Kim Hyunjung, Oh Eun-Jee, Kang Mi-Sook, Kim Sung Hoon, Park Yeon-Joon
Department of Laboratory Medicine, The Catholic University of Korea, Kangnam St Mary's Hospital, 505 Banpo-Dong, Seocho-Ku, Seoul, South Korea.
Ann Clin Lab Sci. 2007 Summer;37(3):256-9.
Serum hepatitis B virus (HBV) markers are the most important data for epidemiological screening and clinical diagnosis of HBV infection, especially in endemic areas. We compared the results of the Roche Modular Analytics E170 assay, the Abbott Architect i2000 assay, and an immunoradiometric assay (IRMA) for HBV surface antigen (HBsAg), anti-HBV surface antigen (anti-HBs), HBV e antigen (HBeAg), and anti-HBV e antigen (anti-HBe). A number of serum samples (264, 263, 224, and 202 for HBsAg, anti-HBs, HBeAg, and anti-HBe, respectively) were studied. For samples giving discrepant results for HBeAg between methods, real-time PCR assays were performed. The concordance rates among the three methods were high for HBsAg (100%) and HBeAg (94.6), but low for anti-HBs (91.6%) and anti-HBe (82.2%). For anti-HBs, which could be measured quantitatively by the Modular E170 and Architect i2000 procedures, discrepant results were observed at low levels of anti-HBs. For anti-HBe, the positive rate was highest with Modular E170 (60.9%) followed by the IRMA kit (54.1%) and Architect i2000 (51.0%). This study shows substantial differences between the assay results by the three methods, which should be taken into account in determinations of serum HBV markers.
血清乙肝病毒（HBV）标志物是乙肝病毒感染流行病学筛查和临床诊断的最重要数据，尤其是在乙肝流行地区。我们比较了罗氏Modular Analytics E170检测法、雅培Architect i2000检测法和免疫放射分析（IRMA）法检测乙肝表面抗原（HBsAg）、抗乙肝表面抗原（抗-HBs）、乙肝e抗原（HBeAg）和抗乙肝e抗原（抗-HBe）的结果。研究了一定数量的血清样本（分别针对HBsAg、抗-HBs、HBeAg和抗-HBe的样本数为264、263、224和202）。对于不同方法检测HBeAg结果存在差异的样本，进行了实时PCR检测。三种方法对HBsAg（100%）和HBeAg（94.6%）的一致性率较高，但对抗-HBs（91.6%）和抗-HBe（82.2%）的一致性率较低。对于可通过Modular E170和Architect i2000程序进行定量检测的抗-HBs，在抗-HBs低水平时观察到结果存在差异。对于抗-HBe，Modular E170的阳性率最高（60.9%），其次是IRMA试剂盒（54.1%）和Architect i2000（51.0%）。本研究表明这三种方法的检测结果存在显著差异，在血清HBV标志物检测中应予以考虑。
