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).

To 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.

manufacturing equipment for lateral flow tests

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.

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