Comparative evaluation of 2nd-generation anti-hepatitis C virus (HCV) Dainabbot PHA assay for combined detection of antibodies to core and non-structural regions, Tokushumenekiken GOR assay containing only core-related antigen, and 1st-generation Ortho c100-3 ELISA was performed on 1, 090 random donors and 102 donors with transfusion histories, as detected by HCV-RNA polymerase chain reaction (PCR). Among 1, 090 donors, HCV-RNA were detected in 8 of 11 samples positive to c100-3, 13 of 17 samples positive to GOR and 16 of 18 samples positive to PHA, indicating that PHA and GOR containing core or core-related antigens are more sensitive to anti-HCV than c100-3. Among 102 donors with transfusion histories, while only one of five PCR-positive samples was detected by c100-3, all five samples were detected by PHA. These marked differences in sensitivity between the 2nd- and 1st-generation assays were also observed in the donors older than 50 years and GPT less than 25 KU. We conclude that core antigen contained in the 2nd-generation assay play an important role in detecting anti-HCV in donated blood and that PHA having higher specificity is especially useful for screening tests of donated blood.
