Bouvier-Alias Magali, Patel Keyur, Dahari Harel, Beaucourt Stéphanie, Larderie Patrick, Blatt Lawrence, Hezode Christophe, Picchio Gaston, Dhumeaux Daniel, Neumann Avidan U, McHutchison John G, Pawlotsky Jean-Michel
Department of Virology (EA 3489), Hôpital Henri Mondor, Université Paris XII, 51 avenue du Maréchal de Lattre de Tassigny, 94010 Créteil, France.
Hepatology. 2002 Jul;36(1):211-8. doi: 10.1053/jhep.2002.34130.
Hepatitis C virus (HCV) RNA detection, viral load quantification, and HCV genotyping are widely used in clinical practice. Recently, the availability of an anticore antigen (Ag) monoclonal antibody allowed development of an enzyme-linked immunosorbent assay (ELISA) detecting and quantifying total HCV core Ag in peripheral blood of HCV-infected patients. The aims of the present study were to investigate the biologic significance of this new marker in HCV infection, to establish the intrinsic performance of the current assay, and to determine its potential utility in the management of HCV-infected patients. A panel of infected sera calibrated to the World Health Organization International Standard and 657 serum samples from infected patients receiving antiviral treatment were studied. We showed that total HCV core Ag quantification is an accurate, precise, and specific indirect marker of HCV replication. We estimated that 1 pg/mL of total HCV core Ag is equivalent to approximately 8,000 HCV RNA international units (IU)/mL, although minor between-patient differences may exist. In conclusion, total HCV core Ag quantification can be used in the various indications of viral load monitoring, including the evaluation of baseline viral load before therapy, the assessment of the virologic response to antiviral treatment, and the study of early viral kinetics during therapy. Nevertheless, the total HCV core Ag assay cannot be used as a marker of viral replication for HCV RNA values below 20,000 IU/mL, limiting its use in the monitoring of late events during and after antiviral treatment.
丙型肝炎病毒（HCV）RNA检测、病毒载量定量及HCV基因分型在临床实践中被广泛应用。最近，一种抗核心抗原（Ag）单克隆抗体的出现使得能够开发出一种酶联免疫吸附测定法（ELISA），用于检测和定量HCV感染患者外周血中的总HCV核心抗原。本研究的目的是探讨这一新标志物在HCV感染中的生物学意义，确定当前检测方法的内在性能，并确定其在HCV感染患者管理中的潜在效用。研究了一组校准至世界卫生组织国际标准的感染血清以及657例接受抗病毒治疗的感染患者的血清样本。我们发现，总HCV核心抗原定量是HCV复制的一种准确、精确且特异的间接标志物。我们估计，1 pg/mL的总HCV核心抗原约相当于8000 HCV RNA国际单位（IU）/mL，尽管患者之间可能存在微小差异。总之，总HCV核心抗原定量可用于病毒载量监测的各种指征，包括治疗前基线病毒载量的评估、抗病毒治疗病毒学应答的评估以及治疗期间早期病毒动力学的研究。然而，对于HCV RNA值低于20000 IU/mL的情况，总HCV核心抗原检测不能用作病毒复制的标志物，这限制了其在抗病毒治疗期间及之后晚期事件监测中的应用。
