Evaluation of the microscopic observation drug susceptibility assay for the rapid detection of MDR-TB and XDR-TB in China: a prospective multicentre study
Evaluation of the microscopic observation drug susceptibility assay for the rapid detection of MDR-TB and XDR-TB in China: a prospective multicentre study
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中国耐多药结核病和广泛耐药结核病快速检测显微观察药敏试验的评价：一项前瞻性多中心研究。
DOI：
10.1093/jac/dku384
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发表时间：
2015-02-01
影响因子：
5.2
通讯作者：
Li, Junming
中科院分区：
文献类型：
--
作者：
Huang, Zikun;Qin, Cheng;Li, Junming
目的：开展一项多中心研究，评估在资源有限的高负担环境中显微镜观察药敏 (MODS) 检测检测耐多药结核病和广泛耐药结核病的性能。方法：我们对中国五个实验室的门诊和住院患者中的耐药结核病疑似病例进行了前瞻性诊断准确性研究。通过涂片显微镜检查、液体[分枝杆菌生长指示管 (MGIT)] 培养和每个部位的 MODS 测定来检测痰液。药敏试验(DST)采用MODS和间接1%比例法。结核分枝杆菌检测的参考标准是MGIT培养物上的生长情况； 1%比例法为利福平、异烟肼、氧氟沙星、卡那霉素、卷曲霉素药敏试验的参考标准。结果：通过参考标准培养，在213/532（40.0%）耐药结核病疑似病例中检出结核分枝杆菌。结核分枝杆菌检测的总体 MODS 敏感性为 87.8%-94.3%，特异性为 96.8%-100%。对于耐药结核病的诊断，大多数地点测试的所有药物都获得了极好的一致性。利福平准确率为87.1%-96.7%，异烟肼准确率为87.1%-93.3%，氧氟沙星准确率为92.7%-100%，卡那霉素准确率为90.9%-100%，卷曲霉素准确率为90.2%-100%。 MODS 培养呈阳性的中位时间明显短于 MGIT 液体培养（8 天与 11 天，P
Objectives: To perform a multicentre study evaluating the performance of the microscopic observation drug susceptibility (MODS) assay for the detection of MDR-TB and XDR-TB in high-burden resource-limited settings.Methods: We performed a prospective diagnostic accuracy study of drug-resistant TB suspects from outpatient and inpatient settings in five laboratories in China. Sputum was tested by smear microscopy, liquid [mycobacterial growth indicator tube (MGIT)] culture and the MODS assay at each site. Drug susceptibility testing (DST) was by MODS and an indirect 1% proportion method. The reference standard for Mycobacterium tuberculosis detection was growth on MGIT culture; the 1% proportion method was the reference standard for rifampicin, isoniazid, ofloxacin, kanamycin and capreomycin DST.Results: M. tuberculosis was identified by reference standard culture among 213/532 (40.0%) drug-resistant TB suspects. Overall MODS sensitivity for M. tuberculosis detection was 87.8%-94.3% and specificity was 96.8%-100%. For drug-resistant TB diagnosis, excellent agreement was obtained for all drugs tested at the majority of sites. The accuracy was 87.1%-96.7% for rifampicin, 87.1%-93.3% for isoniazid, 92.7%-100% for ofloxacin, 90.9%-100% for kanamycin and 90.2%-100% for capreomycin. The median time to culture positivity was significantly shorter for MODS than for the MGIT liquid culture (8 days versus 11 days, P