University of Connecticut/Hartford Hospital Evidence-based Practice Center, Hartford, CT, USA.
Vicerrectorado de Investigación, Universidad San Ignacio de Loyola (USIL), Lima, Peru.
Trop Med Int Health. 2021 Feb;26(2):122-132. doi: 10.1111/tmi.13525. Epub 2020 Nov 30.
This systematic review evaluated the diagnostic accuracy of Xpert MTB/RIF to detect tuberculous meningitis (TBM).
PubMed and five other databases were systematically searched through March 2019. All studies evaluating diagnostic accuracy of Xpert MTB/RIF on cerebrospinal fluid (CSF) samples were included. Reference standards were definitive or definite plus probable TBM. The quality of studies was assessed by the QUADAS-2 tool. We performed bivariate random-effects meta-analysis and calculated summary diagnostic statistics.
We identified 30 studies (n = 3972 participants), including 5 cohort studies and 25 cross-sectional studies. Reference standards were definite TB (n = 28 studies) or definite plus probable TBM (n = 6 studies). The pooled Xpert MTB/RIF sensitivity was 85% (95% CI, 70-93%), and specificity was 98% (95% CI, 97-99%) with a negative likelihood ratio of 0.15 (95% CI, 0.04-0.27) for definite TBM. For probable TBM cases, pooled sensitivity was 81% (95% CI, 66-90%), and specificity was 99% (95% CI, 97-99%). For both reference standard types, meta-analyses showed a C-statistic area under the curve of 0.98. The QUADAS-2 tool revealed low risk of bias as well as low concerns regarding applicability. Methodological heterogeneity was high among studies.
Xpert MTB/RIF showed high accuracy for TBM diagnosis, but a negative Xpert MTB/RIF test does not rule out TBM. Repeat Xpert testing may be necessary. In clinical practice, Xpert MTB/RIF adds speed and sensitivity when compared to classic TBM diagnostic methods or previous commercial nucleic acid amplification techniques. More studies and better strategies for rapidly confirming a diagnosis of TBM in children are urgently needed.
本系统评价评估了 Xpert MTB/RIF 检测结核性脑膜炎（TBM）的诊断准确性。
通过系统检索 PubMed 及其他 5 个数据库，检索时间截至 2019 年 3 月。纳入评估 Xpert MTB/RIF 对脑脊液（CSF）样本检测准确性的所有研究。参考标准为明确或明确加可能的 TBM。采用 QUADAS-2 工具评估研究质量。我们进行了双变量随机效应荟萃分析，并计算了汇总诊断统计数据。
我们共纳入 30 项研究（n=3972 名参与者），包括 5 项队列研究和 25 项横断面研究。参考标准为明确的结核病（n=28 项研究）或明确加可能的 TBM（n=6 项研究）。Xpert MTB/RIF 的汇总敏感度为 85%（95%CI，70-93%），特异度为 98%（95%CI，97-99%），阴性似然比为 0.15（95%CI，0.04-0.27），用于明确的 TBM。对于可能的 TBM 病例，汇总敏感度为 81%（95%CI，66-90%），特异度为 99%（95%CI，97-99%）。对于两种参考标准类型，Meta 分析显示曲线下面积的 C 统计量为 0.98。QUADAS-2 工具显示出低偏倚风险和低适用性担忧。研究间存在高度的方法学异质性。
Xpert MTB/RIF 对 TBM 的诊断具有较高的准确性，但 Xpert MTB/RIF 检测结果阴性并不能排除 TBM。可能需要重复进行 Xpert 检测。在临床实践中，与经典的 TBM 诊断方法或以前的商用核酸扩增技术相比，Xpert MTB/RIF 可提高速度和灵敏度。迫切需要更多的研究和更好的策略来快速确认儿童 TBM 的诊断。
