The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the first at-home COVID-19 diagnostic test, called Ellume COVID-19 Home Test, which you can get without a prescription.
FDA Commissioner Dr. Stephen Hahn said emergency authorization of the test 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,” he added.
The OTC rapid home test, developed by Australia-based Ellume, is a rapid antigen test that detects fragments of the new coronavirus from a nasal swab sample. It also helps detect the virus in asymptomatic people.
The Ellume COVID-19 Home Test has been found to correctly identify 96% of positive samples and 100% of negative samples in people with symptoms. And in asymptomatic people, the test correctly identified 91% of positive samples and 96% of negative samples, according to the FDA.
The test comes with a sterile nasal swab, a dropper, processing fluid, and a Bluetooth-connected analyzer that can be used with an app on the smartphone. The results are automatically transmitted to the smartphone.
Ellume said, “The Ellume COVID-19 Home Test’s core technology combines ultra-sensitive optics, electronics, and proprietary software to leverage best-in-class digital immunoassay technology with next-generation multi-quantum dot fluorescence technology.”
The app requires you to input your ZIP code and date of birth, with your name and email address in optional fields. The app will automatically report your results to public health officials to monitor disease prevalence.
The company expects to produce over 3 million tests in January 2021, with one OTC rapid test costing around $30.
Since the pandemic began, the FDA has issued emergency authorization to more than 225 diagnostic tests for COVID-19, including around 25 tests that allow for home collection of samples, which are then sent to a lab for testing, according to Medscape Medical News.
Dr. Hahn said, “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,”
“This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab,” said Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health.
“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,” he explained.
Like other antigen tests, the Ellume test may be false in rare instances. In asymptomatic patients, positive results should be considered presumptively positive until confirmed by another test, the agency said.
The FDA said, “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 where there is a low prevalence of COVID-19.” People who test negative but have symptoms of COVID-19 should check with their medical provider.
