Over-the-Counter, At-Home COVID Test Approved

December 16, 2020
John Parkinson

This non-prescription test allows users to perform and get results themselves without a medical provider or laboratory needed.

The first over-the-counter at-home diagnostic test for coronavirus disease 2019 (COVID-19) was granted emergency use authorization (EUA) by the US Food and Drug Administration (FDA) yesterday. The EUA was for the Ellume COVID-19 Home Test.

FDA Commissioner Stephen M. Hahn, MD, called the EUA “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.”

The FDA granted an EUA last month to Lucira Health for it’s at-home, self-administered COVID test which can be purchased with a prescription. Since the beginning of the pandemic, the agency has authorized more than 225 COVID-19 diagnostic tests, including more than 25 tests that allow for home collection of samples, which are then sent to a lab for testing.

“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 test may prove especially useful during this second wave of COVID-19.

According to the COVID Tracking Project, yesterday was a record-breaking day in terms of people being hospitalized for COVID-19: 112,816 people were hospitalized for COVID yesterday, the most ever. The next four highest days for hospitalization? They are December 14, 13, 12, and 11—the four previous days.

According to Johns Hopkins University, there were 189,357 confirmed cases of COVID-19 yesterday while 3019 people died from the disease. That’s the third highest one-day death toll for the disease in the United States since the pandemic began.

Overall, in the United States there have been nearly 17 million confirmed cases of COVID-19. And, in the United States, over 300,000 people have died from the disease. In the world, there have been over 70 million confirmed cases of COVID-19. And, in the world, over 1.6 million people have died from the disease.

This story originally appeared in Contagion®.