VALIDATION AND SENSITIVITY OF HCV CORE ANTIGEN IN PATIENT WITH HCV INFECTION IN DIAGNOSIS AND MONITORING POST DAA THERAPY

Abstract

There are 130–150 million people worldwide infected with chronic Hepatitis C Virus (HCV) and approximately 75% of all cases occur in low to middle income countries (LMICs). The development of direct acting antiviral therapy (DAAs) now allows for safe and effective curative treatment, but treatment is the final step in a long cascade of care that requires screening, confirmation, notification of results, and linkage to care. In clinical practice, serological detection of anti-HCV antibodies is usually used for diagnosis of HCV infection. However, most assays are not able to distinguish patients with an ongoing active infection from those who have spontaneously cleared the virus. Sometimes, there is a long seronegative interval throughout the course of HCV infection during which anti-HCV antibodies are undetectable. Immunosuppression may result in an insufficient antibody response as well. Therefore, anti-HCV assays still need additional confirmation Nucleic acid-based techniques for HCV RNA are currently used to confirm the diagnosis of HCV infection and to monitor the antiviral therapy because of their high specificity and sensitivity. However, the complexity and cost of such molecular diagnostics can constrain their use in low-resourced settings. Likewise, cheaper and simple diagnostic tools and follow-up algorithms are in urgent need to enhance the global efforts for HCV eradication by the year 2030 particularly in low- and middle-income countries Assays for the detection of the HCVcAg, a viral protein released into the plasma during viral assembly, have been developed as a more stable, affordable, alternative to HCV nucleic acid tests. Several