Aurora Biomed announces Health Canada approval for FaStep Rapid COVID-19 Antigen Test

24 Mar 2021
Edward Carter
Publishing / Media

Aurora Biomed, one of Canada’s leading suppliers of innovative laboratory solutions, has announced that it will start distributing Assure Tech’s FaStep COVID-19 Antigen Rapid Test Device in Canada. Assure Tech’s FaStep COVID-19 Antigen Rapid Test Device has recently obtained Health Canada authorization.

The new 15-minute Rapid COVID-19 Antigen test is based on a lateral-flow immunochromatographic assay and does not require additional equipment or reader for detection or sample analyses. The test detects antigens specific to SARS-CoV-2 in nasopharyngeal specimens collected from individuals suspected of being infected with COVID-19 or exposed to COVID-19.

“This is a major breakthrough to facilitate international travel,” says Dr. Dong Liang, CEO, Aurora Biomed. “Since this rapid antigen test does not require a reader, they are extremely portable and can be administered in point-of-care settings. We are confident that our test will be a game-changer because it can provide rapid results in doctor’s offices, urgent care clinics and hospitals, they could have a key role in expanding access to testing and providing timely information to patients and providers. It’s not meant to replace PCR and, in fact, a positive result should be further confirmed by a PCR test,” says Dr. Liang

The Rapid COVID-19 Antigen test is a self-contained, single-use test that is easy to administer in a point-of-care setting and can be conducted by non-laboratory healthcare professionals. However, laboratories in British Columbia carrying out these tests for diagnostic purposes will be required to be accredited under the province’s Diagnostic Accreditation Program (DAP) as well as the Clinical Microbiology Proficiency Testing (CMPT) program affiliated with the University of British Columbia.

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