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首页> 外文期刊>Journal of Clinical Microbiology >Comparison of Qualitative (COBAS AMPLICOR HCV 2.0 versus VERSANT HCV RNA) and Quantitative (COBAS AMPLICOR HCV Monitor 2.0 versus VERSANT HCV RNA 3.0) Assays for Hepatitis C Virus (HCV) RNA Detection and Quantification: Impact on Diagnosis and Treatment of HCV Infections
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Comparison of Qualitative (COBAS AMPLICOR HCV 2.0 versus VERSANT HCV RNA) and Quantitative (COBAS AMPLICOR HCV Monitor 2.0 versus VERSANT HCV RNA 3.0) Assays for Hepatitis C Virus (HCV) RNA Detection and Quantification: Impact on Diagnosis and Treatment of HCV Infections

机译：丙型肝炎病毒（HCV）RNA检测和定量的定性（COBAS AMPLICOR HCV 2.0与VERSANT HCV RNA）和定量（COBAS AMPLICOR HCV Monitor 2.0与VERSANT HCV RNA）比较：对HCV感染的诊断和治疗的影响

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Quantitative measurements of serum hepatitis C virus (HCV) RNA are becoming increasingly important in the management of HCV-infected patients. Here we compared two quantitative assays, the COBAS AMPLICOR HCV Monitor 2.0 assay (Roche Diagnostics) and the branched DNA-based VERSANT HCV RNA 3.0 assay (Bayer Diagnostics) for HCV RNA measurement in 344 samples derived from 120 patients with chronic genotype 1 HCV infection. The overall concordance between the results of the two tests was 95%, and the HCV RNA titers within the dynamic ranges of the assays correlated very well (r2 = 0.86). Furthermore, both tests performed equally well in determining an early viral response at week 1 or 4 during antiviral therapy. We also compared two qualitative HCV RNA detection assays: the COBAS AMPLICOR HCV 2.0 assay versus the transcription-mediated amplification (TMA)-based VERSANT HCV RNA qualitative assay. Stored samples from sustained responders to interferon-ribavirin therapy were retested by the HCV TMA assay and were found to contain no detectable HCV RNA, demonstrating complete concordance between the results of PCR and TMA. However, HCV RNA was detected by the TMA assay in end-of-treatment (ETR) samples from 33% of patients with relapses who were HCV RNA negative according to the COBAS AMPLICOR assay. This observation suggests that a TMA assay can lead to a more correct definition of the ETR response.
机译：血清丙型肝炎病毒（HCV）RNA的定量测量在HCV感染患者的管理中变得越来越重要。在这里，我们比较了来自120例慢性基因1型HCV感染患者的344个样品中的两种定量测定方法，即344个样品中的COBAS AMPLICOR HCV Monitor 2.0测定法（Roche Diagnostics）和基于分支DNA的VERSANT HCV RNA 3.0测定法（Bayer Diagnostics）。 。两次测试的结果之间的总体一致性为95％，并且测定动态范围内的HCV RNA滴度之间的相关性非常好（ r 2 = 0.86）。此外，在确定抗病毒治疗期间第1周或第4周的早期病毒反应方面，两项测试均表现出色。我们还比较了两种定性的HCV RNA检测测定：COBAS AMPLICOR HCV 2.0测定与基于转录介导扩增（TMA）的VERSANT HCV RNA定性测定。通过HCV TMA分析重新测试了来自持续应答者对干扰素-利巴韦林治疗的储存样品，发现其中没有可检测到的HCV RNA，这表明PCR结果与TMA结果完全一致。但是，根据COBAS AMPLICOR分析，在33％复发的HCV RNA阴性复发患者中，通过TMA分析在治疗结束（ETR）样本中检测到HCV RNA。该观察结果表明，TMA分析可导致ETR反应的更正确定义。

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