METADATA last updated: 2026-03-06 by BA file_name: FloodLAMP - COVID-19 Tests Summary.md file_date: 2021-05-20 title: FloodLAMP - COVID-19 Tests Summary category: various subcategory: fl-presentations tags: source_file_type: pdf xfile_type: NA gfile_url: NA xfile_github_download_url: https://raw.githubusercontent.com/FocusOnFoundationsNonprofit/floodlamp-archive-wip/main/various/fl-presentations/FloodLAMP%20-%20COVID-19%20Tests%20Summary.NA pdf_gdrive_url: https://drive.google.com/file/d/1Y8Q09VdMMTB1PnBQv2xJuvRAuvq8yv1- pdf_github_url: https://github.com/FocusOnFoundationsNonprofit/floodlamp-archive-wip/blob/main/various/fl-presentations/FloodLAMP%20-%20COVID-19%20Tests%20Summary.pdf conversion_input_file_type: pdf conversion: megaparse license: CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ tokens: 525 words: 321 notes: summary_short: The FloodLAMP Biotechnologies one-page overview presents its low-cost, open-source molecular testing platform for infectious disease mass screening, combining an extraction-free colorimetric LAMP assay (QuickColor) and a higher-sensitivity RT-qPCR assay (EasyPCR) with a purpose-built digital system for pooled collection, accessioning, and reporting. It highlights claimed performance metrics (e.g., sensitivity/specificity and LoD), scaling advantages without capital-intensive instruments, and digital workflow features for participants and labs. It summarizes validation and regulatory posture (Stanford CLIA evaluation, EUAs and a pre-EUA submitted, IRB approval) and includes a clear statement that the tests were not FDA cleared/approved/authorized at the time. CONTENT ***INTERNAL TITLE:*** FloodLAMP Biotechnologies Unlocking mass screening for infectious disease FloodLAMP is a public benefit corporation advancing public health with low cost, open-source, widely accessible molecular testing. We have developed key innovations in testing program administration, the underlying tests themselves, and the test supply chain. FloodLAMP’s flagship test is an isothermal, colorimetric, direct LAMP assay. FloodLAMP has reimagined molecular amplification workflows by pairing our tests with a purpose-built digital solution to streamline sample collection, accession and reporting. FloodLAMP provides a low overhead path for labs to enter the COVID-19 mass screening market today, and is a platform that enables expansion to other targets in the future. ## Tests ### Streamlined Sample Prep - Direct extraction-free assay - Individual and pooled swabs - Highly scalable, integrated processing - Same sample for both tests ### QuickColor(TM) COVID-19 Test - High sensitivity (90%) - 100% specificity - 12 copies/µL LoD - Ideal for serial screening - Uniquely scales without capital intensive instruments ### EasyPCR(TM) COVID-19 Test - Very high sensitivity (98%) - 100% specificity 3 copies/µL LoD - Ideal for diagnostics/reflex/confirm ## Digital Tools ### Easy, smooth UI for participants - Easy, shareable sign up - Electronic consent - Anywhere pooled collection - Results notifications and reporting ### Powerful, lightweight tool for the lab - Rapid QR code scanning Pre-accessioned, pre-pooled sample tubes - Batch flow control - Optimized for confirming negatives in screening (can replace LIS) - Can interface w LIS thru API ## Validation ### Validation kits - Kits and guide available upon request ### Clinical evaluation - Performed by Stanford University CLIA lab - 100% specificity for both tests (no FP) - Praise for "really straightforward" protocol ### Regulatory status - Full EUAs for QuickColorTM and EasyPCR(TM) COVID-19 Tests submitted to FDA - FloodLAMP Pooled Swab Home Collection Kit DTC pre-EUA submitted to FDA - IRB approved for clinical studies **Tests have not been cleared, approved, or authorized by the FDA.**