Instructions for Use - FloodLAMP QuickColor COVID-19 Test v1.1 The Instructions for Use for the FloodLAMP QuickColor COVID-19 Test v1.1 provides CLIA high-complexity laboratories with the complete workflow for an extraction-free, colorimetric RT-LAMP assay with visual result interpretation after chemical and heat inactivation. It details required reagents, primer preparation, step-by-step testing procedures, control requirements, and criteria for interpreting positive, negative, and inconclusive results without specialized instrumentation. It also summarizes analytical and clinical performance, including a 12,500 copies/mL LoD and 90% positive agreement with 100% negative agreement in an 80-specimen clinical evaluation. primary file regulatory fl-fda-submissions 2021-05-18_Instructions for Use - FloodLAMP QuickColor COVID-19 Test v1.1.md regulatory/fl-fda-submissions/2021-05-18_Instructions for Use - FloodLAMP QuickColor COVID-19 Test v1.1.md 2021_05_18 gdoc docx CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ 10031 17475 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