First COVID-19 At-Home Test That Doesn’t Require A Prescription Authorized By The FDA
Ellume Health’s COVID-19 Home Test isn’t just a relatively fast, accurate and easy-to-administer antigen diagnostic, but it’s also available over-the-counter, which greatly expands public access to such tests.
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Pixel kit allows users to send nasal swab samples to be tested with LabCorp’s a real-time reverse transcription polymerase chain reaction test. Health care providers will call consumers who test positive; negative test results will be delivered by email or through LabCorp’s online portal.
In what could be a game-changer in the fight against the coronavirus, Lucira Health has received the first-ever emergency use authorization from the US FDA for an at-home prescription diagnostic test kit for detecting SARS-CoV-2.
The US FDA’s diagnostics chief says the agency isn’t seeing many submissions for rapid antigen tests, but is eager to authorize them.