SBIR Phase I: Personal radiation biodosimetry using thin-film acoustic resonators

这个小型企业创新研究第一阶段项目将开发一个个人辐射生物剂量测量平台，用于辐射暴露的护理点评估。这利用了一种新的传感器阵列平台，它将以低成本、主动的一次性格式实现无标记生物标记物的量化。这项技术利用了集成电路的能力和规模经济，这些集成电路在过去50年里为高性能计算和成像而建立，用于低成本的生物电子应用。薄膜体声谐振器(FBAR)直接与硅集成电路结合，形成密集的生物传感器阵列。与定制的微芯片集成，可以在几平方毫米内并行测量数十个传感器。与抗体固定化相结合，这使得通过一个简单的数字界面实时进行多重蛋白质分析成为可能。这项工作的第一阶段将对已建立的辐射暴露标志物伽马-H_2A.X进行灵敏的生物电子分析，以评估该技术用于生物剂量测定应用的可行性。这项工作包括开发一种基于裂解物的伽马-H_2A.X免疫吸附试验，使该分析适应传感器平台，并展示集成的生物剂量测定装置。该项目更广泛的影响/商业潜力是对现有辐射生物剂量测量解决方案的颠覆性改进。目前的微创生物剂量学策略依赖于建立具有高通量分析处理的集中式测试中心。样本必须被收集并运输到检测中心，运输网络经常在辐射释放事件的同时受到影响。一个医疗点生物剂量测定平台将允许现场剂量量化，以进行适当的医疗分类和紧急处理。这是筹备和应对核释放事件的关键和未得到满足的需要。作为一种商业产品，该设备将被购买，用于预先部署到有核泄漏和辐射暴露风险的地区，包括城市中心、核反应堆地点、医院和当地诊所。潜在客户包括联邦、州和市政当局、商业核反应堆运营商、医院和医疗诊所。一项成功的产品实施将把目前的生物剂量测试网络的覆盖范围从中央实验室直接扩展到应急响应地点。从长远来看，这里采用的基础技术将为一系列多元化的护理点应用奠定基础，在传染病、癌症诊断、自身免疫性疾病监测、创伤响应和现场医疗测试方面具有明确的临床和商业机会。

This Small Business Innovation Research Phase I project will develop a personal radiation biodosimetry platform for point-of-care assessment of radiation exposure. This utilizes a novel sensor array platform that will enable label-free biomarker quantification in a low-cost, active disposable format. This technology leverages the power and economies of scale of integrated circuits, built up over the previous fifty years for high-performance computation and imaging, for low-cost, bioelectronic applications. Thin-film bulk acoustic resonators (FBARs) are incorporated directly with silicon integrated circuits to form a dense biosensor array. Integration with a custom microchip enables parallel measurement of dozens of sensors in a few square millimeters. Combined with antibody immobilization, this enables multiplex protein assays in real time through a simple digital interface. Phase I of this effort will demonstrate a sensitive bioelectronic assay for the established radiation exposure marker gamma-H2A.X to assess feasibility of the technology for biodosimetry applications. This effort includes the development of a lysate-based gamma-H2A.X immunosorbent assay, adaptation of this assay to the sensor platform, and demonstration of the integrated biodosimetry device. The broader impact/commercial potential of this project is the disruptive improvement of existing radiation biodosimetry solutions. Current strategies for minimally-invasive biodosimetry rely on the establishment of centralized testing centers with high-throughput assay processing. Samples must be collected and transported to a testing center, with transportation networks often compromised alongside a radiation release event. A point-of-care biodosimetry platform would allow on-site dose quantitation for appropriate medical triage and emergency management. This is a critical and unmet need for the preparation and response to a nuclear release event. As a commercial product, the device would be purchased for pre-deployment to areas at risk for nuclear release and radiation exposure, including urban centers, nuclear reactor sites, hospitals, and local clinics. Potential customers include federal, state, and municipal authorities, commercial nuclear reactor operators, hospitals, and medical clinics. A successful product implementation will extend the reach of current biodosimetry test networks outward from central laboratories directly to emergency response sites. In the long term, the underlying technology employed here will lay the foundation for a host of multiplexed point-of-care applications, with clear clinical and commercial opportunities in infectious disease, cancer diagnostics, autoimmune disease monitoring, trauma response, and in-the-field medical testing.