SalivaDirect™ is a new process developed at the Yale School of Public Health to test for infection with SARS-CoV-2, the virus that causes COVID-19.
SalivaDirect uses a saliva sample, rather than an invasive nasal or throat sample, to detect the presence of the virus. While it relies on a similar molecular process as earlier tests, it simplifies the test process to drive down costs and ease stress on supply chains.
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SalivaDirect™ has not been FDA cleared or approved. It has been authorized by FDA under an EUA for use by authorized laboratories. This 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 diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.