The US Food and Drug Administration this week has authorized a combination at-home COVID and flu test consumers can use without a prescription.
Other combined COVID and flu tests, like this at-home test from Lucira/Pfizer, are available and have been authorized under "emergency use authorization," but this De Novo authorization is the first to give FDA sign-off outside of pandemic-era marketing rules.
For the consumer, this hopefully results in more choice and access to at-home tests.
"The FDA continues to take actions that support the development and availability of at-home tests for a variety of medical conditions."
It also identified 99.9% of negative Flu A and B samples, and 92.5% and 90.5% of positive Flu A and Flu B samples, the FDA said.

Is It COVID or Flu? FDA Gives 'Official' Authorization to Test That Will Tell You