Pre-EUA Sub - FloodLAMP Proposed Pooling and Asymptomatic Screening Study The "2021-05-18_Pre-EUA Sub - FloodLAMP Proposed Pooling and Asymptomatic Screening Study" document documents outlines proposed validation studies to support swab pooling (up to four swabs) and serial asymptomatic screening claims for the FloodLAMP EasyPCR and QuickColor COVID-19 tests, aligned to FDA pooling/serial testing guidance. It specifies LoD and high-viral-load pooling experiments with replicate counts, acceptance criteria (e.g., ≥95% detection, Ct shift limits, invalid-rate thresholds), and use of inactivated virus controls. It also describes an IRB-approved asymptomatic screening study design using self-collected duplicate anterior nares swabs with a comparator EUA PCR test and app-based consent/kit logistics. primary file regulatory fl-fda-submissions 2021-05-18_Pre-EUA Sub - FloodLAMP Proposed Pooling and Asymptomatic Screening Study.md regulatory/fl-fda-submissions/2021-05-18_Pre-EUA Sub - FloodLAMP Proposed Pooling and Asymptomatic Screening Study.md 2021_05_18 gdoc docx CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ 889 1317 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