Development and Deployment of an Electrochemical Antigen Testing System for SARS-CoV-2

项目总结： 新冠肺炎大流行凸显了现有病毒感染检测方法的缺陷。 使用聚合酶链式反应或其他扩增策略诊断活动性感染仅限于集中检测 容量有限的设施。新的护理点分子检测方法，同时提供了一种手段 要在实验室外进行测试，吞吐量和周转时间较低，与 广泛、快速的筛查。此外，鼻咽拭子的使用是非常有问题的，因为 这种样品类型的获取和处理很困难。集成到横向流动设备中的抗体测试 使用更易处理的样本类型，并有效地估计感染率，但对 正在检测活动感染。 在这个建议中，我们描述了一种新的病毒检测方法，它是快速的，服从于大规模分散的 检测，并提供了一种新的手段来执行病毒感染评估作为一种工具，以应对当前 新冠肺炎大流行和控制未来的病毒爆发。支持这种方法的新技术是一种 使用电化学读数实现无试剂传感的突破，这将使快速 SARS-CoV-2感染筛查。传感器将直接检测病毒颗粒和病毒蛋白，基于 一种独特的信号传递机制，可用于口腔内或口腔内的原位测量 唾液样本。不需要外部试剂的事实使这种方法特别适合于 分散的按需测试。 项目交付成果将包括一个筛查系统，该系统将允许从 在与家庭社区筛查相关的时间范围内采集唾液样本(不产生气雾剂)。这 将加快高质量和实时数据的可用性，以支持快速响应以更好地检测 并管理新冠肺炎。此外，诊断设备的低成本和便携特性将允许 部署到低收入和中等收入国家，帮助防止新冠肺炎在这些国家迅速传播 人口。 快速病毒检测系统将：1)提供基于PCR的检测的替代方案，并加速 提供高质量的诊断信息，使美国人能够更好地管理疫情；2) 制定有效的干预措施，提供有关新冠肺炎状态的快速、可行的诊断信息； 3)使临床研究能够评估病毒载量作为医学对策的功能，通过促进系列 以及持续监测患者的SARS-CoV-2。

Project Summary: The COVID-19 pandemic has highlighted the shortcomings of existing testing approaches for viral infection. Diagnosing active infections using PCR or other amplification strategies is constrained to centralized testing facilities that have limited capacity. New point-of-care molecular testing approaches, while providing a means to test outside of laboratories, have low throughput and turnaround times that are not compatible with widespread, rapid screening. Moreover, the use of nasopharyngeal swabs is highly problematic given the difficultly of acquiring and processing this sample type. Antibody tests integrated into lateral flow devices utilize a more tractable sample type and are effective for estimating infection rates, but are not useful for detecting active infections. In this proposal we describe a new viral detection approach that is rapid, amenable to massively decentralized testing, and provides a new means to perform viral infection assessment as a tool to combat the current COVID-19 pandemic and control future viral outbreaks. The new technology powering this approach is a breakthrough in reagentless sensing accomplished using electrochemical readout that will enable rapid screening for SARS-CoV-2 infection. The sensors will directly detect viral particles and viral proteins based on a unique signal transduction mechanism and can be used for in situ measurements inside of the mouth or in saliva samples. The fact that no external reagents are required makes this approach particularly amenable to decentralized on-demand testing. Project deliverables will include a screening system that will allow for direct SARS-CoV-2 detection from a saliva sample (without the generation of aerosols) in a time frame relevant at-home community screening. This will accelerate the availability of high-quality and real-time data to support a rapid response to better detect and manage COVID-19. In addition, the low cost and portable nature of the diagnostic device will allow for deployment to low- and middle-income countries to help prevent the rapid spread of COVID-19 within those populations. The rapid viral detection system will: 1) Provide an alternative to PCR-based testing and accelerate the availability of high-quality diagnostic information to allow Americans to better manage the pandemic; 2) Develop an effective intervention that will provide rapid, actionable diagnostic information on COVID-19 status; 3) Enable clinical studies that assess viral load as a function of medical countermeasures by facilitating serial and continuous monitoring of patients for SARS-CoV-2.