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

这个小型企业创新研究（SBIR）第二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，以测量呼出气体中13 C与12 C同位素丰度的比率。紧凑型分析仪将作为医疗诊断仪器，并将在护理点设置中运行。该仪器将强大的激光级二极管激光器与离轴ICOS相结合，离轴ICOS是一种创新技术，可提供极长的光程（通常为几公里），以实现激光灵敏度。该仪器将是廉价的，便携式和易于使用的，并报告测量13 CO2/12 CO2具有足够的灵敏度和精度，以取代质谱法在13 C标记的呼吸测试诊断的几种疾病。之前的第一阶段工作已经成功地证明了一个实验室仪器的精度为0.24每密耳（0.024%）在不到6分钟。在第二阶段，将开发一种能够自主操作的原型仪器，并在正在进行的临床试验中进行测试。该项目的商业影响将是巨大的，因为拟议的仪器将有助于在医生办公室快速诊断胃肠道疾病，从而提高患者对治疗方案的依从率。

This Small Business Innovation Research (SBIR) Phase II project proposes to develop a carbon isotope ratio analyzer based on Off-Axis Integrated Cavity Output Spectroscopy to measure the ratio of the isotopic abundances of 13C to 12C in exhaled breath. The compact analyzer will serve as a medical diagnostic instrument and will operate in a point-of-care setting. The instrument combines robust telecommunications-grade diode lasers with Off-Axis ICOS, an innovative technology that provides extremely long optical paths (several kilometers typical) for ultrahigh sensitivity. The instrument will be inexpensive, portable and easy to use and report measurements of 13CO2/12CO2 with sufficient sensitivity and precision to replace mass spectrometry in 13C-labeled breath tests for diagnosis of several diseases. Prior Phase I work has successfully demonstrated a laboratory instrument with a precision of 0.24 per mil (0.024%) in less than 6 minutes. In Phase II, a prototype instrument capable of autonomous operation, will be developed and tested in on-going clinical trials. The commercial impact of the project will be significant, as the proposed instrument will aid in quick diagnosis of gastrointestinal diseases at the doctor's office, thereby enhancing rates of patients' compliance with treatment regimens.