EUA Submission - FloodLAMP FLAMP COVID-19 Test NOT SUBMITTED The EUA Submission draft for the FloodLAMP QuickFluor COVID-19 Test (not submitted) describes an extraction-free, fluorimetric RT-LAMP assay using ORF1ab/N/E primer sets and real-time fluorescence readout on validated RT-PCR instruments (e.g., QuantStudio 7 Pro and Bio-Rad CFX96). It specifies the sample inactivation workflow, reaction setup, controls, and result interpretation criteria, along with proposed “open source” component sourcing for CLIA high-complexity labs. It summarizes stated performance claims including a 50,000 copies/mL LoD and clinical agreement results (80% positive agreement, 100% negative agreement) from an 80-specimen evaluation. primary file regulatory fl-fda-submissions 2021-03-26_EUA Submission - FloodLAMP FLAMP COVID-19 Test NOT SUBMITTED.md regulatory/fl-fda-submissions/2021-03-26_EUA Submission - FloodLAMP FLAMP COVID-19 Test NOT SUBMITTED.md 2021_03_26 docx docx CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ 8581 15555 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