Instructions for Use - FloodLAMP FLAMP COVID-19 Test NOT SUBMITTED The draft Instructions for Use for the FloodLAMP QuickFluor COVID-19 Test describe an extraction-free, fluorimetric RT-LAMP assay with real-time fluorescence detection on RT-PCR instruments following chemical and heat inactivation. It provides detailed procedures for reagent and primer preparation, instrument setup, workflow execution, controls, and Ct-based result interpretation for CLIA high-complexity laboratories. It also documents proposed analytical and clinical performance, including a 50,000 copies/mL LoD and 80–85% positive agreement with 100% negative agreement in an 80-specimen clinical evaluation, for a test that was not submitted for EUA. primary file regulatory fl-fda-submissions 2021-03-26_Instructions for Use - FloodLAMP FLAMP COVID-19 Test NOT SUBMITTED.md regulatory/fl-fda-submissions/2021-03-26_Instructions for Use - FloodLAMP FLAMP COVID-19 Test NOT SUBMITTED.md 2021_03_26 gdoc docx CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ 11985 20466 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