LFA Development: Assay Performance Verification
Formal Assay Performance Verification, often referred to as “claim support”, is a critical step for Lateral Flow Assay (LFA) developers preparing for regulatory submission. These studies provide the data required to support CE-marking, US FDA 510(k) or PMA submissions, and equivalent approvals worldwide.
At Fleet Bioprocessing Ltd., our team of experts ensures your LFA Performance Verification studies are fully aligned with ISO13485 requirements, IVDD/IVDR, and globally recognised technical guidelines such as those published by the Clinical & Laboratory Standards Institute (CLSI).
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We guide clients through the complete Performance Verification process from development of a verification plan and study protocols, through execution and detailed study reporting, to the final summary report. Each stage is documented to demonstrate assay performance against defined acceptance criteria.
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These studies are carried out in house at Fleet, but it is typically also necessary for clinical studies to be carried out in specified countries in a working clinical laboratory environment. We can help you to find the best collaborators for these crucial studies.
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To discuss how our LFA Performance Verification service can support your regulatory strategy and market launch, contact our team today.​
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Why Choose Our LFA Performance Verification Service?
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Regulatory Expertise - Extensive experience with IVDD/IVDR, FDA, and CLSI ensures globally compliant verification studies.
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End-to-End Service - From planning and protocol development to testing and reporting, we manage the full verification workflow.
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ISO13485 Compliance - All studies are conducted under ISO13485, providing robust, traceable documentation for submissions.
Example Projects
Claim support program for allergy assay range generates over 500 reports!
Over an extended period, Fleet coordinated and performed over 500 claim support and stability studies for an automated allergy platform. This required extensive and detailed planning to avoid scheduling conflicts and to manage long term stability studies. This range of assays has subsequently been successfully launched to market globally.
Fleet performance verification study allows CE-marking of ELISA for novel cardiovascular marker
An ELISA for a novel cardiac marker was developed for a French company, and successfully put through a full performance verification program which allowed it to be CE-marked.