Market translation of a rapid aptamer-based COVID-19 saliva test

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The proposed project is focused on commercializing a rapid COVID-19 saliva test prototype developed at McMaster University and licensed by the Canadian company, Zentek. In this test, saliva is deposited on a chip that is inserted into an electrical reader for rapid, 10 minute, COVID-19 testing. This is a reliable rapid test with no discomfort to the user that is tested with more than 70 patients, demonstrating sensitivity of >80%, specificity of 100%, and concordance value of 92% (total agreement of the test result with the gold standard PCR test). Despite the availability of a wide range of COVID-19 tests, there is no regulatory-approved rapid saliva test due to the deterioration of test performance in saliva. Our test combines two technologies for high reliability testing in saliva: dimeric aptamers and electrochemical readout. Aptamers are DNA molecules selected from a large DNA library using in vitro selection to specifically bind target analytes, in this case the spike protein of SARS-CoV-2. Because dimeric aptamers bind the target spike protein from two locations, they result in high affinity binding. Additionally, dimeric aptamers can be rapidly generated in response to new viral variants. We use an ultrasensitive readout method, electrochemical impedance spectroscopy, for translating this target binding to an electrochemical signal. We have developed the test prototype using commercially-available screen printed electrodes coupled to a USB-sized phone dongle as a signal reader to enable rapid technology translation.Technical issues related to scalable fabrication, stability, detection of emerging viral variants, sample collection, and simple assay operation will be addressed in this project. The development of this technology in Canada will create more than 100 direct jobs at Zentek and will contribute to keeping the economy open while maintaining low infection rates. Zentek intends to develop this technology for detecting other infectious diseases, further growing job creation and contribution to the health and economic wellbeing of Canadians.