Evaluation of Genedia HCV Rapid for Rapid Detection of Antibody to Hepatitis C Virus / 대한임상병리학회지

ABSTRACT

BACKGROUND: Hepatitis C virus (HCV) is a major agent of transfusion-associated non-A, non-B hepatitis. The best method for prevention of HCV infection through transfusion is blood donor screening using reliable diagnostic tools. Enzyme immunoassays (EIA) for detection of HCV antibody were developed, but it required equipment and time consuming. In emergency situation such as massive bleeding, HCV screening of blood donor needs more simple, rapid and reliable method. Recently, for rapid detection of HCV antibody, Genedia HCV Rapid assay was developed. To evaluate the usefulness of this assay, comparative studies with third generation anti- HCV EIA and two HCV confirmatory tests (Genedia HCV Confirm 4.0 and Chiron RIBA HCV 3.0 SIA) were performed. METHODS: A total of 156 sera (106 positive and 50 negative), screened by second generation IMx anti-HCV assay (Abbott 2.0; Abbott Laboratories, U.S.A.), were examined with Genedia HCV Rapid (Green Cross, Korea) and Genedia HCV ELISA 3.0 (Green Cross, Korea). The discrepant sera between Genedia HCV Rapid and Genedia HCV ELISA 3.0 were confirmed by both Genedia HCV Confirm 4.0 and Chiron RIBA HCV 3.0 SIA. RESULTS: The concordance rates of Abbott 2.0 vs Genedia HCV Rapid, Abbott 2.0 vs Genedia HCV ELISA 3.0, and Genedia HCV Rapid vs Genedia HCV ELISA 3.0 were 88.4%, 89.7%, and 96.1%, respectively. The sensitivity, specificity, positive predictive value and negative predictive value of Genedia HCV Rapid for Genedia HCV Confirm 4.0 were 97.7%, 100%, 98.9%, and 97.0%, respectively, and for Chiron RIBA HCV 3.0 SIA 97.8%, 98.5%, 98.9%, and 97.0%, respectively. Of discrepant 6 sera between Genedia HCV Rapid and Genedia HCV ELISA 3.0, 2 were positive by Genedia HCV Confirm 4.0, and 3 positive by Chiron RIBA HCV 3.0 SIA. However, 14 negative sera by both Genedia HCV rapid and Genedia HCV ELISA 3.0, which were all positive by Abbott 2.0, were all negative by two confirmatory tests. CONCLUSIONS: These data show that Genedia HCV Rapid could be used in emergency blood donor screening for HCV antibody detection.