SalivaDirect EUA IFU - Yale School of Public Health SalivaDirect assay EUA Summary The SalivaDirect EUA Summary (updated Oct. 15, 2020) outlines Yale’s extraction-free saliva RT-qPCR test authorized for use only in CLIA high-complexity laboratories designated by Yale, including the intended use, workflow, validated instruments, and detailed reagent/vendor options to support supply-chain flexibility. It provides control requirements, result interpretation criteria, and performance data including LoD studies across multiple reagent and instrument combinations and a paired clinical comparison showing high positive agreement with an authorized comparator. primary file regulatory open-euas 2020-10-15_SalivaDirect EUA IFU - Yale School of Public Health SalivaDirect assay EUA Summary.md regulatory/open-euas/2020-10-15_SalivaDirect EUA IFU - Yale School of Public Health SalivaDirect assay EUA Summary.md 2020_10_15 pdf 3rd Party 3161 5102 gfile-url xfile-github-download-url pdf-gdrive-url pdf-github-url github-markdown-url github-markdown-download-url web-pdf-url web-slides-url youtube-url web-url