酶联免疫法与全自动化学发光法检测乙肝表面抗原的特异度及敏感度比较

Comparison of characteristic and sensitivity of HBs Ag detection by enzyme-linked immunosorbent assay and chemiluminescence immunoassay

目的比较酶联免疫法与全自动化学发光法检测乙肝表面抗原(HBsAg)的特异度及敏感度。方法选择该院2017年3月至2019年3月就诊的203例患者并采集外周血标本,采用酶联免疫吸附法(ELISA)、化学发光免疫分析法(CLIA)进行检测,参考中和确认试验比较两种方法检测结果及检测效果。结果203例标本CLIA法检测阳性48例,ELISA法阳性46例,中和确认试验阳性48例,与CLIA法结果一致;对比中和确认试验,ELISA法和CLIA法均有较高的特异度和符合率,分别为100%、99%和100%、100%,但对比中和确认试验灵敏度分别为95.8%、100%,ELISA法、CLIA法的Kappa值分别为0.97、1,而受试者工作特征(ROC)曲线下面积依次为0.88、0.97,差异具有统计学意义(χ^2=5.840,P=0.016)。结论酶联免疫法与化学发光法检测HBsAg的均有较高的特异度,但化学发光法检测敏感度更高。

【Objective】To compare the specificity and sensitivity of HBs Ag(Hepatitis B surface antigen)measured by enzyme-linked immunoadsordent assay(ELISA)and chemiluminescence immunoassay(CLIA).【Methods】A total of 203 patients diagnosed in our hospital from March 2017 to March 2019 were selected and peripheral blood samples were collected.The ELISA method and CLIA method were used for detection.The detection results and performance were compared between the two methods referring to the neutralization confirmation test.【Results】In 203 cases of specimens,48 cases were tested positive by CLIA method,46 cases by ELISA method,and 48 cases by standard reference method,consistent with the CLIA method.Compared with the neutralization confirmation test,the ELISA method and the CLIA method had high specificity and compliance rates,respectively,100%,99%,100%,and 100%,but the sensitivity was 95.8% and 100%,respectively.The values of Kappa of the ELISA method and CLIA method were 0.97 and 1,respectively.The area under the receiver operator characteristic(ROC)curve was 0.88 and 0.97,respectively,with a statistical difference(χ^2=5.840,P=0.016).【Conclusion】Both enzymatic and chemiluminescence methods have high specificity,but chemiluminescence method has higher sensitivity.