NEW YORK – Lucira Health announced on Monday that the Lucira Check It COVID-19 test kit received an Authorization with Conditions from Health Canada.
The authorization was granted under Health Canada's Interim Order, which allows COVID-19 products that might not fully meet Canadian regulatory requirements to be imported and sold if they're manufactured to comparable standards.
The loop-mediated isothermal amplification test can deliver results in 30 minutes or less and will be available for Canadians to buy online in June for around C$75 (US$60), the company said in a statement. Lucira added that its kit is the first self-test authorized by Health Canada for people with or without symptoms.
Lucira's test can determine a positive result within 11 minutes or confirm a negative result within 30 minutes and doesn't require a prescription or supervised assistance to perform. Earlier this month, the test received Emergency Use Authorization from the US Food and Drug Administration for over-the-counter use at home. It previously received a separate EUA in November for prescription use under the name Lucira COVID-19 All-In-One Test Kit.