Helping rapid test concepts become a reality
We are proud of working with a global, multi-industry client base in providing access to fast results via accurate, high quality rapid tests.
Our experienced lateral flow assay development team works alongside in-house planners and regulatory experts to deliver tailored projects irrespective of assay or market complexity.
We have launched our own lateral flow products and managed product registrations for customers across many markets and recognise the pressures of developing a new rapid test. This first-hand experience means Abingdon Health understands our customers’ goals and how best to translate their needs into delivery.
Abingdon Health is certified to ISO 9001 and ISO 13485 and works in accordance with GMP 21CFR820.
Whether a project starts during concept and planning or optimisation our flexible methods using state of the art equipment produces robust assay specifications for long-term routine manufacture.
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.
Assay feasibility and optimisation
- Evaluation of specifications and materials
- Pilot batch
- Assessment of prototypes
- Optimisation of formulations, reagents and materials
- Design freeze
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
- extend the life cycle of rapid tests with the addition of a reader
- 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 appropriate 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
Abingdon Health is proud of being approachable and values its collaborative partnerships with customers. 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.
Providing more people with access to rapid tests is what drives us. Faster diagnosis and screening in the field, accelerates the ability of decision makers to deploy a more rapid response to results, which is positive for all industries.