FEND for TB

摘要 响应RFA-AI-19-030，新的结核病诊断方法在流行国家的可行性 (fend-TB)领导团队召集了一个由经验丰富的调查人员组成的财团 并制定了一项研究计划，以满足关键的未得到满足的结核病诊断需求。 这项计划得益于在美国国立卫生研究院7年的成功任职期间获得的经验。 DMID资助的结核病临床诊断研究联盟(TB-CDRC)，在 领导层、调查人员和现场。该计划已在几个方面进行了调整，以进一步 提高能力以应对目前的外地挑战--与 创新新诊断(FIND)的基础已经得到加强，现在已经完全 将促进获得尖端技术和协调防控结核病工作的伙伴关系 具有全球利益相关者优先事项；印度和秘鲁的临床研究地点已增加到 加快招募和扩大能力，以招募合并疾病和药物的患者- 抵抗力；纳入成熟的分析实验室和修订的技术评估战略 它们共同允许对早期诊断进行合理、灵活和循序渐进的评估；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。这项提议将检验两个主要假设：a.新的早期结核病诊断，即 目标细菌和/或宿主目标，并将在未来五年内准备好进行评估，将具有 适合用于结核病检测的护理点(POC)/近护理使用的性能特征， 分诊，或药物敏感性测试。B.快速非痰诊断将提供辅助 作为诊断儿童结核病和少菌症算法的组成部分的支持 成人的肺结核病和肺外结核病。具体目标是：1.评估诊断 结核病早期诊断试验的准确性。2.识别新的早期阶段 诊断以供评估，并为每一项制定和实施逐步评估计划。3. 利用经济分析和传输模型设计最优诊断算法。

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.