Development of a quantitative PCR assay for monitoring HCV viraemia levels in patients with chronic hepatitis C
Development of a quantitative PCR assay for monitoring HCV viraemia levels in patients with chronic hepatitis C
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开发用于监测慢性丙型肝炎患者 HCV 病毒血症水平的定量 PCR 检测方法
DOI：
10.1111/j.1365-2893.1997.tb00164.x
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发表时间：
1997
影响因子：
2.5
通讯作者：
K. Gutekunst
中科院分区：
文献类型：
--
作者：
G. Colucci;K. Gutekunst
总结。为了提高针对丙型肝炎病毒（HCV）的抗病毒药物的疗效，人们开发了定量检测方法，以监测与治疗相关的病毒血症水平。在这方面，我们开发了一种非竞争性的定量PCR检测方法（Amplicor HCV Monitor1M），该方法基于HCV RNA的5 '非编码区域的单一、组合、反转录和扩增，以及用于评估系统整体效率的内部标准。该检测的动态范围及其精度允许每毫升1000至100万拷贝的病毒基因组的准确定量。该测试的首次临床评估结果表明，在治疗前评估病毒血症的测定可能具有预测价值，因为每毫升少于5万拷贝的HCV RNA的患者往往对干扰素α (IFN α)治疗表现出长期反应。此外，治疗开始后1个月出现的超过1.5 - 2个对数的下降比ALT测量更及时和准确地预测反应。这可能有助于更好地选择患者治疗，治疗方法和时间表，并在成本效益平衡的优化。
Summary. The need to improve the efficacy of anti‐viral agents directed against the hepatitis C virus (HCV) has prompted the development of quantitative tests to monitor viraemia levels in relation to therapy. In this respect, we have produced a non‐competitive, quantitative PCR assay (Amplicor HCV Monitor1M) which is based on the single, combined, reverse transcription and amplification of the 5′ non‐coding region of HCV RNA as well as of an internal standard which serves to assess the overall efficiency of the system. The dynamic range of the assay and its precision allows for an accurate quantification between 1000 and 1000 000 copies of the viral genome per ml. The results of the first clinical evaluation of the test indicated that determination of viraemia may have predictive value when assessed prior to treatment, as patients with less than 50 000 HCV RNA copies per ml tend to show a longterm response to interferon‐α (IFN‐α) treatment. Moreover, a decrease of more than 1.5‐2 logarithms occurring at 1 month post‐initiation of therapy predicts response in a more timely and accurate fashion than ALT measurement. This may help in a better selection of patients to treat, therapy approaches and schedules and in the optimization of the cost‐benefit balance.
影响因子：
2.9
作者：
MYERS, RA;ZAFARALLA, GC;OLIVERA, BM
通讯作者：
OLIVERA, BM