Dynamic range of hepatitis C virus RNA quantification with the cobas ampliprep-cobas amplicor HCV monitor v2.0 assay
Dynamic range of hepatitis C virus RNA quantification with the cobas ampliprep-cobas amplicor HCV monitor v2.0 assay
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DOI：
10.1128/jcm.43.4.1669-1673.2005
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发表时间：
2005-04-01
影响因子：
9.4
通讯作者：
Pawlotsky, JM
中科院分区：
文献类型：
--
作者：
Gourlain, K;Soulier, A;Pawlotsky, JM
在临床实践中，需要准确定量丙型肝炎病毒（HCV）RNA，以决定是否继续或停止聚乙二醇干扰素-α-利巴韦林联合治疗慢性丙型肝炎患者治疗12周。目前，全世界最广泛使用的HCV RNA定量测定是Amplicor HCV Monitor v2.0测定（Roche Molecular Systems，普莱森顿，加利福尼亚州）。HCV RNA提取步骤可以在Cobas Ampliprep装置中自动化。在这项工作中，我们表明Cobas Ampliprep/Cobas Amplicor HCV Monitor v2.0程序的HCV RNA定量动态范围为600至200，000 HCV RNA IU/ml（2.8至5.3 log IU/ml），这并不涵盖感染患者的HCV RNA水平的全部范围。因此，任何含有超过200，000 IU/ml（5.3 log IU/ml）的样品必须在稀释后重新检测，以进行准确定量。这些结果强调了对具有更宽线性定量范围的商业HCV RNA定量测定的需求，例如基于实时PCR的测定。
Accurate quantification of hepatitis C virus (HCV) RNA is needed in clinical practice to decide whether to continue or stop pegylated interferon-alpha-ribavirin combination therapy at week 12 of treatment for patients with chronic hepatitis C. Currently the HCV RNA quantification assay most widely used worldwide is the Amplicor HCV Monitor v2.0 assay (Roche Molecular Systems, Pleasanton, Calif.). The HCV RNA extraction step can be automated in the Cobas Ampliprep device. In this work, we show that the dynamic range of HCV RNA quantification of the Cobas Ampliprep/Cobas Amplicor HCV Monitor v2.0 procedure is 600 to 200,000 HCV RNA IU/ml (2.8 to 5.3 log IU/ml), which does not cover the full range of HCV RNA levels in infected patients. Any sample containing more than 200,000 IU/ml (5.3 log IU/ml) must thus be retested after dilution for accurate quantification. These results emphasize the need for commercial HCV RNA quantification assays with a broader range of linear quantification, such as real-time PCR-based assays.