FerrTest Point-of-care iron stores

Context

FERRTEST is a 3-year project funded by Disruptive Technologies Innovation Fund under Project Ireland 2040 and is run by the Department of Enterprise and Trade with administrative support from Enterprise Ireland. The Project will be focused on the development of diagnostics and automation manufacturing of a cost-effective, quantitative point-of-care (POC) diagnostic platform to determine the body’s iron stores (Ferritin).

 

  1. Radisens diagnostics limited (RAD)
  2. Irish manufacturing research (IMR)
  3. Polypico technologies limited (POLY)
  4. Trinity College Dublin (TCD)

 

Aim

The project aims to develop disruptive technologies for the POC diagnostic platform and in the automated manufacturing processes developed for the production of the POC Ferritin test cartridges. The platform will consist of a quantitative, dried reagent, homogeneous Ferritin immunoassay on a single-use microfluidic cartridge which will be tested on an optical-based POC reader. The project consists of 6 work packages that develop the product, diagnostics process and manufacturing line:

 

1. Ferritin Assay Development (RAD)
2. Microfluidic Cartridge development (RAD)
3. Sample application usability and ferritin Verification studies (TCD)
4. POC Reader development (RAD)
5. Reagent Dispensing Process development (POLY)
6. Cartridge and Pilot Line Design and Development (IMR)

 

 

Additionally, there are two non-technical work packages:

1. Project Management to ensure effective coordination and collaboration between partners to deliver on the milestones in the project.
2. Commercialisation and Communication activities to promote and market the transfer technology from each partner.

Challenge

The challenge for IMR is to transform cartridge manufacturing from a manual process to a fully automated end-to-end manufacturing line.

 

The cartridge production requires innovative robotics and automation techniques to enable the deployment of a high volume manufacturing line in a cost-effective way in Ireland.

 

To facilitate the design-for-automation paradigm, a living test bed for the manufacturing processes will be created in IMR’s demonstrator site in Mullingar. This pilot line will be continually updated throughout the project and in turn, inform the cartridge design constraints to ensure that the final product can be scaled for full automation.

Methodology

IMR will use an agile approach to development comprising 3 phases:

 

Phase 1: Project Initiation Phase: To explore customer needs, develop a concept and define product planning process.

 

Phase 2: Product Release: Products will be delivered over a series of incremental releases during a 3–4-month period which will include scheduled customer reviews to ensure the development meets customer requirements.

 

Phase 3: Project closeout to include technical documents, knowledge transfer, licensing arrangements, reports to the funding body, financial closure of the project, archiving of the Project, dissemination & verification.

Other Information

At the end of the project, a functional pre-commercialisation pilot line will be in place which will produce integrated cartridges for off-site pre-clinical verification studies of the POC Ferritin test. A disruptive business process is envisaged here for blood donation clinics where the POC diagnostics platform is used to immediately stop at risk groups from donating if low Ferritin levels (low iron stores) are detected. This will be used as a product beachhead before expanding the product into the other medical use-cases described.

 

Ferritin is the principal storage protein for iron in tissues and is involved in its uptake, accumulation and release in cells. Only minute amounts of Ferritin is present in plasma but its concentration is directly proportional to total body iron stores. This relationship makes the serum or plasma assay for Ferritin an ideal non-invasive test of iron status.

 

The current clinical use for Ferritin is restricted to laboratory testing as no quantitative point-of-care (POC) in vitro diagnostic solution exists. There are several applications for a quantitative measurement of Ferritin at POC which would avoid the delay in sending a blood sample to a clinical laboratory and allowing for an immediate decision.

 

 

Proposed Ferritin POC product

  1. High sensitivity (~10ng/mL) ferritin test
  2. Storage at room temperature for ≥ 12months
  3. Single use centrifugal microfluidics cartridge
  4. Fingerstick sample application method
  5. POC reader with automated “sample-to-answer” protocol
  6. < 8 minutes time-to-result, to integrate with blood donor work flows.
  7. Build on scalable process concepts for low-cost reagent dispensing & batch drying [insert text here]

Other Project Partners

PROJECT MANAGER

Kevin Dooley

Senior Robotics Researcher

Technical Lead

Philip Long
Senior Researcher

THEMATIC PILLAR

Automation & Advanced Control

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