Diagnosing Tuberculosis: What Do New Technologies Allow Us to (Not) Do?
Diagnosing Tuberculosis: What Do New Technologies Allow Us to (Not) Do?
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DOI：
10.1159/000525142
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发表时间：
2022
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新的结核病（TB）诊断正处于十字路口：其开发、评估和实施受到COVID-19导致的资源转移的严重破坏。然而，一些技术，特别是那些具有非侵入性非痰基检测潜力的技术，有望在护理点附近有效分类和快速确认结核病。然而，这种测试在管道中进展缓慢，需要数年时间才能到达患者和卫生工作者手中。令人信服的是，这些测试将为难以诊断的人群创造新的机会，包括初级保健参与者（所有在高负担环境中的人，无论出现的原因如何）和社区成员（患有早期疾病或艾滋病毒等风险因素），其中许多人不容易产生痰液。至关重要的是，所有即将到来的技术都有局限性，实施者和卫生工作者需要认识到这一点，以确保最佳部署，而不会破坏对一项仍能改善现状的技术的信心。在这个国家的最先进的审查，我们严格评价这些技术的活动性肺结核诊断。我们强调的优势，局限性，突出的研究问题，以及如何当前和未来的测试可以在这些限制和不确定性的存在下使用。在分诊测试中，CRP（商业近点护理设备存在）和计算机辅助检测软件与数字胸部X光检查，以及检测宿主和/或微生物生物标志物的晚期血液检测，都有希望;然而，除了少数原型，后一类缺乏有希望的晚期替代品。此外，新的分流测试的阳性结果可能对没有结核病的人有用;然而，它们在为其他疾病的诊断途径提供信息方面的效用研究不足（大多数接受结核病测试的病人没有结核病）。对于确证性检测，很快就不会有真正的即时检测选择;然而，将舌拭子等新方法与Ultra等已建立的检测方法相结合具有短期前景，但首先需要优化标本采集和处理程序。令人关切的是，目前还没有令人信服的证据表明任何技术符合世界卫生组织的最佳目标产品概况性能标准，特别是对实地部署至关重要的重要业务标准。这是令人震惊的，因为目标产品概况标准本身已经有近十年的历史，需要紧急修订，特别是为了满足COVID-19诊断反应所突出的技术（例如，家庭测试和连接解决方案）。在整个综述中，我们强调了目标人群和设置如何影响测试性能的重要性，以及判断这些测试的标准如何因用例而异，包括在活跃的案例发现中。最后，我们倡导卫生工作者和研究人员自己成为新检测和那些仍然未得到最佳利用的现有检测的积极支持者。
New tuberculosis (TB) diagnostics are at a crossroads: their development, evaluation, and implementation is severely damaged by resource diversion due to COVID-19. Yet several technologies, especially those with potential for non-invasive non-sputum-based testing, hold promise for efficiently triaging and rapidly confirming TB near point-of-care. Such tests are, however, progressing through the pipeline slowly and will take years to reach patients and health workers. Compellingly, such tests will create new opportunities for difficult-to-diagnose populations, including primary care attendees (all-comers in high burden settings irrespective of reason for presentation) and community members (with early stage disease or risk factors like HIV), many of whom cannot easily produce sputum. Critically, all upcoming technologies have limitations that implementers and health workers need to be cognizant of to ensure optimal deployment without undermining confidence in a technology that still offers improvements over the status quo. In this state-of-the-art review, we critically appraise such technologies for active pulmonary TB diagnosis. We highlight strengths, limitations, outstanding research questions, and how current and future tests could be used in the presence of these limitations and uncertainties. Among triage tests, CRP (for which commercial near point-of-care devices exist) and computer-aided detection software with digital chest X-ray hold promise, together with late-stage blood-based assays that detect host and/or microbial biomarkers; however, aside from a handful of prototypes, the latter category has a shortage of promising late-stage alternatives. Furthermore, positive results from new triage tests may have utility in people without TB; however, their utility for informing diagnostic pathways for other diseases is under-researched (most sick people tested for TB do not have TB). For confirmatory tests, few true point-of-care options will be available soon; however, combining novel approaches like tongue swabs with established tests like Ultra have short-term promise but first require optimizations to specimen collection and processing procedures. Concerningly, no technologies yet have compelling evidence of meeting the World Health Organization optimal target product profile performance criteria, especially for important operational criteria crucial for field deployment. This is alarming as the target product profile criteria are themselves almost a decade old and require urgent revision, especially to cater for technologies made prominent by the COVID-19 diagnostic response (e.g., at-home testing and connectivity solutions). Throughout the review, we underscore the importance of how target populations and settings affect test performance and how the criteria by which these tests should be judged vary by use case, including in active case finding. Lastly, we advocate for health workers and researchers to themselves be vocal proponents of the uptake of both new tests and those − already available tests that remain suboptimally utilized.
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影响因子：
3.7
作者：
Cox JA;Lukande RL;Kalungi S;Van Marck E;Van de Vijver K;Kambugu A;Nelson AM;Colebunders R;Manabe YC
通讯作者：
Manabe YC
影响因子：
10
作者：
Chegou, Novel N.;Sutherland, Jayne S.;Walzl, Gerhard
通讯作者：
Walzl, Gerhard
影响因子：
2
作者：
Calkins, Hugh;Hindricks, Gerhard;Yamane, Teiichi
通讯作者：
Yamane, Teiichi
新的XPERT MTB/RIF ULTRA：改善了结核分枝杆菌的检测和对利福平的耐药性，适用于适合护理点测试的测定。
影响因子：
6.4
作者：
Chakravorty S;Simmons AM;Rowneki M;Parmar H;Cao Y;Ryan J;Banada PP;Deshpande S;Shenai S;Gall A;Glass J;Krieswirth B;Schumacher SG;Nabeta P;Tukvadze N;Rodrigues C;Skrahina A;Tagliani E;Cirillo DM;Davidow A;Denkinger CM;Persing D;Kwiatkowski R;Jones M;Alland D
通讯作者：
Alland D
DOI：
10.1056/nejmoa2105470
发表时间：
2021-12-23
期刊：
The New England journal of medicine
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