FEND for TB

摘要 响应RFA-AI-19-030，结核病流行国家新型诊断方法的可行性 （FEND-TB）领导团队汇集了一批经验丰富的调查人员 并制定了一项研究计划，以解决关键的未满足的结核病诊断需求。 该计划受益于NIH成功的7年任期内获得的经验 由DMID资助的结核病临床诊断研究联盟（TB-CDRC）， 领导层、调查人员和研究中心。该计划已在几个方面进行了调整，以进一步 加强能力，以应对目前在外地的挑战-与 创新新诊断基金会（FIND）已得到加强，目前已全面 促进获得尖端技术和协调FEND-TB工作的伙伴关系 与全球利益相关者的优先事项;印度和秘鲁的临床研究中心已被添加到 加速招募并增强招募患有合并症和药物的患者的能力- 阻力;包括一个成熟的分析实验室和修订的技术评价战略 这两个因素共同允许对早期诊断进行合理、灵活、逐步的评估;以及 纳入数学建模能力，为结核病流行的最佳诊断策略提供信息 设置.这个提议将检验两个主要假设：A.新型结核病早期诊断， 目标细菌和/或宿主目标，并将在未来五年内进行评估，将有 适用于TB检测的护理点（POC）/近护理使用的性能特征， 分诊或药物敏感性测试B。快速无痰诊断将提供辅助 支持作为儿童结核病和少杆菌结核病诊断算法的组成部分， 成人肺结核和肺外结核。具体目标是：1。评价其诊断 结核病早期诊断试验的准确性。2.识别新的早期阶段 评估诊断，并制定和实施每一个逐步评估计划。3. 使用经济分析和传输建模来设计最佳诊断算法。

ABSTRACT In response to RFA-AI-19-030, Feasibility of Novel Diagnostics for TB in Endemic Countries (FEND-TB) the leadership team has brought together a consortium of experienced investigators and clinical sites and developed a research plan to address critical unmet TB diagnostic needs. This program benefits from experience gained during the successful 7-year tenure of the NIH DMID-funded TB-Clinical Diagnostics Research Consortium (TB-CDRC), with overlap in leadership, investigators and sites. This program has been adapted in several ways to further enhance capacity to meet the current challenges in the field -- the successful collaboration with the Foundation for Innovative New Diagnostics (FIND) has been strengthened to now a full partnership that will facilitate access to cutting edge technologies and alignment of FEND-TB work with global stakeholder priorities; clinical study sites in India and Peru have been added to accelerate recruitment and augment capacity to enroll patients with co-morbidities and drug- resistance; inclusion of a mature analytic laboratory and revised technology evaluation strategy that together allow for rational, nimble, step-wise evaluation of early-stage diagnostics; and inclusion of mathematical modeling capacity to inform optimal diagnostic strategies in TB endemic settings. This proposal will test two main hypotheses: A. Novel early stage TB diagnostics, that target bacterial and/or host targets and will be ready for evaluation in the next five years, will have performance characteristics suitable for point of care (POC)/near-care use for TB detection, triage, or drug susceptibility testing. B. Rapid non-sputum diagnostics will provide ancillary support as components of algorithms for the diagnosis of childhood TB as well as paucibacillary pulmonary TB and extrapulmonary TB in adults. Specific Aims are: 1. To evaluate the diagnostic accuracy of early stage diagnostic tests for tuberculosis. 2. To identify new early stage diagnostics for evaluation, and to develop and implement for each a stepwise evaluation plan. 3. To use economic analysis and transmission modelling to design optimal diagnostic algorithms.