An Integrated Approach to Rapid Diagnosis of Tuberculosis and Multidrug Resistance Using Liquid Culture and Molecular Methods in Russia
An Integrated Approach to Rapid Diagnosis of Tuberculosis and Multidrug Resistance Using Liquid Culture and Molecular Methods in Russia
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DOI：
10.1371/journal.pone.0007129
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发表时间：
2009-09-23
期刊：
影响因子：
3.7
通讯作者：
Fedorin, Ivan
中科院分区：
文献类型：
--
作者：
Balabanova, Yanina;Drobniewski, Francis;Fedorin, Ivan
目的：分析快速结核病 (TB) 分子和培养系统在高耐多药结核病 (MDR TB) 中等收入地区（俄罗斯萨马拉）的可行性、成本和性能，并为世卫组织政策变化提供证据。方法：进行性能和成本评估，比较用于培养和药敏测试 (DST) 的 BACTEC (TM) MGIT (TM) 960 系统和用于结核病诊断、异烟肼耐药性和耐药性的分子系统。与传统的 Lowenstein-Jensen 培养测定相比，利福平和耐多药结核病鉴定。结果：招募了 698 名具有耐药结核病危险因素的连续患者（2487 份痰样本）。 MGIT 中结核分枝杆菌复合体培养阳性率为 31.6% (787/2487)，LJ 中为 27.1% (675/2487)（涂片阳性标本为 90.5% 和 83.2%）。通过任何方法总共分离出 809 份结核分枝杆菌复合体培养物。 MGIT 的中位检测时间为 14 天，LJ 为 36 天（涂片阳性标本为 10 天和 33 天），MGIT 的间接药敏试验需要 9 天，而 LJ 为 21 天。 LJ 和 MGIT 的 DST 之间具有良好的一致性（利福平为 96.8%，异烟肼为 95.6%）。两种分子杂交检测结果均与 MGIT DST 结果良好相关，尽管分子检测通常会产生较高的耐药率（异烟肼和利福平的耐药率约为 3%）。结论：通过有效的规划和后勤，MGIT 960 和基于分子的方法可以成功引入中等发病率国家的参考实验室环境。俄罗斯联邦耐多药结核病的高发病率使得引入此类检测方法特别有用。
Objective: To analyse the feasibility, cost and performance of rapid tuberculosis (TB) molecular and culture systems, in a high multidrug-resistant TB (MDR TB) middle-income region (Samara, Russia) and provide evidence for WHO policy change.Methods: Performance and cost evaluation was conducted to compare the BACTEC (TM) MGIT (TM) 960 system for culture and drug susceptibility testing (DST) and molecular systems for TB diagnosis, resistance to isoniazid and rifampin, and MDR TB identification compared to conventional Lowenstein-Jensen culture assays.Findings: 698 consecutive patients (2487 sputum samples) with risk factors for drug-resistant tuberculosis were recruited. Overall M. tuberculosis complex culture positivity rates were 31.6% (787/2487) in MGIT and 27.1% (675/2487) in LJ (90.5% and 83.2% for smear-positive specimens). In total, 809 cultures of M. tuberculosis complex were isolated by any method. Median time to detection was 14 days for MGIT and 36 days for LJ (10 and 33 days for smear positive specimens) and indirect DST in MGIT took 9 days compared to 21 days on LJ. There was good concordance between DST on LJ and MGIT (96.8% for rifampin and 95.6% for isoniazid). Both molecular hybridization assay results correlated well with MGIT DST results, although molecular assays generally yielded higher rates of resistance (by approximately 3% for both isoniazid and rifampin).Conclusion: With effective planning and logistics, the MGIT 960 and molecular based methodologies can be successfully introduced into a reference laboratory setting in a middle incidence country. High rates of MDR TB in the Russian Federation make the introduction of such assays particularly useful.