On November 9, 2023, the FDA approved Flowflex COVID-19 Antigen Home Test (Flowflex; ACON Laboratories), the first over-the-counter (OTC) antigen test for COVID-19 for use by individuals aged ≥14 years. Flowflex is the first antigen test for COVID-19 to receive regular FDA approval for home use, and the first COVID-19 test indicated for use in individuals aged <18 years.
On October 4, 2021, the FDA originally issued an emergency use authorization (EUA) to ACON Laboratories for Flowflex COVID-19 Home Test as an OTC test for adults aged ≥18 years. This new FDA approval makes Flowflex available OTC for individuals aged ≥14 years to test themselves at home or for adults to test children aged ≥2 years at home. This is the second COVID-19 home test to complete a traditional FDA premarketing review successfully; earlier this year, the FDA cleared a molecular home test for COVID-19 for consumers.
“This marks the latest step forward in our efforts to help test developers provide Americans with continued options for safe and effective COVID tests that can be performed entirely at home,” said Jeff Shuren, MD, JD, Director of the FDA’s Center for Devices and Radiological Health, in a press release. “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,” he added.
Flowflex is a visually read test that is intended to be used at home by symptomatic individuals within 6 days of the onset of symptoms that are characteristic of COVID-19. As with antigen tests authorized by the FDA for emergency use under the EUA pathway, Flowflex COVID-19 Antigen Home Test is intended to be used at least twice over 3 days, with ≥48 hours between the tests. Symptomatic individuals with an initial negative test result on the Flowflex COVID-19 Antigen Home Test should be retested once between 48 and 72 hours after the first test, using the Flowflex antigen test or a molecular COVID-19 test.
In a study reviewed by the FDA, the Flowflex test correctly identified 89.8% of positive and 99.3% of negative samples of COVID-19 infection in individuals with the signs and symptoms of an upper respiratory infection. The FDA emphasized the importance of informing patients that all tests can have false-negative or false-positive results.
In addition, on March 15, 2023, the FDA granted ACON Laboratories an extension for the shelf life of its Flowflex COVID-19 Home Test, based on stability data that were submitted by the company from the results of its continued studies of the test since the initial EUA release, demonstrating the test’s stability, which allowed the FDA to extend the shelf life of the test by 12 months. Based on these results, the FDA granted the Flowflex test an extension of its shelf-life from 12 months to 24 months, when it is stored at 36°F to 86°F (2°C-30°C). According to the test manufacturer, users should look up the new expiration date by using the lot number printed on the box of each test.
The FDA advises that individuals with positive results on the Flowflex test should seek care from their healthcare provider. Patients who have COVID-like symptoms but have negative results on the Flowflex test should follow up with their healthcare provider to confirm that they do not have COVID-19 infection.