Division of Pulmonary and Critical Care Medicine, University of California San Francisco and Zuckerberg San Francisco General Hospital, 1001 Potrero Avenue, 5K1, San Francisco, CA, 94110, USA.
Curry International Tuberculosis Center, University of California San Francisco, San Francisco, CA, USA.
BMC Infect Dis. 2019 Mar 19;19(1):268. doi: 10.1186/s12879-019-3881-y.
BACKGROUND: The need for a rapid, molecular test to diagnose tuberculosis (TB) has prompted exploration of TB-LAMP (Eiken; Tokyo, Japan) for use in resource-limited settings. We conducted a systematic review to assess the accuracy of TB-LAMP as a diagnostic test for pulmonary TB. METHODS: We analyzed individual-level data for eligible patients from all studies of TB-LAMP conducted between Jan 2012 and October 2015 to compare the diagnostic accuracy of TB-LAMP with that of smear microscopy and Xpert MTB/RIF® using 3 reference standards of varying stringency. Pooled sensitivity and specificity and pooled differences in sensitivity and specificity were estimated using random effects meta-analysis. Study quality was evaluated using QUADAS-2. RESULTS: Four thousand seven hundred sixty individuals across 13 studies met eligibility criteria. Methodological quality was judged to be low for all studies. TB-LAMP had higher sensitivity than sputum smear microscopy (pooled sensitivity difference + 13·2, 95% CI 4·5-21·9%) and similar sensitivity to Xpert MTB/RIF (pooled sensitivity difference - 2·5, 95% CI -8·0 to + 2·9) using the most stringent reference standard available. Specificity of TB-LAMP was similar to that of sputum smear microscopy (pooled specificity difference - 1·8, 95% CI -3·8 to + 0·2) and Xpert MTB/RIF (pooled specificity difference 0·5, 95% CI -0·9 to + 1·8). CONCLUSIONS: From the perspective of diagnostic accuracy, TB-LAMP may be considered as an alternative test for sputum smear microscopy. Additional factors such as cost, feasibility, and acceptability in settings that continue to rely on sputum smear microscopy should be considered when deciding to adopt this technology. Xpert MTB/RIF should continue to be preferred in settings where resource and infrastructure requirements are adequate and where HIV co-infection or drug-resistance is of concern.
背景:需要一种快速的分子检测方法来诊断结核病(TB),这促使人们探索在资源有限的环境中使用 TB-LAMP(Eiken;日本东京)。我们进行了一项系统评价,以评估 TB-LAMP 作为诊断肺结核的诊断测试的准确性。
方法:我们分析了 2012 年 1 月至 2015 年 10 月期间进行的所有 TB-LAMP 研究中符合条件的患者的个体水平数据,以比较 TB-LAMP 与痰涂片显微镜检查和 Xpert MTB/RIF®在三种不同严格程度的参考标准下的诊断准确性。使用随机效应荟萃分析估计汇总敏感性和特异性以及汇总敏感性和特异性差异。使用 QUADAS-2 评估研究质量。
结果:共有来自 13 项研究的 4760 名个体符合纳入标准。所有研究的方法学质量均被评为低质量。TB-LAMP 的敏感性高于痰涂片显微镜检查(汇总敏感性差异+13.2,95%CI 4.5-21.9%),与 Xpert MTB/RIF 的敏感性相似(汇总敏感性差异-2.5,95%CI -8.0 至+2.9),采用最严格的现有参考标准。TB-LAMP 的特异性与痰涂片显微镜检查(汇总特异性差异-1.8,95%CI -3.8 至+0.2)和 Xpert MTB/RIF(汇总特异性差异 0.5,95%CI -0.9 至+1.8)相似。
结论:从诊断准确性的角度来看,TB-LAMP 可作为痰涂片显微镜检查的替代检测方法。在继续依赖痰涂片显微镜检查的情况下,在决定采用该技术时,还应考虑成本、可行性和可接受性等额外因素。在资源和基础设施要求充足且存在 HIV 合并感染或耐药性问题的情况下,应继续优先使用 Xpert MTB/RIF。
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