Abstract：
Only 25% of multidrug-resistant tuberculosis (MDR-TB) cases are currently diagnosed. Line probe assays (LPAs) enable rapid drug-susceptibility testing for rifampicin (RIF) and isoniazid (INH) resistance and Mycobacterium tuberculosis detection. Genotype MTBDRplusV1 was WHO-endorsed in 2008 but newer LPAs have since been developed.This systematic review evaluated three LPAs: Hain Genotype MTBDRplusV1, MTBDRplusV2 and Nipro NTM+MDRTB. Study quality was assessed with QUADAS-2. Bivariate random-effects meta-analyses were performed for direct and indirect testing. Results for RIF and INH resistance were compared to phenotypic and composite (incorporating sequencing) reference standards. M. tuberculosis detection results were compared to culture.74 unique studies were included. For RIF resistance (21 225 samples), pooled sensitivity and specificity (with 95% confidence intervals) were 96.7% (95.6-97.5%) and 98.8% (98.2-99.2%). For INH resistance (20 954 samples), pooled sensitivity and specificity were 90.2% (88.2-91.9%) and 99.2% (98.7-99.5%). Results were similar for direct and indirect testing and across LPAs. Using a composite reference standard, specificity increased marginally. For M. tuberculosis detection (3451 samples), pooled sensitivity was 94% (89.4-99.4%) for smear-positive specimens and 44% (20.2-71.7%) for smear-negative specimens.In patients with pulmonary TB, LPAs have high sensitivity and specificity for RIF resistance and high specificity and good sensitivity for INH resistance. This meta-analysis provides evidence for policy and practice.
摘要：
目前，只有25％的耐多药结核病（MDR-TB）病例得到诊断。线探针测定（LPAs）能够快速进行利福平（RIF）和异烟肼（INH）耐药性和结核分枝杆菌检测的药物敏感性测试。基因型MTBDRplusV1于2008年获得世卫组织认可，但此后开发了较新的LPA。这项系统评价评估了三种LPAs：Hain基因型MTBDRplusV1，MTBDRplusV2和NiproNTMMDRTB。用QUADAS-2评估研究质量。对直接和间接检验进行双变量随机效应荟萃分析。将RIF和INH抗性的结果与表型和复合(并入测序)参考标准进行比较。将结核分枝杆菌检测结果与文化进行比较。纳入了74项独特的研究。对于RIF电阻（21225个样品），合并敏感性和特异性(95%置信区间)分别为96.7%(95.6~97.5%)和98.8%(98.2~99.2%).对于INH电阻(20954个样品)，合并的敏感性和特异性分别为90.2%(88.2-91.9%)和99.2%(98.7-99.5%).直接和间接测试以及跨LPA的结果相似。使用复合参考标准，特异性略有增加。对于结核分枝杆菌检测(3451个样本)，涂片阳性标本的合并敏感性为94％（89.4-99.4％），涂片阴性标本的合并敏感性为44％（20.2-71.7％）。在肺结核患者中，LPAs对RIF抗性具有高敏感性和特异性,对INH抗性具有高特异性和良好敏感性。这种荟萃分析为政策和实践提供了证据。
