Microscopic-observation drug-susceptibility assay for the diagnosis of TB.
Microscopic-observation drug-susceptibility assay for the diagnosis of TB.
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DOI：
10.1056/nejmoa055524
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发表时间：
2006-10-12
期刊：
影响因子：
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通讯作者：
Friedland JS
中科院分区：
文献类型：
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作者：
Moore DA;Evans CA;Gilman RH;Caviedes L;Coronel J;Vivar A;Sanchez E;Piñedo Y;Saravia JC;Salazar C;Oberhelman R;Hollm-Delgado MG;LaChira D;Escombe AR;Friedland JS
迫切需要新的诊断工具来阻断结核病和耐多药结核病的传播。显微观察药物敏感性 (MODS) 测定的原理验证研究已证明可以快速、灵敏地检测痰中的结核病和耐多药结核病，其中通过显微镜检查肉汤培养物以检测特征性生长。在秘鲁的一个操作环境中，我们研究了 MODS 检测在三个目标群体中的培养和药物敏感性测试的性能：未经选择的疑似结核病患者、预先筛查的结核病或耐多药结核病高风险患者以及未经选择的感染人类免疫缺陷病毒的住院患者。我们将 MODS 测定与两种参考方法进行了头对头比较：自动分枝杆菌培养和使用比例法在 Löwenstein-Jensen 培养基上培养。在 3760 份痰样本中，401 份（10.7%）的结核分枝杆菌培养物呈阳性。 MODS 培养的检测灵敏度为 97.8%，自动化分枝杆菌培养为 89.0%，Löwenstein-Jensen 培养为 84.0%（P<0.001）；培养阳性的中位时间分别为7天、13天和26天（P<0.001），药敏试验结果的中位时间分别为7天、22天和68天。第二次 MODS 培养的增量益处微乎其微，特别是对于结核病或耐多药结核病高风险患者。 MODS 与药敏参考标准的一致性为利福平 100%、异烟肼 97%、利福平和异烟肼 99%（多药耐药性的综合结果）、乙胺丁醇 95%、链霉素 92%（kappa 值分别为 1.0、0.89、0.93、0.71 和 0.72，分别）。与现有的金标准方法相比，痰样本的单一 MODS 培养可以更快速、更灵敏地检测结核病和耐多药结核病。
New diagnostic tools are urgently needed to interrupt the transmission of tuberculosis and multidrug-resistant tuberculosis. Rapid, sensitive detection of tuberculosis and multidrug-resistant tuberculosis in sputum has been demonstrated in proof-of-principle studies of the microscopic-observation drug-susceptibility (MODS) assay, in which broth cultures are examined microscopically to detect characteristic growth. In an operational setting in Peru, we investigated the performance of the MODS assay for culture and drug-susceptibility testing in three target groups: unselected patients with suspected tuberculosis, prescreened patients at high risk for tuberculosis or multidrug-resistant tuberculosis, and unselected hospitalized patients infected with the human immunodeficiency virus. We compared the MODS assay head-to-head with two reference methods: automated mycobacterial culture and culture on Löwenstein–Jensen medium with the proportion method. Of 3760 sputum samples, 401 (10.7%) yielded cultures positive for Mycobacterium tuberculosis. Sensitivity of detection was 97.8% for MODS culture, 89.0% for automated mycobacterial culture, and 84.0% for Löwenstein–Jensen culture (P<0.001); the median time to culture positivity was 7 days, 13 days, and 26 days, respectively (P<0.001), and the median time to the results of susceptibility tests was 7 days, 22 days, and 68 days, respectively. The incremental benefit of a second MODS culture was minimal, particularly in patients at high risk for tuberculosis or multidrug-resistant tuberculosis. Agreement between MODS and the reference standard for susceptibility was 100% for rifampin, 97% for isoniazid, 99% for rifampin and isoniazid (combined results for multidrug resistance), 95% for ethambutol, and 92% for streptomycin (kappa values, 1.0, 0.89, 0.93, 0.71, and 0.72, respectively). A single MODS culture of a sputum sample offers more rapid and sensitive detection of tuberculosis and multidrug-resistant tuberculosis than the existing gold-standard methods used.