FDA Authorizes First At-Home, Over-The-Counter COVID-19 Test
The test does not require a prescription.
The U.S. Food and Drug Administration on Tuesday issued an emergency use authorization for the first-ever over-the-counter, fully at-home test for COVID-19, making it easier for people to test themselves for the virus without having to leave home.
The Ellume COVID-19 Home Test, which does not require a prescription, is a rapid antigen test that delivers results in as little as 20 minutes, the agency noted, by using a nasal swab to detect fragments of proteins of the COVID-19 virus. The test is authorized for people 2 years old and older.
“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 said in a statement. “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 test works with a free app, which provides instructions on how to use it as well as displays the results when ready using Bluetooth connectivity, according to Ellume. The app then asks for the user's zip code and date of birth, and reports the results “as appropriate to public health authorities,” the FDA noted.
According to the FDA, the test was found to correctly identify 96% of positive samples and 100% of negative samples in people who had symptoms, as well as 91% of positive samples and 96% of negative samples in people without symptoms. The agency said positive results in asymptomatic individuals “should be treated as presumptively positive until confirmed by another test,” and people who test negative but are experiencing COVID-19-like symptoms should follow up with a health care provider.
“Ellume’s COVID-19 Home Test delivers this important first line of defense – it can be widely available without the need for a prescription, enabling the U.S. to respond to the pandemic in its most urgent stage,” Ellume’s Founder and CEO Dr. Sean Parsons said in a statement.
The issuance of an emergency use authorization comes just days after the FDA authorized a vaccine by U.S. drugmaker Pfizer for emergency use, which has already started to be rolled out across the country. The FDA is currently evaluating another vaccine from drugmaker Moderna.
The home test could make travel easier with many states and countries requiring people to get tested before travel or prior to returning home. It would also make it easier to abide by the Centers for Disease Control and Prevention’s guidance that Americans traveling internationally get tested for the coronavirus three different times.
Alison Fox is a contributing writer for Travel + Leisure. When she’s not in New York City, she likes to spend her time at the beach or exploring new destinations and hopes to visit every country in the world. Follow her adventures on Instagram.