The FDA granted emergency approval Dec. 15 for the first fully at-home COVID-19 diagnostic test, which doesn't need a prescription and doesn't need to be sent to a lab.
The Ellume COVID-19 Home Test is a rapid antigen test that detects proteins from the virus from a nasal swab and can be used on anyone over 2 years old.
"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 Stephen Hahn, MD.
The agency warned that a small percentage of results may be false. The test correctly identified 96 percent of positive samples and 100 percent of negative samples in people with symptoms. In those without symptoms, the test correctly identified 91 percent of positive samples and 96 percent of negative samples.
The FDA said that people without symptoms should treat a positive result from the Ellume test as presumptively positive until confirmed by a lab test. Those with symptoms who get a negative result should follow up with their healthcare provider to decide whether they should get another test, the FDA said.
The Ellume test connects to a smartphone app to give results, which come in about 20 minutes. The app reports the results to public health authorities to help monitor disease prevalence.
Ellume said it expects to make more than 3 million tests in January. The company didn't mention how much the tests will cost.
The FDA previously has given emergency approval for an at-home COVID-19 test from LabCorp that doesn't require a prescription, but must be sent to a lab for results. The agency authorized the first at-home COVID-19 test in November, but that requires a prescription and must be sent to a lab.