At-Home COVID-19 Test Authorized

The U.S. Food and Drug Administration announced it issued an emergency use authorization for the first over-the-counter (OTC) at-home diagnostic test for COVID-19.

The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test that detects fragments of proteins from any individual 2 years of age or older.

The Ellume COVID-19 Home Test is the first COVID-19 test that can be used entirely at home without a prescription, says the FDA.

“By authorizing a test for OTC use, the FDA allows it to be sold in places like pharmacies, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” stated FDA Commissioner Stephen M. Hahn, M.D., in a related press release. 

“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.”

Like other antigen tests, a small percentage of positive and negative results from this test may be false. Therefore, positive results should be treated as presumptively positive for patients without symptoms until confirmed by another test as soon as possible. 

This is especially true if there are fewer infections in a particular community, as false-positive results can be more common when antigen tests are used in populations with little COVID-19 (low prevalence).

Individuals who test negative and experience COVID-like symptoms should follow up with their health care provider as negative results do not preclude an individual from SARS-CoV-2 infection.

The FDA has now authorized about 300 coronavirus diagnostic tests during 2020. Overall, there have been over 213 million completed tests confirmed by the U.S. CDC this year.

Today’s FDA notice follows last month’s authorization of the first prescription COVID-19 test for home use and last week’s announcement of the first non-prescription test system, in which a lab processes the self-collected sample. 

Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health, added: “This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab. However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic.”

The Ellume COVID-19 Home Test uses a mid-turbinate nasal swab (sample is collected further back than the usual nasal swab, but not as far back as nasopharyngeal swabs, which are only appropriate for use by a trained health care provider) to detect specific proteins of the virus known as antigens. 

The Ellume COVID-19 Home Test correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms. The test correctly identified 91% of positive samples and 96% of negative samples in people without symptoms. 

The Ellume COVID-19 Home Test uses an analyzer that connects with a software application on a smartphone to help users perform the test and interpret results. Results are delivered in as little as 20 minutes to individuals via their smartphone. 

The mobile application requires individuals to input their zip code and date of birth, with optional fields including name and e-mail address. It sends the results as appropriate to public health authorities to monitor disease prevalence. Ellume expects to produce more than three million tests in January 2021.

The FDA is an agency within the U.S. Department of Health and Human Services that protect Public Health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

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