Non-invasive diagnosis of adult pulmonary tuberculosis

项目概要/摘要 该项目将验证一种用于诊断活动性肺结核（TB）的新型样本类型。肺 结核病通常通过分析痰液来检测，痰液是一种来自患者气道深处的粘性物质。 通过使用更安全、更简单和更统一的样本，诊断将得到简化。我们假设口腔 拭子分析（OSA）可以满足这一需求。在OSA中，口腔的内表面被轻轻地刮擦， 一次性拭子，然后使用定量PCR（qPCR）检测结核分枝杆菌DNA。 口腔拭子比痰液更容易收集、处理和加工。擦拭是无痛的，非侵入性的， 只需几秒钟;整个教室或工作场所可以在几分钟内采样。的患者 不能产生痰液的患者可以很容易地被OSA采样。 初步结果表明，M.结核病DNA通常在诊断有用的 成人和儿童结核病患者口腔内的表面（舌头和内部脸颊）上的量。的 在成人中OSA的诊断率接近或匹配痰的诊断率。该项目将完善，表征， 并验证OSA作为痰液分析用于肺结核诊断的替代或补充。的 本研究将完成以下目标：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 优化的OSA方法相对于诊断金标准的性能。 OSA可以促进床旁诊断策略，相对于单独痰液提高诊断率， 并大大简化了不能产生痰的病人的护理。它还可以促进积极的案件 寻找战略，从而减少许多环境中的结核病传播。因此，对阻塞性睡眠呼吸暂停综合症的验证可以 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.