丙型肝炎病毒抗体化学发光免疫检测方法的建立及其临床应用简

目的：建立丙型肝炎病毒（rmv）抗体化学发光免疫检测方法，并分析其临床应用价值。方法：应用基因工程重组的HCV抗原包被微孔板，以辣根过氧化物酶标记的羊抗人IgG为二抗，并结合鲁米诺化学发光底物系统，建立HCV抗体化学发光免疫检测方法；应用HCV抗体诊断试剂国家参考品分析所建立方法的特异性、灵敏度、稳定性和精密性，并-9北京万泰公司的ELISA试剂盒同时检测临床血清样本350份，比较检测结果。结果：检测结果符合国家参考品质量标准。批内变异系数5．1％。6．6％，批间变异系数9-5％；试剂盒置37℃考核3d，其稳定性良好；与万泰公司的ELISA检测结果对照，阳性符合率分别为99．0％，阴性符合率分别为100％，总符合率为99．4％；Kappa值为0．986，一致性强度最强。结论：建立了特异、敏感和稳定的HCV抗体化学发光免疫检测方法，适用于HCV感染的批量筛查，具有较大的临床应用价值。

Establishment and Clinical Application of Chemiluminescence Immu- noassay for Hepatitis C Virus Antibody

Objective： To establish chemiluminescence immunoassay（CLIA） for hepatitis C virus（HCV） antibody and evaluate its clinical application value. Methods： Genetic engineered HCV antigen coated on micro-plate, and horse radish peroxidase conjugated goat-anti-human IgG as secondary, combined with luminal chemiluminescence substrate, a CLIA for HCV antibody was established. National reference substances for diagnostics of HCV anti body were used for evaluation of specificity, sensitivity, stability and curacy of the CLIA. A sum of 350 clinical samples was detected by the established CLIA and an ELISA kit produced by the Wantai Company, Beijing. Re shits： The CLIA detection results met the requirement of national conference substances quality criteria. The coeffi cient of variation（CV） for within-run was 5.1%-6.6% and 9.5% for between-run assays. The CLIA kits shown good stability when kept at 37℃ for 3 days. Comparing between results determinated by using the CLIA kits and the ELISA kit, the positive coincidence rate was 99.0%, and negative coincidence rate 100%, total accuracy rate 99.4%, and Kappa value 0.986（highest-level consistency strength）. Conclusion： We have successfully established specific, sensitive and stable CLIA kit for HCV antibody, which showed great clinical application value in large scanning the HCV infection.