Clinical evaluation of the microscopic-observation drug-susceptibility assay for detection of tuberculosis
Clinical evaluation of the microscopic-observation drug-susceptibility assay for detection of tuberculosis
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DOI：
10.1086/511639
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发表时间：
2007-03-01
影响因子：
11.8
通讯作者：
Dorman, Susan E.
中科院分区：
文献类型：
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作者：
Arias, Mayra;Mello, Fernanda C. Q.;Dorman, Susan E.
背景目前迫切需要一种低成本的方法来快速、准确地检测临床标本中的结核分枝杆菌。显微镜观察药物敏感性（MODS）测定是一种相对低成本和简单的液体培养方法，已被提议用于资源有限的环境。本前瞻性研究评价了MODS检测试剂盒检测M.在巴西和洪都拉斯接受肺结核评估的人中发现结核病。使用涂片显微镜、Lowenstein-Jensen培养基培养和MODS检测培养评价呼吸道标本。还使用分枝杆菌生长指示管（MGIT）960自动化系统（Becton Dickinson）培养了一部分标本。如果至少有1份Lowenstein-Jensen培养基培养物为M阳性，则认为研究受试者患有结核病。tuberculosis.Findings.共分析了854例研究受试者的1639份呼吸道标本。在每个受试者的基础上，MODS的敏感性为97.5%（95%置信区间[CI]，95.7 - 98.6），特异性为94.4%（95% CI，93.1 - 95.2）。在Lowenstein-Jensen培养基上培养和MODS检测的中位检测时间分别为21天（四分位距[IQR]，17 - 25天）和7天（IQR，5 - 10天）（P < .01）。对于使用MGIT 960自动化系统培养的64份标本，MODS检测试剂（7天; IQR，7 - 10天）和MGIT 960自动化系统（8天; IQR，6 - 11.5天;）的中位生长时间相似。PP。MODS检测的污染培养物百分比低于Lowenstein-Jensen培养基培养的污染培养物百分比（3.8%对5.8%; P <0.01）。MODS测定是相对简单的测试，其用于检测肺结核的良好性能特征可使其适用于资源有限的环境。
Background. There is an urgent need for low-cost methods for rapid, accurate detection of Mycobacterium tuberculosis in clinical specimens. The microscopic-observation drug-susceptibility (MODS) assay is a relatively low-cost and simple liquid culture method that has been proposed for use in resource-limited environments.Methods. This prospective study evaluated the performance of the MODS assay for detection of M. tuberculosis in persons undergoing evaluation for pulmonary tuberculosis in Brazil and Honduras. Respiratory specimens were evaluated using smear microscopy, culture on Lowenstein-Jensen medium, and culture using the MODS assay. A subset of specimens was also cultured using the Mycobacterial Growth Indicator Tube (MGIT) 960 automated system (Becton Dickinson). A study subject was considered to have tuberculosis if at least 1 culture on Lowenstein-Jensen medium was positive for M. tuberculosis.Findings. A total of 1639 respiratory specimens obtained from 854 study subjects were analyzed. On a persubject basis, MODS sensitivity was 97.5% (95% confidence interval [CI], 95.7 - 98.6), and specificity was 94.4% (95% CI, 93.1 - 95.2). Median times to detection were 21 days (interquartile range [IQR], 17 - 25 days) and 7 days (IQR, 5 - 10) for culture on Lowenstein-Jensen medium and for the MODS assay, respectively (P < .01). For 64 specimens cultured using the MGIT 960 automated system, median time to growth was similar for the MODS assay (7 days; IQR, 7 - 10 days) and the MGIT 960 automated system (8 days; IQR, 6 - 11.5 days;). The Pp. 16 percentage of contaminated cultures was lower for the MODS assay than for culture on Lowenstein-Jensen medium (3.8% vs. 5.8%; P < .01).Conclusions. The MODS assay is a relatively simple test whose good performance characteristics for detection of pulmonary tuberculosis may make it suitable for resource- limited environments.