EUA Submission - FloodLAMP EasyPCR COVID-19 Test v1.0 The EUA Submission for the FloodLAMP EasyPCR COVID-19 Test v1.0 details an extraction-free, duplex RT-qPCR assay for qualitative SARS-CoV-2 detection in upper respiratory swab specimens, including proposed intended use for routine weekly screening in asymptomatic individuals. It specifies the CDC N1 and RNaseP targets, validated instruments, sample inactivation workflow, controls and interpretation criteria, and manufacturing/sourcing assumptions for an “open source” CLIA high-complexity lab deployment. It summarizes analytical and clinical performance claims including a 3,100 copies/mL LoD and clinical agreement results from an 80-specimen evaluation. primary file regulatory fl-fda-submissions 2021-03-22_EUA Submission - FloodLAMP EasyPCR COVID-19 Test v1.0.md regulatory/fl-fda-submissions/2021-03-22_EUA Submission - FloodLAMP EasyPCR COVID-19 Test v1.0.md 2021_03_22 docx docx CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ 5454 9057 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