Department of Global Health, University of Washington, Seattle, Washington.
Department of Medicine, University of Washington, Seattle, Washington.
J Infect Dis. 2019 Oct 8;220(220 Suppl 3):S108-S115. doi: 10.1093/infdis/jiz356.
The World Health Organization's (WHO) "End TB" strategy calls for development and implementation of novel tuberculosis (TB) diagnostics. Sputum-based diagnostics are challenging to implement and often less sensitive in high-priority populations. Nonsputum, biomarker-based tests may facilitate TB testing at lower levels of the healthcare system, accelerate treatment initiation, and improve outcomes. We provide guidance on the design of diagnostic accuracy studies evaluating nonsputum, biomarker-based tests within the context of WHO's target product profile for such tests. Study designs should account for the intended use when choosing the study population, setting, and reference standards. Although adults with respiratory symptoms may be an initial target population, other high-priority populations regardless of symptoms-including people living with human immunodeficiency virus, those unable to produce sputum samples or with extrapulmonary TB, household contacts, and children-should be considered. Studies beyond diagnostic accuracy that evaluate feasibility and population-level impacts are also needed. A biomarker-based diagnostic may be critical to ending the TB epidemic, but requires appropriate validation before implementation.
世界卫生组织（WHO）的“终止结核病”战略呼吁开发和实施新型结核病（TB）诊断方法。基于痰液的诊断方法实施起来具有挑战性，并且在高优先级人群中往往不那么敏感。非痰液、基于生物标志物的检测方法可能有助于在医疗保健系统的较低级别进行结核病检测，加速治疗启动，并改善结果。我们在 WHO 针对此类检测的目标产品概况范围内，就评估非痰液、基于生物标志物的检测方法的诊断准确性研究的设计提供了指导。在选择研究人群、设置和参考标准时，研究设计应考虑到预期用途。虽然有呼吸道症状的成年人可能是最初的目标人群，但无论是否有症状，包括艾滋病毒感染者、无法产生痰液样本或患有肺外结核病、接触者以及儿童等其他高优先级人群也应考虑在内。还需要开展评估可行性和人群水平影响的超出诊断准确性的研究。基于生物标志物的诊断方法对于终结结核病流行可能至关重要，但在实施之前需要进行适当的验证。
