FDA Grants EUA for First Non-prescription, Fully-at-home COVID-19 Test Kit

The rapid antigen test for the detection of active COVID-19 in those with and without symptoms produces results within 20 minutes and will retail for about $30.

The Food and Drug Administration (FDA) on December 15, 2020 granted Emergency Use Authorization (EUA) to digital diagnostics company Ellume for its rapid, at home COVID-19 antigen test, according to an agency press release

The test, which has demonstrated 96% accuracy in a US clinical trial of both adults and children, will be available for non-prescription home use for the detection of active COVID-19 in individuals with or without symptoms.

The test, the first of its kind to be granted an EUA, will retail for approximately $30.

“Today’s authorization is a major milestone in diagnostic testing for COVID-19,” said FDA Commissioner Stephen M. Hahn, MD, in the FDA announcement. “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.” Hahn notes that authorization of home kits like Ellume’s will help expand access to testing and, importantly, help reduce the burden on laboratories and use of testing supplies.

The EUA is based on data from an independently run, multisite US clinical study of 198 subjects aged 2 to 82 years in which the Ellume test correctly identified 96% of positive samples and 100% of negative samples in individuals with virus symptoms. In people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples.

In Tuesday's announcement, however, FDA emphasized that, like other antigen tests, a small percentage of positive and negative results from the Ellume test may be false.

"Therefore, for patients without symptoms, positive results should be treated as presumptively positive until confirmed by another test as soon as possible,” according to the agency.

"However, the fact that it [the test] can be used completely at home and return results quickly means that it can play an important role in response to the pandemic,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in the press release.

The Ellume COVID-19 Home Test includes a sterile nasal swab with child adapter, a dropper, processing fluid, and an analyzer. The sample must be collected further back than with the usual nasal swab, but not as far back as with the nasopharyngeal swabs used by healthcare providers. A Bluetooth-enabled app connects with the analyzer to walk the user through the instructions for performing the test and reading the results. Results are available in approximately 20 minutes.

The company expects to produce more than 3 million tests in January and to deliver 20 million to the US within the first have of 2021. The test was developed with $30 million contract from NIH's Rapid Acceleration of Diagnostics (RADx) initiative.