Li Shiying, Liu Bin, Peng Mingli, Chen Min, Yin Wenwei, Tang Hui, Luo Yuxuan, Hu Peng, Ren Hong
Key Laboratory of Molecular Biology for Infectious Diseases (Ministry of Education), Institute for Viral Hepatitis, Department of Infectious Diseases, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, PR, China.
PLoS One. 2017 Jul 14;12(7):e0180725. doi: 10.1371/journal.pone.0180725. eCollection 2017.
To estimate the diagnostic accuracy of Xpert MTB/RIF, a systematic review and meta-analysis were carried out.
Up to June 20, 2015, multiple databases were screened for relevant studies.
Accordingly, 106 studies included 52,410 samples were selected. Diagnostic accuracy of Xpert MTB/RIF for TB detection was validated against either culture or a composite reference standard (CRS). Additionally, selected studies were further subgrouped in four groups based on sample's type, subject's age, status of HIV co-infection and smear-positivity. The overall pooled sensitivity and specificity of Xpert MTB/RIF was 0.85 (95% confidence interval [CI] 0.82-0.88) and 0.98 (95% CI 0.96-0.98), respectively, compared to culture; while it was 0.59 (95% CI 0.44-0.72) and 0.99 (95% CI 0.97-1.00) compared to CRS. The overall sensitivity was lower in countries with high TB prevalence than countries with middle/low prevalence (0.84, 95% CI: 0.80-0.88 versus 0.89, 95% CI: 0.84-0.93). Furthermore, Xpert MTB/RIF has higher sensitivity in patients with positive smears (0.99, 95% CI 0.97-0.99), in patients with pulmonary TB samples (0.87, 95% CI 0.83-0.90), in adults (0.82, 95% CI 0.76-0.86) and in HIV-positive patients (0.81, 95% CI 0.73-0.87).
Taken together, Xpert MTB/RIF is a quick and accurate diagnostic assay for TB which will significantly help the physicians to make their clinical decisions.
为评估Xpert MTB/RIF的诊断准确性,开展了一项系统评价和荟萃分析。
截至2015年6月20日,对多个数据库进行了相关研究筛选。
据此,选取了包含52410份样本的106项研究。Xpert MTB/RIF检测结核病的诊断准确性通过与培养法或综合参考标准(CRS)进行验证。此外,根据样本类型、受试者年龄、HIV合并感染状况和涂片阳性情况,将所选研究进一步分为四组。与培养法相比,Xpert MTB/RIF的总体合并敏感性和特异性分别为0.85(95%置信区间[CI] 0.82 - 0.88)和0.98(95% CI 0.96 - 0.98);与CRS相比,分别为0.59(95% CI 0.44 - 0.72)和0.99(95% CI 0.97 - 1.00)。结核病高流行国家的总体敏感性低于中/低流行国家(0.84,95% CI:0.80 - 0.88对0.89,95% CI:0.84 - 0.93)。此外,Xpert MTB/RIF在涂片阳性患者(0.99,95% CI 0.97 - 0.99)、肺结核样本患者(0.87,95% CI 0.83 - 0.90)、成人(0.82,95% CI 0.76 - 0.86)和HIV阳性患者(0.81,95% CI 0.73 - 0.87)中具有更高的敏感性。
总体而言,Xpert MTB/RIF是一种快速、准确的结核病诊断检测方法,将显著有助于医生做出临床决策。