Abstract: Objective To Investigate the rechecked strategy of chemiluminescence immunoassay（CLIA） combined with enzyme linked immunosorbent assay（ELISA）in order to detect Hepatitis C virus antibodies. Methods Two hundred and one sera samples of CLIA anti-HCV S/CO﹥0.40 were collected from the patients by ELISA. and the samples over the cutoff value with at least one reagent detection were checked for HCV RNA by realtime fluorescence quantitative PCR（FQ-PCR） . Results Among the positive 201 samples,CLIA provided by Johnson,ELISA by MUREX,and ELISA by Kehua companies revealed positivities of 2.5％,1.6%,and 1.5%,respectively. There were 75 （1.3%,75/5 800）samples that had both CLIA and two ELISA reagents positive detections. FQ-PCR positive detections were noted in 51（0.9%,51/5 800）samples. Forty samples exhibited anti-HCV S/CO﹥0.40 and <0.90 in CLIA detection. Eight samples showed anti-HCVS/CO﹥0.90 and <0.99 in CLIA detection. There were 153 samples that revealed the anti-HCV S/CO≥1.0 in CLIA detection,among them,66 samples indicated S/CO 1.00-5.00,16 samples,S/CO 5.01-10.00; 5 samples,S/CO 10.01-20.00; and 66 samples,S/CO﹥20.00. Conclusion CLIA is reliable for detection of anti- HCV with S/CO﹥0.40 and <0.90. HCV RNA detection is useful for laboratory diagnosis and treatment evaluation in the samples that have showed positive anti-HCV by using CLIA and ELISA.

Key words: Chemiluminescence immunoassay, Enzyme linked immunosorbent assay, Hepatitis C virus antibody