FDA Authorizes the First At-Home COVID-19 Test
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older.
The announcement today of the first fully at-home OTC COVID-19 diagnostic test follows last month’s authorization of the first prescription COVID-19 test for home use and last week’s announcement of the first non-prescription test system, in which a lab processes the self-collected sample. The FDA has authorized more than 225 diagnostic tests for COVID-19 since the start of the pandemic, including more than 25 tests that allow for home collection of samples, which are then sent to a lab for testing. The Ellume COVID-19 Home Test is the first COVID-19 test that can be used completely at home without a prescription.
🔺 USP 795 & 797 NEWS
Know Where Your Pharmacy Needs Attention
Patient Safety + Worker Safety x Environmental Protection = SurfaceShield
Who We Are
Eagle consultants and scientists are helping compounding facilities implement successful quality systems. Our team has over 200 years of combined experience in the FDA-regulated pharmaceutical industry and can provide guidance in establishing the systems and processes that will help facilities producing compounded medications meet and exceed regulatory expectations. Follow the link below to learn more about our consulting services.
