Germer Jeffrey J, Harmsen W Scott, Mandrekar Jayawant N, Mitchell P Shawn, Yao Joseph D C
Division of Clinical Microbiology, Mayo Clinic, 200 First St. SW, Rochester, MN 55905, USA.
J Clin Microbiol. 2005 Jan;43(1):293-8. doi: 10.1128/JCM.43.1.293-298.2005.
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 10(6) 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.
在COBAS TaqMan 48分析仪（罗氏分子系统公司）上进行的用于丙型肝炎病毒（HCV）检测的COBAS TaqMan HCV检测法（TaqMan HCV；罗氏分子系统公司，新泽西州布兰奇堡）目前依赖手工样本处理方法。实施自动化样本处理方法将有助于该检测法的临床应用。在本研究中，我们评估了经MagNA Pure LC仪器（MP；罗氏应用科学公司，印第安纳州印第安纳波利斯）进行自动化样本处理后TaqMan HCV的性能特征。经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至15.2）。该检测法在广泛的HCV RNA水平范围（25至5×10⁶ IU/ml）内显示出良好的线性（R² = 0.99），变异系数范围为10%至46%。在83份临床标本中，与COBAS AMPLICOR丙型肝炎病毒检测法2.0版（COBAS AMPLICOR；罗氏分子系统公司）相比，TaqMan HCV的灵敏度和特异性分别为100%和95%，TaqMan HCV比COBAS AMPLICOR多检测出两份HCV RNA阳性标本。这两份标本均通过VERSANT HCV RNA定性检测法（拜耳医疗保健有限责任公司，纽约州塔里敦）确认为HCV RNA阳性。在一组93份临床标本中，TaqMan HCV的结果与VERSANT HCV RNA 3.0检测法（分支DNA）（拜耳医疗保健有限责任公司）之间也存在强相关性（R² = 0.95）和良好一致性。MP是一个通用的、节省人力的样本处理平台，适用于TaqMan HCV的可靠检测。
