A portable agglutination test with automated serial dilution for COVID-19 infection and immunity

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We propose to develop a hand-held point-of-care (POC) diagnostic test for COVID-19 that can be used in non-traditional settings - for example, at extended care facilities, at the workplace, in airports and at border crossings, and at home. This grant will fund the optimization of microfluidic agglutination assays for virus found in nasopharyngeal samples and antibody found in blood samples, with a focus on quantitation by means of serial dilution and parallel analysis. We note that there are many groups developing point of care tests for COVID-19 - why support this one? There are several key technical advantages of our system, including: (1) our test reports results within one minute (much faster than any other that we are aware of), and (2) unlike nucleic-acid-based tests, our test reports both infection and immunity. But equally as important, our plan is highly credible. It is "easy" to demonstrate proof-of-concept results for fancy new tests in a laboratory; however, it is far more challenging to generate high-quality results in the field, where unpredictable conditions can carry the day. Given the serious nature of the COVID-19 crisis, it is critical that we invest in teams with established track-records for delivering point-of-care test results in the field. Our team, which includes an academic research group and two industry partners, has this background. The academic group has developed a system that has been rigorously validated for viral diagnostic testing in a remote refugee camp in Kenya [Science Translational Medicine 2018, 10, eaar6076] and in outdoor testing sites in communities suffering from viral outbreaks in Democratic Republic of Congo (not yet published). Industry partner one, a startup company based in Ontario, sells a hand-held instrument that will run the new COVID-19 tests. Industry partner two is Canada's leading medical device service provider, and will contribute unique experience and resources to assist in designing the single-use cartridge for scalable manufacture. Together, this team is well positioned to carry out the work described here, which has the potential to transform how COVID-19 infection and immunity is diagnosed, tracked and reported in Canada and around the world.