An Automated Molecular Point of Care Testing Device for Rapid Detection of SARS-CoV-2 and New Variants

Since the beginning of COVID-19 pandemic in March 2020, over 130,000,000 confirmed cases and 3,000,000 deaths have been identified. The shortage of approved low cost rapid diagnostic tests has inhibited the testing of individuals with mild or hidden symptoms, facilitating viral spread the spread of the virus. In this proposal, we gather a team of experts from McGill University, Lady Davis Institute and McGill University Health Centre to address this need. Our team has already developed a testing device for molecular detection of SARS-CoV-2 RNA in a portable and quantifiable fashion with a turnaround time of 10 min. The prototype demonstrate the full cycle of sample preparation (on-chip viral RNA extraction from saliva/nasal swab and amplification) and viral RNA detection via an established RT-LAMP assay. Here, we propose a 1 year modular plan to interface our platform with a smartphone, so that it be easily operated in remote locations, validate our rapid RNA-based testing device with new SARS-CoV-2 variants, B.1.1.7 and 501Y.V2 and to investigate distribution of SARS CoV2 variants in clinical samples. We will also develop an automation approach that can potentially simplify testing of SARS-CoV-2 and new variants in remote locations, making it easier and cheaper to manufacture tests. Our aim is to provide easy access to the results of diagnostics testing in remote locations and avoid overloading hospitals and lab facilities. Overall, the potential to increase COVID-19 testing rate at a low cost will benefit the Canadian health system during the current pandemic and help prevent similar pandemics in the future.