Instructions for Use - FloodLAMP EasyPCR COVID-19 Test v1.1 The Instructions for Use for the FloodLAMP EasyPCR COVID-19 Test v1.1 provides CLIA high-complexity labs with the complete protocol for an extraction-free, duplex RT-qPCR assay (CDC N1 + RNaseP) used in routine screening programs with at least weekly testing. It details required reagents and equipment, inactivation and amplification workflows, instrument template setup, data export/compilation, and Ct-based interpretation with control acceptance criteria. It also summarizes stated analytical and clinical performance, including a 3,100 copies/mL LoD and 97.5% positive agreement with 100% negative agreement in an 80-specimen evaluation. primary file regulatory fl-fda-submissions 2021-05-18_Instructions for Use - FloodLAMP EasyPCR COVID-19 Test v1.1.md regulatory/fl-fda-submissions/2021-05-18_Instructions for Use - FloodLAMP EasyPCR COVID-19 Test v1.1.md 2021_05_18 gdoc docx CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ 9133 14252 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