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疫情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检测 能力有限的设施。新的即时分子检测方法，同时提供一种手段 在实验室外进行测试，吞吐量低，周转时间短，与 广泛快速的筛查此外，由于使用鼻咽拭子， 这类样品的采集和处理困难。抗体检测集成到侧流装置中 利用更易处理的样本类型，有效估计感染率，但对 检测活动性感染 在这项提案中，我们描述了一种新的病毒检测方法，该方法快速，易于大规模分散 测试，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，以打击目前的 COVID-19大流行及控制未来病毒爆发。为这种方法提供动力的新技术是 使用电化学读出实现无试剂传感的突破， 筛查SARS-CoV-2感染。传感器将直接检测病毒颗粒和病毒蛋白， 独特的信号传导机制，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得这种方法特别适合于 分散式按需测试。 项目交付成果将包括一个筛查系统，该系统将允许从一个或多个国家直接检测SARS-CoV-2。 唾液样本（不产生气溶胶）在一个时间框架相关的家庭社区筛查。这 将加快高质量和实时数据的可用性，以支持快速响应，更好地检测 并应对COVID-19。此外，诊断设备的低成本和便携性质将允许 部署到低收入和中等收入国家，以帮助防止COVID-19在这些国家的快速传播 人口。 快速病毒检测系统将：1）为基于PCR的检测提供替代方案，并加速 提供高质量的诊断信息，使美国人能够更好地管理流行病; 2） 制定有效的干预措施，提供关于COVID-19状况的快速、可操作的诊断信息; 3)通过促进系列研究，使临床研究能够评估病毒载量作为医学对策的函数 并持续监测患者的SARS-CoV-2情况。