Rapid, Low-cost Diagnostics and Deployable Surge Capacity for COVID- 19

The outbreak of the coronavirus, first identified in Wuhan, China, highlights the importance of the capacity for a rapid and nimble response to infectious disease. As we have seen, the world in highly interconnected and outbreaks in one region quickly become global concerns. Diagnostics are a key tool in the fight against spread of the virus, allowing frontline responders to quickly triage patients. Over the past five years, our team has developed low-cost and de-centralized paper-based diagnostics that are simple to use and easy to distribute. During the Zika virus outbreak, we developed diagnostics within weeks and have since completed patient trials in Latin America showing performance equal to the gold standard CDC tests used in clinical labs (sensitivity equal qPCR test, 98.5% accuracy). These diagnostic, programmable by design, thus hold promise for managing future outbreaks. Seeking to contribute to the COVID-19 outbreak response, we have already begun the development of diagnostics for the virus and anticipate having validated tools within a month. Here we propose the following project to create a deployable diagnostic infrastructure for the virus: 1) A lab-in-a-box kit that can provide diagnostic surge capacity for COVID-19 (14,000 tests), 2) A package with the "pop-up capacity" to manufacture the diagnostics on-site for sustained response to the outbreak and 3) A point-of-need test for rapid screening of patients (e.g. cruise ships, airports). Such tools are important in Canada but are especially so in countries where health care systems do not have the resilience to handle a large outbreak. We have assembled a team of researchers from four countries with expertise in virology, diagnostics technologies and delivering impactful research outcomes. Our goal is a diagnostic platform capable of providing the capacity to respond to COVID-19 here in Canada or aboard, and the companion technologies, protocols and training to ensure effective deployment. Pillai