Abingdon Health’s core expertise lies in the development, manufacturing and commercialisation of rapid lateral flow immunoassay and reader systems. Owing to this expertise, we offer a bespoke lateral flow assay development service that is tailored to your needs.
We have experience in different markets including healthcare, veterinary, food and agriculture. Each lateral flow product we manufacture adheres to the regulatory standards necessary for that market.
Our manufacturing facility is certified to ISO 13485-2003 (including EN ISO 13485:2012) for the design, development and manufacture of lateral flow immunodiagnostic medical devices.
In addition, Abingdon Health’s manufacturing facilities are GMP compliant, with the U.S. Food and Drug Administration (FDA), for the design, development and manufacture of lateral flow devices, and device readers for in vitro diagnostic medical use.
Lateral flow immunoassays have enabled testing to move from the laboratory to the point of contact. Providing results in minutes, these rapid tests are straightforward to use and have found wide application.
Lateral flow devices (LFDs) use immunoassay technology via a combination of antibodies (or other binding moieties such as aptamers and affirmers), nitrocellulose membranes and coloured nanoparticles in order to produce qualitative (visual) results or quantitative results in combination with reader technology.
Read how we combine lateral flow and reader technology in order to produce quantitative assays.
Planning, Feasibility and Optimisation
Lateral Flow Assay Development
Whether customers are looking to convert an existing ELISA assay into a lateral flow test, or are looking to apply a novel biomarker to an LFD, Abingdon Health uses a comprehensive step-by-step quality-driven approach to lateral flow test development.
Our experience in lateral flow diagnostics means we are able to develop assays for different sample matrices including saliva, serum, plasma, blood, urine, milk, plant material and much more.
Concept and planning phase
Discussions will be held concerning the market requirements, product specifications, component supply and regulatory considerations. The output of these discussions will result in the completion of a product development plan which will incorporate all the phases required to take the product through to manufacture and then commercial launch. If we are also developing a lateral flow reader for you, we will have these discussions in parallel.
Assay feasibility and optimisation
A number of different parameters will be evaluated during this first experimental stage of assay development. Abingdon Health will prepare a series of prototypes to be assessed against development goals at the end of these extensive studies.
The formulations, materials and processes used to make the working prototypes will then be optimised to ensure reproducibility. Following client approval of the final assay specification, the assay is classed as having reached design freeze and no further modifications are made.
Lateral flow manufacturing
Once design freeze is reached, the selected prototype needs to transfer from Research and Development through to routine manufacturing.
At this point, our technical transfer team, with involvement from key members of our production team, will typically manufacture 3 batches of the product using high volume automated reel-to-reel machines. This stage is important for validating and verifying the performance of the assay following scale-up.
To learn more about our manufacturing capabilities please visit our lateral flow manufacturing page.
To find out more about our lateral flow assay development and lateral flow manufacturing services, please call on +44 (0) 1904 406060 or email email@example.com with an outline of your requirements. If you would like a quotation for our service please visit our quotations page.
Download our Development & Manufacturing Brochure
Download a copy of our Lateral Flow Reader OEM eBook