How to Analyse Lateral Flow Tests (LFT/LFA) in compliance with 21 CFR Part 11 Using Phoretix 1D



February 27, 2023

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  • In this video, I'll show you how you can obtain quantifiable data from lateral flow tests (LFT/LFA) in a 21 CFR Part 11/GxP/EU Annex 11 compliant manner using Phoretix 1D, which allows you to produce a full audit trail for every single lateral flow test you analyse to ensure regulatory compliance. 00:00 - Intro 00:20 - Explanation of TotalLab GxP Compliance Module 00:50 - How to log in to the software 01:40 - Username entry 01:50 - Password entry 02:17 - 21 CFR Sign in 02:23 - Project screen overview 02:32 - Creating a new compliant project 02:46 - Attaching notes to the audit trail of a project 03:10 - Adding files to your project 03:42 - Audit trail explanation 04:20 - Checking out a project for analysis 04:32 - Software integrations with the TotalLab GxP module 04:39 - Opening Phoretix 1D analysis software 04:50 - Analysing lateral flow tests 10:27 - Saving your analysis 10:32 - Audit trail build-up explanation 10:48 - Extended notes within the audit trail 11:40 - Checking a project back in to the secure folder 12:05 - Adding notes to a project check-in 12:23 - Checking the revision number of a project 12:54 - Viewing previous revisions of a project 13:08 - Viewing changes in data between revisions 13:41 - Exporting a 21 CFR compliant project report in .pdf 14:00 - Overview of report 15:20 - Sending a project for sign-off 15:50 - Adding notes for project sign-off to the audit trail 17:22 - Signing off a project 17:36 - Identifying projects awaiting sign-off 17:50 - Audit trail for project awaiting sign-off 18:36- Checking out a read-only copy of a project for inspection 19:20 - Password-protected sign-off 19:35 - Adding notes to project sign-off 21:05 - Project signed-off and closed Quantifying the bands allows accurate comparison of the reactivity of different antibodies to positive samples and the definition of the limits of detection of those antibodies to positive samples (to determine the minimum testing sample volume). A previous version of our 1D analysis software, CLIQS, has already been used for this purpose with the research published here: Another of our products, CLIQS 1D Pro, allows the building of a database of lateral flow tests that can be searched or allow tests to be compared to the entire database for similarities and differences. For a free trial of Phoretix 1D to see how well it works with your lateral flow test images, please fill in the form here: For a free trial of CLIQS 1D Pro to see how well it works creating a database of your lateral flow test images, please fill in the form here: For a free trial of our Phoretix 1D GxP software, to see how well it operates within a 21 CFR Part 11/GxP/Annex 11 compliant format, please fill in the form here: #21CFR #GxP #lateralflowtest #LFA #analysis #GxP #database #software #LFT #1D #imageanalysis #automatic #howto #antibody #testing

    Analytical TechniquesAutomationImaging/MicroscopyMolecular Biology
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