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

这个小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，用于即时评估辐射暴露。这利用了一种新颖的传感器阵列平台，将以低成本、主动的一次性形式实现无标签生物标志物定量。这项技术利用了集成电路的力量和规模经济，在过去的50年里，集成电路建立了高性能计算和成像，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。集成了定制的微芯片，可以在几平方毫米内平行测量几十个传感器。结合抗体固定化，这可以通过简单的数字界面实时进行多重蛋白质检测。这项工作的第一阶段将展示一种灵敏的生物电子分析方法，用于既定的辐射暴露标记γ - h2a。X评估该技术应用于生物剂量学的可行性。这项工作包括开发一种基于裂解物的γ - h2a。X免疫吸附试验，该试验适用于传感器平台，以及集成生物剂量测定装置的演示。该项目的更广泛影响/商业潜力是对现有辐射生物剂量测定解决方案的颠覆性改进。目前的微创生物剂量测定策略依赖于建立具有高通量分析处理的集中检测中心。样本必须收集并运送到一个测试中心，而运输网络往往会在辐射释放事件发生时受到影响。医疗点生物剂量测定平台将允许为适当的医疗分类和应急管理进行现场剂量定量。这是准备和应对核泄漏事件的关键和未得到满足的需求。作为一种商业产品，将购买该装置，以便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、核反应堆场址、医院和地方诊所。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。产品的成功实施将使目前的生物剂量测定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许多多路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、创伤反应和现场医学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.