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

Abstract EN

Background/Aim : 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.

Patients & Methods : samples were collected from 30 anti-HCV antibody negative healthy subjects (Gl, and 46 anti-HCV antibody positive patients (G2.

All included samples were subjected to HCV core antigen and HCV-RNA PCR.

Results : 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 n 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.

Conclusion : 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.