Evaluation of the COBAS hepatitis C virus (HCV) TaqMan analyte-specific reagent assay and comparison to the COBAS amplicor HCV Monitor V2.0 and Versant HCV bDNA 3.0 assays
Evaluation of the COBAS hepatitis C virus (HCV) TaqMan analyte-specific reagent assay and comparison to the COBAS amplicor HCV Monitor V2.0 and Versant HCV bDNA 3.0 assays
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DOI：
10.1128/jcm.43.5.2133-2140.2005
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发表时间：
2005-05-01
影响因子：
9.4
通讯作者：
Hillyard, DR
中科院分区：
文献类型：
--
作者：
Konnick, EQ;Williams, SM;Hillyard, DR
使用临床样本，评价了使用QIAGEN BioRobot 9604进行RNA提取的COBAS丙型肝炎病毒（HCV）TaqMan分析物特异性试剂（TM-ASR）检测的性能特征，并与COBAS Amplicor HCV Monitor V2. 0（Amplicor）和Versant HCV bDNA 3. 0（Versant）检测进行了比较。使用Armored RNA校准TM-ASR可以使用22，399份临床样本确定HCV RNA在临床样本中的分布。使用多个临床样本组在多次测定中测定了TM-ASR检测试剂盒的检出限、线性以及检测间和检测内精密度。使用评价的不同HCV RNA基因型样本确定TM-ASR检测试剂的基因型特异性，并与预定结果进行比较。使用在12次运行（共96份样本）中以棋盘模式检测的HCV RNA阳性和阴性样本池评价了TM-ASR检测试剂盒的污染控制。使用100份配对临床样本和德明回归分析确定TM-ASR、Amplicor和Versant检测试剂的相关性。TM-ASR在线性、精密度和污染控制方面表现良好。TM-ASR与Amplicor和Versant检测之间的相关性较差，单个样本的检测结果之间存在较大差异。用Armored RNA校准TM-ASR检测试剂盒，可获得较宽的动态范围，并可描述临床样本中HCV RNA的分布。
Performance characteristics of the COBAS hepatitis C virus (HCV) TaqMan analyte-specific reagent (TM-ASR) assay using the QIAGEN BioRobot 9604 for RNA extraction were evaluated and compared to the COBAS Amplicor HCV Monitor V2.0 (Amplicor) and Versant HCV bDNA 3.0 (Versant) assays using clinical samples. Calibration of TM-ASR using Armored RNA allowed determination of the distribution of HCV RNA in clinical samples, using 22,399 clinical samples. Limit of detection, linearity, and inter- and intraassay assay precision were determined for the TM-ASR assay using multiple clinical specimen panels across multiple determinations. Genotype specificity for the TM-ASR assay was determined using samples with different HCV RNA genotypes evaluated and compared against predetermined results. Contamination control of the TM-ASR assay was evaluated using pools of HCV RNA-positive and -negative samples tested in a checkerboard pattern over 12 runs of 96 samples. Correlation of the TM-ASR, Amplicor, and Versant assays was determined using 100 paired clinical samples and Deming regression analysis. The TM-ASR performed well with respect to linearity, precision, and contamination control. The correlation between TM-ASR and the Amplicor and Versant assays was poor, with large differences between assay results for individual samples. Calibration of the TM-ASR assay with Armored RNA allowed for a wide dynamic range and description of the distribution of HCV RNA in clinical samples.