Theme Leads: Dr Andrew Lewington and Dr Kerrie Davies
Background
Early diagnosis of complications from surgery will improve patient outcomes, minimising expensive remedial treatments and increasing quality of life and survival.
In the context of ambitious national targets (e.g., NHS Long Term plan) and the NHS workforce crisis, efforts are focused on identifying individuals or groups who are most at risk and most likely to benefit from additional tests/treatment. Research efforts should be focused on innovations that meet a clear unmet clinical need, target underserved groups, have the potential to be easily implemented within routine clinical practice, and are cost-effective.
Our work on early modelling, target product profiles, adaptive trial designs, and comparative technology evaluations provides an innovative methodology platform for improving the efficient evaluation and adoption of new technologies. We have enhanced our IVD expertise during the pandemic, notably working closely with NHSE, Test and Trace, UKHSA, MHRA and industry on the design and assessment of novel infection IVDs.
Areas of Focus
Sepsis: Clinical decision making is hampered by slow diagnostic methods, such as blood cultures. There is an NHS England drive to improve the blood culture pathway with rapid differentiation of bacterial from viral infection speeding up clinical decision making and timely antimicrobial susceptibility testing to guide appropriate therapy. Acute Kidney Injury (AKI) is a common sequalae of sepsis, affecting 50% – 70% of critically unwell patients and is associated with adverse outcomes, including long term chronic kidney disease and increased mortality. Early identification of patients at risk of progression to severe AKI or persistent AKI is critical and applying novel diagnostic assays and predictive models are key to improving outcomes.
Urinary tract infections (UTIs): tests available at the point of care (POC) to accurately diagnose UTIs are lacking, as are the rapid antimicrobial susceptibility tests (ASTs) to help guide appropriate antimicrobial therapy. Such tests currently take >18 hours with delays from collecting the sample and shipping to the laboratory, meaning that these laboratory-based tests often have little impact as empirical treatment has already been started. This delay can have long-term consequences. Accurate POC tests would speed up diagnosis of infection leading to more timely treatment with better preservation of kidney function. They would address the problem of AKI becoming one of the top five causes of premature death by 2040.
Kidney transplantation: there is a huge variation in access to kidney transplant surgery with respect to gender, age and ethnicity and this is partly due to lack of robust diagnostic tests for risk stratification and often overcautious approaches resulting in delay or denial to access. We will have a particular focus on tackling disparities in access to diagnosis and treatment, particularly in the community setting. Through our current community and patient and public involvement events, we are building relationships with them towards inclusive research activities.
We recently contributed to the EXPANDIA project , which is an international initiative led by the International Centre for Genetic Engineering and Biotechnology (ICGEB) to strengthen diagnostic and surveillance capabilities across sub-Saharan Africa.
The team led on one of the project’s core work packages, focused on the development of a decision-support tool to help African reference laboratories select diagnostic testing modalities that are best suited to their clinical priorities, available infrastructure, and public health needs.
Key deliverables included:
• A needs assessment and stakeholder engagement report
• A thematic evidence review and accompanying report
• An algorithm prototype developed through stakeholder feedback
• A comprehensive final report to support the adoption and scaling of context-appropriate diagnostics
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Working with public health laboratories in countries including Cameroon, Senegal, Nigeria, Kenya, Ethiopia and Zimbabwe, the Leeds HRC team helped translate both local insights and global evidence into a usable, scalable tool for decision-making in diagnostics.
This work represents the value of international collaboration, technology transfer, and innovation tailored to real-world public health challenges.
We extend our thanks to the project team – including Dr Kerrie Davies MBE (Co-theme lead), Dr Virginie Viprey, Dr Jane Freeman, Naomi Ajenifuja, Robyn Meurant, Professor Mike Messenger, Dr Margaret Głogowska, and Dr Philip Turner, who represented the team at the final stakeholder dialogue in Cameroon.
Huge thanks to the team’s partners:
ICGEB, ACT-IVD, Insightful Health Ltd, NIHR HealthTech Research Centre – Community Healthcare, University of Oxford, University of Leeds. A special shout-out to Dr Kerrie Davies MBE, Dr Jane Freeman, Dr Virginie Viprey, Robyn Meurant, Prof Mike Messenger, Dr Margaret Glogowska and Dr Philip Turner (special thanks for representing the team in Cameroon).
Learn more about the project at EXPANDIA: Introducing technologies empowering African labs – ICGEB
EXPANDIA: Expanding Access to Sustainable Diagnostics Africa – ICGEB
