FDA clears Acon's OTC home antigen test for COVID

The U.S. Food and Drug Administration (FDA) on Thursday cleared an over-the-counter at-home COVID-19 antigen test made by Acon Laboratories.

Acon's test is the second coronavirus test to get marketing authorization using the agency's traditional premarket review pathway and the first indicated for use in children under 18, the health regulator said. The FDA had granted emergency-use authorization for the test in 2021 to make it available to consumers without a prescription.

In a study reviewed by the FDA, the test correctly identified 89.8% of positive and 99.3% of negative samples in individuals with signs and symptoms of upper respiratory infection.