SBIR Phase I: Novel Breath Diagnostic Instrument for Detection of Disease

这项小型企业创新研究（SBIR）第一阶段项目建议开发一种基于离轴集成腔输出光谱的碳同位素比率分析仪，以真实的时间测量呼出气体中C13与C12的比率。该分析仪将作为医疗诊断仪器，将在护理点设置和参考实验室中运行。该仪器将是廉价的、便携式的、易于使用的，并且以足够的灵敏度和精确度报告C13/ C12测量，以取代C13标记的呼吸测试中的质谱法，用于诊断许多状况，包括暴露于化学和生物战剂、败血症、评估肝脏和胰腺功能、胃排空延迟、细菌过度生长、肠易激综合征和病毒感染。 第一阶段项目将开发一种仪器，使用C13-尿素呼气试验确定幽门螺杆菌（一种1类致癌物）引起的感染。第二阶段的项目将开发一个用于临床试验的原型商业仪器。该项目的商业应用是在医疗诊断领域。

This Small Business Innovation Research (SBIR) Phase I project proposes to develop a carbon isotope ratio analyzer based on Off-Axis Integrated Cavity Output Spectroscopy to measure the ratio of C13 to C12 in exhaled breath in real time. The analyzer will serve as a medical diagnostic instrument that will operate in a point-of-care setting and reference labs. The instrument will be inexpensive, portable, easy-to-use and report C13/ C12 measurements with sufficient sensitivity and precision to replace mass spectrometry in C13-labeled breath tests for diagnosis of a number of conditions, including exposure to chemical and biological warfare agents, sepsis, assessment of liver and pancreatic function, delayed gastric emptying, bacterial overgrowth, irritable bowel syndrome and viral infection. The Phase I Project will develop an instrument to determine infection due to Helicobacter pylori, a Class-1 carcinogen, using the C13-urea breath test. The follow on Phase II Project will develop a prototype commercial instrument for clinical trials.The commercial application of this project is in the area of medical diagnostics.