biostudies-literatureVogels CBFYale Institute for Global HealthNCATS NIH HHSNIA NIH HHSNIAID NIH HHSEmergent Ventures at the Mercatus CenterNational Basketball AssociationDutch Research Council (NWO)George Mason UniversityNational Basketball Players Associationthe Beatrice Kleinberg Neuwirth FundNWO RubiconHuffman Family Donor Advised Fund263-280.e6https://www.ebi.ac.uk/biostudies/studies/S-EPMC7836249biostudies-literatureUnknown2(3)<h4>Background</h4>Scaling SARS-CoV-2 testing to meet demands of safe reopenings continues to be plagued by assay costs and supply chain shortages. In response, we developed SalivaDirect, which received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).<h4>Methods</h4>We simplified our saliva-based diagnostic test by (1) not requiring collection tubes with preservatives, (2) replacing nucleic acid extraction with a simple enzymatic and heating step, and (3) testing specimens with a dualplex qRT-PCR assay. Moreover, we validated SalivaDirect with reagents and instruments from multiple vendors to minimize supply chain issues.<h4>Findings</h4>From our hospital cohort, we show a high positive agreement (94%) between saliva tested with SalivaDirect and nasopharyMed (New York, N.Y.)SalivaDirect: A simplified and flexible platform to enhance SARS-CoV-2 testing capacity.PMC7836249T32 AI007517K24 AG042489T32 AI007210019.181EN.004UL1 TR001863Khoury-Hanold WMcDonald DPeng XNouws JEarnest RMoore AJObaid ASewanan LKalinich CCKrumholz HMRose KAWang JLu-Culligan ADeIuliis GRice TDatta RYale IMPACT Research TeamMatos IVogels CBFGrubaugh NDMinasyan MKo AIGoldman-Israelow BKuang MTodeasa CNelson AStrong YSonnert NWatkins AEHui PFarhadian SFBucklin MLHandoko RPark HJVenkataraman AShafer JCahill SSharma LOtt IMYang YLinehan MPark ABermejo SLu PDela Cruz CSFauver JROdio CKim DPetrone MFournier JKnaggs LBrower KMatheus JDOh JEAnastasio KNakahata MIwasaki ABickerton SCasanovas-Massana AWhite EBSikka RAskenase MHCourchaine EShaw ACOmer SCaraballo CKudo ENaushad NProphet SLapidus SSmolgovsky MVelazquez SCampbell MTokuyama MMartin AVijayakumar PMuenker MCGeng BHarden CACao YLim JBrackney DELiu CShepard DBatsu MWyllie ALValdez JfalseSalivaDirect: A simplified and flexible platform to enhance SARS-CoV-2 testing capacity.<h4>Background</h4>Scaling SARS-CoV-2 testing to meet demands of safe reopenings continues to be plagued by assay costs and supply chain shortages. In response, we developed SalivaDirect, which received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).<h4>Methods</h4>We simplified our saliva-based diagnostic test by (1) not requiring collection tubes with preservatives, (2) replacing nucleic acid extraction with a simple enzymatic and heating step, and (3) testing specimens with a dualplex qRT-PCR assay. Moreover, we validated SalivaDirect with reagents and instruments from multiple vendors to minimize supply chain issues.<h4>Findings</h4>From our hospital cohort, we show a high positive agreement (94%) between saliva tested with SalivaDirect and nasophary2021-01-01T00:00:00Z2021 Mar2026-04-29T07:35:04.08Z2021-02-21T05:16:09ZS-EPMC78362493352174810.1016/j.medj.2020.12.010