VOLATILE MARKERS OF PULMONARY TUBERCULOSIS IN THE BREATH

描述（由申请人提供）：背景：肺结核（TB）是一个日益严重的公共卫生问题，检测往往昂贵且耗时。对分枝杆菌挥发性标记物的呼气测试可能为该病提供一种新的测试方法。一种先进的新呼吸测试常规检测呼吸中的挥发性有机化合物（VOCs），浓度为皮摩尔（10-12 mol/l）。结核分枝杆菌制造挥发性脂肪酸和其他挥发性代谢物；在呼吸中检测这些挥发性有机化合物可为活动性肺结核患者提供一种准确、快速、廉价和无创的感染新标志物。

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.