Cytomegalovirus (CMV) appears to be an ubiquitous viral pathogen. It is a highly opportunistic agent and a member of the Herpes family of viruses. Due to its latency, it can recur abruptly, erupting as a lethal infection. The spectrum of the morbidity and mortality caused by CMV includes congenital, perinatal, postnatal, organ transplant, and transfusion infections. Current diagnosis is not well standardized, and is based on the appearance of cytopathic effect in a suitable host tissue culture. Time for diagnosis is long (7-21 days) and specificity is poor.This research project is designed to develop an enzyme immunoassay to rapidly detect CMV antigen in urine. During Phase I development of monoclonal antibodies to various polypeptides of the CMV virion is taking place. In Phase 11, the monoclonal antibodies will be fully characterized and then used (1) as tools to purify CMV polypeptides for use as immunogens in the production of polygonal rnonospecific antisera and (2) as potential diagnostic reagents in conjunction with the polygonal reagents to develop a sensitive (polygonal), specific (monoclonal), rapid assay to detect CMV shed in the urine of infected individuals. It is anticipated that sensitivity will have to be greatly increased over that of conventional calorimetric enzyme-linked immunosorbent assays (ELISA), and this will be approached in several novel ways by examining other enzymes, fluorogenic substrates, and alternate solid phases. Potential commercial applications of such an assay are great, as this need is not currently being met. Such an assay could be expected to be widely used in pediatric wards, prenatal clinics, oncology chemotherapy settings, transplantation clinics, and transfusion centers.National Institute Of Allergy And Infectious Diseases
