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This test has received FDA Emergency Use Authorization for self-testing without the need to ship samples to a lab or for a prescription from your healthcare provider. Health Canada has authorized a variety of COVID-19 tests based on data supporting their intended use. A combined total of 677 samples were tested across both studies, of which 425 samples were included in the Retrospective Remnant Study and an additional 252 subjects enrolled in the Prospective Study. Learn more: Number of rapid tests distributed in Canada. The Lucira Covid-19 & Flu Test is approved under Interim Order for emergency use and commercialisation in Canada. Can be used to test for COVID-19 infection before travel or a social interaction whether or not someone has symptoms. Health Canadas decision is based on performance data reviewed under Health Canadas expedited authorization pathway, Interim Order No. Lucira Health's PCR-Quality At-Home COVID-19 Test Now - Insider The chance of getting an invalid result is low, 2%. If you continue using our website, we'll assume that you are happy to receive all cookies on this website. Useful Links. How accurate are the Lucira COVID Test Kits? Sensitivity is a measure of the accuracy of a test against a reference standard. The Lucira COVID-19 & Flu Test is a NAAT test utilizing the same platform and device design as Luciras COVID-19 Test to provide independent diagnoses for COVID-19, Flu A, and Flu B. For Americans looking for swift answers, the cheapest over-the-counter COVID-19 test is the Abbott Laboratories BinaxNOW two-pack for $23.99. Chris Iorfida, based in Toronto, has been with CBC since 2002 and written on subjects as diverse as politics, business, health, sports, arts and entertainment, science and technology. The Lucira COVID-19 & Flu Test is a 99% accurate rapid molecular test that delivers results in 30 minutes or less from one shallow nasal swab. A COVID-19 rapid test kit produced by Abbott is shown at Humber River Hospital in Toronto in November. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on managements assumptions and estimates as of such date. The analysi. Each Lucira test is packaged with everything needed to run a single test: the test device, two AA batteries, sample vial, swab, and simple instructions. We reviewed these findings and continue to recommend that COVID-19 testing devices be used according to the instructions contained in the test kit. If you have a special inquiry about offering Covid testing for a group, school, event, or for your employees, email [emailprotected]. LUCIRA's prescription version was the first U.S. FDA EUA-authorized, prescription, molecular diagnostic test for COVID-19 that can be self-administered by patients at home or used in a. How does the Lucira COVID-19 Test Kit work? Rapid tests are procured through these standing offers to meet Health Canada's requirements. How accurate is the Flowflex COVID-19 Antigen Home Test? Variants of a virus are versions of the virus in which the nucleic acids are different. Health Canada, European Medicines Agency, and other regulatory authorities are planned for the second quarter of 2022 with decisions expected before this upcoming flu season. To help consumers use COVID-19 testing devices safely and effectively, we have published available authorized instructions for use (IFU) for authorized devices.