Development of a rapid point-of-care diagnostic test for COVID-19 [Supplement added: COVID-19 Variant Supplement]

This research addresses the urgent need of rapid point-of-care diagnostics of COVID-19. The collaborative research is conducted by a multi-disciplinary team of virologists, chemists, infectious disease specialists, front-line practitioners, and public health researchers from the University of Alberta, Canadian Food Inspection Agency, and Wuhan Institute of Virology (China). The immediate priority focuses on developing two complementary techniques to be performed on-site and in resource-limited settings, in support of rapid diagnosis of COVID-19. The diagnostic innovation takes advantage of the most recent advances in chemistry, molecular biology, genome technology, and nanotechnology. Chemical reactions required for efficient amplification and sensitive detection of the viral RNA take place in a single tube at a moderate temperature, simplifying the operation procedures. The specific reaction products are visible to the naked eyes, thus eliminating the need for any elaborate equipment. The first test reads color changes, with red color indicating negative and blue color indicating positive. Readout for the second test is color band on paper strips, similar to those of pregnancy tests, with two red bands indicating positive whereas a single control band indicating negative. The mid-term priority focuses on validating and evaluating the new diagnostic tests for field applications in the epidemic center of COVID-19. Our team members in Wuhan who currently perform the standard diagnostic tests will lead this effort. Once validated and approved, the new diagnostic tools will be used to support screening and diagnosis of COVID-19 at the community level. The mid-term objective also includes adapting the point-of-care diagnostics at other collaborating sites, e.g., Karachi (Pakistan) and Nairobi (Kenya). A longer-term priority of this research includes refining the new diagnostic tools to enable monitoring of mutational changes of the virus as it continues to evolve.