Abstract

We previously developed a technique that uses the anti-HBs monoclonal antibody panel (MAbs) to determine the major variants of hepatitis B virus (HBV) genotypes and surface antigen (HBsAg) subtypes circulating in the Russian Federation: D/ayw2, D/ayw3, A/adw2, C/adrq+. To identify HBV genotypes and HBsAg subtypes in HBsAg-positive blood-serum samples of patients with chronic HBV infection in three Russian regions using the designed reagents; to compare the obtained data with the results obtained by the molecular biological methods of HBV genotype and HBsAg subtype identification and to combine them with the results of the previous tests. The comparative study included 127 HBsAg-positive serum samples of patients with chronic HBV infection from Barnaul, Krasnodar, and Blagoveshchensk collected in 2017–2019. HBV genotypes and HBsAg subtypes were determined in ELISA (enzyme immunoassay) using the designed reagents and by molecular-biology methods (DNA sequence analysis of detected HBV isolates). Among the 127 HBsAg-positive samples in which HBV genotypes/HBsAg subtypes were identified using the designed reagents, the results were distributed as follows: 65 (51.6%) D/ayw2, 47 (36.5%) D/ayw3, 14 (11.1%) A/adw2, and 1 (0.8%) C/adrq+. For the 98 samples studied by both methods, HBV genotypes matched in 100% (98/98) of cases and HBsAg subtypes matched in 92% (90/98) of cases. Using the designed reagents, HBV genotypes and HBsAg subtypes in the HBsAg-positive blood-serum samples of patients with chronic HBV infection in three Russian regions were determined. The new results of comparative studies of the reagents designed by us to determine HBV genotypes and HBsAg subtypes in HBsAg-positive blood-serum samples were combined with our previously published data.

中文翻译：

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用于乙型肝炎病毒基因型和 HBsAg 亚型鉴定的单克隆抗体组合：从俄罗斯三个地区的血清样本中获得的结果

摘要

我们之前开发了一种技术，使用抗 HBs 单克隆抗体组 (MAbs) 来确定俄罗斯联邦流行的乙型肝炎病毒 (HBV) 基因型和表面抗原 (HBsAg) 亚型的主要变异：D/ayw2、D/ayw3 、A/adw2、C/adrq+。使用设计的试剂鉴定俄罗斯三个地区慢性乙型肝炎病毒感染者的HBsAg阳性血清样本中的HBV基因型和HBsAg亚型；将获得的数据与HBV基因型和HBsAg亚型鉴定的分子生物学方法获得的结果进行比较，并与前期检测结果相结合。该对比研究包括 2017-2019 年从巴尔瑙尔、克拉斯诺达尔和布拉戈维申斯克收集的 127 份慢性 HBV 感染患者的 HBsAg 阳性血清样本。使用设计的试剂和分子生物学方法（对检测到的 HBV 分离株进行 DNA 序列分析），通过 ELISA（酶免疫分析）确定 HBV 基因型和 HBsAg 亚型。使用设计的试剂对127份HBsAg阳性样本进行HBV基因型/HBsAg亚型鉴定，结果分布如下：D/ayw2 65份（51.6%）、D/ayw3 47份（36.5%）、D/ayw3 14份（11.1%） ) A/adw2 和 1 (0.8%) C/adrq+。对于通过这两种方法研究的 98 个样本，100% (98/98) 的病例 HBV 基因型匹配，92% (90/98) 的病例 HBsAg 亚型匹配。利用设计的试剂，对俄罗斯三个地区慢性乙型肝炎病毒感染者的HBsAg阳性血清样本中的HBV基因型和HBsAg亚型进行了测定。