- U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in the nostrils. The test is the first molecular test authorized for at-home use without a prescription.
- FDA issued an EUA for the first over-the-counter, at-home, rapid diagnostic test for COVID-19. The Ellume COVID-19 Home Test, authorized for individuals 2 years old and older, with or without symptoms, detects proteins of the SARS-CoV-2 virus from a nasal swab sample. It can be used completely at home without a prescription and requires the use of a compatible smartphone and a downloadable app to provide testing instructions and deliver results in as little as 20 minutes.
- FDA issued a new Emergency Use Authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test for at-home use with a prescription. The BinaxNOW COVID-19 Ag Card Home Test is an antigen test.
As with any type of personal protective equipment (PPE), the key to proper selection and use of gowns and coveralls, is to understand the hazards and the risk of exposure.
Medical Devices (PPEs)
OTC Drugs (Hand Sanitizers)