Fundamental evaluation of HCV core antigen method comparison with Cobas Amplicor HCV monitor v2.0 (high range method)

: Quantitative measurement of hepatitis C virus (HCV) has been performed by PCR method. However, PCR method has problems such as a special instrument, a complicated manual skill and a high cost. Recently, simple and highly sensitive HCV core antigen (Ag) method has been developed. We performed fundamental evaluation of HCV core Ag method, and compared HCV core Ag method with HCV PCR high-range method. The intra-assay and inter-assay variation coefficients for HCV core Ag were calculated to be within the ranges of 1.0-11.3% and 0.8-9.3%, respectively. The test of dilution linearity revealed the unstableness in the vicinity of a cut-off level of 50 fmol/L. Based on the result of the high-range method; sensitivity, specificity, positive predictive value, negative predictive value, and agreement rate were 97.0%, 100%, 100%, 82.0%, and 96.5%, respectively. The correlation between the HCV core Ag method and the high-range method was r = 0.87. Cost per sample and time from sample preparation to final report for HCV core Ag were cheaper and shorter than those of HCV PCR method, respectively. We consider that the HCV core Ag method seems to be useful as the quantitative measurement of HCV with respect to rapidness, easiness and low cost.