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CASE STUDY

In addition to developing and manufacturing rapid lateral flow tests for our clinical and contract customers, Abingdon Health manufactures a range of rapid tests for plant diseases called Pocket Diagnostic®.

The following areas are discussed to highlight how Pocket Diagnostic® was brought to market in order to help fight devastating plant diseases.

  • Assay development
  • Scale-up
  • Manufacture

Assay development

Pocket Diagnostic® was initially developed for use by the UK Government Plant Health Inspectors in order to provide them with a cost-effective and user-friendly, in-field rapid testing solution to use during their inspections.

Knowing that the Pocket Diagnostic® range would need to test a variety of plants and plant material the tests were enhanced to work with a variety of sample matrices such as leaf and woody plant materials.

With this in mind, the team followed a development plan that covered the following areas in order to ensure the tests worked with the intended matrices.

  • Reagents testing
  • Selection of membranes, samples pads, buffer selection
  • Feasibility, optimisation and scale-up
  • Validation

Scale-up and large volume manufacture

a lateral flow assay rapid test for plant diseasesFollowing assay development, the Pocket Diagnostic® range was scaled-up via a verification and validation phase in order to assess how Pocket Diagnostics performance would cope with the rigours of routine manufacture.

The manufacture of Pocket Diagnostic® is carried out in Abingdon’s fully automated and climatically controlled manufacturing facility, which is ISO 9001 and ISO 13485 certified and works to GMP requirements.

Since its launch, Pocket Diagnostic® has been used by a global audience across 6 continents and has provided professionals working in horticulture, forestry and food production with an in-field rapid testing solution for pathogens such as Phytophthora spp*, Potato virus Y, Erwinia amylovora (Fire Blight) and Ralstonia solanacearum (Brown Rot/Bacterial Wilt).

manufacturing equipment for lateral flow testsTo learn more about Abingdon Health’s services, there are a series of videos which can be viewed by visiting https://www.abingdonhealth.com/videos/.

Alternatively, please read one of our other case studies on how we launched a rapid quantitative lateral flow test for haematology oncology. Or read about the process we will take in order to develop a multiplexed on-farm rapid test to identify a disease in cattle that affects milk production.

Why work with Abingdon Health?

  • Ability to apply reagents to a lateral flow device (LFD) or convert an ELISA assay into an LFD
  • Aid the transfer from initial stage R&D into a full development and manufacturing project
  • Cost-effective solutions with assay and customer requirements at the forefront
  • Proven track record of developing and manufacturing qualitative, semi-quantitative, quantitative, single target and multiplexed assays
  • A dedicated quantitative lateral flow assay development team
  • Experience of working with different sample matrices
  • Access to a quality and sustainable supply of reagents and materials
  • Scale-up to High volume batches utilising state of the art manufacturing facilities
  • Experience of working in regulated markets
  • Academia-commercial collaboration
*The Pocket Diagnostic® Phytophthora test detects species such as P. ramorum (Ramorum Blight/Sudden Oak Death), P. infestans (Late Blight, the causal pathogen of the Irish Potato Famine), P. kernoviae, P. lateralis, P. cinnamomi and P. cactorum.
Lateral flow manufacturing contract services brochure front cover Development and manufacturing guide front cover

Abingdon Health lateral flow development complete integrated solution bannerReagent sourcing  –  Assay development  – Reader development  –  Scale-up  –  Lateral flow manufacturing  –  Packaging

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Published 25th October 2018