Case Studies: Advancing quantitative diagnosis

Measurement challenges

Quantitative diagnosis of healthcare conditions using robust scientific techniques and requiring less individual judgement are needed to improve health outcomes. Reliable quantification requires measurement techniques that are traceable to the SI system to ensure accuracy from the lab to the patient.

EMRP research has supported research that addresses traceability of chemical and biological measurements across a range of diagnosis methods. Examples are given in the following case studies:

Better infant hearing tests

Three in every 1000 babies are born with hearing impairment, which hampers development of language skills. Rapid identification is key for early intervention, so many national health authorities have hearing testing programs for babies. However the headphones used for hearing tests are set up using ear simulators designed for larger adult ears. Tailoring these to smaller ear sizes will improve the accuracy of assessments of hearing loss in young children.

The EMRP project 'Metrology for a universal ear simulator and the perception of non-audible sound' addressed two aspects of human hearing. The first part of the project improved the quality of hearing impairment diagnosis, particularly for neonates and children, through the development of new instrumentation for calibrating the acoustic stimuli used in clinical hearing assessments.

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Spotting inter cell communications

Extracellular vesicles are small cell-derived particles present in all body fluids. They are fundamental to biological processes and have been recently shown to be involved in the spread of cancer around the body. The detection and counting of extracellular vesicles gives an opportunity to develop new diagnostic tools and treatments for many diseases. However, these rely on first producing high quality blood samples for analysis using robust, simple and standardised approaches.

The EMRP project 'Metrological characterisation of microvesicles from body fluids as non-invasive diagnostic biomarkers' developed measurement methods and reference materials to improve standardisation of extracellular vesicles concentration measurements.

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Counting particles to spot cancer

New research into extracellular vesicles, small particles in the blood, is leading to exciting new possibilities for detecting and treating life-threatening diseases such as cancer, diabetes and heart problems. Extracellular vesicles can indicate when a patient has a disease, and may play a role in how it spreads. Developing reliable extracellular vesicles measurement methods could lead to fast, routine diagnosis techniques and new treatments, improving quality of life and reducing healthcare costs.

The EMRP project 'Metrological characterisation of microvesicles from body fluids as non-invasive diagnostic biomarkers' developed measurement methods and reference materials to improve standardisation of extracellular vesicles concentration measurements.

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Simpler disease diagnostics

Biomarkers are small molecules found in the bloodstream, which can be directly related to diseases such as cancer, HIV and Hepatitis. At the heart of many new diagnostic tools, biomarkers enable early detection of disease making successful treatment more likely. However, their small size and often low numbers can hamper detection without expensive specialist equipment. Innovation in measurement cell design is needed for simple and low-cost biomarker detection in complex samples.

The EMRP project 'Metrology for the characterisation of biomolecular interfaces for diagnostic devices' developed methods and reference materials to reliably and consistently measure the performance of biochemical interfaces used in in-vitro diagnostic devices (IVDs).

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Increasing access to anaemia testing

Anaemia is a common health condition that affects around 2 billion people worldwide. Timely treatment effectively restores health and can raise national productivity levels by as much as 20 %, according to the World Health Organisation. However, the current reference diagnostic test uses potassium cyanide to measure haemoglobin levels in blood, and the difficulties in procuring and disposing of this toxic compound are driving demand for alternative test methods.

The EMRP project 'Metrology for metalloproteins' developed reference measurement methods to separate, identify and quantify a range of metalloproteins – proteins containing metallic ions. Metalloproteins play a crucial role in a range of biological processes, from respiration to photosynthesis. This makes their analysis a powerful tool in the diagnosis and treatment of diseases such as anaemia and cancer. The methods developed by the project will directly improve the quality of measurement results obtained from patient samples in clinical laboratories and ensure improved diagnosis and treatment outcomes.

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Metrology for next-generation safety standards and equipment in MRI

The EMRP project 'Metrology for next-generation safety standards and equipment in MRI' improved the diagnostic value and efficiency of magnetic resonance imaging (MRI) by developing measurement methods and models which enhance the safety of patients and staff while simultaneously eliminating unnecessarily restrictive exposure limits. A new patient safety concept developed in this project will help manufacturers to speed up innovation cycles, supporting faster market introduction of emerging technologies, and will allow the safe scanning of previously excluded patient groups. In addition a robust magnetic field compatible
traceability chain has been introduced for MRI-guided radiotherapy- a new use for MRI in cancer therapy.

High resolution brain scans

Magnetic Resonance Imaging (MRI) is an effective way to diagnose serious brain conditions and also has potential use in diagnosing degenerative diseases like Alzheimer’s. Using more powerful MRI magnetic fields will improve disease diagnosis, but may also create risks for patients. Before new powerful MRI machines can enter routine clinical use, hospitals and manufacturers must have improved measurement methods and standards to be able to demonstrate patient safety.

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MRI standards spur innovation

With 30 million scans per year in Europe, Magnetic Resonance Imaging (MRI) is an important medical imaging technique that is increasingly being used during surgical procedures. However, staff tending patients also experience effects from the strong MRI magnetic fields and safe exposure limits are set by EU Directives. Highly accurate magnetic field measurements and ways to relate them to exposure are needed to ensure staff and patients remain safe at all times.

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Safer MRI for metal implant wearers

Magnetic Resonance Imaging (MRI) can detect cancers, as well as joint and spinal injuries. However there are restrictions on MRI scanning for patients with metal implants as the implants can move or generate heat due to the MRI’s strong magnetic field interacting with the metal. A better understanding of MRI heating effects will contribute to making this imaging technique as safe as possible.

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Improving radiotherapy success

Radiotherapy is a powerful tool in modern cancer treatment – around 40 % of people who survive cancer do so because of radiotherapy. MRI-guided radiotherapy can further improve the success of radiotherapy by offering more targeted treatment through real-time imaging. However, before this new technique can be widely adopted in clinics, accurate dosimetry needs to be established to ensure patients are consistently treated with safe and effective doses of radiation.

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Faster TB diagnosis

Tuberculosis (TB) is caused by bacteria which are becoming increasingly resistant to antibiotics. Doctors in the developing world have to frequently rely on diagnostic techniques that are insensitive or slow leading to the over prescription of antibiotics. By providing access to faster diagnostic methods, doctors will be able to target treatment effectively slowing the development of drug resistant TB bacteria.

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