VOLATILE MARKERS OF PULMONARY TUBERCULOSIS IN THE BREATH

描述(申请人提供)：背景：肺结核是一个日益严重的公共卫生问题，检测通常是昂贵和耗时的。对分枝杆菌挥发性标志物的呼气测试可能会为这种疾病提供一种新的测试方法。一种先进的新呼气测试常规检测呼气中的挥发性有机化合物(VOC)，浓度为皮摩尔(10-12mol/L)。结核分枝杆菌制造挥发性脂肪酸和其他挥发性代谢物；检测呼吸中的这些VOCs可以提供一种准确、快速、廉价和非侵入性的新标记物，用于诊断活动性肺结核患者的感染情况。 实验计划：体外研究：用气相色谱和质谱仪鉴定结核分枝杆菌培养物中的挥发性代谢物。人体研究：在被评估为疑似肺结核的患者中，呼吸VOCs将在有疾病和没有疾病的患者中进行比较。呼气试验的敏感度、特异度、阳性预测值和阴性预测值将被确定。 长期目标：a.科学：确定呼吸标志物诊断结核分枝杆菌的准确性。B.技术：开发一种相对便宜、小型化和快速的呼吸测试，适用于临床和欠发达国家。C.商业：获得食品和药物管理局(FDA)对该设备的批准并将其推向市场。

DESCRIPTION (provided by applicant): Background: Pulmonary tuberculosis (TB) is a growing public health problem, and detection is often costly and time-consuming. A breath test for volatile markers of Mycobacteria could provide a new test for the disease. An advanced new breath test routinely detects volatile organic compounds (VOCs) in breath in picomolar (10-12 mol/l) concentrations. M. tuberculosis manufactures volatile fatty acids and other volatile metabolites; detection of these VOCs in breath could provide an accurate, rapid, inexpensive and non-invasive new marker of infection in patients with active pulmonary TB. Experimental plan: In vitro study: Volatile metabolites in cultures of M. tuberculosis will be identified by gas chromatography and mass spectroscopy. Human study: In patients evaluated for suspected pulmonary TB, breath VOCs will be compared in those with and without disease. The sensitivity, specificity, and positive and negative predictive values of the breath test will be determined. Long term aims: a. Scientific: To determine the diagnostic accuracy of breath markers of M. tuberculosis. b. Technical: to develop a comparatively inexpensive miniaturized and rapid breath test suitable for clinical use and in less developed countries. c. Commercial: To obtain Food and Drug Administration (FDA) approval of the device and market it.