Evaluation of clinical and laboratory aspects of antibody tests for detection of hepatitis C virus infection in blood donors and recipients from a low‐risk population

Background: When the first‐generation enzyme immunoassay (EIA) for detection of antibody to hepatitis C virus (anti‐HCV) was approved in May 1990, blood banking agencies recommended testing of all components in inventory. In many cases, one or more components from these units had already been transfused. Study Design and Methods: Donors that reacted in first‐generation EIAs and recipients of their components were identified, and anti‐HCV test methods (including first‐generation EIA, second‐generation EIA, and recombinant immunoblot assay [RIBA]) were evaluated. Results: Of 66 donors identified as anti‐HCV‐positive by first‐generation EIA, 17 were positive in second‐generation EIA. Of these 17, 9 reacted in RIBA; 6 of these showed evidence of HCV infection in polymerase chain reaction (4) and/or probable transmission of HCV to a transfusion recipient (3). Of the 48 specimens that were positive in first‐generation EIA and negative in second‐generation EIA, only 1 was positive in RIBA; serum was not available for polymerase chain reaction testing, and there were no living transfusion recipients in whom to assess evidence of transmission of HCV. Conclusion: This study documents the low predictive value of EIAs for anti‐HCV in a low‐ prevalence blood donor population and emphasizes the need for additional testing to confirm the specificity of samples that react in the screening tests. 1994 AABB