Evaluation of third-generation hepatitis C antibody assay in chronic hepatitis C and chronic non-B, non-C hepatitis

Second-generation hepatitis C virus (HCV) antibody assays are more sensitive and specific than first-generation assays in the detection of HCV infection; such tests are widely used. However, there are still HCV-infected patients who test seronegative for anti-HCV even by second-generation assays. In this study we evaluated the performance of the new third-generation HCV assay (HCV 3.0) in 230 individuals with different second-generation anti-HCV (HCV 2.0) and HCV RNA patterns. Our results showed the followings: only one healthy adult had a discrepant result in 200 subjects negative (group I) or positive (group II) for HCV 2.0 and HCV RNA; 7 of 13 (54%) HCV 2.0-negative but HCV RNA-positive patients (group III) were HCV 3.0-positive; two of 17 (12%) so-called chronic non-B, non-C hepatitis patients (group IV) were positive for HCV 3.0. We conclude that third-generation anti-HCV assays are more sensitive and specific than second-generation assays in the detection of chronic HCV infection; however false-positive results may be observed among low-risk healthy persons.