Lateral Flow Assay Development Service

Helping rapid test concepts become a reality

Our lateral flow development team is proud of working with a global, multi-industry client base. By combining experience and passion we work closely with clients to produce tests that make a difference: this is what drives us.

Many years of developing lateral flow assays for clients and having launched our own products, means we recognise the pressures of developing new rapid tests. Through tried and tested methods, our assay development scientists work alongside in-house regulatory experts and a network of quality suppliers to take tests from R&D into routine manufacture.

Abingdon Health is certified to ISO 9001 and ISO 13485, and is compliant to FDA 21 CFR 820 and GMP. Abingdon Health also meets regulatory requirements of UK MDR 2002, the IVDD 98/79/EC and the IVDR 2017/746. In addition, our facilities have an establishment registration with the FDA.

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Our process

Whether a project starts during concept and planning or optimisation our established methods produce robust assay specifications suitable for routine LFT manufacture.

1

Concept and planning phase
- Define market, product, supply and regulatory requirements
- Production of a phase-by-phase project plan. A parallel desktop or Smartphone reader customisation plan will be drawn up if applicable.
2

Assay feasibility and optimisation
- Evaluation of specifications and materials
- Pilot batch
- Assessment of prototypes
- Optimisation of formulations, reagents and materials
- Design freeze
3

Scale-up and transfer to manufacture
- Validation batches at small, medium and delivery batch scale
- Manufacturing schedules and processes for transfer to manufacture

Whether looking to develop new tests, or transfer existing ones for use in the field, Abingdon Health helps its customers:

develop rapid test solutions for both single and multiple analytes
convert lab-based assays (e.g. ELISA) to lateral flow for use at the Point Of Care (POC)
design semi-quantitative or quantitative lateral flow testing solutions
navigate complex regulatory, legal, and commercial barriers to launching products to market

Tailored lateral flow assay development

Focus in the following areas allows us to transfer tests from development into routine lateral flow manufacturing:

Defining optimum user protocols and sample preparation for different sample matrices (blood, serum, urine, milk, food, plant material, plus more)
The use of optimum conjugation techniques and immunoassay formats depending on the target
Choosing the right quality raw materials: antibodies, reagents, nitrocellulose membranes and labels (colloidal gold, carbon, latex, plus others).
Securing a sustainable supply of materials via our established supply chain
Optimum configuration with applicable desktop or Smartphone readers
Offering stable costs from development through to market entry

Working Hard To Help You Achieve Your Goals

Abingdon Health is proud of being approachable and values its long-term collaborative partnerships. Dedicated account managers and experienced teams of R&D, tech transfer and manufacturing experts work hard to ensure the delivery of optimum rapid test solutions for the life cycle of product portfolios.

We’re passionate about imparting our knowledge and expertise to help you hit your goals. Contact our team to see how can take your assay from R&D to end-users.