FDA authorizes combo COVID-19 and flu home test for emergency use
The U.S. Food and Drug Administration (FDA) granted emergency use authorization on Friday to the first at-home diagnostic test for both the novel coronavirus (COVID-19) and influenza A and B.
The agency authorized Quest Diagnostics RC COVID-19 + Flu RT-PCR Test and Self-Collection Kit for COVID-19 + Flu for prescription use with patients who are suspected of respiratory viral infection consistent with COVID-19. Under a healthcare provider’s order, patients can collect a sample at home.
“Today’s authorization for a COVID-19 plus flu test using samples collected at home is a significant step toward FDA’s nationwide response to COVID-19,” said FDA Commissioner Stephen Hahn, MD, in a statement. “With just one swab or sample, combination tests that are authorized for use with home-collected samples can be used to get answers to Americans faster, in the comfort and relative safety of their home, which allows patients to continue to quarantine while awaiting results. This efficiency can go a long way to providing timely information for those sick with an unknown respiratory ailment.”