FDA guidance provides pathway for developers and manufacturers to obtain EUAs for at-home and over-the-counter COVID-19 testing. The US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) template for test developers attempting to create at-home and over-the-counter SARS-CoV-2 diagnostic tests. The FDA announced this new template in a press release July 29, 2020, providing […]
Nursing Homes: First Wave of Testing Begins as HHS’ Large Scale Distribution of SARS-CoV-2 POC Antigen Tests Takes Shape in Hotspots
While the antigen test initiative of HHS will play a role in reducing the spread of COVID-19 among vulnerable populations and surrounding communities, mass rapid point of care testing will have implications for clinical laboratories.