高敏化学发光法测定丙肝病毒抗体的临床性能评价  

Applicable Evaluation of Determination of Hepatitis C Virus Antibody with High-Sensitivity Chemiluminescence

作　　者：石玉玲[1] 谢思[1] 许蔓春[1] 廖扬[1] 张卫云[1] 陈建芸[1] 

机构地区：[1]广州军区广州总医院检验科,广东广州510010

出　　处：《生物技术通讯》2018年第1期100-104,共5页Letters in Biotechnology

基　　金：广东省省级科技计划项目(2013B031800009)

摘　　要：目的:对新检测系统HISCL-5000高敏化学发光免疫法测定丙肝病毒抗体(HCVAb)进行性能评价。方法:对HCVAb的精密度、血清转化盘、一致率、临床特异性与临床灵敏度、干扰试验测定结果进行分析评价;经抗HCV重组免疫印迹试验(RIBA)对不一致结果进行确认。结果:新检测系统HISCL-5000测定HCVAb的批内CV分别为5.31%、8.21%,批间CV分别为4.33%、7.16%;HISCL使用血清转化盘检测比雅培ARCHITECT提前1周测定出由阴转阳的血清转化,检测窗口期提前1周;与雅培定量试剂的总一致率为99%,与科华ELISA检测弱阳性及弱阴性标本的总一致率为95.3%;临床特异性99.7%、临床灵敏度100.0%均高于雅培i2000及科华ELISA。结论:新检测系统Sysmex HISCL-5000高敏发光全自动免疫分析测定HCVAb灵敏度高、特异性强、简便且窗口期短,适于临床HCV感染的检测。Objective: To evaluate the performance of HISCL-5000 high-sensitivity chemiluminescence immunoassay in the determination of hepatitis C virus antibody(HCVAb). Methods: The precision of HCVAb, serum conversion plate, consistency rate, clinical specificity and clinical sensitivity, interference test results were analyzed and evaluated. Anti-HCV recombinant immunoblotting assay(RIBA) was used to retest the inconsistent results. Results: The intra-assay CV at two levels of HCVAb were 5.31% and 8.21% respectively, and the inter-assay CV were 4.33% and 7.16% respectively. HISCL was detected by modified serum discs. The overall coincidence rate was 95.3%, and the clinical specificity was 99.7%. The overall positive rate was 99.3%, and the overall specificity was 99%. The clinical sensitivity of 100.0% were higher than that of Abbott i2000 and Kehua ELISA. Conclusion: Luminous automatic immunoassay HCVAb determination by the new detection system Sysmex HISCL 5000 has high sensitivity, strong specificity, simple and short window period, which is suitable for the detection of clinical HCV infection.

关 键 词：丙肝病毒抗体 高敏化学发光免疫法 微粒子酶免疫发光法 ELISA 

分 类 号：R446[医药卫生—诊断学]