三种自动化免疫分析系统测定HBV血清标志物结果比较

目的　探讨不同的自动化免疫分析系统检测乙肝病毒血清标志物结果的一致性。方法　采用AxSYM、Elecsys 2 0 1 0和ARCHITECTi2 0 0 0三种自动化免疫分析系统分别对 1 2 0例随机选择的住院患者血清标本进行乙肝表面抗原 (HBsAg)及其抗体 (抗 HBs)、乙肝核心抗体 (抗 HBc)、乙肝e抗原 (HBeAg)及其抗体 (抗 HBe)等五项血清标志物测定 ,并以AxSYM结果为参照 ,计算三种方法所获结果的符合率。结果　对 1 2 0例随机血清标本 ,Elecsys 2 0 1 0与AxSYM比较测定结果符合率分别为HBsAg 99.2 %、抗 HBs 85 .8%、抗 HBc 87.5 %、HBeAg 99.2 %、抗 HBe 90 .0 % ;ARCHITECTi2 0 0 0与AxSYM比较测定结果符合率分别为HBsAg 1 0 0 % ,抗 HBs96 .7%、抗 HBc 91 .7%、HBeAg1 0 0 %以及抗 HBe95 8%。Elecsys 2 0 1 0与AxSYM测定抗 HBs的相关系数r =0 .90 ,ARCHITECTi2 0 0 0与AxSYMr =0 .98。Elecsys 2 0 1 0与AxSYM测定HBV五项标志物模式符合率为 6 5 .8% ,ARCHITECTi2 0 0 0与AxSYM测定五项标志物模式符合率为 85 .0 %。结论　三种方法测定HBV结果有一定差异 ,主要存在于三项抗体标志物以及低浓度抗原标志物的测定 ,有待进一步标准化

Comparison of the results by three automatic immunoassay for determination of HBV markers in serum

Objective To discuss the agreement of three automatic immunoassay systems for determining HBV markers in serum. Methods A total of 120 serum samples were collected randomly from hospitalized patients determined for five HBV markers including HBsAg, Anti HBs, Anti HBc, HBeAg and Anti HBe by AxSYM, Elecsys 2010 and ARCHITECT i2000,respectively .The concordance rates by Elecsys 2010 and ARCHITECT i2000 were calculated and compared with that by AxSYM.Results The concordance rates (%) by Elecsys 2010 with AxSYM was 99.2% for HBsAg, 85.8% for Anti HBs, 87.5% for Anti HBc, 99.2% for HBeAg and 90.0% for Anti HBe, respectively,and the concordance rate by ARCHITECT i2000 with AxSYM was 100% for HBsAg, 96.7% for Anti HBs,91 7% for Anti HBc, 100% for HBeAg and 95.8% for Anti HBe, respectively.The correlation coefficient (r) of Elecsys 2010 with AxSYM was 0.90 for Anti HBs, lower than that of ARCHITECT i2000 with AxSYM( r =0.98).The concordance rate by Elecsys 2010 for the five HBV markers was 65.8% and that of ARCHITECT i2000 was 85.0%.Conclusion There were some discrepant results among three automated immunoassay systems for determining HBV markers in serum,mostly in HBV specific antibodies and low level antigens.The determining methods should be standardized furtherly.