Non-invasive diagnosis of adult pulmonary tuberculosis

项目摘要/摘要 该项目将验证一种用于诊断活动性肺结核(TB)的新样本类型。肺 肺结核通常是通过分析痰来发现的，痰是一种来自患者呼吸道深处的粘性物质。 使用更安全、更简单、更均匀的样本将简化诊断。我们假设口头的 拭子分析(OSA)可以满足这一需求。在阻塞性睡眠呼吸暂停综合症中，口腔的内表面被一块 一次性拭子，然后用定量聚合酶链式反应(QPCR)检测结核分枝杆菌DNA。 口腔拭子比痰更容易收集、处理和处理。擦拭是无痛的，非侵入性的， 只需要几秒钟；整个教室或工作场所的样本可以在几分钟内完成。患者是 不能产生痰可以很容易地被OSA采样。 初步结果表明，结核分枝杆菌dna在诊断中的常规积累是有用的。 成人和儿童结核病患者口腔表面(舌头和面颊内侧)的数量。这个 成人OSA的诊断率接近或匹配于痰。这个项目将提炼，刻画， 并验证OSA作为痰分析诊断肺结核的替代或补充方法。这个 将完成以下目标：1)优化和验证OSA采样方法；2)表征 影响OSA结果的行为、微生物、生理和临床因素；3)量化 相对于诊断黄金标准的优化OSA方法的性能。 OSA可以促进就诊诊断策略，相对于单纯的痰，提高诊断效率， 并极大地简化了对不能产生痰的患者的护理。它还可以促进正在审理的案件 寻找战略，导致在许多情况下减少结核病传播。因此，OSA的验证可以 改变全球抗击结核病的斗争。

Project Summary/Abstract This project will validate a novel sample type for diagnosis of active pulmonary tuberculosis (TB). Pulmonary TB is usually detected by analysis of sputum, a viscous material derived from deep in the airways of patients. Diagnosis would be simplified by using a safer, simpler, and more uniform sample. We hypothesize that oral swab analysis (OSA) can meet this need. In OSA an interior surface of the mouth is gently scraped with a disposable swab, which is then tested for Mycobacterium tuberculosis DNA by using quantitative PCR (qPCR). Oral swabs are much easier to collect, handle, and process than sputum. Swabbing is painless, non-invasive, and requires just seconds; an entire classroom or workplace can be sampled in minutes. Patients who are unable to produce sputum can easily be sampled by OSA. Preliminary results demonstrate that M. tuberculosis DNA routinely accumulates in diagnostically useful amounts on surfaces (tongues and interior cheeks) within the mouths of adult and pediatric TB patients. The diagnostic yield of OSA in adults approaches or matches that of sputum. This project will refine, characterize, and validate OSA as an alternative or supplement to sputum analysis for pulmonary TB diagnosis. The following Aims will be completed: 1) To optimize and validate OSA sampling methodologies; 2) to characterize behavioral, microbiological, physiological, and clinical factors affecting OSA results; 3) to quantify the performance of optimized OSA methodologies relative to diagnostic gold standards. OSA could facilitate point-of-care diagnostic strategies, improve diagnostic yields relative to sputum alone, and greatly simplify the care of patients who cannot produce sputum. It could also facilitate active case finding strategies, leading to reduced TB transmission in many settings. Thus, validation of OSA could transform the global fight against TB.