SPECIFIC DETECTION OF ANTI-HBC ANTIBODIES WITH AN ENZYME-IMMUNOASSAY USING RECOMBINANT HBCAG AND MONOCLONAL-ANTIBODIES

An enzyme immunoassay for the detection of total anti-HBc antibodies i n undiluted serum samples was developed. This assay utilizes an anti-H Bc monoclonal antibody and a recombinant HBc antigen. The results of t he clinical validation are now reported. A total of 1,301 sera were te sted using both the Recombinant TOTAL HBc Ab EIA and a reference assay . The specificity was evaluated on a panel of 573 normal human sera an d human sera from subjects with pathological findings unrelated to a h epatitis B virus infection. The sensitivity was studied on a total of 455 sera from HBV infected patients at different stages of infection. The final results indicate 99.8% sensitivity and 99.8% specificity. In addition, 273 sera with either isolated anti-HBc antibodies or with a nti-HCV antibodies were tested. The agreement between the Recombinant and the reference assay for these two populations, 96.6 and 90.1%, res pectively, is discussed.