From lab based analysis to mobile and disposable ‘point of care testing’ (POCT)
Magnasense Technologies Oy (Magnasense) has a unique product incorporating an improved technology for lateral flow tests, using superparamagnetic nanospheres as a label. This novel approach allows Magnasense to deliver a CE marked product that is both robust, quantitative and highly sensitive.
Magnasense had identified that their lateral flow testing platform, whilst 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.
The brief from Magnasense was for ITL to undertake a feasibility study to identify a suitable method of miniaturising 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.
Current method for lab use:
Manual sample dilution with a separate disposable and instrument:
Accurate dilution of plasma is a powerful and unique key function, as 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 intervention by the user, such as multiple-step timed events or quantitative liquid handling, and with a disposable-friendly price tag.
ITL worked with Magnasense to create several concepts, ranging from low cost options with more potential issues to resolve, through to more complex expensive options. Eventually a single concept was chosen that gave the best of both worlds.
Moving forward, ITL built and tested the selected concept which produced impressive performance proving the concept has high potential to perform as required at scale up.
New method - disposable point-of-care device (no instrument needed):
Whole blood added to the “front end” port, on-board magnetic detection and result display
Managing Director of Magansense, Mika Laitinen 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.
ITL’s achievements together with Magnasense’s latest progress with miniaturisation of the magnetic detection are a quantum leap in disposable self-testing. I believe we are developing a device that has the potential to revolutionise point of care testing and open the door to widespread veterinary and home medical diagnostics in the future.”
The project has involved the use of ITL’s new in-house 3D printing capabilities to produce fluidic channels and other elements of the design. Therefore, ITL have eliminated the need to outsource most prototyping, whilst increasing the productivity and speed of the development process.
ITL Project Leader, Mark Tickner commented:
“My background in laboratory analysis enabled me develop a bespoke method to accurately and quickly measure the dilution factor of the device using a blood mimicking fluid. It was part of ITL’s 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 and the top-class engineers at ITL on this cutting edge and state of the art development”
Mechanical Systems Engineer II for ITL, Tom Haydon said:
“It was a pleasure to work with the Magnasense team, this project has presented a great opportunity to be at the cutting edge of Point of Care test development. While working with Magnasense we’ve developed a series of tools that have allowed us to rapidly develop low cost systems to build and test a series of micro, macro and hybrid fluidic systems”
Design & Development with ITL
ITL is a trusted partner for the full design, development and manufacturing of medical, diagnostic and analytical systems. Our expertise across the entire product development lifecycle allows us to commercialise new technologies with a focus on building value, risk reduction, design for manufacture and streamlining time to market. With over 42 years in the industry, we know what will work, what won’t and what requires fine tuning.
If you’re looking to develop a complex point of care diagnostic device or you are considering another of our services then please contact us. For more information about how we can help you, please complete our enquiry form here, call us +44 (0)1233 638383, email us firstname.lastname@example.org or simply start a conversation with our team on LiveChat.
Want to know more about Magnasense? Please visit magnasense.com