电化学发光免疫法和化学发光微粒免疫分析法在HBsAg检验中的价值比较

目的 比较电化学发光免疫法(CI)和化学发光微粒免疫分析法(CMIA)在乙肝表面抗原(HBsAg)检验中的价值.方法 纳入我院收治的乙型肝炎疑似病例396例,分别使用CMIA、CI法进行HBsAg水平的测定.以CMIA为金标准,分析CI对HBsAg的诊断灵敏度、特异度和符合率.计算CMIA、CI检测HBsAg的检测批次...

Comparison of the value of electrochemiluminescence immunoassay and chemiluminescence particle immunoassay in HBsAg test

Objective To compare the value of electrochemiluminescence immunoassay(CI)and chemiluminescence particle immunoassay(CMIA)in hepatitis B surface antigen(HBsAg)test.Methods A total of 396 suspected cases of hepatitis B admitted in our hospital were enrolled.CMIA and CI methods were used to determine the level of HBsAg.Taking CMIA as the gold standard,the diagnostic sensitivity,specificity and coincidence rate of CI to HBsAg were analyzed.The intra and inter batch precisions of CMIA and CI were calculated.Bland-Altman deviation analysis was used to analyze the diagnostic consistency of CI and CMIA.Results Taking CMIA as the gold standard,the diagnostic sensitivity of CI detection was 95.03%(287/302),the diagnostic specificity was 97.87%(92/94),and the diagnostic coincidence rate was 95.71%(379/396).There was no statistically significant difference between the intra and interbatch variation coefficient of CI and CMIA for HBsAg detection(P>0.05).The intra-group correlation coefficient of CI and CMIA for HBsAg diagnosis was 0.896,CI and CMIA showed good consistency in the diagnosis of HBsAg.The Bland-Altman deviation analysis showed that the confidence interval of the degree of bias of the two detection methods was(-6.36-23.24).In the diagnosis of HBsAg,CI and CMIA had a good consistency in the range of 0-23 IU/mL.With the level of HBsAg increased,the deviation increased,the 2.02%(8/396)points were outside the 95%confidence interval for the degree of bias.Conclusion Compared with CMIA,CI has good diagnostic sensitivity,coincidence rate and precision in the test of HBsAg.In addition,CMIA and CI have good consistency in the diagnosis of HBsAg.However,there is still a certain deviation in the detection of high levels of HBsAg.