The Food and Drug Administration Tuesday issued an emergency use authorization (EUA) to the first non-prescription Covid-19 test, that can be taken fully at home and provides results within 20 minutes.
"Ellume COVID-19 Home Test", developed by Australian company Ellume Limited, is a rapid antigen test, where the test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age and older.
"This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab. 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," said Jeff Shuren, M.D., J.D., director of FDA's Center for Devices and Radiological Health.
This fully at-home Covid-19 test follows the first prescription test authorized last month and first OTC test authorized last week, in which swab sample is processed by a lab.
Authorization of more home-use tests provide more people access to tests without burdening laboratories, the FDA stated.
Since the start of the pandemic, the FDA has authorized more than 225 Covid-19 diagnostic tests including more than 25 tests in which swab samples can be collected at home and then send to a lab for testing.
"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 M. Hahn, M.D.
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