Moving ahead in HCV diagnostics: Need for the introduction of HCV core antigen assay in low and middle-income countries

Abstract

Hepatitis C virus (HCV) infections are associated with significant morbidity and mortality globally. The diagnosis of HCV is primarily based on indirect serological assays such as enzyme-linked immunosorbent assay (ELISA), chemiluminescence immunoassay (CIA), and rapid diagnostic tests to detect HCV antibodies. Direct tests detect/quantify components of HCV virions, such as HCV ribonucleic acid (RNA) (nucleic acid test or nucleic acid amplification test [NAT]) and HCV core antigen (HCVcAg). The HCVcAg assay (CIA, Abbott ARCHITECT) is an immune assay used for the quantitative determination of the HCVcAg. This test is simple and fast with the potential to be incorporated into diagnostic guidelines and be used in combination with anti-HCV (CIA) as an effective screening test. HCVcAg can also be used as a potential biomarker for treatment initiation and monitoring patients to assess the treatment response. Apart from this, the scope for implementation of the HCVcAg assay in resource limited setting lies in screening of immune compromised patients where anti-HCV serology is not dependable. However, concerns related to lower sensitivity compared to HCV RNA do exist. Nevertheless, the HCVcAg assay can make a significant difference in the measures taken for the control and eradication of hepatitis C and its complications in India.