Improved serodiagnosis of chronic hepatitis C in Japan by a second‐generation enzyme‐linked immunosorbent assay

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Abstract
To clarify the role of hepatitis C virus (HCV) infection in chronic liver disease, sera from Japanese patients which were negative by the original anti‐HCV assay (Ortho) were subjected to a second‐generation anti‐HCV assay based on a combination of structural (C22) and nonstructural (C200) recombinant HCV proteins. Of 29 patients with chronic non‐A, non‐B hepatitis, 20 (69%) were anti‐HCV‐positive by the second‐generation enzyme‐linked immunosorbent assay (ELISA) and also positive by the reverse transcription‐polymerase chain reaction (RT‐PCR) which detects the HCV genome. Of 41 chronic hepatitis B virus carriers, 3 (7%) were positive by the second‐generation ELISA; 1 of 3 was positive by RT‐PCR. The HCV genome was detected in ail cases positive for anti‐HCV with high titers. Of 59 healthy subjects negative by the second‐generation ELISA, none were positive by RT‐PCR. These findings indicate that HCV is a major causative agent of chronic non‐A, non‐B hepatitis in Japan and that second‐generation ELISA is specific and a more sensitive diagnostic assay for chronic hepatitis C.