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首页> 外文期刊>Journal of Clinical Microbiology >Comparison of Performance Characteristics of Three Real-Time Reverse Transcription-PCR Test Systems for Detection and Quantification of Hepatitis C Virus
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Comparison of Performance Characteristics of Three Real-Time Reverse Transcription-PCR Test Systems for Detection and Quantification of Hepatitis C Virus

机译：三种实时定量检测丙型肝炎病毒的实时逆转录-PCR测试系统的性能特征比较

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We evaluated the performance characteristics of three real-time reverse transcription-PCR test systems for detection and quantification of hepatitis C virus (HCV) and performed a direct comparison of the systems on the same clinical specimens. Commercial HCV panels (genotype 1b) were used to evaluate linear range, sensitivity, and precision. The Roche COBAS TaqMan HCV test for research use only (RUO) with samples processed on the MagNA Pure LC instrument (Roche RUO-MPLC) and Abbott analyte-specific reagents (ASR) with QIAGEN sample processing (Abbott ASR-Q) showed a sensitivity of 1.0 log10 IU/ml with a linear dynamic range of 1.0 to 7.0 log10 IU/ml. The Roche ASR in combination with the High Pure system (Roche ASR-HP) showed a sensitivity of 1.4 log10 IU/ml with a linear dynamic range of 2.0 to 7.0 log10 IU/ml. All of the systems showed acceptable reproducibility, the Abbott ASR-Q being the most reproducible of the three systems. Seventy-six clinical specimens (50 with detectable levels of HCV RNA and various titers and genotypes) were tested, and results were compared to those of the COBAS Amplicor HCV Monitor v2.0. Good correlation was obtained for the Roche RUO-MPLC and Abbott ASR-Q (R2 = 0.84 and R2 = 0.93, respectively), with better agreement for the Abbott ASR-Q. However, correlation (R2 = 0.79) and agreement were poor for Roche ASR-HP, with bias relative to concentration and genotype. Roche ASR-HP underestimated HCV RNA for genotypes 3 and 4 as much as 2.19 log10 IU/ml. Our study demonstrates that Roche RUO-MPLC and Abbott ASR-Q provided acceptable results and agreed sufficiently with the COBAS Amplicor HCV Monitor v2.0.
机译：我们评估了三种实时逆转录-PCR检测系统对丙型肝炎病毒（HCV）的检测和定量的性能特征，并在相同的临床标本上对该系统进行了直接比较。商业HCV面板（基因型1b）用于评估线性范围，灵敏度和精度。仅用于研究目的（RUO）的Roche COBAS TaqMan HCV测试（在MagNA Pure LC仪器（Roche RUO-MPLC）上处理过的样品）和在QIAGEN样品处理（Abbott ASR-Q）下进行的雅培分析物特异性试剂（ASR）显示为1.0 log 10 IU / ml，线性动态范围为1.0至7.0 log 10 IU / ml。罗氏ASR与高纯度系统（Roche ASR-HP）结合使用时，灵敏度为1.4 log 10 IU / ml，线性动态范围为2.0至7.0 log 10 IU /毫升。所有系统均显示出可接受的重现性，雅培ASR-Q在这三个系统中重现性最高。测试了76份临床标本（其中50份具有可检测的HCV RNA水平以及各种效价和基因型），并将结果与​​COBAS Amplicor HCV Monitor v2.0的结果进行了比较。 Roche RUO-MPLC和Abbott ASR-Q（ R 2 = 0.84和 R 2 = 0.93），与雅培ASR-Q的协议更好。然而，罗氏ASR-HP的相关性（ R 2 = 0.79）和一致性较差，相对于浓度和基因型存在偏差。 Roche ASR-HP低估了基因型3和4的HCV RNA，最高为2.19 log 10 IU / ml。我们的研究表明，罗氏RUO-MPLC和雅培ASR-Q提供了可接受的结果，并且与COBAS Amplicor HCV Monitor v2.0完全一致。

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