Instructions for Use - FloodLAMP QuickColor COVID-19 Test v1.2 The FloodLAMP QuickColor COVID-19 Test Instructions for Use v1.2 (draft) provides updated procedures for an extraction-free, colorimetric RT-LAMP assay with visual interpretation (including photo-based review) for routine weekly screening in CLIA high-complexity labs. It details reagents, primer preparation, inactivation and amplification steps, controls, and revised guidance for handling inconclusive results using a triplicate repeat and defined result-mapping rules. It also summarizes analytical and clinical performance claims consistent with prior versions, 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 2021-10-01_Instructions for Use - FloodLAMP QuickColor COVID-19 Test v1.2.md regulatory/fl-fda-submissions/2021-10-01_Instructions for Use - FloodLAMP QuickColor COVID-19 Test v1.2.md 2021_10_01 gdoc docx CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ 10085 17554 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