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Roche, SD Biosensor SARS-CoV-2 Rapid Antigen Test Nabs Health Canada Approval Under Interim Order

NEW YORK – Roche Diagnostics announced on Wednesday that its SARS-CoV-2 Rapid Antigen Test received approval under Health Canada's Interim Order.

The rapid chromatographic immunoassay, which was developed by Korean diagnostic firm SD Biosensor, qualitatively detects the SARS-CoV-2 nucleocapsid protein in the nasopharynx and returns results in 15 minutes without an instrument. The test is intended to diagnose patients with SARS-CoV-2 within five days of symptom onset, Roche said in a statement. 

The test has shown sensitivity of between 86 percent and 90 percent with specificity between 98 percent and 99 percent in patients within the first five days of symptom onset. Roche is the global distributor of the antigen test and said "tens of millions of tests" have been dedicated to Canada.

Health Canada's Interim Order allows products that may not fully meet Canadian regulatory requirements to be imported if they are manufactured to comparable standards, according to the Canadian government's website. The order is meant to help prevent shortages of items needed to address the COVID-19 pandemic.