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 EN

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 RT-PCR, which considered as a golden standard test.

In this study, we compared the HCV core antigen test with the HCV RNA assay for confirming anti-HCV results to determine whether the HCV core antigen test may be used as an alternative confirmatory test to the HCV RNA test and to assess the diagnostic values of the total HCV core antigen test by determining the diagnostic specificity and sensitivity rates compared with the HCV RNA test.

Sera from 100 patients were analyzed for anti-HCV and HCV core antigen both with the ELISA and with the molecular HCV RNA assay consisting of a real time-PCR method as a confirmatory test.

The diagnostic sensitivity, specificity, and positive and negative predictive values of the HCV core antigen assay compared to the HCV RNA test were 76.1%, 86.2%, 80%, and 82.5%, respectively.

The HCV core antigen 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 core antigen detection assay is significantly lower than that of PCR-based methods.