Yale’s Saliva Test for COVID-19 Gets Renewed EUA

Yale University’s SalivaDirect direct-to-consumer (DTC) saliva collection kit has received a renewed Emergency Use Authorization from the FDA for use with the SalivaDirect test to detect the SARS-CoV-2 virus that causes COVID-19 in individuals without symptoms.

The DTC kit, which includes a bulb pipette and a labeled tube with a funnel, is meant for self-collection of saliva samples at home or in a community-based setting by people age 18 and up.

Testing of the self-collected saliva samples may only be done by laboratories designated by the Yale School of Public Health, including Yale’s clinical molecular diagnostics laboratory in New Haven, Conn.