FDA Issues Emergency Use Authorization for SalivaDirect Test

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On August 15, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) 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.

This test does not require any special swab or collection device extraction or storage and can be processed by most high-complexity labs with common reagents under an "open-source" protocol. Since it does not require a separate nucleic acid extraction kit the capacity for testing will greatly increase.

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“The SalivaDirect test for rapid detection of SARS-CoV-2 is yet another testing innovation game changer that will reduce the demand for scarce testing resources,” said Assistant Secretary for Health and COVID-19 Testing Coordinator Admiral Brett P. Giroir, M.D.

This test is currently being validated through a program testing asymptomatic NBA players. Current results show that SalivaDirect is highly sensitive, yielding similar results as the more invasive nasal (NP) swabbing. The fact that this will decrease both testing times and costs as well is making it widely available should increase the effectiveness of timely tracking and prevention of COVID spread.

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-use-authorization-yale-school-public-health