Guidance for Studies Evaluating the Accuracy of Tuberculosis Triage Tests
Guidance for Studies Evaluating the Accuracy of Tuberculosis Triage Tests
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DOI：
10.1093/infdis/jiz243
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发表时间：
2019-11-15
影响因子：
6.4
通讯作者：
Schumacher, Samuel G.
中科院分区：
文献类型：
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作者：
Nathavitharana, Ruvandhi R.;Yoon, Christina;Schumacher, Samuel G.
每年大约有360万例活动性结核病（TB）可能未被诊断，部分原因是在社区和初级卫生保健环境中获得确证性诊断检测（如分子测定或分枝杆菌培养）的机会有限。这篇文章提供了结核病分诊试验评价的指导。结核病分类测试旨在用于有结核病症状和/或结核病重大风险因素的人。分诊测试是简单和低成本的测试，旨在提高访问和实施的便利性（与确认测试相比），并减少需要更昂贵的确认测试的患者比例。分类测试的评估应在预期用途的环境中进行，例如社区和初级医疗保健中心。分类检测评价的重要考虑因素包括研究设计、人群、样本类型、检测通量、阈值的使用、参考标准（理想情况下为培养物）和标本流量。分流测试的影响将在很大程度上取决于准确性之外的问题，主要集中在实施方面。
Approximately 3.6 million cases of active tuberculosis (TB) go potentially undiagnosed annually, partly due to limited access to confirmatory diagnostic tests, such as molecular assays or mycobacterial culture, in community and primary healthcare settings. This article provides guidance for TB triage test evaluations. A TB triage test is designed for use in people with TB symptoms and/or significant risk factors for TB. Triage tests are simple and low-cost tests aiming to improve ease of access and implementation (compared with confirmatory tests) and decrease the proportion of patients requiring more expensive confirmatory testing. Evaluation of triage tests should occur in settings of intended use, such as community and primary healthcare centers. Important considerations for triage test evaluation include study design, population, sample type, test throughput, use of thresholds, reference standard (ideally culture), and specimen flow. The impact of a triage test will depend heavily on issues beyond accuracy, primarily centered on implementation.