Stéphane Chevaliez1, Alexandre Soulier2, Lila Poiteau2, Magali Bouvier-Alias2, Jean-Michel Pawlotsky2. 1. National Reference Center for Viral Hepatitis B, C and Delta, Department of Virology, Hôpital Henri Mondor, Université Paris-Est, Créteil, France; INSERM U955, Créteil, France. Electronic address: stephane.chevaliez@hmn.aphp.fr. 2. National Reference Center for Viral Hepatitis B, C and Delta, Department of Virology, Hôpital Henri Mondor, Université Paris-Est, Créteil, France; INSERM U955, Créteil, France.
Abstract
BACKGROUND: Hepatitis C virus (HCV) core antigen has been proposed as a surrogate marker of HCV replication. HCV core antigen detection and quantification can thus theoretically be used instead of nucleic acid testing (NAT) to diagnose infection and manage antiviral therapy, with several advantages compared to HCV RNA assays. HCV core antigen can now be easily detected and quantified by means of a chemiluminescent microparticle immunoassay on the Abbott Architect device. OBJECTIVE: The aim of the present study was to evaluate the clinical performance of the Architect HCV Ag assay for the detection and quantification of HCV core antigen in patients with chronic HCV genotype 1-6 infections. RESULTS: The Architect HCV Ag assay had a specificity of 100% (95%CI: 97.8-100%). HCV core antigen levels were not influenced by the HCV genotype. The lower limit of detection of 3fmol/L corresponded to approximately 1000IU/mL of HCV RNA, regardless of the real-time PCR assay used. HCV core antigen and HCV RNA levels correlated for HCV genotype 1-4 (r=0.89 and r=0.88 for the m2000 and the CAP/CTM v2.0 assay, respectively). CONCLUSIONS: The Architect HCV Ag assay is highly specific and easy to perform. It represents a valuable screening, diagnostic and monitoring tool, especially in the era of new all-oral, interferon-free antiviral strategies that do not require high analytical sensitivity.
BACKGROUND:Hepatitis C virus (HCV) core antigen has been proposed as a surrogate marker of HCV replication. HCV core antigen detection and quantification can thus theoretically be used instead of nucleic acid testing (NAT) to diagnose infection and manage antiviral therapy, with several advantages compared to HCV RNA assays. HCV core antigen can now be easily detected and quantified by means of a chemiluminescent microparticle immunoassay on the Abbott Architect device. OBJECTIVE: The aim of the present study was to evaluate the clinical performance of the Architect HCV Ag assay for the detection and quantification of HCV core antigen in patients with chronic HCV genotype 1-6 infections. RESULTS: The Architect HCV Ag assay had a specificity of 100% (95%CI: 97.8-100%). HCV core antigen levels were not influenced by the HCV genotype. The lower limit of detection of 3fmol/L corresponded to approximately 1000IU/mL of HCV RNA, regardless of the real-time PCR assay used. HCV core antigen and HCV RNA levels correlated for HCV genotype 1-4 (r=0.89 and r=0.88 for the m2000 and the CAP/CTM v2.0 assay, respectively). CONCLUSIONS: The Architect HCV Ag assay is highly specific and easy to perform. It represents a valuable screening, diagnostic and monitoring tool, especially in the era of new all-oral, interferon-free antiviral strategies that do not require high analytical sensitivity.
Authors: J Morgan Freiman; Trang M Tran; Samuel G Schumacher; Laura F White; Stefano Ongarello; Jennifer Cohn; Philippa J Easterbrook; Benjamin P Linas; Claudia M Denkinger Journal: Ann Intern Med Date: 2016-06-21 Impact factor: 25.391
Authors: Linh Thuy Nguyen; Linda Dunford; Ines Freitas; Paul Holder; Lan Anh Nguyen; Joanne O'Gorman; Jeff Connell; Michael Carr; William Hall; Cillian De Gascun Journal: J Clin Microbiol Date: 2015-05-20 Impact factor: 5.948