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Abingdon Health provides a comprehensive lateral flow assay development service for qualitative, semi-quantitative and quantitative assays using multiple labels, and sample matrices. We work with a global customer base active in a variety of industries including but not limited to:

• Autoimmune
• Infectious disease
• Drugs of Abuse
• Pharmaceutical and therapy monitoring
• Animal health
• Environmental
• Agriculture
• Food testing

Lateral flow assay development is part of our unique, flexible, end-to-end service which starts with concept design at the R&D stage through to flexible and scalable small and high-volume automated or semi-automated manufacturing solutions. In addition, Abingdon Health will also handle the regulatory requirements and adopt legal manufacturing status on your behalf if required.

We also offer assay quantitation through the customisation of complementary  desktop and Smartphone lateral flow reader systems.

Work with us if you are looking to:

• develop a single-target or multiple-target lateral flow test
• require semi-quantitative or quantitative results
• convert your ELISA to a Point of Care (POC) lateral flow assay
• evolve your existing assay into a higher performing next generation lateral flow assay
• extend the life-cycle of your assay with addition of a diagnostic data solution
• take advantage of our regulatory and legal manufacturer commercial experience

Our promise

Abingdon Health supports our customer’s product and organisational ambitions by offering a flexible and value for money service that consistently produces devices that meet product specifications, market needs and stakeholder expectations.

Our approach to every project

Each lateral flow assay development project is unique and we undertake a robust, tried-and-tested product development and design review process that draws on our many years of experience to deliver the specific assay solution. We strongly believe this approach combined with a close collaboration with our customers delivers a transparent process that is at the heart of successful project outcomes. Once complete, the Project Design History File is transferred to you, the customer.

Lateral Flow Assay Development

Concept and planning phase

• Determine market requirements, product specifications, component supply and regulatory considerations.
• Production of a phase-by-phase project plan including key deliverables and milestones.
• For semi- or fully-quantitative assay development, a reader or Smartphone customisation plan will be carried out in parallel.

Assay feasibility and optimisation

• Evaluation of assay target specifications and material parameters.
• Preparation and extensive assessment of prototypes.
• Optimisation of formulations, reagents, materials and processes used to make the working prototypes to ensure robustness and reproducibility.
• Design freeze following client approval of assay specification.
• Preparation of pilot batches to demonstrate performance.

Technical transfer, scale-up and manufacture

• Preparation of three process validation batches at small, medium and delivery batch scale
• Agree manufacturing schedules for the routine manufacturing of product

Visit our lateral flow manufacturing page to learn more about our technical transfer, scale-up and manufacturing capabilities.

Sample Types for Lateral Flow

Abingdon Health has experience of developing assays that detect a number of target analytes in different sample matrices including:

• Milk
• Whole blood
• Serum
• Saliva
• Urine
• Tissue samples
• Food
• Animal feed
• Plant material
• Water
• Fuel

Label selection and conjugation

We choose labels depending on several factors such as the target, sample matrix and antibody. The optimisation of the assay will ensure the label interacts correctly with the antibody and antigen to ensure efficiency and accuracy of results.

Typically, lateral flow assays utilise conjugated colloidal gold, carbon, or coloured latex nanoparticles within the conjugate pad. Other labels include magnetic or fluorescent beads.

Reagent sourcing and available reagents

Abingdon Health have extensive Industry networks and can assist with sourcing a sustainable supply of quality and exclusive reagents:

• Search for commercially available reagents
• Antibody and antigen generation and the growth and maintenance of cell lines
• Targeted list of assay reagents exclusively available to our customers. Visit our lateral flow assay reagents page for more information.

Case studies

Visit our Case Studies pages to learn more about some of the assay development projects undertaken by Abingdon Health.

Contact Us

To find out more about how our lateral flow assay development service can help you achieve your ambitions for your assay, please call on +44 (0) 1904 406080 or email info@abingdonhealth.com with an outline of your requirements.

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