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Clin Chem Lab Med. 2018 May 24;56(6):880-888. doi: 10.1515/cclm-2017-0754.

HCV core antigen comes of age: a new opportunity for the diagnosis of hepatitis C virus infection.

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Associate Director, Medical Scientific Liaison Europe, Abbott Diagnostics, Viale Giorgio Ribotta 9, 00144 Rome, Italy.
International Health Economics and Outcomes Research, Medical Affairs, Abbott Diagnostics, Wiesbaden, Germany.
Department of Laboratory Medicine, University-Hospital of Padova, Padova, Italy.


The diagnosis of hepatitis C virus (HCV) infection has been traditionally based on the detection of the host antibody response. Although antibody assays are available in different formats and are fairly accurate, they cannot distinguish between an ongoing infection with HCV replicative activity and a past infection where HCV has been cleared, spontaneously or after a successful therapy. As a chronic infection is mostly asymptomatic until the late clinical stages, there is a compelling need to detect active HCV infection by simple and reproducible methods. On this purpose, the clinical guidelines have suggested to search for the HCV ribonucleic acid (HCV-RNA) after anti-HCV has been detected, but this second step carries several limitations especially for population screening. The availability of fast and automated serological assays for the hepatitis C core antigen (HCVAg) has prompted an update of the guidelines that now encompass the use of HCVAg as a practical alternative to HCV-RNA, both for screening and monitoring purposes. In this paper, we summarize the features, benefits and limitations of HCVAg testing and provide an updated compendium of the evidences on its clinical utility and on the indications for use.


HCV core antigen assay; diagnosis; hepatitis C virus; viral infection

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