乙型肝炎病毒前S1抗原化学发光免疫法与酶联免疫法检测试剂的临床比对  

Clinical comparative evaluation between a chemiluminescence immunoassay kit and an ELISA kit for detecting of HBV PreS1 antigen

作　　者：温珠妹[1] 郑丽萍[1] 柳丽娟[1] 谢玉玲[2] 戴振贤 吴玉水[2] 

机构地区：[1]福建医科大学附属福州市传染病医院检验科,福州350025 [2]工业微生物教育部工程研究中心洪诚生物技术研究所,莆田351254

出　　处：《福建医药杂志》2014年第2期73-75,共3页Fujian Medical Journal

基　　金：国家科技型中小企业技术创新基金无偿资助项目(11C26213504886);福建省区域科技计划重大项目(2010Y3004)

摘　　要：目的将国产乙型肝炎病毒前S1抗原化学发光检测试剂与ELISA试剂进行临床比对评价。方法收集临床乙肝患者的血清标本452份,分别用乙型肝炎病毒前S1抗原化学发光检测试剂与ELISA试剂进行检测。与ELISA试剂比对,计算化学发光检测试剂的特异度、灵敏度以及总符合率。并计算Kappa值,比较二者结果一致性。结果与ELISA试剂比对,化学发光检测试剂的特异度为99.4%,灵敏度为100%,总符合率为99.8%,Kappa值为0.995,一致性强度为最强。结论快速、特异、敏感的前S1抗原化学发光免疫检测试剂适合在临床上推广应用。Objective To clinically evaluate and compare a chemiluminescence immunoassay （CLIA） kit with an ELISA kit for detecting of HBV PreS1 antigen. Methods A sum of 452 clinical sera samples from hepatitis patients were collected, and HBV PreS1 antigen in sera were parallely detected by the CLIA and ELISA methods. Compared with the ELISA kit, the speci- ficity, sensitivity and accuracy （overall concordance rate） of the CLIA kit were calculated. Kappa value was also calculated for a- greement analysis. Results Compared with the ELISA kit, the specificity, sensitivity and accuracy （overall concordance rate） of the CLIA kit were 99.4%, 100% and 99.8% respectively, and a highest degree of agreement was observed （the Kappa value= 0. 995）. Conclusion The rapid, sensitive and specific CLIA kit for detecting of HBV PreS1 will be fit for wide application in clinical laboratory.

关 键 词：乙型肝炎病毒前S1抗原 化学发光免疫法 

分 类 号：R446.61[医药卫生—诊断学]