Analysis of discordant test results among five second-generation assays for anti-hepatitis C virus antibodies also tested by polymerase chain reaction-RNA assay and other laboratory and clinical tests for hepatitis

Abstract

The diagnostic performances of five commercially available second-generation assays for anti-hepatitis C virus antibody, two enzyme-linked immunosorbent assays, one enzyme immunoassay, and two particle agglutination assays (passive hemagglutination assay and particle agglutination assay), were evaluated. Among 104 samples from healthy subjects and 300 consecutive samples from patient ordered for routine determinations of anti-hepatitis C virus antibody in serum, assay results showed variable degrees of discordance for 17 samples (4.2%). These 17 samples were further tested by an immunoblot assay, the polymerase chain reaction-RNA assay, and the hemagglutination inhibition assay. Four of the 17 samples were regarded as true positive, since all supplementary assays and clinical data indicated active hepatitis C virus infection. Another five samples were considered false positive because no confirmatory evidence was obtained from the laboratory analysis or clinical data. The remaining eight samples were negative for hepatitis C virus RNA, but the results of the other supplementary tests were indeterminate. Some of these samples with indeterminate results may have been from patients with subclinical cases of disease who spontaneously recovered from hepatitis with persistent anti-hepatitis C virus antibody in their sera.