Washington, D.C. -- The FDA's Oct. 4 authorization of an over-the-counter (OTC) COVID-19 antigen test, the ACON Laboratories Flowflex COVID-19 Home Test, adds to the growing list of tests that can be used at home without a prescription.
The authorization should significantly increase the availability of rapid, at-home tests and is expected to double rapid at-home testing capacity in the U.S. over the next several weeks. By years end, the manufacturer plans to produce more than 100 million tests per month, and this number will rise to 200 million per month by February 2022.
Since March 2020, the FDA has authorized more than 400 COVID-19 tests and sample collection devices, including authorizations for rapid, OTC at-home tests. The FDA considers at-home COVID-19 diagnostic tests to be a high priority and has continued to prioritize their review given their public health importance.
Most antigen tests for at-home use are authorized for serial testing, or testing the same individual more than once within a few days. These authorizations followed the announcement of a streamlined approach to help facilitate the authorization of rapid tests for use with serial testing programs, which has increased consumer access to testing.
Notably, based on the data provided for asymptomatic individuals, the ACON Laboratories Flowflex COVID-19 Home Test does not require serial testing. As such, the product will facilitate greater access and testing capacity.
The FDA wants to remind patients that all tests can experience false negative and false positive results. Individuals with positive results should self-isolate and seek additional care from their health care provider. Individuals who test negative and experience COVID-like symptoms should follow up with their health care provider as negative results do not rule out a COVID-19 infection.