FDA Authorizes First OTC COVID-19 Test

In another first during the COVID-19 pandemic, the FDA authorized the first over-the-counter COVID-19 test, a viral antigen test with an analyzer where a smartphone helps interpret the results, the agency said on Tuesday.

The FDA granted emergency use authorization to the Ellume COVID-19 Home Test, the first "fully at-home diagnostic test" that can be used without a prescription. Patients not only perform their own nasal swab, but analyze it themselves, without sending it to a lab. The Ellume test is described as a rapid, lateral flow antigen test that detects SARS-CoV-2 proteins in the sample of anyone age 2 and older.

"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 Hahn, MD, said in a statement.

However, Jeff Shuren, MD, JD, director of FDA's Center for Devices and Radiological Health, added that like other antigen tests, it is "less sensitive and less specific than typical molecular tests run in a lab."

The FDA said the Ellume test identified 96% of positive samples and 100% of negative samples in individuals with symptoms, and 91% of positive samples and 96% of negative samples in individuals without symptoms. It is performed using a mid-turbinate nasal swab.

Users insert the included sample collection device into their noses, then place it in a small, Bluetooth-enabled analyzer, which transmits the result to a smartphone placed nearby. An app on the phone then informs the user. Results are delivered in as little as 20 minutes via the smartphone, and reported to appropriate public health authorities. Users are required to input their zip code and date of birth in the app, but name and email address are optional.

The agency advised individuals with positive results to self-isolate and follow up with their healthcare provider. If individuals test negative and experience symptoms, they should also contact a provider, since negative results "do not preclude an individual from SARS-CoV-2 infection," the FDA noted.

Sen. Lamar Alexander (R-Tenn.), chairman of the Senate Health, Education, Labor, & Pensions Committee, noted in a statement that technology for the test was developed as a result of the National Institute of Health's Rapid Acceleration of Diagnostics (RADx) Initiative, a "Shark Tank"-like endeavor that worked in coordination with the Biomedical Advanced Research and Development Authority (BARDA) and the private sector to fast-track new testing technologies.

Ellume said it will manufacture more than 3 million tests in January 2021.

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