NEW YORK – The US Food and Drug Administration recently granted Emergency Use Authorization to iHealth Labs for a point-of-care antigen test for COVID-19 and influenza A/B as well as updated clearances for home-use and point-of-care combination tests from CorDx.
All three tests are used for the simultaneous detection and differentiation of SARS-CoV-2 and flu A/B nucleocapsid protein antigens in anterior nasal swab samples from patients with signs and symptoms of respiratory infection.
The iHealth COVID-19/Flu A&B Rapid Test Pro is authorized for use within four days of symptom onset when patients are tested at least twice in three days with at least 48 hours between tests. The California-based firm received a separate EUA in May for its over-the-counter iHealth COVID-19/Flu A&B Rapid Test as well as 510(k) clearance last month for its over-the-counter iHealth COVID-19 Antigen Rapid Test.
The FDA also granted EUA updates that establish a 12-month shelf life for the point-of-care CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test that received EUA in March and the over-the-counter CorDx Tyfast Flu A/B & COVID-19 At-Home Multiplex Rapid Test that received EUA in April. Both tests are authorized for use within five days of symptom onset when patients are tested at least twice over three days with at least 48 hours between tests.