The U.S. Food and Drug Administration (FDA) has cleared the first over-the-counter (OTC) COVID-19 antigen test for marketing. The Flowflex COVID-19 Antigen Home Test by ACON Laboratories was initially authorized for emergency use in 2021 and is the first such test indicated for use in children under 18.
- Intended Users: Suitable for symptomatic individuals within six days of symptom onset, and for adults testing children aged two years or older.
- Efficacy: Identified 89.8% of positive cases and 99.3% of negative samples in symptomatic individuals.
- Usage Frequency: Recommended to be used at least twice over three days, with a minimum of 48 hours between tests.
The FDA’s clearance of this test signifies a major advancement in making effective at-home testing options for COVID-19 more accessible, as part of a broader initiative to enhance patient access to testing for various medical conditions. [“]