The Food and Drug Administration granted emergency authorization Tuesday to Ellume’s over-the-counter antigen COVID-19 test for fully at-home use.
Why it matters: Once available, a person, in theory, would be able to buy the test in a drug store, swab their nose, and run the test for results in about 20 minutes.
The company anticipates selling the test at about $30 or less. Ellume’s goal is to produce 3 million tests by January and to deliver 20 million tests by the first half of next year.
The big picture: Currently, home kits that test for the novel coronavirus either still need a prescription or require swabs to be shipped to a lab, which could take days for results.
How it works: The rapid test can be used by symptomatic and asymptomatic users ages 2 years and above. This type of test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample.
A clinical study demonstrated an overall sensitivity of 95% and specificity of 97%, according to Ellume.
Yes, but: Like all other antigen tests, “a small percentage of positive and negative results from this test may be false,” the FDA notes.
“Patients without symptoms, positive results should be treated as presumptively positive until confirmed by another test as soon as possible.”