NEW YORK — Aurora Biomed said on Wednesday that the FaStep COVID-19 Rapid Antigen Test Device has received authorization from Health Canada.
Developed by Hangzhou, China-based Assure Tech, the lateral flow immunochromatographic assay is designed to detect SARS-CoV-2 antigens in nasopharyngeal specimens. It is authorized for use at the point of care and provides results within 15 minutes, Vancouver, British Columbia-based Aurora said.
With the authorization, Aurora said that it will begin distributing the test in Canada. Although the test can be conducted by non-laboratory professions, the company said that labs in British Columbia performing the test must be accredited by the province and under the University of British Columbia's Clinical Microbiology Proficiency Testing program.
Earlier this year, Assure Tech's Ecotest COVID-19 serological rapid test for SARS-CoV-2 infection received authorization from regulators in Canada, where it is marketed by Verify Diagnostics.