Caliendo A M, Valsamakis A, Zhou Y, Yen-Lieberman B, Andersen J, Young S, Ferreira-Gonzalez A, Tsongalis G J, Pyles R, Bremer J W, Lurain N S
Emory University School of Medicine, Atlanta, Georgia, USA.
J Clin Microbiol. 2006 May;44(5):1726-32. doi: 10.1128/JCM.44.5.1726-1732.2006.
We report a multilaboratory evaluation of hepatitis C virus (HCV) viral load assays to determine their linear range, reproducibility, subtype detection, and agreement. A panel of HCV RNA samples ranging in nominal concentration from 1.0 to 7.0 log10 IU/ml was constructed by diluting a clinical specimen (genotype 1b). Replicates of the panel were tested in multiple laboratories using the Abbott TaqMan analyte-specific reagent (Abbott reverse transcription-PCR [RT-PCR]), Roche TaqMan RUO (Roche RT-PCR), Roche Amplicor Monitor HCV 2.0 (Roche Monitor), and Bayer VERSANT HCV RNA 3.0 (Bayer bDNA) assays. Bayer bDNA-negative specimens were tested reflexively using the Bayer VERSANT HCV RNA qualitative assay (Bayer TMA). Abbott RT-PCR and Roche RT-PCR detected all 28 replicates with a concentration of 1.0 log10 IU/ml and were linear to 7.0 log10 IU/ml. Roche Monitor and Bayer bDNA detected 27 out of 28 and 13 out of 28 replicates, respectively, of 3.0 log10 IU/ml. Bayer TMA detected all seven replicates with 1.0 log10 IU/ml. Bayer bDNA was the most reproducible of the four assays. The mean viral load values for panel members in the linear ranges of the assays were within 0.5 log10 for the different tests. Eighty-nine clinical specimens of various genotypes (1 through 4) were tested in the Bayer bDNA, Abbott RT-PCR, and Roche RT-PCR assays. For Abbott RT-PCR, mean viral load values were 0.61 to 0.96 log10 greater than the values for Bayer bDNA assay for samples with genotype 1, 2, or 3 samples and 0.08 log10 greater for genotype 4 specimens. The Roche RT-PCR assay gave mean viral load values that were 0.28 to 0.82 log10 greater than those obtained with the Bayer bDNA assay for genotype 1, 2, and 3 samples. However, for genotype 4 samples the mean viral load value obtained with the Roche RT-PCR assay was, on average, 0.15 log10 lower than that of the Bayer bDNA. Based on these data, we conclude that the sensitivity and linear range of the Abbott and Roche RT-PCR assays enable them to be used for HCV diagnostics and therapeutic monitoring. However, the differences in the viral load values obtained with the different assays underscore the importance of using one assay when monitoring response to therapy.
我们报告了一项针对丙型肝炎病毒(HCV)病毒载量检测方法的多实验室评估,以确定其线性范围、重复性、亚型检测能力及一致性。通过稀释一份临床标本(基因型1b)构建了一组名义浓度范围为1.0至7.0 log10 IU/ml的HCV RNA样本。该样本组的复制品在多个实验室中使用雅培TaqMan分析物特异性试剂(雅培逆转录 - 聚合酶链反应[RT-PCR])、罗氏TaqMan RUO(罗氏RT-PCR)、罗氏Amplicor Monitor HCV 2.0(罗氏监测法)和拜耳VERSANT HCV RNA 3.0(拜耳分支DNA检测法)进行检测。拜耳分支DNA检测为阴性的标本使用拜耳VERSANT HCV RNA定性检测法(拜耳转录介导扩增法)进行复检。雅培RT-PCR和罗氏RT-PCR检测到了所有浓度为1.0 log10 IU/ml的28个复制品,并且在7.0 log10 IU/ml范围内呈线性。罗氏监测法和拜耳分支DNA检测法分别检测到了3.0 log10 IU/ml的28个复制品中的27个和13个。拜耳转录介导扩增法检测到了所有浓度为1.0 log10 IU/ml的7个复制品。拜耳分支DNA检测法是这四种检测方法中重复性最好的。在各检测方法的线性范围内,样本组成员的平均病毒载量值在不同检测之间相差不超过0.5 log10。89份不同基因型(1至4型)的临床标本在拜耳分支DNA检测法、雅培RT-PCR和罗氏RT-PCR检测法中进行了检测。对于雅培RT-PCR,对于基因型1、2或3的样本,其平均病毒载量值比拜耳分支DNA检测法的值高0.61至0.96 log10,对于基因型4的标本高0.08 log10。罗氏RT-PCR检测法对于基因型1、2和3的样本,其平均病毒载量值比拜耳分支DNA检测法得到的值高0.28至0.82 log10。然而,对于基因型4的样本,罗氏RT-PCR检测法获得的平均病毒载量值平均比拜耳分支DNA检测法低0.15 log10。基于这些数据,我们得出结论,雅培和罗氏RT-PCR检测法的灵敏度和线性范围使其可用于HCV诊断和治疗监测。然而,不同检测方法获得的病毒载量值存在差异,这突出了在监测治疗反应时使用单一检测方法的重要性。