LFA Development: Feasibility
​​​​​​The feasibility stage focuses on translating selected assay components and configurations into a defined prototype design. Key activities include evaluating assay formats and pad materials, assessing conjugation parameters, nitrocellulose coating, optimising buffer formulations, and refining operational parameters such as read time and sample volume.
ISO13485 Design control principles are applied throughout including defining design requirements, managing risks, and initiating early stability assessments. The objective is to establish a single prototype that meets the desired performance criteria, is robust under expected conditions, and is fit for purpose in its intended environment.
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The activities detailed below form the core deliverables and outputs of the feasibility stage, but each project can be tailored to meet the specific needs and priorities of our customers. For projects that move into further development, outputs from feasibility will be advanced during the Optimisation phase.
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To discuss how these services can be customised for your Lateral Flow Assay development, please get in touch with our team below.
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Key Deliverables
Project Definition
Overview
Clear definition of project scope, objectives, timelines, and responsibilities.​​
Design Requirements
Establishment of product requirements, intended use, and key performance criteria.
Risk Management
Identification and management of technical and project risks throughout development.
Material Selection & Assay Performance Assessment
Selection and optimisation of assay formats, materials and operating parameters.
Prototype Development
Production and supply of initial lateral flow assay prototypes.
Interference Assessment
Evaluation of potential sample matrix effects and cross-reactivity.
Indicative Stability
Early stage stability assessment to support development decisions.
Feasibility Summary
Summary report outlining performance, findings, and recommendations.
Design Review
Review and confirmation that the assay meets agreed development objectives.