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首页> 外文期刊>Journal of Clinical Microbiology >Comparative Evaluation of the VERSANT HCV RNA 3.0, QUANTIPLEX HCV RNA 2.0, and COBAS AMPLICOR HCV MONITOR Version 2.0 Assays for Quantification of Hepatitis C Virus RNA in Serum
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Comparative Evaluation of the VERSANT HCV RNA 3.0, QUANTIPLEX HCV RNA 2.0, and COBAS AMPLICOR HCV MONITOR Version 2.0 Assays for Quantification of Hepatitis C Virus RNA in Serum

机译：VERSANT HCV RNA 3.0，QUANTIPLEX HCV RNA 2.0和COBAS AMPLICOR HCV MONITOR 2.0版测定血清中丙型肝炎病毒RNA定量分析的比较评估

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A comparison of quantitative results expressed in hepatitis C virus (HCV) international units per milliliter, obtained from the VERSANT HCV RNA 3.0 (bDNA-3.0) assay, the QUANTIPLEX HCV RNA 2.0 (bDNA-2.0) assay, and the COBAS AMPLICOR HCV MONITOR version 2.0 (HCM-2.0) test was performed. A total of 168 patient specimens submitted to the Mayo Clinic Molecular Microbiology Laboratory for HCV quantification or HCV genotyping were studied. Of the specimens tested, 97, 88, and 79% yielded quantitative results within the dynamic range of the bDNA-3.0, bDNA-2.0, and HCM-2.0 assays, respectively. Overall, there was substantial agreement between the results generated by all three assays. A total of 15 out of 29 (52%) of the specimens determined to contain viral loads of <31,746 IU/ml by the bDNA-3.0 assay were categorized as containing viral loads within the range of 31,746 to 500,000 IU/ml by the bDNA-2.0 assay. Although substantial agreement was noted between the results generated by the bDNA-2.0 and bDNA-3.0 assays, a bias toward higher viral titer by the bDNA-2.0 assay was noted (P = 0.001). Likewise, although substantial agreement was noted between the results generated by the HCM-2.0 and bDNA-3.0 assays, a bias toward higher viral titer by the bDNA-3.0 assay was noted (P ≤ 0.001). The discrepancy between the HCM-2.0 and bDNA-3.0 results was more pronounced when viral loads were >500,000 IU/ml and resulted in statistically significant differences (P ≤ 0.001) in determining whether viral loads were above or below 800,000 IU/ml of HCV RNA, the proposed threshold value for tailoring the duration of combination therapy. The expression of quantitative values in HCV international units per milliliter was a strength of both the bDNA-3.0 and HCM-2.0 assays.
机译：从VERSANT HCV RNA 3.0（bDNA-3.0）测定法，QUANTIPLEX HCV RNA 2.0（bDNA-2.0）测定法和COBAS AMPLICOR HCV MONITOR测定法获得的以每毫升丙肝病毒（HCV）国际单位表示的定量结果的比较进行了2.0版（HCM-2.0）测试。共研究了168例患者标本，这些标本已提交给Mayo临床分子微生物实验室进行HCV定量或HCV基因分型。在测试的样本中，分别在bDNA-3.0，bDNA-2.0和HCM-2.0分析的动态范围内，分别有97％，88％和79％产生了定量结果。总体而言，所有三种测定所产生的结果之间存在实质性的一致性。通过bDNA-3.0分析确定的29份样本中有15份（52％）的病毒载量被bDNA归类为包含31,746到500,000 IU / ml的病毒载量-2.0测定。尽管在bDNA-2.0和bDNA-3.0分析产生的结果之间达成了基本一致，但注意到bDNA-2.0分析偏向于更高的病毒滴度（ P = 0.001）。同样，尽管在HCM-2.0和bDNA-3.0分析产生的结果之间达成了基本一致，但注意到bDNA-3.0分析偏向于更高的病毒滴度（ P ≤0.001）。当病毒载量> 500,000 IU / ml时，HCM-2.0和bDNA-3.0结果之间的差异更加明显，并且在确定病毒载量高于还是低于0.001时具有统计学显着性差异（ P ≤0.001）。 HCV RNA低于800,000 IU / ml时，建议的用于调整联合治疗时间的阈值。 HCV国际单位每毫升中定量值的表达是bDNA-3.0和HCM-2.0分析的强项。

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