NEW YORK – Roche Diagnostics announced on Tuesday that its Elecsys Anti-SARS-CoV-2-S test has received approval under Health Canada's Interim Order.
The immunoassay qualitatively and semi-quantitatively measures the level of antibodies against the viral spike protein of SARS-CoV-2 from a blood sample in people who have either been exposed to the virus or vaccinated. It can help clinicians determine potential immunity and vaccine efficacy, Roche said in a statement.
"These antibodies have been shown to have potent antiviral activity and correlate to potential immunity," Michele D'Elia, director of medical affairs at Roche, said in a statement. "Measuring antibody levels could also be important in establishing vaccine efficacy in the prevention of infection and/or the development of severe COVID-19."
The test has specificity of nearly 100 percent and sensitivity of 98.8 percent two weeks after SARS-CoV-2 diagnosis with PCR. Roche added that across panels of potentially cross-reactive samples from endemic human coronaviruses, infectious respiratory and other diseases, autoimmune diseases, and liver-related diseases, the test "demonstrated zero cross reactivity."
Roche's test can be run on the company's Cobas e analyzers, which can return results in 18 minutes and run up to 300 tests per hour. The test received Emergency Use Authorization from the US Food and Drug Administration in November and was used in Moderna vaccine research trials.
Health Canada's Interim Order allows COVID-19 products that may not fully meet Canadian regulatory requirements to be imported and sold if they are manufactured to comparable standards, according to the Canadian government's website.