I-Corps: Development of a rapid point-of-care test for coronavirus (COVID-19) and antibody testing

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The broader impact/commercial potential of this I-Corps project is the development of a rapid point-of-care (POC) diagnostic test for COVID-19 based on a lateral flow assay (LFA). The goal is to decrease community spread of infection and help mitigate the negative economic impacts of world-wide pandemics. The proposed diagnostic may allow for universal access to testing of both coronavirus infection and immunity via protein-protein interactions with virions and antibodies at once as compared with using a polymerase chain reaction (PCR)-based test that relies on time-consuming reverse transcription of RNA to detect the virus only. The consensus among public health experts is that safely emerging from a lockdown will require regular testing of millions of Americans. Current testing technologies are limited due to a large percentage of false negatives (up to 20%). Additionally, access to coronavirus and antibody testing is limited in low resource settings that lack reliable electrical services, running water, and diagnostic devices and personnel to operate them. Although testing capabilities are increasing among currently employed technologies such as at-home nasopharyngeal sampling, the creation of a rapid, simple POC test has not been addressed. The proposed technology may decrease community spread of infection and help mitigate the negative economic impacts of the COVID-19 pandemic. This I-Corps project is based on the translation of a lateral flow assay (LFA) diagnostic COVID-19 test, akin to a pregnancy test, that will report the presence of both the virus and its antibody in patient samples. Because LFAs employ capillary force on a polymeric strip with detection zones, they are easy-to-use, eliminate the need for specialized equipment, and may be carried out as a single step, reducing the amount of sample handling. Using commercially available computational software, detector proteins with high sensitivity and high specificity have been designed. Preliminary experimental results confirm the high sensitivity and computational results confirm high specificity. DNA constructs are concurrently under development with optimization of LFA test strips. For precise, rapid and large-scale loading, the requirements for aa multiplex lateral flow test strip (MLFTS) process design from a commercially-available, drop-on-demand printer that will accommodate the protein designs and facilitate scale-up and manufacturing will be evaluated.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.