Chen Yu, Wu Wei, Li Lan-juan, Lou Bin, Zhang Jie, Fan Jian
Department of Infectious Disease, First Hospital of Zhejiang University, Key Laboratory of Infectious Disease of Health Ministry of China, 79 Qingchun Road, Zhejiang, Hangzhou, 310003, China.
Clin Chim Acta. 2006 Oct;372(1-2):129-33. doi: 10.1016/j.cca.2006.03.032. Epub 2006 May 19.
Automated immunoassay analyzers are used to identify hepatitis B virus (HBV) serum markers. In regions with high prevalence of HBV, it is imperative to compare test results from different immunoassay analyzers.
Samples from 496 subjects were collected and HBV markers were determined (double-blind, parallel manner) using Abbott AxSYM, Roche Modular Analytics E170, and Abbott Architect i2000).
Concurrence between AxSYM and E170 was 97.78% for HBsAg, 91.13% for anti-HBs, 98.79% for anti-HBc, 98.39% for HBeAg, and 88.91% for anti-HBe. Positive rates of anti-HBs and anti-HBe from AxSYM were lower than E170 (P<0.01). Concurrence between AxSYM and Architect i2000 was 98.79% for HBsAg, 91.33% for anti-HBs, 95.97% for anti-HBc, 98.39% for HBeAg, and 95.77% for anti-HBe. Positive anti-HBs rates from AxSYM were lower than Architect i2000 (P<0.01). Concurrence between E170 and Architect i2000 was 97.38% for HBsAg, 94.15% for anti-HBs, 95.56% for anti-HBc, 99.60% for HBeAg, and 88.10% for anti-HBe. Positive anti-HBe rates using Architect i2000 were lower than E170 (P<0.01). Overall, the greatest differences were observed in samples with low-level serum HBV markers.
Significant discrepancies were observed among results for the 3 automated immunoassay analyzers, especially for low-level anti-HBs and anti-HBe results.
自动免疫分析仪器用于鉴定乙型肝炎病毒（HBV）血清标志物。在HBV高流行地区，比较不同免疫分析仪器的检测结果很有必要。
收集496名受试者的样本，并使用雅培AxSYM、罗氏Modular Analytics E170和雅培Architect i2000（双盲、平行方式）检测HBV标志物。
AxSYM与E170之间，HBsAg的一致性为97.78%，抗-HBs为91.13%，抗-HBc为98.79%，HBeAg为98.39%，抗-HBe为88.91%。AxSYM的抗-HBs和抗-HBe阳性率低于E170（P<0.01）。AxSYM与Architect i2000之间，HBsAg的一致性为98.79%，抗-HBs为91.33%，抗-HBc为95.97%，HBeAg为98.39%，抗-HBe为95.77%。AxSYM的抗-HBs阳性率低于Architect i2000（P<0.01）。E170与Architect i2000之间，HBsAg的一致性为97.38%，抗-HBs为94.15%，抗-HBc为95.56%，HBeAg为99.60%，抗-HBe为88.10%。使用Architect i2000的抗-HBe阳性率低于E170（P<0.01）。总体而言，在血清HBV标志物水平较低的样本中观察到的差异最大。
在这3种自动免疫分析仪器的检测结果中观察到显著差异，尤其是低水平抗-HBs和抗-HBe的结果。
