Pre-EUA Sub - FloodLAMP Proposed Pooling and Asymptomatic Screening Study The Pre-EUA document 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