化学发光法检测抗HEV IgG试剂盒的研制和评价  

Development and assessment of a chemiluminescence assay kit for detecting anti-HEV IgG

作　　者：张敏娜[1,2] 胡燕[3] 侯俊[3] 高蓉[3] 史素娟 王保君 欧卫军 杨永平[2] 貌盼勇[1,3] 

机构地区：[1]解放军医学院,北京100853 [2]解放军302医院肝脏肿瘤诊疗与研究中心,北京100039 [3]解放军302医院实验技术研究保障中心,北京100039 [4]北京科卫临床诊断试剂有限公司,北京100043

出　　处：《细胞与分子免疫学杂志》2015年第5期648-651,共4页Chinese Journal of Cellular and Molecular Immunology

基　　金：国家自然科学基金(81271846)

摘　　要：目的研制化学发光法检测血清抗戊型肝炎病毒(HEV)IgG试剂盒,并评价其临床应用。方法以HEV重组抗原包被化学发光微孔板,辣根过氧化物酶(HRP)标记的单克隆抗人IgG为二抗,鲁米诺化学发光反应体系作为底物。通过检测抗HEV抗体国家参考品评价其灵敏度、特异性、精密性等技术指标,并与已商品化的化学发光法抗HEVIgG检测试剂盒对比检测1012份临床血清样本。结果3个批次的试剂盒的灵敏度、特异性、精密性、稳定性均达到国家标准。对1012例临床血清样本检测,两种试剂盒检测阳性符合率为97.4%,阴性符合率为99.4%,总符合率达98.4%。结论成功研制出化学发光法检测抗HEVIgG试剂盒,该试剂盒敏感性高、特异性强、操作简便,适用于HEV感染的临床诊断及流行病学调查。Objective To develop an anti-hepatitis E virus （anti-HEY） IgG chemiluminescence assay kit and assess its clinical application. Methods The HEV recombinant antigen was used as coating antigen, horseradish peroxidase （HRP）- conjugated monoclonal anti-human IgG as the secondary antibody, and the luminol chemiluminescent reaction system as a substrate. The sensitivity, specificity, precision and other technical indicators of the kit were evaluated using the HEV national reference product, and a contrast experiment was conducted on 1012 serum samples by the kit developed in this research and a commercialized anti-HEY IgG chemiluminescence assay kit. Results The sensitivity, specificity, precision and stability of all the three batches of kit reached national standard. In the detection of 1012 clinical serum samples, the positive coincidence rate of both kits was 97.4%, the negative coincidence rate was 99.4%, and the total coincidence rate reached 98.4%. Conclusion An anti-HEV IgG chemiluminescence assay kit has been successfully developed. The kit is of high sensitivity and specificity, easy to operate. It is applicable to the clinical diagnosis and epidemiological survey of HEV infection.

关 键 词：化学发光法 戊型肝炎 抗体 诊断 

分 类 号：R392.11[医药卫生—免疫学] R392.33[医药卫生—基础医学]