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Evaluation of clinical usefulness of second-generation HCV core antigen assay: comparison with COBAS AMPLICOR HCV MONITOR assay version 2.0


Osamu Yokosuka, MD, Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan.
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Abstract: Background: Hepatitis C virus (HCV) is an important etiologic agent for chronic liver diseases.

Methods: The aim of this study was to evaluate the clinical usefulness of second-generation HCV core antigen assay by comparing the results of the assay with those of the COBAS AMPLICOR HCV MONITOR version 2.0 (COBAS v2.0).

Results: HCV core antigen was detectable by this assay in 142/149 (95.3%) of serotype 1 (3821±322 fmol/l; mean±SD), in 56/58 (96.6%) of serotype 2 (2589±449 fmol/l), and in 6/6 (100%) of serotypes 1+2 (1240±548 fmol/l). The HCV core antigen levels measured by this assay correlated well with the HCV RNA levels by COBAS v2.0 (r=0.848, P<0.0001). In relation to the outcome of interferon monotherapy, the pretreatment HCV core antigen levels of sustained and non-sustained virological responders were 659±189 and 4904±376 fmol/l in serotype 1, 1993±740 and 3145±519 fmol/l in serotype 2. The cutoff values with the best accuracy for HCV core Ag levels to discriminate between sustained and non-sustained virological response were 699 fmol/l for serotype 1 and 292 fmol/l for serotype 2, respectively, by receiver operating characteristic curve analysis.

Conclusion: This new assay was considered to be useful in evaluating the HCV levels in patients with chronic hepatitis C.

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