FDA Approves First Non-Prescription, OTC Test for At-Home COVID-19 Detection

The U.S. Food and Drug Administration (FDA) has authorized the first non-prescription, over-the-counter, at-home antigen test that can be used to identify infection with SARS-CoV-2, the virus responsible for COVID-19, in people two years of age or older.

According to the FDA, the newly approved Ellume COVID-19 Home Test is a rapid, lateral flow antigen test that effectively detects protein fragments of the SARS-CoV-2 virus using a nasal swab sample. The test can even be used in asymptomatic people to detect the virus.

The nasal swap “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,” according to a statement made by the FDA.

Approval of the Ellume COVID-19 Home Test was made based on data showing it correctly identifies up to 96% of positive samples and 100% of negative samples in people displaying common COVID-19 symptoms. Also, in asymptomatic individuals, the test has been shown to correctly identified approximately 91% of positive samples and 96% of negative samples.

The test uses an analyzer connected to smartphone software to help users conduct the test and analyze their results at home. Test results are delivered in about 20 minutes to the user’s smartphone application. Users of the at-home test must enter personal information, including zip code and date of birth. Results of the tests, when appropriate, are reported to public health authorities to monitor the prevalence of COVID-19. According to the FDA statement, Ellume expects to produce over three million tests in January 2021.

“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,” according to a statement made by 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.”

Since the onset of the pandemic, the FDA has authorized more than 225 diagnostic COVID-19 tests. This includes more than 25 tests that allow for at-home sample collection, all of which are sent to outside labs. Just last month, the FDA authorized the first prescription at-home COVID-19 test. Also, the FDA recently granted Emergency Use Authorization to the first non-prescription test system from LabCorp last week that allows labs to process a self-collected sample to identify whether or not a person has COVID-19.

In contrast to the other authorized at-home COVID-19 tests, the Ellume COVID-19 Home Test represents the first system that can be used completely at home without the need to get a prescription.

“The FDA strongly supports innovation in test development and we have worked tirelessly with test developers to support the shared goal of getting more accurate and reliable tests to Americans who need them,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health, in a statement. “Today is a promising step forward and we are eager to continue advancing additional innovation in COVID-19 testing that the science supports.” He added that the test, similar to other antigen tests, is less specific and less sensitive than typical molecular tests that are run in a lab setting. “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,” added Shuren.

The agency notes that there may be a small proportion of false positives and negatives with the newly approved Ellume COVID-19 Home Test, which is common for other similar testing systems. “Therefore, for patients without symptoms, positive results should be treated as presumptively positive until confirmed by another test as soon as possible,” the FDA said in their statement. The agency added that this is particularly true if fewer infections are reported in a certain community “as false positive results can be more common when antigen tests are used in populations where there is little COVID-19.”

Participants who test positive with the test are urged to self-isolate and seek care from their healthcare provider. Similarly, people who receive a negative test result but have COVID-19-like symptoms should consult with their physician, the FDA noted.