NIH-funded COVID-19 home test is first to receive over-the-counter authorization from FDA

The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid test that detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older. The results are available in 15 to 20 minutes.

Users can share real-time results from the test — selling for approximately $30 — with healthcare professionals, employers, and schools for efficient COVID-19 tracking. Ellume plans to scale-up manufacturing to deliver millions of home tests per month in 2021.

The announcement of the first fully at-home OTC COVID-19 diagnostic test 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.

“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,” said FDA Commissioner Stephen M. Hahn, M.D. “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 FDA reminds patients that all tests can experience false negative and false positive results. Individuals with positive results should self-isolate and seek additional care from their health care provider. 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.

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