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.