Rapid molecular screening for multidrug-resistant tuberculosis in a high-volume public health laboratory in South Africa
Rapid molecular screening for multidrug-resistant tuberculosis in a high-volume public health laboratory in South Africa
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DOI：
10.1164/rccm.200709-1436oc
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发表时间：
2008-04-01
影响因子：
24.7
通讯作者：
Bosiman, Marlein E.
中科院分区：
文献类型：
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作者：
Barnard, Marinus;Allbert, Heidi;Bosiman, Marlein E.
在南非，结核病控制面临的艾滋病毒感染和多重耐药性的双重挑战尤为紧迫。检测结核分枝杆菌耐药性的常规方法需要数周至数月才能产生结果。耐药性的快速分子检测是可用的，但尚未在高TB负担settings.Objectives实施：为了评估实施用于快速检测利福平和异烟肼耐药性的市售分子线探针测定的性能和可行性。我们直接对536份来自多药耐药（MDR）风险增加患者的连续涂片阳性痰标本进行了检测。南非开普敦一个忙碌繁忙的常规诊断实验室里的结核病。结果进行了比较，与传统的液体培养和药物敏感性测试的固体medium. Measures和主要结果：总体而言，97%的涂片阳性标本给出了可解释的结果在1-2天内使用的分子检测。检测利福平耐药的敏感性、特异性、阳性预测值和阴性预测值分别为98.9%、99.4%、97.9%和99.7%，检测异烟肼耐药的敏感性、特异性、阳性预测值和阴性预测值分别为94.2%、99.7%、99.1%和97.9%;多药耐药的检出率分别为98.8%、100%、100%和99.7%。该检测也表现良好的标本上污染的常规文化和涂片阴性，文化阳性specimes.Conclusions：这种分子检测是一种高度准确的筛选工具，耐多药结核病，实现了大幅减少诊断延迟。分子检测具有优于传统培养和药物敏感性检测的上级整体性能特征，以及高通量和大幅节省成本的可能性，具有彻底改变MDR TB诊断的潜力。
Rationale The dual challenges to tuberculosis (TB) control of HIV infection and multidrug resistance are particularly pressing in South Africa. Conventional methods for detecting Mycobacterium tuberculosis drug resistance take weeks to months to produce results. Rapid molecular testing for drug resistance is available but has not been implemented in high-TB-burden settings.Objectives: To assess the performance and feasibility of implementation of a commercially available molecular line-probe assay for rapid detection of rifampicin and isoniazid resistance.Methods: We performed the assay directly on 536 consecutive smear-positive sputum specimens from patients at increased risk of multidrug-resistant (MDR) TB in a busy routine diagnostic laboratory in Cape Town, South Africa. Results were compared with conventional liquid culture and drug susceptibility testing on solid medium.Measurements and Main Results: Overall, 97% of smear-positive specimens gave interpretable results within 1-2 days using the molecular assay. Sensitivity, specificity, and positive and negative predictive values were 98.9, 99.4, 97.9, and 99.7%, respectively, for detection of rifampicin resistance; 94.2,99.7,99.1, and 97.9%, respectively, for detection of isoniazid resistance; and 98.8, 100, 100, and 99.7%, respectively, for detection of multidrug resistance compared with conventional results. The assay also performed well on specimens that were contaminated on conventional culture and on smear-negative, culture-positive specimens.Conclusions: This molecular assay is a highly accurate screening tool for MDR TB, which achieves a substantial reduction in diagnostic delay. With overall performance characteristics that are superior to conventional culture and drug susceptibility testing and the possibility for high throughput with substantial cost savings, molecular testing has the potential to revolutionize MDR TB diagnosis.