peptides Diagnostic Quality-Standards Diagnostic Tests, Cytodiagnosis Diagnostic Tests, Cytodiagnosis, Vaginal Smears Diagnostic Tests, Design, Development And Evaluation Of Diagnostic Tests Diagnostic Tests, Early Diagnosis Histochemistry And Cytochemistry Human, Human Tissues, Fluids Etc. From Non-Related Sources Outside Immedia Immunochemistry Immunological Preparations, Monoclonal Antibodies Immunological Tests And Immunoassay, Immunoassay Immunology, Antibodies Viral Immunology, Antibody Specificity Immunology, Antigens Viral Indicators And Reagents Neoplasms Diagnosis, Immunodiagnosis Of Neoplasms Neoplasms Of Reproductive System Female, Uterus Neoplasms, Cervix Neoplasm Neoplasms Of Reproductive System Female, Uterus Preneoplastic States Nucleic Acid Hybridization Nucleic Acids, Nucleic Acid Probes Proteins, Viral Proteins Tissue And Cell Preparation, Staining Viruses, Papovaviridae, Papillomavirus, Warts VirusesNational Institute of Allergy and Infectious Diseases (NIAID)
