AN IMMUNOSPECIFIC ASSAY FOR HUMAN PAPILLOMAVIRUSES

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. HUMAN PAPILLOMAVIRUS INFECTION HAS BEEN STRONGLY ASSOCIATED WITH CERVICAL CANCER, AS WELL AS PRECANCEROUS LESIONS AND IS CONSIDERED TO BE A MAJOR HEALTH PROBLEM IN THIS COUNTRY AND WORLDWIDE. IT IS EASILY TREATABLE FOLLOWING EARLY DIAGNOSIS, MAKING THE CLINICAL NEED AND USEFULNESS OF AN OBJECTIVE ASSAY USED AS AN ADJUNCT TO PAPANICOLAOU SMEARS APPARENT. THE PHASE I EFFORT CONSISTS OF THE PREPARATION OFBOVINE PAPILLOMAVIRUS PROTEINS AS IMMUNOGENS 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 THEIR INCORPORATION INTO AN OBJECTIVE IMMUNOCYTOCHEMICAL ASSAY FOR THE DETECTION OF PAPILLOMAVIRUS INFECTION IN HUMANS IS PLANNED FOR PHASE II. THE UNIQUENESS OF THE PRODUCT DERIVES FROM ANTICIPATED IMPROVEMENTS IN SENSITIVITY, SPECIFICITY, AND COST OVER EXISTING METHODOLOGIES.