Evaluation of the HCV core antigen assay as a second-line supplemental test for diagnosis of active hepatitis c infection

ABSTRACT

Hepatitis C virus core [HCV] antigen assays have been produced to exclude infectious donations collected the preseroconversion window phase. For the same purpose, we evaluated the specificity and sensitivity of a novel hepatitis C virus core antigen detection immunoassay and the applications of this assay in clinical diagnosis. Samples were collected from 30 anti-HCV antibody negative healthy subjects [Gi], and 46 anti-HCV antibody positive patients [G2]. All included samples were subjected to HCV core antigen and HCV-RNA PCR. Among the 46 anti-HCV Ab positive samples, HCV core antigen was positive in 38 samples from 40 samples positive for HCV-RNA with sensitivity of 95% [38/40]. All the 30 anti-HCV Ab negative samples [n=30] were negative for both HCV core antigen and HCV-RNA with specificity of 100% .There was no significant variation in the sensitivity of HCV core antigen between genotype 1 [100%] and genotype 4 [94.5%]. Viral load in HCV core antigen positive samples [906653 +/- 133803] was significantly increased than that of HCV core antigen negative samples [16342 +/- 5245] with P value<0.05. HCV core antigen assay is a useful method in screening strategy of HCV infection and provides a reliable means of distinguishing between current and cleared HCV infections that is well correlated with HCV-RNA testing