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

Document text

Principal Investigator: Shana O Kelley
Organization: UNIVERSITY OF TORONTO
Fiscal Year: 2021
Award: $295,888
Funding agency: National Institute of Biomedical Imaging and Bioengineering

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.

Terms: <2019 novel corona virus><2019 novel coronavirus><2019-nCoV><2019-nCoV S protein><2019-nCoV spike glycoprotein><2019-nCoV spike protein><Aerosols><American><Antibodies><Assay><BSL-3 facility><BSL3 facility><Binding><Bioassay><Biologic Assays><Biological><Biological Assay><Biological Markers><Buccal Cavity><Buccal Cavity Head and Neck><COVID crisis><COVID epidemic><COVID infected patient><COVID pandemic><COVID patient><COVID positive patient><COVID-19><COVID-19 S protein><COVID-19 assay><COVID-19 crisis><COVID-19 detection><COVID-19 epidemic><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health crisis><COVID-19 infected patient><COVID-19 infection><COVID-19 pandemic><COVID-19 patient><COVID-19 positive patient><COVID-19 public health crisis><COVID-19 spike glycoprotein><COVID-19 spike protein><COVID-19 virus><COVID19><COVID19  detection><COVID19 S protein><COVID19 assay><COVID19 crisis><COVID19 epidemic><COVID19 global health crisis><COVID19 global pandemic><COVID19 health crisis><COVID19 infection><COVID19 pandemic><COVID19 patient><COVID19 positive patient><COVID19 public health crisis><COVID19 spike glycoprotein><COVID19 spike protein><COVID19 virus><CV-19><CV19><Cavitas Oris><Cell Communication and Signaling><Cell Signaling><Clinical Research><Clinical Study><CoV-2><CoV2><Collaborations><Collection><Communicable Diseases><Communities><Complex><Data><Decentralization><Detection><Development><Device or Instrument Development><Devices><Diagnosis><Diagnostic><Diffusion><Disease><Disease Outbreaks><Disorder><Electrochemistry><Electrodes><Engineering><Future><Generations><Home><In Situ><Individual><Infection><Infectious Disease Pathway><Infectious Diseases><Infectious Disorder><Influenza Virus><Intracellular Communication and Signaling><Investigators><LMIC><Laboratories><Lateral><Liquid substance><Measurement><Methods><Molecular><Molecular Interaction><Motion><Mouth><Nature><Nucleic Acids><Oral cavity><Outbreaks><Patient Monitoring><Population><Process><Rapid screening><Reagent><Research Personnel><Researchers><SARS corona virus 2><SARS-CoV-2><SARS-CoV-2 S protein><SARS-CoV-2 assay><SARS-CoV-2 detection><SARS-CoV-2 epidemic><SARS-CoV-2 global health crisis><SARS-CoV-2 global pandemic><SARS-CoV-2 infected patient><SARS-CoV-2 infection><SARS-CoV-2 pandemic><SARS-CoV-2 patient><SARS-CoV-2 positive patient><SARS-CoV-2 spike glycoprotein><SARS-CoV-2 spike protein><SARS-CoV2><SARS-CoV2 S protein><SARS-CoV2 epidemic><SARS-CoV2 infection><SARS-CoV2 pandemic><SARS-CoV2 spike glycoprotein><SARS-CoV2 spike protein><SARS-associated corona virus 2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-coronavirus-2 epidemic><SARS-coronavirus-2 pandemic><SARS-related corona virus 2><SARS-related coronavirus 2><SARSCoV2><Saliva><Sampling><Severe Acute Respiratory Distress Syndrome CoV 2><Severe Acute Respiratory Distress Syndrome Corona Virus 2><Severe Acute Respiratory Distress Syndrome Coronavirus 2><Severe Acute Respiratory Syndrome CoV 2><Severe Acute Respiratory Syndrome CoV 2 epidemic><Severe Acute Respiratory Syndrome CoV 2 pandemic><Severe Acute Respiratory Syndrome-associated coronavirus 2><Severe Acute Respiratory Syndrome-related coronavirus 2><Severe acute respiratory syndrome associated corona virus 2><Severe acute respiratory syndrome corona virus 2><Severe acute respiratory syndrome coronavirus 2><Severe acute respiratory syndrome coronavirus 2 S protein><Severe acute respiratory syndrome coronavirus 2 epidemic><Severe acute respiratory syndrome coronavirus 2 infection><Severe acute respiratory syndrome coronavirus 2 pandemic><Severe acute respiratory syndrome coronavirus 2 spike glycoprotein><Severe acute respiratory syndrome coronavirus 2 spike protein><Severe acute respiratory syndrome related corona virus 2><Signal Transduction><Signal Transduction Systems><Signaling><Specificity><Surface><System><Systems Development><Technology><Testing><Time><United States><Universities><Validation><Viral><Viral Burden><Viral Diseases><Viral Gene Products><Viral Gene Proteins><Viral Load><Viral Load result><Viral Proteins><Virus><Virus Diseases><Wuhan coronavirus><antibody based test><antibody test><antigen based test><antigen test><base><bio-markers><biologic marker><biological signal transduction><biomarker><biosafety level 3 facility><combat><corona virus disease 2019><corona virus disease 2019 epidemic><corona virus disease 2019 pandemic><coronavirus disease 2019><coronavirus disease 2019 S protein><coronavirus disease 2019 assay><coronavirus disease 2019 crisis><coronavirus disease 2019 detection><coronavirus disease 2019 epidemic><coronavirus disease 2019 global health crisis><coronavirus disease 2019 global pandemic><coronavirus disease 2019 health crisis><coronavirus disease 2019 infected patient><coronavirus disease 2019 infection><coronavirus disease 2019 pandemic><coronavirus disease 2019 patient><coronavirus disease 2019 positive patient><coronavirus disease 2019 public health crisis><coronavirus disease 2019 spike glycoprotein><coronavirus disease 2019 spike protein><coronavirus disease 2019 virus><coronavirus disease crisis><coronavirus disease epidemic><coronavirus disease infected patient><coronavirus disease pandemic><coronavirus disease patient><coronavirus disease positive patient><coronavirus patient><cost><cost effective><design><designing><detect COVID-19><detect COVID19><detect SARS-CoV-2><detect severe acute respiratory syndrome coronavirus 2><detection assay><detection platform><detection system><developmental><device development><effective intervention><fluid><hCoV19><infected with COVID-19><infected with COVID19><infected with SARS-CoV-2><infected with SARS-CoV2><infected with coronavirus disease 2019><infected with severe acute respiratory syndrome coronavirus 2><infection rate><influenzavirus><instrument><instrument development><liquid><low and middle-income countries><medical countermeasure><mortality><mouse model><multidisciplinary><murine model><nCoV2><nasopharyngeal swab><new technology><novel><novel technologies><pandemic><pandemic disease><particle><pathogenic virus><patient infected with COVID><patient infected with COVID-19><patient infected with SARS-CoV-2><patient infected with coronavirus disease><patient infected with coronavirus disease 2019><patient infected with severe acute respiratory syndrome coronavirus 2><patient with COVID><patient with COVID-19><patient with COVID19><patient with SARS-CoV-2><patient with coronavirus disease><patient with coronavirus disease 2019><patient with severe acute respiratory distress syndrome coronavirus 2><point of care><portability><prevent><preventing><prototype><rapid testing><rate of infection><response><saliva analysis><saliva sample><salivary sample><screening><sensor><severe acute respiratory syndrome coronavirus 2 assay><severe acute respiratory syndrome coronavirus 2 detection><severe acute respiratory syndrome coronavirus 2 global health crisis><severe acute respiratory syndrome coronavirus 2 global pandemic><severe acute respiratory syndrome coronavirus 2 infected patient><severe acute respiratory syndrome coronavirus 2 patient><severe acute respiratory syndrome coronavirus 2 positive patient><tool><viral detection><viral infection><viral pathogen><virus detection><virus infection><virus pathogen><virus protein><virus-induced disease>