化学发光法检测HCVIgG抗体方法的建立和初步应用  

The establishment of HCV IgG antibody chemiluminescence detection method and preliminary application

作　　者：侯俊 胡燕 邬顺全 白冰珂[1] 姜棋予 史素娟 王保君 欧卫军 貌盼勇[1] 

机构地区：[1]解放军第三O二医院实验技术研究保障中心,北京100039 [2]北京科卫临床诊断试剂有限公司,北京100039

出　　处：《中华检验医学杂志》2015年第3期159-162,共4页Chinese Journal of Laboratory Medicine

基　　金：国家自然科学基金面上项目（81271846）

摘　　要：目的利用化学发光原理建立一种检On,0HCVIgG抗体的方法，用于HCV感染的检测并为试剂盒研制奠定基础。方法方法学建立。2013年1月至6月完全随机选取的解放军第三。二医院的198份丙型肝炎患者和222份献血员的血清样本。采用间接ELISA方法，用基因工程表达的丙型肝炎病毒（HCV）-NS3、HCV-Core抗原包被化学发光微孔板，辣根过氧化物酶标记抗人IgG抗体，初步建立HCVIgG抗体的化学发光检测方法，进一步与已批准的丙型肝炎病毒抗体检测试剂（化学发光法）同时检测并进行结果对比。结果自制试剂与对照试剂的阳性符合率为99．0％（196／198），阴性符合率为98．2％（218／222），总符合率为98．6％（414／420）。用自制试剂同时检测同1份HCV阳性血清重复10次，其变异系数〈10％。结论初步建立了HCVIgG抗体的化学发光检测方法，此法特异性强、敏感性高，适用于献血员的筛选和临床HCV感染的检测及流行病学调查。Objective To establish a chemiluminecentdetection method （CLIA） of HCV IgG antibody for the detection of HCV infection and therefore lay a foundation for the research and development of testing kit. Methods Based upon the indirect ELISA method, the mierowell plate was coated with HCV- NS3 and HCV-Core antigen expressed through gene engineering, and the anti-human IgG antibody was labeled with horse radish peroxidase. In this way, the chemiluminesent detection method of HCV IgG antibody was established. Meanwhile, the serum specimen of randomly selected 198 patients infected with HCV from No. 302 Hospital of PLA and 222 blood donors, and the results were compared. Results The HCV-IgG antibody, a positive consistent rate of 99.0% （196/198）, a negative consistent rate of 98.2% （218/222） , and a total consistent rate of 98.6% （414/420） were found through testing 420 serum specimen with self-made agent and contrast agent. One HCV positive serum was repetitively tested with the self-made agent for 10 times, and a coefficient of variation （CV） of less than 10% was found. Conclusion The chemilumineseent detection method of HCV IgG antibody is initially established, and the method, with an outstanding specificity and sensitivity, is applicable for screening blood donors, clinically detecting HCV infection as well as epidemiolozical survey. （Chin J Lab Med,2015,38：159-162）

关 键 词：丙型肝炎抗体 免疫球蛋白G 发光测定法 

分 类 号：R446.6[医药卫生—诊断学]