Saliva testing collection videosCheck out these helpful videos on the Saliva Testing Collection Process
ProtocolsFor diagnostic and screening purposes, only labs designated by Yale and that follow the Instructions For Use, which we will provide, can use SalivaDirect.Read More
Protocol validation dataOne of our goals with SalivaDirect™ is to test a number of alternate reagents, and combinations of alternate reagents, at each step.Read More
Saliva vs. swabs for SARS-CoV-2 detectionSaliva can be a reliable and sensitive sample type for SARS-CoV-2 detection when appropriate sample processing methods are applied.Read More
Additional resources for the COVID-19 pandemicRead More
Important Regulatory Information about SalivaDirect™
SalivaDirect™has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.