Xiong H Y, Luo Y F, Liu H Y, Han W H, Hu A Q, Wang Y, Zheng Y J
Anqing City Hospital, Anqing 246003, China, Department of Hygienic Microbiology, School of Public Health; Anqing City Hospital, Anqing 246003, China, Key Laboratory for Health Technology Assessment, National Commission of Health and Family Planning; Anqing City Hospital, Anqing 246003, China, Key Laboratory for Public Health Safety, Ministry of Education-School of Public Health.
Anqing City Hospital, Anqing 246003, China, Department of Hygienic Microbiology, School of Public Health; Anqing City Hospital, Anqing 246003, China, Key Laboratory for Public Health Safety, Ministry of Education-School of Public Health.
Zhonghua Liu Xing Bing Xue Za Zhi. 2017 Nov 10;38(11):1537-1540. doi: 10.3760/cma.j.issn.0254-6450.2017.11.020.
To evaluate and compare the detection consistency of hepatitis B surface antigen (HBsAg) by two immunoassays: enzyme-linked immunosorbent assay (ELISA) and electrochemiluminescent immunoassay (ECLIA). A prospective study was conducted among 2 296 pregnant women recruited consecutively from January 1, 2014 to January 31, 2015 in a hospital. Blood samples were collected from them for the detection of HBsAg by using ELISA and ECLIA, test was performed on the results. Nested polymerase chain reaction and sequencing of HBV S gene were also performed in all samples. Phylogenetic analysis was performed using Mega 6.0 software. The two methods had high detection consistence of HBsAg (=0.71). There were significant differences in detection result of B genotype and adw2 serotype HBV strains between two methods. Among 123 identified HBV strains, 113 belonged to genotype B and available for further analysis. The difference in detection of substitution rates between two methods or different positive groups were not significant. Compared with ELISA single positive group, the ECLIA single positive group had completely different substitution sites. The two methods had high detection consistence of HBsAg, but there were still 32.4% HBV DNA positive cases in ELISA/ECLIA single positive group, and complete complementary substitution sites between ELISA single positive group and ECLIA single positive group. Our results suggested that more effective detection procedure should be considered for the possible impact of the HBV silent transmission and infection.
评估并比较两种免疫测定法检测乙型肝炎表面抗原（HBsAg）的一致性：酶联免疫吸附测定法（ELISA）和电化学发光免疫测定法（ECLIA）。对2014年1月1日至2015年1月31日在一家医院连续招募的2296名孕妇进行了一项前瞻性研究。采集她们的血样，分别采用ELISA和ECLIA检测HBsAg，并对结果进行检验。对所有样本还进行了巢式聚合酶链反应和HBV S基因测序。使用Mega 6.0软件进行系统发育分析。两种方法对HBsAg的检测一致性较高（κ=0.71）。两种方法对B基因型和adw2血清型HBV毒株的检测结果存在显著差异。在123株鉴定出的HBV毒株中，113株属于B基因型，可供进一步分析。两种方法或不同阳性组之间在替代率检测方面的差异不显著。与ELISA单阳性组相比，ECLIA单阳性组有完全不同的替代位点。两种方法对HBsAg的检测一致性较高，但ELISA/ECLIA单阳性组中仍有32.4%的HBV DNA阳性病例，且ELISA单阳性组与ECLIA单阳性组之间存在完全互补的替代位点。我们的结果表明，鉴于HBV隐匿传播和感染的可能影响，应考虑采用更有效的检测程序。
