Establishing a Centre of Excellence for the Evaluation of Diagnostic Tests to Accelerate Efficient Emergency Stroke Care

The NIHR Newcastle In Vitro Diagnostics Co-operative (one of the eleven MedTech and In vitro diagnostics Co-operatives, MICs) and the Newcastle University Stroke Research Group, are collaborating to support SMEs in the evaluation of rapid point of care tests which support correct pre-hospital stratification for patients that paramedics suspect are experiencing a stroke.

Sarissa Biomedical Ltd have developed a test to identify patients with stroke symptoms caused by other conditions, such as epilepsy and migraine (called ‘mimics’).  These comprise 30-40% of suspected stroke cases, occupying specialised stroke service resources until a clearer diagnosis is made. A very large clinical study, funded by Innovate UK and involving up to 500 ambulances, will start in 2018, to evaluate the accuracy of this new test for recognising mimic conditions.

A second project is funded by the Medical Research Council (MRC) Confidence in Concept scheme, aiming to demonstrate proof of concept that a non-invasive test developed by Cerebrotech Ltd can recognise patients with the most severe stroke for redirection to regional neuroscience centres.


 “Treating stroke patients rapidly in specialist units is critical to improving recovery. However many other conditions initially resemble stroke, and treatments for certain stroke subgroups are only available in regional centres. Better outcomes and service efficiency would be achieved by point of care diagnostics to identify stroke and its main subgroups”.   

Dr Chris Price, Clinical Reader in Stroke Medicine, Newcastle University.







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Stroke is responsible for a high global burden of mortality and disability. It is a common medical emergency (86,000 UK admissions per year), with a UK economic impact of £9 billion per year in health and social care costs.

The UK strategy for stroke care is centralisation in specialised centres. There are 144 Hyperacute Stroke Units (HASU) that provide care for patients who have had a stroke.  Patients with evolving severe stroke may need urgent procedures that are available only in 25 regional neuroscience “hubs”.

For this strategy to be effective, the patients should be rapidly directed to the correct centre. But paramedics are not doctors, and their ability to recognise complex conditions like mimics or severe stroke is limited. They need support from simple and portable new technologies to make sure that expensive, highly specialised resources are allocated to the patients who need them.

The technologies being evaluated must be point of care, rapid, stable and easy to use. The collaboration supporting evaluation involves expertise in emergency stroke care, clinical trial design and delivery, diagnostic evaluation methodology, ambulance service logistics, and health services research.

Both Innovate UK and MRC projects will start data collection from patients in Summer 2018. Study protocols have been developed and research governance processes have started.  Clinical, academic and industry partnerships are being formalised through these projects, which will form the basis of pre-hospital diagnostics research collaboration.

There are currently no tests that support stratification of patients with suspected stroke in the pre-hospital setting. The Newcastle University Stroke Research Group and the MIC are the first to clinically evaluate these new technologies, which will change the care pathways for patients with suspected stroke, to improve access to treatments and efficient use of resources. Early, accurate stratification will prevent patients with stroke mimic conditions from inappropriate transfer to specialised units with limited resources for stroke patients, and will identify those patients with severe stroke who require rapid admission to regional neuroscience centres for procedures which increase the chances of recovery.

These technologies are planned to be low cost and user friendly.  If their performance during clinical deployment is as predicted, then there may be a net saving in health and/or social care costs through faster access to emergency treatments, reduction in inappropriate displacement of patients, and fewer complex investigations.

Through successful development, delivery and deployment, the project aims to raise the national and international profile of the Newcastle pre-hospital stroke diagnosis collaboration, and attract interest from other industry and academic partners.

Specialised NHS resources will be used more efficiently for patients requiring centralised specialist stroke care. Patients with mimic conditions will be identified sooner and not displaced from more appropriate local emergency care. This will reduce pressures on ambulance services and also be more convenient for patients and their families.

Treatment for patients with severe stroke will start earlier, improving the chances of recovery with less disability. Patients will have fewer radiological examinations done.

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The AHSN NENC has supported the NIHR Diagnostic Evidence Co-operative (DEC), and now the MIC, financially and in kind.

The Oxford AHSN is involved with the Innovate UK-funded project, to determine the commissioning and dissemination landscape. There is currently no AHSN involvement with the MRC study, which will be sought according to the results. As the pre-hospital diagnostic collaboration matures, we will seek more formal links with the AHSN.


At present, there is no widespread adoption as the project is still in an evaluation phase. Data is also being collected regarding interaction with existing clinical assessment processes to optimise diagnostic performance. The next steps will be a large interventional study to evaluate the impact upon patient and economic benefit.

Work will continue to develop a pre-hospital diagnostic collaboration and strategy to improve efficient use of healthcare resources and patient outcomes.

Start date: January 2017

End date: Ongoing

Contact Details

[email protected], Newcastle University

AHSN:   Donna Smith, Comms Team, [email protected]