FDA clears first OTC at-home COVID-19 test

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FDA clears first OTC at-home COVID-19 test

By David Salazar - 12/16/2020

The Food and Drug Administration has approved the first at-home test for COVID-19 that can be purchased over the counter. The Ellume COVID-19 Home Test is a rapid, lateral-flow antigen test that detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab for anyone 2 years old and older. 

“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 Dr. Stephen Hahn. “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.”

So far, the FDA has approved more than 225 diagnostic tests for COVID-19, including more than 25 that allow for home collection of samples that are then sent to a lab for testing. The Ellume test is the first that can be used entirely at home without a prescription.

The test includes a sterile nasal swab, a dropper, processing fluid, and a Bluetooth-connected analyzer. Ellume’s test works in conjunction with a free smartphone app that offers step-by-step testing instructions, including a how-to video. All analysis is performed using the test’s electronic analyzer, which displays the test result on the user’s smartphone in 15 minutes or less via Bluetooth.

“As COVID-19 case numbers hit record highs, the world needs access to fast, affordable, easy-to-use home testing,” said Ellume founder and CEO, Dr. Sean Parsons. “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.”

Ellume — which is based in Valencia, Calif., and Brisbane, Australia — said the test is priced at $30 and that it expects to ship the first tests in the United States in the first week of January. A spokesperson said the company was in advanced discussions about national retail commercialization. As it prepares to ship the test, Ellume is ramping up its manufacturing efforts, with production on track to create 100,000 tests per day in January. The company noted that this is made possible by the support of a $30 million WP-2 grant from the National Institutes of Health’s Rapid Acceleration of Diagnostics initiative.

In data submitted from a simulated home-setting clinical study of 198 participants, the test showed an overall sensitivity of 95% and specificity of 97% when results were compared with an RT-PCR lab test. In patients with symptoms, sensitivity was 96% and specificity was 100%, while asymptomatic individuals saw a test sensitivity rate of 91% and specificity of 96%. 

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