FDA Clears First COVID-19 Home Antigen Test
WASHINGTON — The Food and Drug Administration has approved the sale of the first over-the-counter antigen test for COVID-19.
The product, ACON Laboratories’ Flowflex COVID-19 Antigen Home Test, originally authorized for emergency use in 2021, is now the second home COVID-19 test to successfully complete a traditional FDA premarket review pathway.
In June the agency granted “market authorization” for the Cue COVID-19 Molecular Test.
That product is a molecular nucleic acid amplification test that is intended to detect genetic material from SARS-CoV-2 virus present in nasal swabs from adults with signs and symptoms of upper respiratory infection.
The FDA’s latest approval, announced Thursday, also marks the first time the test has been approved for use in children under 18. Today’s announcement follows clearance of a molecular home test earlier this year.
Dr. Jeff Shuren, J.D., director of the FDA’s Center for Devices and Radiological Health, said Thursday’s decision was part of an ongoing effort by the agency to help test developers provide consumers with additional options for safe and effective at-home COVID tests.
“The FDA continues to proactively work with test developers that desire to market their products beyond emergency use authorities. This is part of the FDA’s broader effort to advance the development and availability of at-home tests for a variety of medical conditions to expand patient access to testing,” Shuren said in a written statement.
The Flowflex COVID-19 Antigen Home Test is a visually read test cleared for OTC home use for symptomatic individuals within six days of symptom onset.
The FDA said it can be used by individuals aged 14 years or older to test themselves, or by adults testing individuals aged two years or older.
In a study reviewed by the FDA, the Flowflex COVID-19 Antigen Home Test correctly identified 89.8% of positive and 99.3% of negative samples in individuals with signs and symptoms of upper respiratory infection.
The agency went on to say that, as with antigen tests authorized for emergency use, the Flowflex test is intended to be used at least twice over three days with at least 48 hours between tests.
“This means that a symptomatic individual with an initial negative test result should be re-tested once between 48 and 72 hours after the first test using an antigen test for COVID-19 or followed up with a molecular COVID-19 test,” the FDA explained in the release announcing its decision.