Evaluation of the COBAS TaqMan HCV Test with automated sample processing using the MagNA pure LC instrument
Evaluation of the COBAS TaqMan HCV Test with automated sample processing using the MagNA pure LC instrument
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DOI：
10.1128/jcm.43.1.293-298.2005
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发表时间：
2005-01-01
影响因子：
9.4
通讯作者：
Yao, JDC
中科院分区：
文献类型：
--
作者：
Germer, JJ;Harmsen, WS;Yao, JDC
COBAS TaqMan HCV测试（TaqMan HCV; Roche Molecular Systems Inc.，Branchburg，NJ）在COBAS TaqMan 48分析仪（RocheMolecularSystems）上进行的丙型肝炎病毒（HCV）检测目前依赖于手动样品处理方法。自动化样本处理方法的实施将促进该检测的临床使用。在这项研究中，我们评估了TaqMan HCV在MagNA Pure LC仪器（MP; Roche Applied Science，Indianapolis，Ind.）自动化样品处理后的性能特征。MP处理样本后，TaqMan HCV的分析灵敏度为8.1 IU/ml（95%置信区间，6.1 - 15.2）。该检测方法在HCV RNA水平范围（25 - 5 × 106 IU/ml）内显示出良好的线性（R-2 = 0.99），变异系数范围为10%-46%。在83份临床标本中，TaqMan HCV与COBAS AMPDRCOR丙型肝炎病毒检测试剂盒2.0版（COBAS AMPDRCOR; Roche Molecular Systems）相比，灵敏度和特异性分别为100%和95%，TaqMan HCV比COBAS AMPDRCOR多检出2份HCV RNA阳性标本。经VERSANT HCV RNA定性检测（Bayer HealthCare LLC，Tarrytown，NY）证实，两份标本均为HCV RNA阳性。在一组93份临床标本中，TaqMan HCV和VERSANT HCV RNA 3.0检测试剂盒（bDNA）（Bayer HealthCare LLC）的结果之间也存在强相关性（R-2 = 0.95）和良好一致性。MP是一种多功能、省力的样品处理平台，适用于TaqMan HCV的可靠性能。
The COBAS TaqMan HCV Test (TaqMan HCV; Roche Molecular Systems Inc., Branchburg, N.J.) for hepatitis C virus (HCV) performed on the COBAS TaqMan 48 Analyzer (Roche Molecular Systems) currently relies on a manual sample processing method. Implementation of an automated sample processing method would facilitate the clinical use of this test. In this study, we evaluated the performance characteristics of TaqMan HCV following automated sample processing by the MagNA Pure LC instrument (MP; Roche Applied Science, Indianapolis, Ind.). The analytical sensitivity of TaqMan HCV following sample processing by MP was 8.1 IU/ml (95% confidence interval, 6.1 to 15.2). The assay showed good linearity (R-2 = 0.99) across a wide range of HCV RNA levels (25 to 5 X 106 IU/ml), with coefficients of variation ranging from 10% to 46%. Among 83 clinical specimens, the sensitivity and specificity of TaqMan HCV were 100% and 95%, respectively, when compared to the COBAS AMPLICOR hepatitis C virus test, version 2.0 (COBAS AMPLICOR; Roche Molecular Systems), with TaqMan HCV detecting two more HCV RNA-positive specimens than COBAS AMPLICOR. Both specimens were confirmed to be HCV RNA positive by the VERSANT HCV RNA qualitative test (Bayer HealthCare LLC, Tarrytown, N.Y.). There was also strong correlation (R-2 = 0.95) and good agreement between the results from TaqMan HCV and the VERSANT HCV RNA 3.0 assay (bDNA) (Bayer HealthCare LLC) among a group of 93 clinical specimens. The MP is a versatile, labor-saving sample processing platform suitable for reliable performance of TaqMan HCV.