Congrats to SalivaDirect team @YaleMed @YaleSPH! @FDA_US just granted their first EUA as a protocol so this LDT can be distributed for labs around the country. Should be low cost, convenient, and good test performance. Maybe a turning point on testing. @NathanGrubaugh @awyllie13
@YaleMed @YaleSPH @FDA_US @NathanGrubaugh @awyllie13 About SalivaDirect… you can go here for more information. medrxiv.org/content/10.110… 
@YaleMed @YaleSPH @FDA_US @NathanGrubaugh @awyllie13 Importantly, this team has developed and validated an approach that is designed to be shared… it is a protocol. And something being shared with the world w/o cost. Also, kudos @NBA and NBAPA for their support of the validation efforts. Professional sports supporting the science.
@YaleMed @YaleSPH @FDA_US @NathanGrubaugh @awyllie13 @NBA And there will be much more innovation to come in testing… from this team and others. But having a simple, effective, saliva test… that should be inexpensive, can be widely available - should be gamechanging. Now to test the heck out of this pandemic and beat it back.
@YaleMed @YaleSPH @FDA_US @NathanGrubaugh @awyllie13 @NBA And nice how preprints @medrxivpreprint helped to move this science about SalivaDirect… series of outstanding contributions for the scientific community to review. As they go through peer review, you can see them now. And comment. Thx @VogelsChantal @awyllie13 @NathanGrubaugh
@YaleMed @YaleSPH @FDA_US @NathanGrubaugh @awyllie13 @NBA @medrxivpreprint @VogelsChantal And here is the @US_FDA press release: '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’ fda.gov/news-events/pr… @YaleMed @YaleSPH
@YaleMed @YaleSPH @FDA_US @NathanGrubaugh @awyllie13 @NBA @medrxivpreprint @VogelsChantal @US_FDA Here from @FDACommissioner about SalivaDirect: 'Providing this type of flexibility for processing saliva samples to test for COVID-19 infection is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents’ fda.gov/news-events/pr…
@YaleMed @YaleSPH @FDA_US @NathanGrubaugh @awyllie13 @NBA @medrxivpreprint @VogelsChantal @US_FDA @FDACommissioner "SalivaDirect does not require any special type of swab or collection device; saliva sample can be collected in any sterile container...does not require separate nucleic acid extraction step…sig because extraction kits used for this step in other tests prone to shortages..."
@YaleMed @YaleSPH @FDA_US @NathanGrubaugh @awyllie13 @NBA @medrxivpreprint @VogelsChantal @US_FDA @FDACommissioner "Yale intends to provide SalivaDirect protocol to interested laboratories as an “open source” protocol, meaning that designated laboratories could follow the protocol to obtain the required components and perform the test in their lab according to Yale’s instructions for use."
@YaleMed @YaleSPH @FDA_US @NathanGrubaugh @awyllie13 @NBA @medrxivpreprint @VogelsChantal @US_FDA @FDACommissioner "Because this test does not rely on any proprietary equipment from Yale & can use variety of commercially available testing components, it can be assembled & used in high-complexity labs throughout the country, provided they comply with conditions of authorization in the EUA."
@YaleMed @YaleSPH @FDA_US @NathanGrubaugh @awyllie13 @NBA @medrxivpreprint @VogelsChantal @US_FDA @FDACommissioner "While FDA has seen variable performance in tests using saliva, Yale submitted data w/its EUA request from which FDA determined that Yale’s test meets criteria for emergency authorization when used to test saliva samples for SARS-CoV-2, the virus that causes COVID-19 infection."
