B형 간염바이러스 표면항원 및 C형 간염바이러스 항체 검출용 국산 제3세대 효소면역측정법 시약의 검토

Abstract

Background : Serologic assays for hepatitis B surface Ag (HBsAg) andhepatitis C virus antibody (anti-HCV) are useful markers in the assessment of viral hepatitis. The purpose of this study was to evaluate the newly improved domestic third-generation enzyme immunoassay kits for detecting HBsAg and anti-HCV. Methods: To evaluate the usefulness of EIA kit for detecting HBsAg, 239 screening-positive, 176 screening-negative and 450 blood donors' sera were subjected to compare Genedia 3.0 (Greencross, Korea) with Enzygnost(r) EIA kit (Behringwerke, Germany). To the effectiveness of third-generation EIA kit for detecting anti-HCV, 104 screening-positive, 300 screening-negative and blood donors' sera were analyzed with Abbott 3.0 (Abbott Laboratories, Chicago, USA), Innotest 3.0 (Innogenetics, Belgium) and Genedia 3.0 (Greencross, Korea) EIA kits. Results: Overall agreement between Behring Enzygnost and Genedia HBsAg EIA was 99.6% (817 of 820 tests). Agreement between each group showed 239 of 239 (100%) in HBsAg screening-positive, 175 of 176 (99.4%) in HBsAg screening- negative and 448 of 450 (99.6%) in blood donor group, respectively, The results of Abbott, Innotest and Genedia anti-HCV 3.0 EIAs showed agreement of 98.5% (398 of 404 sera). Each group revealed 102 of 104 (98.1%) anti-HCV screening-positive 296 of 300 (98.7%) anti-HCV screening-negative and blood donor group, respectively. Conclusions: Good agreement of third-gen3eration domestic EIA kits and other imported kits in the results of HBsAg and anti-HVC kits were observed in screening-positive, screening-negative and blood donor group, Domestic third-generation HBsAg and anti-HCV EIA kits were considered to be useful screening reagents for identifying hepatitis B and C virus infections respectively.