Clinical Usefulness of HCV Core Antigen Assay for the Management of Patients with Chronic Hepatitis C

Abstract

Aim: The study aimed to evaluate the clinical utility of the chemiluminescent HCV core Ag test compared to viral load assessment in the management of patients with chronic hepatitis C.

Methods: A retrospective study was performed at a tertiary-care infectious diseases hospital on samples collected from anti-HCV positive patients. Seventy-six samples were tested with the Architect HCV core Antigen kit and Cobas AmpliPrep/Cobas Taqman HCV kit. The HCV Ag test accuracy was estimated using data from all the HCV RNA tested samples received between January 2011 and December 2012.

Results: The HCV Ag test showed a good correlation between the logarithmic values of HCV RNA and HCV Ag (R=0.98), with a 100% specificity and PPV, but with reduced sensitivity for viral loads lower than 1,000 UI/ mL. In a model using data from 2,478 HCV RNA tested samples and a cut-off of the Ag assay corresponding to 1,000 UI/mL HCV RNA, the Ag test would have a sensitivity of 82.4%, a NPV of 80.9% and a high specificity and PPV (100%) compared to the viral load. The sensitivity would be higher for baseline evaluation compared to on-treatment samples (98.5 vs. 50%). The highest NPV (98%) would be obtained at 48 and 72 weeks after the initiation of treatment, with a sensitivity of 88.2% and 96.1%, respectively.

Conclusion: The Architect HCV core Ag assay might be an alternative for the diagnosis of active HCV infection if molecular tests are not available, and a useful method for the evaluation of sustained virological response in treated patients.