Microscopic observation drug susceptibility assay, a rapid, reliable diagnostic test for multidrug-resistant tuberculosis suitable for use in resource-poor settings
Microscopic observation drug susceptibility assay, a rapid, reliable diagnostic test for multidrug-resistant tuberculosis suitable for use in resource-poor settings
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DOI：
10.1128/jcm.42.10.4432-4437.2004
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发表时间：
2004-10-01
影响因子：
9.4
通讯作者：
Serpa, J
中科院分区：
文献类型：
--
作者：
Moore, DAJ;Mendoza, D;Serpa, J
迫切需要新的工具来提高我们在资源匮乏的环境中诊断结核病 (TB) 和耐多药结核病 (MDR-TB) 的能力。在结核病高发地区进行的一项回顾性分析中，我们评估了显微镜观察药敏试验 (MODS) 的性能，这是一种在秘鲁开发的新型试验，使用倒置光学显微镜和 Middlebrook 7H9 肉汤培养物来检测分枝杆菌生长。在 1,908 份阳性痰培养物中，MODS 检测出 94.0%，而 Lowenstein-Jensen (LJ) 培养仅检测出 86.9%（P < 0.001）。培养呈阳性的中位时间为 8 天（相比之下，LJ 培养的相同 208 个样品为 16 天；P < 0.001，Wilcoxon 符号秩检验）。使用 MODS 直接药敏试验获得的结果表明，异烟肼和利福平以及多药耐药性检测与通过间接比色法获得的结果具有极好的一致性：微孔板阿拉玛蓝测定 (MABA) 和四唑微孔板测定 (TEMA)（一致度为 95%、98% 和 94%；kappa 值分别为 0.8、0.7 和 分别为 0.7）。乙胺丁醇和链霉素药敏试验结果一致性较差。 MODS 是一种新颖的检测方法，可以直接从痰中检测出导致结核病和耐多药结核病的微生物，成本低廉、快速且有效。秘鲁正在对 MODS 进行全面的前瞻性评估，并应尽早在非研究实验室进行独立验证。
There is an urgent need for new tools to improve our ability to diagnose tuberculosis (TB) and multidrug-resistant TB (MDR-TB) in resource-poor settings. In a retrospective analysis undertaken in a region with a high incidence of TB, we evaluated the performance of the microscopic observation drug susceptibility assay (MODS), a novel assay developed in Peru which uses an inverted light microscope and culture in Middlebrook 7H9 broth to detect mycobacterial growth. MODS detected 94.0% of 1,908 positive sputum cultures, whereas Lowenstein-Jensen (LJ) culture detected only 86.9% (P < 0.001). The median time to culture positivity was 8 days (compared to 16 days for the same 208 samples by LJ culture; P < 0.001, Wilcoxon signed rank test). The results obtained by direct susceptibility testing using MODS demonstrated excellent concordance for isoniazid and rifampin and the detection of multidrug resistance with those obtained by indirect colorimetric methods: the microplate Alamar Blue assay (MABA) and the tetrazolium microplate assay (TEMA) (agreement, 95, 98, and 94%; kappa values, 0.8, 0.7, and 0.7, respectively). The concordance of the susceptibility testing results for ethambutol and streptomycin was poor. MODS is a novel assay which can detect the organisms responsible for TB and MDR-TB directly from sputum inexpensively, rapidly, and effectively. A comprehensive prospective evaluation of MODS is under way in Peru, and independent validation in nonresearch laboratories should be undertaken at the earliest opportunity.