Instructions for Use - FloodLAMP QuickColor COVID-19 Test v1.0 The Instructions for Use for the FloodLAMP QuickColor COVID-19 Test v1.0 provides CLIA high-complexity laboratories with the complete protocol for an extraction-free, colorimetric RT-LAMP assay with visual readout after chemical and heat inactivation. It details required reagents and equipment, primer preparation, step-by-step testing workflow, control requirements, result interpretation by color change, and contamination precautions. It also documents analytical and clinical performance claims, including a 12,500 copies/mL LoD and 90% positive agreement with 100% negative agreement in an 80-specimen evaluation. primary file regulatory fl-fda-submissions 2021-03-22_Instructions for Use - FloodLAMP QuickColor COVID-19 Test v1.0.md regulatory/fl-fda-submissions/2021-03-22_Instructions for Use - FloodLAMP QuickColor COVID-19 Test v1.0.md 2021_03_22 gdoc docx CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ 10007 17430 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