Evaluation of clinical usefulness of second-generation HCV core antigen assay: comparison with COBAS AMPLICOR HCV MONITOR assay version 2.0
Version of Record online: 3 OCT 2005
Volume 25, Issue 6, pages 1136–1141, December 2005
How to Cite
Yokosuka, O., Kawai, S., Suzuki, Y., Fukai, K., Imazeki, F., Kanda, T., Tada, M., Mikata, R., Hata, A. and Saisho, H. (2005), Evaluation of clinical usefulness of second-generation HCV core antigen assay: comparison with COBAS AMPLICOR HCV MONITOR assay version 2.0. Liver International, 25: 1136–1141. doi: 10.1111/j.1478-3231.2005.01185.x
- Issue online: 11 NOV 2005
- Version of Record online: 3 OCT 2005
- Received 25 January 2005, accepted 2 May 2005
- hepatitis C virus;
- polymerase chain reaction;
- viral load
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.