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

SARS-CoV-2 电化学抗原检测系统的开发和部署

• 批准号: 10195248
• 负责人: Shana O Kelley
• 金额: $ 29.59万
• 依托单位: UNIVERSITY OF TORONTO
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10195248
• 关键词: 2019-nCoV; Aerosols; American; Antibodies; Binding; Biological; Biological Assay; Biological Markers; COVID-19; COVID-19 assay; COVID-19 detection; COVID-19 pandemic; COVID-19 patient; Clinical Research; Collaborations; Collection; Communicable Diseases; Communities; Complex; Data; Decentralization; Detection; Development; Device or Instrument Development; Devices; Diagnosis; Diagnostic; Diffusion; Disease; Disease Outbreaks; Electrochemistry; Electrodes; Engineering; Future; Generations; Home; In Situ; Individual; Infection; Laboratories; Lateral; Liquid substance; Measurement; Methods; Molecular; Motion; Nature; Nucleic Acids; Oral cavity; Patient Monitoring; Population; Process; Rapid screening; Reagent; Research Personnel; SARS-CoV-2 infection; SARS-CoV-2 spike protein; Saliva; Sampling; Signal Transduction; Specificity; Surface; System; Systems Development; Technology; Testing; Time; United States; Universities; Validation; Viral; Viral Load result; Viral Proteins; Virus; Virus Diseases; antibody test; antigen test; base; biosafety level 3 facility; combat; cost; cost effective; design; detection assay; detection platform; effective intervention; infection rate; influenzavirus; instrument; low and middle-income countries; medical countermeasure; mortality; mouse model; multidisciplinary; nasopharyngeal swab; new technology; novel; pandemic disease; particle; pathogenic virus; point of care; portability; prevent; prototype; rapid testing; response; saliva analysis; saliva sample; screening; sensor; tool; viral detection

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.

项目概要： COVID-19 大流行凸显了现有病毒感染检测方法的缺陷。 使用 PCR 或其他扩增策略诊断活动性感染仅限于集中测试 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 在实验室外进行测试，吞吐量低且周转时间与 广泛、快速的筛查。此外，鉴于鼻咽拭子的使用存在很大问题 获取和处理这种样本类型很困难。抗体测试集成到侧流装置中 使用更容易处理的样本类型，可有效估计感染率，但对以下情况没有用处： 检测活动性感染。 在本提案中，我们描述了一种新的病毒检测方法，该方法快速且适合大规模去中心化 测试，并提供了一种进行病毒感染评估的新方法，作为对抗当前病毒感染的工具 COVID-19 大流行并控制未来的病毒爆发。支持这种方法的新技术是 使用电化学读数实现无试剂传感的突破，这将使得快速 筛查 SARS-CoV-2 感染。传感器将直接检测病毒颗粒和病毒蛋白 独特的信号转导机制，可用于口腔内或体内的原位测量 唾液样本。不需要外部试剂的事实使得这种方法特别适合 分散的按需测试。 项目可交付成果将包括一个筛查系统，该系统将允许直接检测来自 在与家庭社区筛查相关的时间范围内采集唾液样本（不产生气溶胶）。这 将加速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 COVID-19。此外，诊断设备的低成本和便携性将允许 向低收入和中等收入国家部署，以帮助防止 COVID-19 在这些国家内迅速传播 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这一流行病； 2） 制定有效的干预措施，提供有关 COVID-19 状态的快速、可操作的诊断信息； 3) 通过促进一系列临床研究来评估病毒载量作为医疗对策的函数 持续监测患者的 SARS-CoV-2。