【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。更多还原

【Abstract】 Objective To clinically evaluate and compare a chemiluminescence immunoassay(CLIA)kit with an ELISA kit for detecting of HBV PreS1antigen.Methods A sum of 452clinical sera samples from hepatitis patients were collected,and HBV PreS1antigen in sera were parallely detected by the CLIA and ELISA methods.Compared with the ELISA kit,the specificity,sensitivity and accuracy(overall concordance rate)of the CLIA kit were calculated.Kappa value was also calculated for agreement 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 PreS1will be fit for wide application in clinical laboratory.更多还原