Bai Yuanyuan, Wang Yueling, Shao Chunhong, Hao Yingying, Jin Yan
Department of Clinical Laboratory, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, PR China.
PLoS One. 2016 Mar 2;11(3):e0150321. doi: 10.1371/journal.pone.0150321. eCollection 2016.
There is an urgent demand for rapid and accurate drug-susceptibility testing for the detection of multidrug-resistant tuberculosis. The GenoType MTBDRplus assay is a promising molecular kit designed for rapid identification of resistance to first-line anti-tuberculosis drugs, isoniazid and rifampicin. The aim of this meta-analysis was to evaluate the diagnostic accuracy of GenoType MTBDRplus in detecting drug resistance to isoniazid and rifampicin in comparison with the conventional drug susceptibility tests.
We searched PubMed, EMBASE, and Cochrane Library databases to identify studies according to predetermined criteria. A total of 40 studies were included in the meta-analysis. QUADAS-2 was used to assess the quality of included studies with RevMan 5.2. STATA 13.0 software was used to analyze the tests for sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, diagnostic odds ratio, and area under the summary receiver operating characteristic curves. Heterogeneity in accuracy measures was tested with Spearman correlation coefficient and Chi-square.
Patient selection bias was observed in most studies. The pooled sensitivity (95% confidence intervals were 0.91 (0.88-0.94) for isoniazid, 0.96 (0.95-0.97) for rifampicin, and 0.91(0.86-0.94) for multidrug-resistance. The pooled specificity (95% CI) was 0.99 (0.98-0.99) for isoniazid, 0.98 (0.97-0.99) for rifampicin and 0.99 (0.99-1.00) for multidrug-resistance, respectively. The area under the summary receiver operating characteristic curves ranged from 0.99 to 1.00.
This meta-analysis determined that GenoType MTBDRplus had good accuracy for rapid detection of drug resistance to isoniazid and/or rifampicin of M. tuberculosis. MTBDRplus method might be a good alternative to conventional drug susceptibility tests in clinical practice.
对于检测耐多药结核病,迫切需要快速准确的药敏试验。GenoType MTBDRplus检测是一种很有前景的分子检测试剂盒,旨在快速鉴定对一线抗结核药物异烟肼和利福平的耐药性。本荟萃分析的目的是评估GenoType MTBDRplus与传统药敏试验相比,在检测异烟肼和利福平耐药性方面的诊断准确性。
我们检索了PubMed、EMBASE和Cochrane图书馆数据库,根据预定标准识别研究。共有40项研究纳入荟萃分析。使用QUADAS-2和RevMan 5.2评估纳入研究的质量。使用STATA 13.0软件分析敏感性、特异性、阳性似然比、阴性似然比、诊断比值比以及汇总接受者操作特征曲线下面积的检测结果。用Spearman相关系数和卡方检验准确性指标的异质性。
大多数研究中观察到患者选择偏倚。汇总敏感性(95%置信区间)异烟肼为0.91(0.88 - 0.94),利福平为0.96(0.95 - 0.97),耐多药为0.91(0.86 - 0.94)。汇总特异性(95%CI)异烟肼为0.99(0.98 - 0.99),利福平为0.98(0.97 - 0.99),耐多药为0.99(0.99 - 1.00)。汇总接受者操作特征曲线下面积范围为0.99至1.00。
本荟萃分析确定GenoType MTBDRplus在快速检测结核分枝杆菌对异烟肼和/或利福平的耐药性方面具有良好的准确性。MTBDRplus方法可能是临床实践中传统药敏试验的良好替代方法。