C형 간염 항체 검출을 위한 새로운 제3세대 전자동 미세 밉자 효소면역측정법의 평가

Abstract

An evaluation of a new third generation AXSYM HCV microparticle enzyme immunoassay (AXSYM HCV3.0 MEIA , ABBOTT) for the detection of antibodies directed to hepatitis C virus was undertaken. This assay, which can be run fully automated on a random access analyzer, was compared with the third generation ABBOTT HCV EIA (HCV EIA3.0). Discrepant results were further investigated using the CHIRON RIBA HCV3.0 and HCV RNA assays. A total of 237 samples were used in this study. The overall concordance between the AXSYM HCV3.0 and HCV EIA3.0 was 90.3%. Although it is not possible to provide absolute figures for clinic for specificity and sensitivity, diagnostic specificity and sensitivity were 100% and 93.1%. In this study , the AXSYM HCV3.0 could be expected to reduce the number of false positive results in HCV EIA3.0 and was proved to be a effective altemative to HCV EIA3.0 for screening of antibodies to the hepatitis C virus.