摘要
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的检测批次内和批次间精密度。使用Bland-Altman偏差分析对CI、CMIA的诊断一致性进行分析。结果以CMIA为检测金标准,CI检测的诊断灵敏度为95.03%(287/302),诊断特异度为97.87%(92/94),诊断符合率为95.71%(379/396)。CI、CMIA对HBsAg检测的批次内变异系数和批次间变异系数比较,差异无统计学意义(P>0.05)。CI和CMIA对HBsAg诊断的组内相关系数为0.896,CI、CMIA在对HBsAg的诊断中,一致性较好。经Bland-Altman偏差分析得,两种检测方法的偏倚程度置信区间为(-6.36~23.24),CI、CMIA在0~23 IU/mL的区域内具有良好的一致性,随着机体HBsAg水平的增加,偏差逐渐上升,2.02%(8/396)的点位于偏倚程度95%置信区间以外。结论与CMIA相比,CI在对HBsAg的检验中具有良好的诊断灵敏度、符合率以及精密度。此外,CMIA、CI对HBsAg的诊断一致性良好,然而在高水平HBsAg的检测中仍然存在一定偏差。
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.
作者
张云
白重阳
吴继敏
ZHANG Yun;BAI Chongyang;WU Jimin(Clinical Laboratory Department,Xi'an Electric Power Center Hospital,Xi'an 710032;Clinical Laboratory Department,Tangdu Hospital,the Second Affiliated Hospital of Air Force Military Medical University,Xi'an 710038,China)
出处
《临床医学研究与实践》
2021年第11期110-112,共3页
Clinical Research and Practice
关键词
电化学发光免疫法
化学发光微粒免疫分析法
乙肝表面抗原
诊断价值
electrochemiluminescence immunoassay
chemiluminescence particle immunoassay
hepatitis B surface antigen
diagnostic value
