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

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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.