US FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19

U.S. FDA recently issued an emergency use authorization (EUA) of the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19 which does not require a doctor's prescription and does not require a laboratory to provide results. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample from the nose. The test is an antigen test which detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older. PCR Tests are considered more accurate than antigen tests, but overall the FDA found the device to be safe and effective sufficient for an EUA. 

For More information see source here: fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-antigen-test-first-over-counter-fully-home-diagnostic 

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