Evaluation of an enzyme immunoassay for hepatitis C virus antibody detection using a recombinant protein derived from the core region of hepatitis C virus genome

This study was undertaken to evaluate an enzyme immunoassay (EIA) for hepat itis C virus antibody detection (anti-HCV), using just one antigen. Anti-HC V EIA was designed to detect anti-HCV IgG using on the solid-phase a recomb inant C22 antigen localized at the N-terminal end of the core region of HCV genome, produced by BioMerieux. The serum samples diluted in phosphate buf fer saline were added to wells coated with the C22, and incubated. After wa shings, the wells were loaded with conjagated anti-IgG, and read in a micro titer plate reader (492 nm). Serum samples of 145 patients were divided in two groups: a control group of 39 patients with non-C hepatitis (10 acute h epatitis A, 10 acute hepatitis B, 9 chronic hepatitis B, and 10 autoimmune hepatitis) and a study group consisting of 106 patients with chronic HCV he patitis. In the study group all patients had anti-HCV detected by a commerc ially available EIA (Abbott(R)) specific for HCV structural and nonstructur al polypeptides, alanine aminotransferase elevation or positive serum HCV-R NA detected detected-PCR. They also had a liver biopsy compatible with chro nic hepatitis. The test was positive in 101 of the 106 (95%) sera from pati ents in the study group and negative in 38 of the 39 (97%) sera from those in the control group, showing an accuracy of 96%. According to these result s, our EIA could be used to detect anti-HCV in the serum of patients infect ed with hepatitis C virus.