FDA Issues Emergency Use Authorization to Yale School of Public Health for SalivaDirect

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COVID-19 Update: FDA Issues Emergency Use Authorization to Yale University for its SalivaDirect COVID-19 diagnostic test, which uses a New Method of Sample Processing

Today, the U.S. Food and Drug Administration (FDA) issued Yale School of Public Health an emergency use authorization (EUA) for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19. This molecular test is for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva collected without preservatives in a sterile container from individuals suspected of COVID-19 by their healthcare provider. SalivaDirect does not require any special type of swab or collection device – a saliva sample can be collected in any sterile container.  It is also unique because it does not require a separate nucleic acid extraction step. This is significant because the extraction kits used for this step in other tests have been prone to shortages in the past.

Read More Questions? If you have questions, contact COVID19DX@fda.hhs.gov