G&H | ITL Case Study: Magnasense

Overview

Magnasense Technologies Oy has a unique product incorporating an improved technology for lateral flow tests, using superparamagnetic nano particle as a label. This novel approach allows Magnasense to deliver a CE marked product that is robust, quantitative, and highly sensitive.

Requirements

Magnasense had identified that their lateral flow testing platform, while highly sensitive, required a degree of preparation as part of their Magnia® CRP assay for the quantitative determination of C-Reactive Protein (CRP) in blood. Their existing method involved manual sample dilution with a separate disposable and instrument.

The brief from Magnasense was for G&H | ITL to undertake a feasibility study to identify a suitable method of miniaturizing this process into a “front-end” device to their existing disposable. This process involves being able to collect a droplet of blood, filter the blood to remove red blood cells, measure a specific microlitre volume of plasma, dilute the plasma to a known ratio, and then dispense the mixture onto a lateral flow test strip.

Accurate dilution of plasma is a powerful and unique key function. It removes the inaccuracy inherent in many other blood test devices due to the variable red blood cell count (haematocrit) from person to person and between animal species.

All this functionality had to be designed into the smallest possible dimensions, with no user intervention, such as multiple-step timed events or quantitative liquid handling, and with a disposable-friendly price tag.

We worked with Magnasense to create several concepts, ranging from low-cost options with more potential issues to more complex, expensive options. Eventually, a single concept was chosen that provided the best of both worlds.

Moving forward, our engineers built and tested the selected concept, which produced impressive performance proving the concept has high potential to perform as required at scale-up.

Results

New method

We developed a disposable point-of-care device with no instrument required. Whole blood added to the front-end port, on-board magnetic detection, and result display.

The project involved using our new in-house 3D printing capabilities to produce fluidic channels and other design elements. Therefore, we eliminated the need to outsource prototyping while increasing productivity and speeding up the development process.

Mika Laitinen, Managing Director, Magnasense, commented, “The “front-end” sampling device makes the current product extremely easy to use and enables haematocrit correction, which currently is not performed within whole blood assay devices. This advancement will competitively improve the accuracy of the tests. G&H | ITL’s achievements together with Magnasense’s latest progress with the miniaturization of magnetic detection, are a quantum leap in disposable self-testing. I believe we are developing a device that has the potential to revolutionize point of care testing and open the door to widespread veterinary and home medical diagnostics in the future.”

Mark Tickner, Project Manager, G&H | ITL, commented, “My background in laboratory analysis enabled me to develop a bespoke method to accurately and quickly measure the dilution factor of the device using a blood mimicking fluid. It was part of our multidisciplinary approach, and it allowed rapid product development, resulting in excellent results with fresh whole blood. It was an absolute privilege to work with Magnasense on this cutting edge and state of the art development.”

Ian McCutcheon, Global R&D Director, Life Sciences, shared, "Collaborating with the Magnasense team has been a rewarding experience. This project gave us a unique opportunity to push the boundaries of point-of-care diagnostics. Together, we developed a suite of tools that enabled us to quickly design and test a range of cost-effective micro, macro, and hybrid fluidic systems."