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Principal Investigator: DAVID S DANDY
Organization: COLORADO STATE UNIVERSITY
Fiscal Year: 2021
Award: $988,864
Funding agency: National Institute of Biomedical Imaging and Bioengineering
PROJECT SUMMARY
The current SARS-CoV-2 outbreak has begun to reshape how we think about and use diagnostic assays for
preventing the spread of infectious diseases. Early diagnostic efforts specific to SARS focused almost solely
on detecting the virus using nucleic acid amplification tests; more recently detection of circulating antibodies
using ELISA to complete serological screening. While these techniques can provide accurate results, they
require laboratory facilities and equipment, creating a significant delay between sampling and results. Rapid
diagnostic tests in the form of lateral flow assays have appeared more recently but so far have lacked the
sensitivity and selectivity to be useful for slowing disease spread. Another challenge with current approaches is
that they require different molecular approaches for different markers making creation of a single test that can
determine if an individual is or has been infected is challenging. As a result, there is a clear and pressing need
to develop a single sensing platform that can quantitatively detect ng/mL levels of both viral antigens
produced during infection and circulating antibodies at the point-of-care from blood, saliva, or nasal swabs
that can be used by essentially anyone with little or no training. The goal of this project is to create a simple,
inexpensive, and deployable electrochemical paper-based analytical device (ePAD) for detecting SARS-CoV-2
antigens and antibodies in blood, saliva, and nasopharyngeal swabs. Our device will combine three innovative
components: a label-free electrochemical biosensor, a disposable near field communication (NFC)
potentiostat, and a self-powered microfluidic device that performs complex sample preparation steps without
user intervention. This system, the NFC-ePAD, will allow a user to literally add sample and press a button on
the sensor and then place their phone on the unit to initiate the measurement. The phone activates the sensor
and reports the results to the user. To achieve our goal, we are collaborating with colleagues at Chulalongkorn
University and Silicon Craft™ in Thailand. Our aims are 1) demonstrate a sensitive label-free biosensor for
circulating SARS-CoV-2 nucleocapsid protein and anti-spike receptor binding domain (RBD) antibodies, 2)
create a self-power microfluidic device for sample processing, and 3) validate the system using deidentified,
banked clinical samples. Once developed, the system will provide a fast, simple, and easy-to-use platform for
healthcare providers and individuals alike to rapidly determine the infection and immune status of potential
COVID-19 patients.
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2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-related corona virus 2><SARS-related coronavirus 2><SARSCoV2><Saliva><Sampling><Sensitivity and Specificity><Serology><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><Severe Acute Respiratory Syndrome CoV 2><Severe Acute Respiratory Syndrome CoV disease><Severe Acute Respiratory Syndrome coronavirus disease><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 outbreak><Severe acute respiratory syndrome related corona virus 2><Si element><Silicon><Surface><Surface 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coronavirus 2 antigen><severe acute respiratory syndrome coronavirus 2 detection><severe acute respiratory syndrome coronavirus 2 diagnostic><severe acute respiratory syndrome coronavirus 2 infected patient><severe acute respiratory syndrome coronavirus 2 patient><severe acute respiratory syndrome coronavirus 2 positive patient><treatment provider><virus antigen><waiver>