The development of a UTI point-of-care diagnostic test.
Research type
Research Study
Full title
The development of a rapid affordable point-of-care diagnostic test for detecting bacteria in urinary tract infections.
IRAS ID
274038
Contact name
Jeroen Nieuwland
Contact email
Sponsor organisation
University of South Wales
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Urinary tract infections (UTIs) are one of the most common types of bacterial infections worldwide. It is estimated that 150 million people a year suffer from a UTI, and they are responsible for approx. 5,000 deaths a year in England and Wales alone. These figures are predicted to increase further due to an ageing population. There is also a significant prescription burden associated with UTI treatment, with antibiotic prescriptions for UTIs accounting for 13.7% of the total for community prescriptions. The current 'gold standard' for diagnosing patients with UTI symptoms is microscopy and culture analysis of a midstream urine sample, taking 24-72 hours. In primary care, most UTIs are treated empirically with broad spectrum antibiotics without attempting to identify a causative agent. Large scale broad spectrum antibiotic prescription is correlated with increasing levels of multi-drug resistant pathogens. There is therefore a need for a test which will allow clinicians to make point of care decisions to tailor (or reduce) prescriptions appropriately. The solution we propose is a portable low-cost device which will detect and quantify bacterial DNA markers (both species-specific, and general) within a time frame of 20 minutes. This will provide health practitioners with immediate information on the causative pathogen, which will in turn reduce the AMR health burden associated with inappropriate prescribing. We already have a prototype ready for testing. Our development plan involves additional prototype design and engineering in consultation with users, optimisation of our assay’s specificity and sensitivity for pathogen detection in clinical samples, optimisation of the prototype for use with clinical samples, and characterisation of the manufacturing process and route to market. Our proposed solution is a platform technology, so development of additional future assays will also be considered in consultation with clinicians.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
19/SC/0580
Date of REC Opinion
16 Dec 2019
REC opinion
Further Information Favourable Opinion