DIAGNOSIS OF HEPATITIS-C VIRUS-INFECTION USING 2 2ND-GENERATION ENZYME IMMUNOASSAYS WITH A RECOMBINANT IMMUNOBLOT ASSAY FOR CONFIRMATION

A total of 1,016 serum samples from patients with either non-A, non-B hepatitis or risk factors for hepatitis C virus (HCV) infection were e xamined in two second-generation enzyme immunoassays (EIAs), the UBI H CV EIA (Organon Teknika, The Netherlands) and the Wellcozyme anti-HCV (Murex Diagnostics, UK), for detection of antibodies to HCV. An immuno blot assay that uses four recombinant antigens, the 4-RIBA (Chiron, US A), was used as a confirmatory assay. Of the 1,016 samples, 195 (19.2% ) were reactive in both EIAs, while ten yielded discrepant results. On e hundred eighty of the 195 (92%) positive reactions were confirmed in the 4-RIBA; 13 sera yielded an indeterminate result and two were nega tive. None of the sera with discrepant results reacted positively in t he confirmatory test, while two sera showed an indeterminate pattern. In contrast to the screening of antibodies to HCV among blood donors, confirmatory testing of antibodies to HCV with the 4-RIBA seems to hav e limited added value in the diagnostic examination of clinical sample s from patients with suspected HCV infection.