FDA issues EUA for Yale’s SalivaDirect

Create PDF

Sept. 28, 2020—The FDA issued an emergency use authorization to Yale School of Public Health for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 infection, the agency says.

SalivaDirect does not require a special type of swab or collection device; a saliva sample can be collected in any sterile container. The test does not require a separate nucleic acid extraction step.