Objective Among individuals with chronic hepatitis B, those with hepatitis B e-antigen (HBeAg)-negative chronic hepatitis (CHB) can be difficult to distinguish from those with HBeAg-negative chronic HBV infection, also referred to as inactive HBV carriers (ICs), but both require different medical management. The level of HBV surface antigen (HBsAg) has been proposed as a marker to discriminate between chronic infection and hepatitis stages. HBsAg consists of large, middle and small HBs. The aim of this study was to determine whether the composition of HBsAg improved the identification of ICs among HBsAg-positive subjects with different phases of HBV infections. Design HBV large surface proteins (LHBs) and HBV middle surface proteins (MHBs) were quantified in serum samples from 183 clinically well-characterised untreated patients with acute (n=14) HBV infection, ICs (n=44), CHBs (n=46), chronic HBeAg-positive phase (n=68) and hepatitis delta coinfection (n=11) using an ELISA, with well-defined monoclonal antibodies against the preS1 domain (LHBs) and the preS2-domain (MHBs). A Western blot analysis was used to verify the quantitation of the components of HBsAg. Total HBsAg was quantified using a modified commercially available assay (HBsAg V.6.0, Enzygnost, Siemens, Erlangen). Results The composition of HBsAg showed specific patterns across different phases of hepatitis B. Individuals in the IC phase had significantly lower proportions of LHBs and MHBs than patients in acute or chronic phases irrespective of their HBV e-antigen status (p<0.0001) or HBsAg level. Both LHBs and MHBs ratios better predicted the IC phase than total HBsAg levels. Conclusion Quantification of MHBs, particularly LHBs represents a novel tool for the identification of the IC stage.

中文翻译：

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乙型肝炎病毒表面抗原 (HBsAg) 大中蛋白的定量作为鉴定非活动性 HBV 携带者的新工具

目的在慢性乙型肝炎患者中，乙型肝炎e抗原（HBeAg）阴性慢性肝炎（CHB）患者与HBeAg阴性慢性HBV感染者（也称为非活动性HBV携带者（IC））难以区分，但两者都需要不同的医疗管理。HBV 表面抗原 (HBsAg) 水平已被提议作为区分慢性感染和肝炎阶段的标志物。HBsAg 由大、中、小 HBs 组成。本研究的目的是确定 HBsAg 的组成是否改善了 HBV 感染不同阶段的 HBsAg 阳性受试者的 IC 识别。设计的 HBV 大表面蛋白 (LHBs) 和 HBV 中间表面蛋白 (MHBs) 在来自 183 名临床充分表征的未经治疗的急性 (n=14) HBV 感染、ICs (n=44)、CHBs (n= 46)、慢性 HBeAg 阳性阶段 (n=68) 和乙型肝炎共感染 (n=11) 使用 ELISA，具有明确的针对 preS1 域 (LHBs) 和 preS2 域 (MHBs) 的单克隆抗体。使用蛋白质印迹分析来验证 HBsAg 成分的定量。使用改进的市售测定法（HBsAg V.6.0，Enzygnost，Siemens，Erlangen）定量总 HBsAg。结果 HBsAg 的组成在乙型肝炎的不同阶段表现出特定的模式。无论 HBV e 抗原状态 (p<0.0001) 或 HBsAg 水平如何，IC 期个体的 LHB 和 MHB 比例均显着低于急性或慢性期患者。LHBs 和 MHBs 比率都比总 HBsAg 水平更能预测 IC 阶段。结论 MHBs，尤其是 LHBs 的量化代表了一种用于识别 IC 阶段的新工具。