HARLINGEN, Texas (ValleyCentral) — The U.S. Food and Drug Administration issued an emergency use authorization for another COVID-19 at home antigen test.
Monday’s approval allows the public to purchase ACON Laboratories Flowflex without a prescription, according to the FDA.
“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,” said Jeffrey E. Shuren, Director of Center for Devices and Radiological Health at the Food and Drug Administration in a statement.
Flowflex gives results in approximately 15 minutes via a nasal swab and has a 99.3% accuracy rate, according to ACON Labs.
Shuren added a disclaimer to the announcement, stating that all tests can experience false results and that anybody with a positive test or that is experiencing COVID-like symptoms should visit their healthcare provider.
Since the start of the pandemic, the FDA has authorized 235 molecular, 88 antibody, 34 antigen tests, according to its website.