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Papers & Protocols

Protocols

SalivaDirect™

For diagnostic and screening purposes, only labs designated by Yale and that follow the Instructions For Use, which we will provide, can use SalivaDirect. For research purposes, our open-source protocol can be used.
Current Protocol

Other Research Protocols

We have made other protocols available for SARS-CoV-2 research, such as saliva collection, RNA extraction, and development of positive control standards.

Important 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.