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Tel: +44 (0) 1904 406082

The partner of choice for lateral flow development

Abingdon Health has been developing and manufacturing lateral flow devices for over 10 years. We develop and manufacture lateral flow devices for our clients and in addition to this have our own range of specialist blood cancer assays that we sell and market globally. This means we understand the challenges and complexities our customers are faced with when considering developing diagnostic assays. These can include:

  • Scale up large volume manufacturing
  • Clinical Studies
  • Extensive Validation and Verification
  • Operating in complex global regulatory environments

The Seralite® –FLC range

The Seralite® –FLC range

Seralite® – FLC is a rapid test for the quantitative measurement of kappa (K) and lambda (λ) immunoglobulin free light chains (FLCs) in serum or urine. FLCs are used as an aid in the diagnosis and monitoring of a type of blood cancer Multiple Myeloma. The format of this rapid test enables a free light chain service to be offered in all clinical laboratories. This enables the provision of FLC results in ~10 minutes rather than days or weeks. Therefore, with this simple to use, compact, rapid test, clinicians are able to monitor patients in “real time” supporting faster decision making.

Abingdon Health’s development experience

Abingdon Health’s development experience

Critical to the success of Seralite® – FLC and other assays are ensuring the assay meets the users’ needs.
Our start-to-finish approach includes how the test will be used, by whom, and where the test will be performed. We use this information to begin the development and consideration is given to:

  • Collection of sample
  • Type of sample
  • Workflow analysis
  • Requirement for quantitative or qualitative result
  • The need for a quantitative lateral flow reader

Our knowledge of available reagents allows us to efficiently screen and select the right reagents to achieve the required specification and will include the following:

  • Antibody or aptamer screening
  • Selection of membranes, samples pads, buffer selection
  • Optimisation and scale-up
  • Full design history and technical files

Quantitative reader market launch

Abingdon Health’s reader experience

For Seralite® – FLC lateral flow quantitative assay Abingdon Health developed a reader, the ADxLR5®. The ADxLR5® is CE marked and FDA cleared and has been not only developed to meet our own specific assay requirements but to also offer reader solutions to our contract customers.

The ADxLR5® includes the following features:

  • Flexible sized soft close sample draw which can be used to read a wide range of devices
  • Sample data imported via barcode scanner to provide rapid and accurate results
  • Data can be transferred via Wi-Fi, USB or securely using the Ethernet connection enabling tailored data transfer
  • Ease of use via an icon driven graphical display which guides operator through the test process with on-screen and audio prompts
  • Ability to upload batch specific information via 2D barcode enabling full traceability and reduces the number of user steps
  • Compliance with regulatory requirements which ensures suitability for individual market needs

Manufacturing experience

Manufacturing lateral flow devices

Once we reach design freeze stage, the Seralite® – FLC products and our custom products transfer to manufacturing for validation. Our manufacturing facility, which is fully automated in a climatically controlled environment, is ISO 9001 and ISO 13485 accredited and GMP compliant and offers:

  • Non-contact jets for dispensing
  • Reel-to-reel web handling system for reagent spraying
  • Auto-laminator for assembly of membranes and other components
  • Advanced laser guided robotic technology
  • Automated dispensing of buffers
  • Our manufacturing service extends to foil packaging of each individual device as well as final kit assembly

Abingdon Health’s regulatory and compliance experience

Regulatory and compliance experience

Our customers benefit from the experience Abingdon Health has gained in developing, manufacturing and launching our own range of assays in a highly regulated global market. Therefore, we understand what is required at each stage because we have been on the same journey.

What you can expect from Abingdon Health

What you can expect from Abingdon Health

  • Extensive scientific knowledge in developing complex lateral flow assays
  • Understanding of the different levels of assay validation and verification including extensive clinical studies
  • Expertise and advice on global regulatory requirements
  • High volume, state of the art manufacturing facilities
  • Lateral flow reader development to meet the needs of a wide range of lateral flow assays
  • Access to an expert team that have not only developed tests for the clinical market but also other industry sectors including bio-pharma, animal health, plant health, food and feed.

If you are looking for a company with extensive experience in developing and manufacturing lateral flow devices please contact a member of our team on +44 (0) 1904 406080 or info@abingdonhealth.com.