FDA Authorizes Over the Counter At-Home Antigen Test

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Posted: Dec 15, 2020 4:30 PM
FDA Authorizes Over the Counter At-Home Antigen Test

Source: AP Photo/Taimy Alvarez

On Tuesday the Food and Drug Administration issued an emergency use authorization for the first over-the-counter fully at-home COVID-19 diagnostic test. The Ellume COVID-19 Home Test is a nasal swab that can be taken by anyone 2 years or older. It is the first COVID test that can be used completely at home without a prescription, the FDA explains.

"Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19, and that the known and potential benefits of your product, when used for diagnosing COVID-19, outweigh the known and potential risks of such product," FDA Chief Scientist Denise M. Hinton wrote in a letter to Ellume Limited's Myriam Battistutta.

“Today’s authorization is a major milestone in diagnostic testing for COVID-19," said FDA Commissioner Stephen M. Hahn, M.D. "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. 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.”

A few more specifics for those interested in how the at-home test works:

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 certain 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. In people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples. 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, and reports the results as appropriate to public health authorities to monitor disease prevalence. Ellume expects to produce more than three million tests in January 2021.

On Monday, a critical care nurse in Queens, New York became the first person in the U.S. to receive the coronavirus vaccine developed by Pfizer and BioNTech, a few days after the FDA officially approved the vaccine for emergency use. The vaccine was found to be over 95 percent effective in clinical trials. The agency will meet again this week to discuss the emergency authorization request from Moderna, whose vaccine was found to be over 94 percent effective.

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