A simple and rapid point-of-care (POC) test for SARS-CoV-2

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There is presently an urgent need to increase the diagnostic testing capability for COVID-19 (SARS-CoV-2) in Canada and elsewhere. However, currently approved tests, as well as those in the pipeline, suffer from one or more deficiencies, such as competition for crucial biological reagents, high false-negative rates, cost, poor user-friendliness, or limited availability in Canada. In addition, current testing methods, which rely on sample collection using a swab, followed by the shipping of swabs to a central testing facility, are plagued by very long delays. The goal of this proposal is to develop a rapid point-of-care test for SARS-CoV-2 based on a novel RNA processing method and an isothermal amplification technique, coupled to a paper sensing device. The test will utilize a novel DNAzyme to excise RNA from the virus, followed by rolling circle amplification to amplify the RNA and convert the output to a long DNA strand. The DNA output will be enriched on a paper device that is capable of generating a color change if the virus is present in the test sample. The simplicity of the test will allow it to be done at home, in airports or other points-of-entry, or on cruise ships, and will allow "sample-to-answer" in under an hour, with no need to visit an external testing location. This will reduce the burden on front-line workers and centralized labs, while minimizing exposure of potentially infected patients to the community. Such tests will also make it easier to identify asymptomatic carriers, will allow for more rapid testing of potential contacts, and ultimately help to contain future outbreaks at an earlier stage, thus reducing the potential time needed for physical distancing measures.