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首页> 美国卫生研究院文献>The Journal of Molecular Diagnostics : JMD >Performance Characteristics of a Quantitative Hepatitis C Virus RNA Assay Using COBAS AmpliPrep Total Nucleic Acid Isolation and COBAS TaqMan Hepatitis C Virus Analyte-Specific Reagent
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Performance Characteristics of a Quantitative Hepatitis C Virus RNA Assay Using COBAS AmpliPrep Total Nucleic Acid Isolation and COBAS TaqMan Hepatitis C Virus Analyte-Specific Reagent

机译：使用COBAS AmpliPrep总核酸分离和COBAS TaqMan丙型肝炎病毒分析物特异性试剂进行定量丙型肝炎病毒RNA分析的性能特征

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Performance characteristics of a hepatitis C virus (HCV) RNA quantification assay comprised automated specimen extraction [COBAS AmpliPrep (CAP) using total nucleic acid isolation reagents (TNAI)], and real-time polymerase chain reaction [COBAS TaqMan 48 HCV with analyte-specific reagents (CTM48)] were determined. CAP TNAI/CTM48 performed linearly from approximately 2.0 to at least 6.7 log10 IU/ml for HCV genotypes (Gts) 1, 2, and 3. The limit of detection for the World Health Organization International Standard was 23 IU/ml. Variabilities ranged from 1.3 to 2.1%. Excellent quantitative agreement was observed in clinical samples using CTM48 and two different methods for HCV RNA extraction (CAP TNAI and BioRobot M48; regression line slope, 0.98; y-intercept, 0.11; R2, 0.98; mean difference, 0.003). Good agreement was also observed between CAP TNAI/CTM48 and COBAS Amplicor Monitor (regression line slope, 0.94; y-intercept, 0.08; R2, 0.96), although HCV RNA concentrations were on average greater by COBAS Amplicor Monitor (mean difference −0.27 log10 IU/ml). Better overall agreement was observed for Gt 1 than non-Gt 1 specimens when comparing extraction and quantification methods; however, no consistent genotype-dependent quantification bias was observed. These data suggest that CAP TNAI/CTM48 offers an alternative method for the quantification of HCV in plasma samples.
机译：丙型肝炎病毒（HCV）RNA定量分析的性能特征包括自动标本提取[使用总核酸分离试剂（TNAI）的COBAS AmpliPrep（CAP）]和实时聚合酶链反应[COBAS TaqMan 48 HCV，具有特定分析物测定试剂（CTM48）。对于HCV基因型（Gts）1、2和3，CAP TNAI / CTM48从大约2.0到至少6.7 log10 IU / ml线性执行。世界卫生组织国际标准的检出限为23 IU / ml。变异范围为1.3％至2.1％。使用CTM48和两种不同的HCV RNA提取方法（CAP TNAI和BioRobot M48）在临床样品中观察到极佳的定量一致性（CAP TNAI和BioRobot M48;回归线斜率0.98; y截距0.11; R 2 0.98;均值差异，0.003）。 CAP TNAI / CTM48和COBAS Amplicor Monitor之间也观察到良好的一致性（回归线斜率0.94； y截距0.08； R 2 0.96），尽管COBAS的HCV RNA浓度平均更高Amplicor Monitor（平均差异-0.27 log10 IU / ml）。比较提取和定量方法时，与非Gt 1标本相比，Gt 1标本具有更好的总体一致性。但是，没有观察到一致的基因型依赖性定量偏差。这些数据表明，CAP TNAI / CTM48提供了另一种定量血浆样品中HCV的方法。

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