BACKGROUND The Xpert® MTB/RIF assay (Xpert; Cepheid, Sunnyvale, CA, USA) is a cartridge-based nucleic acid amplification assay for rapidly diagnosing tuberculosis and assessing antibiotic sensitivity. Although previous evidence supports the use of Xpert for diagnosing extrapulmonary tuberculosis (EPTB) in adults, information regarding the accuracy of Xpert for EPTB only in children is lacking. This meta-analysis was performed to assess the accuracy of Xpert for detecting EPTB in children. METHODS We searched the MEDLINE, EMBASE, and Cochrane Infectious Diseases Group Specialized Register from January 1, 2010 to July 16, 2019 for studies of the diagnostic performance wherein Xpert was analyzed against cultures or composite reference standards for < 18-year-old children with EPTB. RESULTS In only pediatric studies, 8 studies including 652 samples were selected. The pooled sensitivity and specificity of Xpert for all samples were 71% (95% CI 0.63-0.79) and 97% (95% CI 0.95-0.99), respectively. The area under the summary receiver operating characteristic (sROC) curve was 0.89. For lymph node tissues or aspirates, the pooled sensitivity and specificity of Xpert were 80% (95% CI 0.70-0.88) and 94% (95% CI 0.89-0.97), respectively; for cerebrospinal fluid (CSF), these values were 42% (95% CI 0.22-0.63) and 99% (95% CI 0.95-1.00), respectively. CONCLUSION Overall, Xpert displayed high specificity but modest sensitivity across various samples for diagnosing pediatric EPTB compared to the composite reference standard. Xpert sensitivity varied with the sampling site and was especially lower in CSF samples. Positive Xpert results may be considered to indicate a presumptive case of pediatric EPTB, whereas negative test results indicate that the possibility of pediatric EPTB should not be excluded.

中文翻译：

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Xpert MTB / RIF测定法用于儿童肺外结核的诊断：系统评价和荟萃分析。

背景技术Xpert®MTB / RIF测定法（Xpert； Cepheid，Sunnyvale，CA，美国）是一种基于卡式盒的核酸扩增测定法，用于快速诊断结核病和评估抗生素敏感性。尽管以前的证据支持使用Xpert诊断成人肺外结核（EPTB），但仍缺乏有关Xpert仅用于儿童的准确性的信息。进行这项荟萃分析，以评估Xpert检测儿童EPTB的准确性。方法我们从2010年1月1日至2019年7月16日在MEDLINE，EMBASE和Cochrane传染病小组专业登记册中搜索了诊断性能的研究，其中对Xpert对照文化或复合参考标准进行了分析，以分析<18岁以下儿童EPTB。结果仅在儿科研究中，选择了包括652个样本的8个研究。对于所有样品，Xpert的合并敏感性和特异性分别为71％（95％CI 0.63-0.79）和97％（95％CI 0.95-0.99）。摘要接收机工作特性（sROC）曲线下的面积为0.89。对于淋巴结组织或抽吸物，Xpert的合并敏感性和特异性分别为80％（95％CI 0.70-0.88）和94％（95％CI 0.89-0.97）。对于脑脊液（CSF），这些值分别为42％（95％CI 0.22-0.63）和99％（95％CI 0.95-1.00）。结论总体而言，与复合参考标准品相比，Xpert在诊断儿科EPTB的各种样品中显示出高特异性，但灵敏度中等。Xpert灵敏度随采样点而变化，在CSF样品中尤其低。