Laboratoire de Microbiologie Fondamentale et Pathogénicité UMR 5234, Centre Hospitalier Universitaire (CHU) et Université Bordeaux Ségalen, Hôpital Pellegrin, Bordeaux, France.
J Virol Methods. 2012 Apr;181(1):131-3. doi: 10.1016/j.jviromet.2012.01.006. Epub 2012 Jan 20.
In the ANRS CO13 HEPAVIH Cohort, HCV RNA measurement was performed with one of the two available real-time PCR assays [Roche Cobas AmpliPrep-Cobas TaqMan HCV (CAP-CTM) and the Abbott Real-Time HCV (ART)], according to the assay used in each center. To comply with the recommendations for using the same assay in multicenter clinical trials, all the 204 samples analyzed with ART were retested retrospectively by CAP-CTM. The aim of this study was to assess the usefulness of this strategy in real-life situations. A significant and positive correlation was observed between HCV RNA levels measured in the same samples with ART and CAP-CTM with all the genotypes tested. However, in 33 of the 204 (16%) clinical samples, the individual difference between HCV RNA levels measured by both assays was above ±0.5 log(10)IU/ml. Such viral load variations above 0.5 log(10) should be considered as significant. HCV RNA levels estimated by CAP-CTM for genotype 4 were significantly lower than those for genotypes 1, 2, and 3 (P<0.0001). This study shows that using the same assay in multicenter trials and cohorts is still relevant due to inter-assay differences observed in HCV plasma load measurements.
在 ANRS CO13 HEPAVIH 队列研究中，根据各中心使用的检测方法，采用两种可用的实时 PCR 检测法之一[罗氏 Cobas AmpliPrep-Cobas TaqMan HCV（CAP-CTM）和雅培实时 HCV（ART）]来检测 HCV RNA。为了遵守在多中心临床试验中使用相同检测方法的建议，所有用 ART 分析的 204 个样本都用 CAP-CTM 进行了回顾性复测。本研究旨在评估这种策略在实际情况中的有用性。用 ART 和 CAP-CTM 检测相同样本中的 HCV RNA 水平之间观察到显著的正相关，所有检测的基因型均如此。然而，在 204 个临床样本中的 33 个（16%）中，两种检测方法测量的 HCV RNA 水平之间的个体差异大于±0.5 log(10)IU/ml。这种超过 0.5 log(10)的病毒载量变化应被视为显著。用 CAP-CTM 估计的基因型 4 的 HCV RNA 水平明显低于基因型 1、2 和 3（P<0.0001）。本研究表明，由于在 HCV 血浆载量测量中观察到的检测方法之间的差异，在多中心试验和队列研究中使用相同的检测方法仍然是相关的。
