Micro-PADs On Call: Out of Hours Disease Monitoring and Early Diagnosis

Lead Research Organisation: University of Liverpool
Department Name: Electrical Engineering and Electronics

Abstract

This research project seeks a new clinical sensing platform to facilitate rapid screening, early diagnosis, effective disease monitoring, personalised treatment and better-informed referral decisions. The exemplar focus of this research project is children suffering from endocrine disorders and the pressing need for new analytical innovations to enable simple and effective disease monitoring in the community. The versatile approach proposed has great promise, beyond the exemplar, as it can be applied in a general-purpose fashion for a whole range of diseases and clinical scenarios, ultimately increasing the likelihood of successful health outcomes.

Planned Impact

This research project will pursue disruptive technology that has potential to lead to a revolutionary sensing platform for routine clinical use. The overwhelming focus in terms of societal and economic impact relates to healthcare. The project offers an extraordinary opportunity to combine clinical expertise with technological innovation to accomplish an ambitious research project. Clinicians, as well as NIHR patient groups and potential end users (Pituitary Foundation), will be involved throughout to provide advice and feedback on design specifications, implementation and validation. The research is of direct relevance to developing a healthy nation and therefore industry, government and the public should all have a strong interest. In particular, this project can be of direct benefit to children and young people who suffer from endocrine disorders, in particular adrenal insufficiency, to enable out of hours and non-invasive disease monitoring. By effectively having micro-PADs "on call", there is significant potential to allow people to get the right care at the right time in the optimal care setting (for example, avoiding emergency hospital admissions) and ensuring both patients' time and specialists' expertise are used most appropriately. This can improve upstream prevention of avoidable illness and exacerbations. In particular, this research can enable patients, carers and volunteers to enable 'supported self-management' particularly of long-term health conditions. Outputs resulting from this work will be disseminated widely. The University is keen to support new IP that is likely to be generated (see institutional LoS) and assist in exploitation by way of developing marketable products, either through the creation of a "spin-out" company or through licensing the generated IP to appropriate companies. Further support is offered in this regard by various project partners, in particular Alder Hey Children's Hospital, LGC, Sensor City and Liverpool Health Partners (see respective LoS).
 
Title Journal Front Cover 
Description Journal Front Cover Image 
Type Of Art Artwork 
Year Produced 2023 
Impact n/a 
URL https://pubs.rsc.org/en/content/articlelanding/2023/an/d3an90075d
 
Description Ongoing research relating to new readout technology for paper-based devices.
Exploitation Route The main focus is clinical but the approaches being developed are potentially universal in relation to application scope.
Sectors Agriculture

Food and Drink

Chemicals

Environment

Healthcare

Pharmaceuticals and Medical Biotechnology

 
Description Clinical study initiated and currently active.
Sector Healthcare
Impact Types Societal

 
Description Developing a Non-Invasive Test for Paracetamol in Paediatrics
Amount £19,995 (GBP)
Organisation United Kingdom Research and Innovation 
Department Research England
Sector Public
Country United Kingdom
Start 09/2023 
End 06/2024
 
Title Paper Arrow 
Description A novel approach for testing biomedia, called Paper-Arrow Mass Spectrometry (PA-MS), has been developed. This technique combines sample collection, extraction, enrichment, separation and ionisation onto a single paper strip, and the entire analysis process, from sample to result, can be carried out in less than 10 min requiring only 2 µL of raw human biomedia. 
Type Of Material Technology assay or reagent 
Year Produced 2023 
Provided To Others? Yes  
Impact As an exemplar, PA-MS was applied to the measurement of paracetamol direct from human saliva achieving an LOQ of 185 ng mL-1, mean recovery of 107 ± 7%, mean accuracy of 11 ± 8% and precision =5% using four concentrations, and had excellent linearity (r2 = 0.9988) in the range of 0.2-200 µg mL-1 covering the treatment concentration range, surpassing the best-in-class methods currently available for paracetamol analysis. Furthermore, from a panel of human saliva samples, inter-individual variability was found to be <10% using this approach. To validate PA-MS against an established clinical method, 17 adult participants were recruited. Samples were collected before and at 15, 30, 60, 120 and 240 minutes after ingestion of 1.0 g paracetamol. Plasma paracetamol measurement with the established method served as the reference standard test to validate plasma, resting saliva (RS) and stimulated saliva (SS) detected with PA-MS. Participants' views of blood, RS and SS sampling procedures were assessed qualitatively. The cross-validation was assessed using Lin's concordance correlation coefficients (CCC), Bland-Altman difference plots, and ratios of PA-MS over the reference standard test (denoted as ratios). PA-MS using SS proved to be reliable, cost-effective and convenient for paracetamol quantification (CCC: 0.93, the mean of differences with the reference standard test: -0.14mg/L, ratios: 0.84-1.27). 
URL https://pubs.rsc.org/en/content/articlelanding/2023/an/d3an00850a
 
Title Apparatus and Method 
Description The present invention relates to paper spray mass spectrometry. 
IP Reference GB2219434.4 
Protection Patent / Patent application
Year Protection Granted
Licensed No
Impact PCT filing has been completed.
 
Title DPDM Detection of Paracetamol in Different Matrices 
Description Background: Suspected overdose of paracetamol is a common reason to visit an Emergency Department. Annually in the UK, paracetamol overdose results in approximately 100,000 Emergency Department presentations and 50,000 acute hospital admissions and is the direct cause of death in around 150 people. Accurate and timely detection of paracetamol concentrations are essential for clinical decision making. Initial Stage Research Trial. Under development. To compare detection results of paracetamol in: saliva by paper-based collection and direct mass spectrometry; sweat by two means, the first requiring harvesting using procedures currently deployed for obtaining sweat samples for testing for cystic fibrosis followed by HPLC-UV, the second means using reported procedures utilising direct electrochemical methods at the skin surface; with respect to blood by clinically accepted LC-MS. This research is being carried out in collaboration with Alder Hey Children's Hospital. Funding is provided by both University of Liverpool and Alder Hey Children's Hospital at this stage. This study is currently active. 
Type Diagnostic Tool - Non-Imaging
Current Stage Of Development Initial development
Year Development Stage Completed 2023
Development Status Under active development/distribution
Impact Actively under development. 
 
Description School visit 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Schools
Results and Impact One of the research team, a female STEM researcher, introduced our project to a group of 20-30 high school girls. They were really inspired, asked several questions, and increased their confidence in learning more about STEM.
Year(s) Of Engagement Activity 2022