Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, QC, Canada.
Lancet Infect Dis. 2010 Oct;10(10):688-98. doi: 10.1016/S1473-3099(10)70165-1. Epub 2010 Aug 31.
Simple, rapid, and affordable tests are needed to detect drug resistance in Mycobacterium tuberculosis. We did a systematic review and meta-analysis to investigate the accuracy of microscopic-observation drug susceptibility (MODS) and thin layer agar (TLA) assays for rapid screening of patients at risk of drug-resistant tuberculosis.
In accordance with protocols and methods recommended by the Cochrane Diagnostic Test Accuracy Working Group, we systematically searched PubMed, Embase, and Biosis for reports published between January, 1990, and February, 2009. We included studies investigating detection of drug resistance in M tuberculosis with the MODS or TLA assay, and in which an accepted reference standard was used. Data extracted from the studies were combined by use of bivariate random-effects regression models and hierarchical summary receiver operating characteristic curves to estimate sensitivity and specificity for detection of resistance to specific drugs.
We identified 12 studies, of which nine investigated the MODS assay and three investigated the TLA assay. For the MODS assay of rifampicin resistance, pooled estimates were 98·0% (95% CI 94·5-99·3) for sensitivity and 99·4% (95·7-99·9) for specificity. For the MODS assay of isoniazid resistance with a 0·1 μg/mL cutoff, pooled sensitivity was 97·7% (94·4-99·1) and pooled specificity was 95·8% (88·1-98·6), but with a 0·4 μg/mL cutoff, sensitivity decreased to 90·0% (84·5-93·7) and specificity increased to 98·6% (96·9-99·4). All assessments of rifampicin and isoniazid resistance with the TLA assay yielded 100% accuracy. Mean turnaround time was 9·9 days (95% CI 4·1-15·8) for the MODS assay and 11·1 days (10·1-12·0) for the TLA assay.
MODS and TLA assays are inexpensive, rapid alternatives to conventional methods for drug susceptibility testing of M tuberculosis. Our data and expert opinion informed WHO's recommendation for use of selected non-commercial drug susceptibility tests, including MODS, as an interim solution until capacity for genotypic or automated liquid culture drug susceptibility testing is developed.
Stop TB Department of WHO.
需要简单、快速且经济实惠的检测方法来检测结核分枝杆菌的耐药性。我们进行了一项系统评价和荟萃分析，以调查在有耐药风险的结核患者中快速筛选时，显微镜观察药物敏感性（MODS）和薄层琼脂（TLA）检测的准确性。
根据 Cochrane 诊断测试准确性工作组的方案和方法，我们系统地检索了 PubMed、Embase 和 Biosis 中 1990 年 1 月至 2009 年 2 月发表的报告。我们纳入了研究使用 MODS 或 TLA 检测方法检测 M 结核分枝杆菌耐药性的研究，并且其中使用了公认的参考标准。从研究中提取的数据通过双变量随机效应回归模型和分层综合接收者操作特征曲线进行合并，以估计对特定药物耐药性的检测敏感性和特异性。
我们确定了 12 项研究，其中 9 项研究了 MODS 检测，3 项研究了 TLA 检测。对于 rifampicin 耐药性的 MODS 检测，汇总估计值为 98.0%（95%CI 94.5-99.3）的敏感性和 99.4%（95.7-99.9）的特异性。对于 0.1μg/mL 截止值的 isoniazid 耐药性的 MODS 检测，汇总敏感性为 97.7%（94.4-99.1），特异性为 95.8%（88.1-98.6），但 0.4μg/mL 截止值时敏感性降至 90.0%（84.5-93.7），特异性增至 98.6%（96.9-99.4）。TLA 检测 rifampicin 和 isoniazid 耐药性的所有评估均得出 100%的准确性。MODS 检测的平均周转时间为 9.9 天（95%CI 4.1-15.8），TLA 检测的平均周转时间为 11.1 天（10.1-12.0）。
MODS 和 TLA 检测是经济实惠的快速替代方法，可替代常规的 M 结核药物敏感性检测方法。我们的数据和专家意见为世卫组织建议使用选定的非商业性药敏检测方法提供了依据，包括 MODS，作为在建立基因或自动化液体培养药敏检测能力之前的临时解决方案。
世卫组织遏制结核病司。
