FDA Authorizes First At-Home, OTC COVID-19 Diagnostic Test

FDA recently issued an emergency use authorization (EUA) for the first over-the-counter (OTC), at-home COVID-19 diagnostics test.

The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, which means that it runs a liquid sample along a surface with reactive molecules, FDA stated. The test will detect if SARS-CoV-2 is present in individuals two years of age and older.

In previous studies, the test correctly identified 96 percent of positive samples and 100 percent of negative samples in individuals with symptoms. In those without symptoms, the test correctly identified 91 percent of positive samples and 96 percent of negative samples.

“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 the announcement.

The Ellume COVID-19 Home Test works simultaneously with a software app that individuals can download onto a smartphone. The app helps users to perform and analyze the test with step-by-step instructions and a how-to video. 

An electronic analyzer performed the analysis of the sample and delivers results within 20 minutes using Bluetooth connectivity.

The only personal information the app requires is zip code and date of birth.

Notably, the Ellume COVID-19 Home Test is the first COVID-19 test that can be used completely at home without a prescription. The company expects to produce more than 3 million tests in January 2021.

“As COVID-19 case numbers hit record highs, the world needs access to fast, affordable, easy-to-use home testing,” Sean Parsons, MD, Ellume founder and CEO, said in a press release following the authorization. 

“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,” Parsons continued. 

But the FDA is warning that a small percentage of positive and negative results from this test may be false. So, even for patients without symptoms, positive results should be treated as presumptively positive until confirmed by another test.

The Ellume COVID-19 Home Test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab. But FDA stated that because it can be used at home and returns results quickly, it will play an important role in response to the pandemic.

Following the FDA authorization of the Ellume COVID-19 Home Test, HHS Secretary Alex Azar issued a statement:

“FDA has authorized the first COVID-19 test that you can purchase over-the-counter, take at home, and get a rapid result, representing a major breakthrough for Americans’ ever-expanding access to convenient COVID-19 testing options. HHS provided support for this new option through NIH’s RADx initiative, the diagnostics component of Operation Warp Speed, which supports not only development work but also efforts to scale up production to deliver the broadest possible access to new testing options. 

“With new at-home options emerging and tens of millions of rapid tests already strategically distributed by HHS this fall to states, we have brought together the best of the public and private sectors to build the world’s greatest testing system.” 

Throughout the pandemic, FDA has authorized over 225 diagnostics tests for COVID-19, including more than 25 tests that allow for at-home collection of samples.

The authorization of the Ellume COVID-19 Home Test comes at the heels of two FDA approvals for emergency use of COVID-19 diagnostic tests.
The first authorization in mid-November cleared the use of Lucira Health’s COVID-19 All-In-One Test Kit ,and the most recent authorization was at the beginning of December, which granted emergency use authorization to Quest Diagnostics for its RC COVID-19 + Flu RT-PCR Test.