Developing a rapid blood diagnostic test: collaborative efforts to fast-track pandemic response
Published: March 2023
Blood testing is the process of examining cells, chemicals, proteins or other substances in the blood. Typically, this involves a healthcare professional taking a sample from the patient, which is then sent to a laboratory to undergo a series of tests. The results of these tests help the doctor to diagnose conditions and diseases in the patient.
However, the delay in receiving these results can lead to increased patient anxiety while delaying diagnosis and appropriate treatment. This has led to the advancement in ‘rapid’ blood diagnostic technology, which aims to provide immediate results, ideally at the point of care (PoC).
Developing a next-generation PoC diagnostic platform
Shore was approached by an existing customer with the objective of developing a next-generation diagnostic platform, consisting of a PoC device; microfluidic test strip; standardised workflow; and seamless, secure digital connectivity. We were subsequently selected as the primary medical design consultancy for the development of the PoC device.
The new platform promised to be a game-changer in the diagnostic industry – scaling down and integrating laboratory techniques to provide comparable results in a matter of minutes. A broad ‘menu’ of blood tests would be offered on a single instrument across cardiovascular, infectious disease, diabetes, and coagulation disorders. The platform would provide real-time transfer of results to the cloud or to a patient’s digital record. The instrument itself would be compact, portable, and simple to use.
Collaborating with a range of stakeholders
The project involved close collaboration with a wide range of stakeholders including the client, industry experts across various disciplines, a multinational manufacturing company and a global supply chain. This required clear and concise communication throughout – something that we pride ourselves on at Shore.
Overcoming challenges
The project did not follow a conventional phased product development process. Many challenges had to be overcome in the core technology, resulting in conceptual work being conducted in parallel with the design of the final production tooling. We had multiple designers and engineers on the project at any one time, ensuring we could be flexible and react to rapid changes in direction, this ensured the customer was fully supported throughout an extensive and iterative R&D process.
Providing design expertise
Our brief was to help transform the new technology into a mass-manufacturable and certified medical device. We formed a key part of a cross-functional project team and were responsible for delivering the mechanical design and overall product architecture. One of our early tasks was to design the test strip; a vital component of the device as it allows accurate and reliable detection of the target biomarker in blood samples.
The instrument involved the integration of highly complex and sensitive technologies, including microfluidics, optical spectrometry, magnetic and thermal cycling. This introduced a multitude of technical challenges, the solving of which relied heavily on our design expertise, in-house prototyping and testing capabilities.
In addition to the instrument design, Shore designed and supplied a range of bespoke equipment to meet testing and production requirements, including:
- Optical calibration test rigs
- Thermal calibration equipment
- Reagent mixing equipment
- Assembly jigs and fixtures
Fast-tracking the PoC device for a global pandemic
At the start of the 2020 pandemic, the client identified that the instrument was capable of testing for the SARS-CoV-2 virus – offering a rapid, affordable and scalable solution to the worldwide COVID-19 crisis.
We were tasked with helping to fast-track a new version of the PoC device for this urgent application. Despite the initial adjustments to working from home during lockdown, the re-design was expedited and delivered to the client in a matter of days. The team also supplied additional production equipment to meet the increase in output – all from our living rooms/garden sheds!
The new instrument would go on to demonstrate great results versus the PCR test, making it the most sensitive antigen test commercially available. It was subsequently authorised by the FDA under the emergency use authorisation (EUA).
It also proved to become the fastest PoC antigen test on the market and was soon deployed for use in clinics, high street pharmacies, schools, workplaces, live events, and many other applications across the globe.
The Bill & Melina Gates Foundation granted significant funds to the project, specifically to develop a low-cost test aimed at low-income countries. These included active Tuberculosis (TB), sickle cell disease and three further tests for maternal and antenatal care.
Delivering success
This project was a great demonstration of what can be achieved through effective collaboration. We are proud to have made a significant contribution to the development of the PoC device, a project that leveraged our knowledge, skills and capabilities. The result is a class-leading medical product that has brought success to our client.
If we can support you with your medical device development, please get in touch.
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