FDA issues emergency authorization for first over-the-counter COVID-19 test

Updated: Dec 15, 2020 / 11:59 AM CST

Food and Drug Administration building is shown Thursday, Dec. 10, 2020 in Silver Spring, Md. A U.S. government advisory panel convened on Thursday to decide whether to endorse mass use of Pfizer’s COVID-19 vaccine to help conquer the outbreak that has killed close to 300,000 Americans. (AP Photo/Manuel Balce Ceneta)

SILVER SPRINGS, Md. (NewsNation Now) — The Food and Drug Administration issued an emergency use authorization for the first over-the-counter fully at-home diagnostic test for COVID-19 Tuesday.

The Ellume COVID-19 Home Test is a rapid antigen test. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any persons two years old and up. The FDA authorized the test individuals two years of age or older, including those not showing symptoms

The FDA issued the following statement:

“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,” said FDA Commissioner Stephen M. Hahn, M.D. “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.”
the u.s. Food and Drug Administration

The announcement of the first fully at-home OTC COVID-19 diagnostic test follows last month’s authorization of the first prescription COVID-19 test for home use.

The FDA approved the first COVID-19 vaccine for emergency use in the U.S. on Friday and the vaccine is already being administered throughout the country.