Guidance for Studies Evaluating the Accuracy of Rapid Tuberculosis Drug-Susceptibility Tests
Guidance for Studies Evaluating the Accuracy of Rapid Tuberculosis Drug-Susceptibility Tests
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DOI：
10.1093/infdis/jiz106
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发表时间：
2019-11-15
影响因子：
6.4
通讯作者：
Denkinger, Claudia M.
中科院分区：
文献类型：
--
作者：
Georghiou, Sophia B.;Schumacher, Samuel G.;Denkinger, Claudia M.
结核病 (TB) 药物敏感性测试的快速分子诊断的开发和实施对于为患者的治疗提供信息并防止耐药性的出现和传播至关重要。现有测试和正在开发的测试的最佳试验计划对于快速收集为世界卫生组织审查提供信息和支持潜在政策建议所需的证据至关重要。必要的证据包括对结核病和耐药性检测性能的评估以及对这些平台操作特征的评估。性能评估应包括分析研究，以确认检测限度和检测能力，以检测全球代表性菌株中产生耐药性的突变。分析评估之后通常进行多地点临床评估研究，以确认预期用途的地点和人群的诊断性能。本文总结了这些分析和临床研究设计的考虑因素。
The development and implementation of rapid molecular diagnostics for tuberculosis (TB) drug-susceptibility testing is critical to inform treatment of patients and to prevent the emergence and spread of resistance. Optimal trial planning for existing tests and those in development will be critical to rapidly gather the evidence necessary to inform World Health Organization review and to support potential policy recommendations. The evidence necessary includes an assessment of the performance for TB and resistance detection as well as an assessment of the operational characteristics of these platforms. The performance assessment should include analytical studies to confirm the limit of detection and assay ability to detect mutations conferring resistance across globally representative strains. The analytical evaluation is typically followed by multisite clinical evaluation studies to confirm diagnostic performance in sites and populations of intended use. This paper summarizes the considerations for the design of these analytical and clinical studies.