Reischl U, Lehn N, Wolf H, Naumann L
Institute of Medical Microbiology and Hygiene, University of Regensburg, D-93053 Regensburg, Germany.
J Clin Microbiol. 1998 Oct;36(10):2853-60. doi: 10.1128/JCM.36.10.2853-2860.1998.
We evaluated the COBAS AMPLICOR PCR system (Roche Diagnostics) for the routine detection of Mycobacterium tuberculosis complex (MTBC) in clinical specimens. Diagnostic culture, considered as the reference method, was performed with BACTEC, Löwenstein-Jensen, Stonebrink, and Kirchner media. Occasionally MB-Redox, ESP, or MGIT medium was also used. A total of 643 respiratory and 506 nonrespiratory specimens collected from 807 patients were investigated. Of the 95 culture-positive specimens, 80 were COBAS AMPLICOR MTB positive, and of the 1,054 culture-negative specimens, 1,044 were COBAS AMPLICOR MTB negative. After resolving discrepancies by review of the medical history, the overall sensitivity, specificity, and positive and negative predictive values for the COBAS AMPLICOR MTB assay, respectively, were 83.5, 98.8, 86.7, and 98.6% compared to those of diagnostic culture. In smear-positive specimens, the sensitivity of the COBAS AMPLICOR MTB assay was 96%, versus 48% for smear-negative specimens. No significant differences in the test performance between respiratory and nonrespiratory specimens were observed. The overall inhibition rate was less than 2%, excluding stool specimens. The clear advantages of the COBAS AMPLICOR PCR system are standardized procedures and reagents for specimen processing as well as an internal control for reliable monitoring of PCR inhibitors. By simplifying the work flow through a completely automated amplification and amplicon detection procedure, the COBAS AMPLICOR PCR system proved itself as a very useful component for routine diagnostic procedures.
我们评估了COBAS AMPLICOR PCR系统（罗氏诊断公司）用于临床标本中结核分枝杆菌复合群（MTBC）的常规检测。诊断培养被视为参考方法，使用BACTEC、罗氏培养基、斯通布林克培养基和基尔希纳培养基进行。偶尔也会使用MB-氧化还原培养基、ESP培养基或MGIT培养基。对从807名患者收集的643份呼吸道标本和506份非呼吸道标本进行了研究。在95份培养阳性标本中，80份COBAS AMPLICOR MTB检测呈阳性；在1054份培养阴性标本中，1044份COBAS AMPLICOR MTB检测呈阴性。通过回顾病史解决差异后，与诊断培养相比，COBAS AMPLICOR MTB检测的总体敏感性、特异性、阳性预测值和阴性预测值分别为83.5%、98.8%、86.7%和98.6%。在涂片阳性标本中，COBAS AMPLICOR MTB检测的敏感性为96%，而涂片阴性标本的敏感性为48%。在呼吸道标本和非呼吸道标本之间未观察到检测性能的显著差异。总体抑制率低于2%，粪便标本除外。COBAS AMPLICOR PCR系统的明显优势在于标本处理的标准化程序和试剂以及用于可靠监测PCR抑制剂的内部对照。通过完全自动化的扩增和扩增子检测程序简化工作流程，COBAS AMPLICOR PCR系统证明自身是常规诊断程序中非常有用的组成部分。
