Grant: Operating Grant: COVID-19 Rapid Research Funding Opportunity - Diagnostics

Here we propose to develop and demonstrate the hardware and molecular tools needed for high-capacity de-centralized COVID-19 diagnostics in Canada, Colombia and Ecuador. We will do this by adapting our portable plate reader, called PLUM, for distributed deployment of two key diagnostic modalities using our patient validated tests. 1) A rapid molecular SARS-CoV-2 diagnostic (RT-LAMP, 15 min) to prevent a resurgence of infection as our communities begin to reduce lockdown restrictions. 2) Serological testing to determine population antibody-levels and allow for strategic use of precious, future vaccine stocks. To bring these diagnostics assays (96 or 384 well plate) out of the laboratory setting and to the point-of-need, we will adapt the PLUM reader to provide the high-temperature incubation (65 C) needed for RT-LAMP. PLUM will also be augmented with purpose-built software and training materials to enable the use of diagnostics by users in the field (e.g. health care workers). This will include automated software for guidance on sample collection, running the assays, data analysis and secure data sharing to public health networks. The RT-LAMP assay, which has already been extensively tested with SARS-CoV-2 patient samples, will be augmented with new safeguard features to prevent false negative results and adapted to allow for RNA extraction-free use. The COVID-19 serological assay has also already been extensively validated with SARS-CoV-2 patient samples and here will be optimized for use in PLUM. Implementation and testing of this de-centralized diagnostic capacity will be performed at small businesses in Canada, and with hospital workers and remote populations in Colombia and Ecuador. Taken together, this proposed project combines a strong technical solutions with patient trials outside of conventional laboratory settings and will enable the development of the crucial de-centralized COVID-19 testing capacity needed for recovery from the pandemic.