FDA authorizes first over-the-counter COVID-19 test
The FDA has issued the first emergency use authorization for an over-the-counter home diagnostic test for COVID-19.
The Ellume COVID-19 Home Test is approved for use in persons aged 2 years or older, whether or not they show any COVID-19 symptoms.
During analysis, the test correctly identified 96% of positive samples and 100% of negative samples in persons with COVID-19 symptoms, the FDA said.
“Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” FDA Commissioner Stephen M. Hahn, MD, said in a press release.
“As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies and giving Americans more testing options from the comfort and safety of their own homes,” Hahn said.
The FDA first issued an emergency use authorization for an at-home COVID-19 test in November, but it required a prescription.
Since the beginning of the pandemic, more than 225 COVID-19 diagnostic tests have been authorized, including 25 that offer collection of samples at home.
Collapse
Read more about