Mizuochi Toshiaki, Okada Yoshiaki, Umemori Kiyoko, Mizusawa Saeko, Sato Shinichiro, Yamaguchi Kazunari
Department of Research on Blood and Biological Products, National Institute of Infectious Diseases, Tokyo 208-0011, Japan.
Jpn J Infect Dis. 2005 Apr;58(2):83-7.
Hepatitis B virus (HBV) surface antigen (HBsAg) is one of the most important serological markers of current HBV infection. However, there are significant antigenic variations of HBsAg caused by genotypic diversity as well as mutation of the HBV genome. It is predictable that amino acid substitutions occurring in the HBsAg "a" determinant of a particular HBV genotype will affect the sensitivity of some diagnostic kits, since all the diagnostic kits currently available utilize monoclonal and/or polyclonal antibodies against the "a" determinant. One possible concern is that there may be a significant variation in the sensitivity of HBsAg diagnostic kits to HBsAg encoded by HBV of different genotypes, which might result in a failure to detect HBsAg of a particular HBV genotype. In this study, we assessed the reactivity of HBsAg specimens derived from three different HBV genotypes (A, B, and C) that are prevalent in Japan by 10 commercially available EIA (enzyme immunoassay), CLIA (chemiluminescent immunoassay), and CLEIA (chemiluminescent enzyme immunoassay) diagnostic kits. Specimens included both clinical samples and recombinant HBsAg. Our results showed that all the diagnostic kits evaluated were able to detect HBsAg irrespective of HBV genotypes. At the same time, it is apparent that some, but not all of the kits showed clear differences in sensitivity to the three HBV genotypes.
乙肝病毒（HBV）表面抗原（HBsAg）是当前HBV感染最重要的血清学标志物之一。然而，由于基因型多样性以及HBV基因组的突变，HBsAg存在显著的抗原变异。可以预见，特定HBV基因型的HBsAg“a”决定簇中发生的氨基酸替换会影响某些诊断试剂盒的灵敏度，因为目前所有可用的诊断试剂盒都使用针对“a”决定簇的单克隆和/或多克隆抗体。一个可能令人担忧的问题是，HBsAg诊断试剂盒对不同基因型HBV编码的HBsAg的灵敏度可能存在显著差异，这可能导致无法检测到特定HBV基因型的HBsAg。在本研究中，我们通过10种市售的酶免疫分析（EIA）、化学发光免疫分析（CLIA）和化学发光酶免疫分析（CLEIA）诊断试剂盒，评估了源自日本流行的三种不同HBV基因型（A、B和C）的HBsAg标本的反应性。标本包括临床样本和重组HBsAg。我们的结果表明，所有评估的诊断试剂盒都能够检测HBsAg，而与HBV基因型无关。同时，很明显，部分（但不是全部）试剂盒对三种HBV基因型的灵敏度存在明显差异。
