CAJ | 학술논문

目的：建立丙型肝炎病毒（HCV）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，并与北京万泰公司的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3 d，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。
목적：건립병형간염병독（HCV）항체화학발광면역검측방법，병분석기림상응용개치。방법：응용기인공정중조적HCV항원포피미공판，이랄근과양화물매표기적양항인IgG위이항，병결합로미낙화학발광저물계통，건립HCV항체화학발광면역검측방법；응용HCV항체진단시제국가삼고품분석소건립방법적특이성、령민도、은정성화정밀성，병여북경만태공사적ELISA시제합동시검측림상혈청양본350빈，비교검측결과。결과：검측결과부합국가삼고품질량표준。비내변이계수5.1%~6.6%，비간변이계수9.5%；시제합치37℃고핵3 d，기은정성량호；여만태공사적ELISA검측결과대조，양성부합솔분별위99.0%，음성부합솔분별위100%，총부합솔위99.4%；Kappa치위0.986，일치성강도최강。결론：건립료특이、민감화은정적HCV항체화학발광면역검측방법，괄용우HCV감염적비량사사，구유교대적림상응용개치。
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-sults: 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.