两种国产化学发光系统检测HBsAg和HBeAg的效果分析

Effects analysis of two domestic chemiluminescence systems for detecting HBsAg and HBeAg

目的探讨两种国产化学发光免疫分析系统用于检测乙型肝炎病毒表面抗原(HBsAg)和乙型肝炎病毒e抗原(HBeAg)的性能与主流进口检测系统的符合性,为国产系统的使用提供依据。方法用一种主流进口系统(美国雅培公司,ARCHITECT SYSTEM i2000SR,简称S1)分别检测HBsAg(n=492)和HBeAg(n=464)为阳性或阴性的标本,使用两种国产系统(迈克生物,Maccura i3000,简称S2;迈瑞生物,Mindray CL6000i,简称S3)对上述标本进行复测,并分析几种系统间定量和定性结果的符合性。结果(1)S2、S3分别与S1相比,对HBsAg的定性结果差异均有统计学意义(均P=0.012);S2、S3对HBsAg的定性结果与S1的定性总符合率均为97.76%、阳性符合率均为96.58%、阴性符合率均为99.50%,定性结果一致检验均为Kappa值=0.954(P<0.001);15例定性结果不符的标本,均来自S1 HBsAg<1.00 IU/mL的标本;于HBsAg各定量区间,S2和S3检测的HBsAg定量水平与S1的相对偏倚均在-50%左右。(2)S3检测HBeAg的定性结果与S1检测结果的总体符合率、阳性符合率、阴性符合率分别为96.77%、99.20%、93.93%,一致性检验为Kappa值=0.936(P<0.001);S2检测HBeAg的定性结果与S1检测结果的总体符合率、阳性符合率、阴性符合率分别为97.84%、98.40%、97.20%,Kappa值=0.957(P<0.001);S3检测HBeAg的定性结果与S1差异有统计学意义(P=0.007);S2检测HBeAg的定性结果与S1差异无统计学意义(P=0.754)。结论两种国产化学发光免疫分析系统检测HBsAg和HBeAg的结果与主流进口系统具有较高的一致性。

Objective To investigate the performance of two domestic chemiluminescence immunoassay systems for detecting hepatitis B virus surface antigen(HBsAg)and hpatitis B virus e antigen(HBeAg)and their coincidence to the mainstream imported detection system in order to provide the basis for the use of domestic system.Methods The mainstream imported system ARCHITECT SYSTEM i2000SR(S1)was used to detect the samples of HBsAg positive(n=492)or HBeAg negative(n=464),and the above samples were re-detected by two kinds of domestic systems[Maccura i3000(S2),Mindray CL6000I(S3)].The coincidence of quantitative and qualitative detection results by these kinds of systems were analyzed.Results(1)In the comparison between S2 and S3 with S1,the HBsAg qualitative detection results had statistically significant differences(all P=0.012);the total coincidence rate of HBsAg qualitative results between S2 and S3 with S1 was 97.76%,the positive coincidence rate was 96.58%,the negative coincidence rate was 99.50%,and the consistency test of qualitative results was Kappa value=0.954(P<0.001);the 15 samples of qualitative results non-conformance all were come from the samples of HBsAg<1.00 IU/mL;in each quantitative interval,the relative deviation between S2 and S3 with S1 was about-50%.(2)The overall coincidence rate,positive coincidence rate and negative coincidence rate of HBeAg qualitative results detected by S3 and S1 were 96.77%,99.20%and 93.93%respectively,and the consistency test was Kappa value=0.936(P<0.001);the overall coincidence rate,positive coincidence rate and negative coincidence rate of HBeAg qualitative results detected by S2 and S1 were 97.84%,98.40%and 97.20%respectively,Kappa value=0.957(P<0.001);the qualitative results of HBeAg detected by S3 and S1 were statistically significant difference(P=0.007);There was no statistically significant difference between the HBeAg qualitative results detected by S2 and S1(P=0.754).Conclusion The two domestic systems for the detection of HBsAg and HBeAg have higher coincidence to the mainstream imported one.