STTR Phase I: Rapid Diagnosis of Tuberculosis at the Point of Care Using a Handheld Volatile Biomarker Sensor

这个小型企业技术转移(STTR)第一阶段项目旨在开发一种廉价、快速的检测技术，用于在护理点(POC)检测结核病(TB)。在农村地区快速筛查结核病是困难的，因为目前的诊断方法昂贵、耗时(几天到几周)，而且需要专门的设备(实验室和医院)，而在农村结核病猖獗的地区，这些设备是不容易获得的。这项传感技术利用了基于金属功能化3D二氧化钛纳米管阵列的固态传感器，该阵列结合了导致结核病的分枝杆菌释放的特定挥发性生物标记物。终端用户的读数是一种电子信号，它根据电流的变化给出快速、肯定/否定的答案。该传感器操作简单，不需要专门的生物试剂进行传感(即抗体、荧光标记等)，只需一个简单的恒电位器即可操作。该项目有可能被开发成一种廉价的快速POC设备，用于使用类似呼气测定仪的设备来筛查结核病高危人群，该设备只需要最少的培训就可以操作。该项目的更广泛的影响/商业潜力是巨大的。结核病是世界上一种毁灭性的传染病，全世界约有1400万人感染。虽然西方世界的发病率有所下降，但在亚洲和非洲国家内仍有世界性的大流行。该公司打算满足市场对结核病快速诊断的需求，特别是在农村地区没有足够资源诊断结核病的流行国家。此外，预计该项目将把二氧化钛纳米管传感平台的应用范围扩大到结核病和其他领域以外的其他疾病。例如，众所周知，VOB与心脏移植排斥反应、肺癌、缺血性心脏病、妊娠先兆子痫、糖尿病和乳腺癌有关。该技术还可以应用于非生物医学应用，如检测饮用水中的挥发性有机化合物，以及检测简易爆炸装置。

This Small Business Technology Transfer (STTR) Phase I project is to develop an inexpensive and rapid sensing technology for detection of tuberculosis (TB) at the point of care (POC). Rapid screening of TB in rural areas is difficult because current diagnostic methods are expensive, time consuming (several days to weeks), and require specialized equipment (laboratories and hospitals) that are not readily available in rural TB rampant areas. This sensing technology utilizes a solid-state sensor based on metal functionalized 3D TiO2 nanotube arrays that bind specific volatile biomarkers that are given off by the mycobacterium that cause TB. The readout for the end-user is an electronic signal that gives a rapid, positive/negative answer based on change in current. The sensor is simple to operate, requires no specialized biological reagents for sensing (i.e. antibodies, fluorescent tags, etc.), and requires a simple potentiostat for operation. This project has the potential to be developed into an inexpensive rapid POC device for screening populations at risk for TB using a breathalyzer like device that requires minimal training to operate.The broader impact/commercial potential of this project is substantial. TB is a devastating infectious disease in the world with approximately 14 million people worldwide infected. Although incidences within the Western World have declined, there is still a worldwide pandemic within countries of Asia and Africa. The company intends to address the market need for a rapid diagnosis of TB, specifically in endemic countries where there are insufficient resources for diagnosis of the disease in rural areas. In addition it is envisioned that this project will expand the application of the TiO2 nanotube sensing platform to other diseases beyond TB and other fields. For example VOBs are known to be associated with heart transplant rejection, lung cancer, ischemic heart disease, preeclampsia of pregnancy, diabetes mellitus, and breast cancer. The technology can also be applied to non-biomedical applications such as detection of volatile organic compounds in drinking water, and detection of improvised explosive devices.