Detection of Chronic Hepatitis C Virus Infection by Four Diagnostic Systems: First–Generation and Second–Generation Enzyme–Linked Immunosorbent Assay, Second–Generation Recombinant Immunoblot Assay and Nested Polymerase Chain Reaction Analysis

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Abstract
Serum samples from 100 patients with non–A, non–B hepatitis-related chronic liver disease and 100 patients with hepatitis B-related chronic liver disease were tested by first–generation and second–generation enzyme–linked immunosorbent assays, a second–generation recombinant immunoblot assay and the nested polymerase chain reaction. In non–A, non–B hepatitis-related chronic liver disease, second–generation enzyme–linked immunosorbent assay (anti–c22 and/or c200) and second–generation recombinant immunoblot assay showed 98% positivity, whereas first–generation enzyme–linked immunosorbent assay (anti–c100–3) showed 89% positivity. The two second–generation recombinant immunoblot assay-negative samples were positive by nested polymerase chain reaction, but one second–generation recombinant immunoblot assay-positive sample was polymerase chain reaction negative. However, when this second–generation recombinant immunoblot assay-positive sample was tested by polymerase chain reaction using another set of primers, it was polymerase chain reaction positive. Therefore, 100% of the non–A, non–B hepatitis-related chronic liver disease serum samples were hepatitis C virus RNA positive by polymerase chain reaction. Nine hepatitis B-related chronic liver disease samples were first–generation enzyme–linked immunosorbent assay positive. Of the eight second–generation enzyme–linked immunosorbent assay positive hepatitis B-related chronic liver disease samples, six were first–generation enzyme–linked immunosorbent assay positive and five were second–generation recombinant immunoblot assay positive and polymerase chain reaction positive. One indeterminate secon–generation recombinant immunoblot assay sample was polymerase chain reaction negative. Therefore, second–generation recombinant immunoblot assay appears to be as useful as polymerase chain reaction for detecting a chronic hepatitis C virus infection, although some discrepancies were noted. Second–generation enzyme–linked immunosorbent assay is also a useful method, but false–positive results were found in two samples (2.0%) from patients with type B cirrhosis. (Hepatology 1992;16:300-305.)