SBIR Phase I: Breathalyzer for Non-invasive Disease Detection Using a Single Ammonia Sensor

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力在于有机会提供准确的实时信息，以激励患者管理他们的疾病；推动基于证据的早期干预；以及防止不必要的医生就诊和住院。这种非侵入性的呼吸测定仪将测量呼气中氨的水平。高氨水平与晚期肝病、尿素循环紊乱(UCD)或药物不良反应等情况有关。它有严重的后果：迷失方向、器官/大脑损伤、昏迷甚至死亡，因此必须采取措施迅速减少全身氨，如果原因不明，还会引发进一步的诊断活动。目前，氨水平是通过血液测试来确定的，这是有创的，需要时间，需要去实验室/医院就诊，而且容易出错。目前还没有工具可以实时准确地测量氨。该设备将使患者和家属能够控制并做出更好的决定：吃什么，什么时候不开车，什么时候去医院，等等。这可以提高生产力，提高患者及其家人的生活质量，避免不必要的医疗支出，并拯救生命。拟议中的项目寻求开发一种呼气测定仪原型，以检测呼气中的氨。预计该设备将向患者和临床医生提供临床上准确的实时信息。氨作为蛋白质新陈代谢的副产品自然出现，但如果水平升高，它就是疾病的征兆，可能会产生非常严重的后果。当代研究已经在呼气中发现了大约250种常见的挥发性有机化合物，其中许多与特定的疾病有关。微小的浓度差异可以检测一个人是健康的还是生病的。这需要高灵敏度、高选择性和耐用的传感器，能够在高湿度下工作。核心平台是反应喷射沉积技术，这是一种专有的传感器制造技术，可以创建多孔纳米结构金属氧化物颗粒层，并能够以低成本提供快速响应时间的结果。这是因为能够通过一步法从开放大气中的气相中轻松且廉价地生产不同形态的材料。该项目的最终产品将是利用单一传感器检测NH3的原型。它将包括一种新型的呼气输送系统和相关的信号处理算法，用于根据传感器的响应来量化呼气中的气体浓度。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project lies in the opportunity to provide accurate, real time information to motivate patients to manage their disease; drive early, evidenced-based interventions; and prevent unnecessary physician visits and hospital stays. This non-invasive device, a breathalyzer, will measure the level of ammonia in exhaled breath. High ammonia levels are associated with conditions such as advanced liver disease, urea cycle disorders (UCD), or adverse reactions to medication. It has serious consequences: disorientation, organ/brain damage, coma and even death, making it important to take steps to quickly reduce systemic ammonia and, if the cause is unknown, trigger further diagnostic activities. Currently, ammonia levels are determined through blood testing, which is invasive, takes time, requires a lab/hospital visit, and is prone to errors. There are no tools available to accurately measure ammonia, real time. The device will enable patients and families to take control and make better decisions: what to eat, when not to drive, when to go to the hospital, among other things. This can improve productivity, enhance quality of life for patients and their families, avoid unnecessary healthcare expenditures, and save lives. The proposed project seeks to develop a breathalyzer prototype to detect ammonia in exhaled breath. The device is expected to provide clinically-accurate, real time information to patients and clinicians. Ammonia occurs naturally as a by-product of protein metabolism but, at elevated levels, it is indicative of disease and can have very serious consequences. Contemporary research has identified roughly 250 common volatile organic compounds in exhaled breath, many associated with specific diseases. Small concentration differences can detect whether someone is healthy or ill. This requires highly sensitive, selective and durable sensors that can perform in high humidity. The core platform is a Reactive Spray Deposition technology, a proprietary sensor manufacturing technology that creates a porous nanostructure metal oxides grains layer, and is able to provide results with a fast response time at a low cost. This results from the ability to easily and inexpensively produce different morphologies of materials from the vapor phase in the open atmosphere in a one-step process. The end-product of this project will be a prototype utilizing a single sensor for detection of NH3. It will include a novel breath delivery system and associated signal processing algorithms for quantification of the gas concentration in breath, based on the sensor response.