Evaluation Of An Enzyme Immunoassay For Hepatitis C Virus Core Antigen As A Diagnostic Test For Detection Of Hepatitis C Virus Infection In Comparison To Real-Time RT-PCR

Abstract

Key words:HCV, ELISA, real-time RT-PCR, HCV core antigen Hepatitis C virus (HCV) is a global public health care problem. Diagnosis of HCV infection was mainly based on the detection of anti-HCV antibodies as a screening test with serum samples and detection of HCV RNA by using real-time RT-PCR, which considered as a golden standard test. In this study, we compared the HCV core antigen (HCV cAg) test with the HCV RNA assay for confirming anti-HCV results to determine whether the HCV cAg test may be used as an alternative confirmatory test to the HCV RNA test and to assess its diagnostic values by determining the specificity and sensitivity rates compared to the realtime RT-PCR test. Sera samples from 100 persons were analyzed by ELISA for anti-HCV and HCV core antigen and with the molecular HCV RNA assay as a confirmatory test. The diagnostic sensitivity, specificity, positive and negative predictive values of the HCV cAg assay compared to the HCV RNA test were 76.1%, 86.2%, 80%, and 82.5%, respectively. The HCV cAg levels showed a poor correlation with those from the HCV RNA quantification (r = 0.321, p= 0.079). In conclusion, the core antigen detection test can be more valuable in HCV diagnosis than anti-HCV antibodies but it cannot replace HCV RNA in confirmation of the diagnosis of HCV because the sensitivity of the HCV cAg detection assay is significantly lower than that of real-time RT-PCR based methods