Yokosuka Osamu, Kawai Shigenobu, Suzuki Yoichi, Fukai Kenichi, Imazeki Fumio, Kanda Tatsuo, Tada Motohisa, Mikata Rintarou, Hata Akira, Saisho Hiromitsu
Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba University, Chiba, Japan.
Liver Int. 2005 Dec;25(6):1136-41. doi: 10.1111/j.1478-3231.2005.01185.x.
Hepatitis C virus (HCV) is an important etiologic agent for chronic liver diseases.
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).
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.
This new assay was considered to be useful in evaluating the HCV levels in patients with chronic hepatitis C.
丙型肝炎病毒（HCV）是慢性肝病的重要病因。
本研究旨在通过比较第二代HCV核心抗原检测结果与COBAS AMPLICOR HCV MONITOR 2.0版（COBAS v2.0）的结果，评估该检测方法的临床实用性。
该检测方法在149例1型血清型患者中的142例（95.3%）检测到HCV核心抗原（3821±322 fmol/l；平均值±标准差），在58例2型血清型患者中的56例（96.6%）检测到（2589±449 fmol/l），在6例1+2型血清型患者中的6例（100%）检测到（1240±548 fmol/l）。该检测方法测得的HCV核心抗原水平与COBAS v2.0测得的HCV RNA水平高度相关（r = 0.848，P < 0.0001）。关于干扰素单药治疗的结果，1型血清型持续和非持续病毒学应答者的治疗前HCV核心抗原水平分别为659±189和4904±376 fmol/l，2型血清型分别为1993±740和3145±519 fmol/l。通过受试者工作特征曲线分析，区分持续和非持续病毒学应答的HCV核心抗原水平的最佳准确性临界值，1型血清型为699 fmol/l，2型血清型为292 fmol/l。
这种新的检测方法被认为有助于评估慢性丙型肝炎患者的HCV水平。
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