Clinical utility of total HCV core antigen quantification: A new indirect marker of HCV replication

Magali Bouvier-Alias, Keyur Patel, Harel Dahari, Stéphanie Beaucourt, Patrick Larderie, Lawrence Blatt, Christophe Hezode, Gaston Picchio, Daniel Dhumeaux, Avidan U. Neumann, John G. McHutchison, Jean Michel Pawlotsky

Research output: Contribution to journalArticlepeer-review

188 Scopus citations


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.

Original languageEnglish
Pages (from-to)211-218
Number of pages8
Issue number1
StatePublished - Jul 2002


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