Evaluation of UTI-Scope
Research type
Research Study
Full title
Evaluation of the UTI-Scope for the rapid diagnosis of urinary tract infections
IRAS ID
278311
Contact name
Estee Torok
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Duration of Study in the UK
0 years, 9 months, 31 days
Research summary
Urinary tract infections (UTI) are a common clinical problem, estimated to affect 600,000 per year in the UK. The diagnosis of UTI relies on a combination of clinical symptoms and supportive diagnostic tests. Current methods to test for UTI include bacterial culture (growth) and antibiotic sensitivity testing (what antibiotics to treat with) which takes 2-3 days to produce a result. Patients with suspected UTI are often treated with empirical (best guess) antibiotics which may be more broad spectrum than required, increasing the risk of bacteria developing antibiotic resistance.
We have developed a novel rapid cartridge based testing system for UTI (UTI-Scope) which combines bacterial growth and antibiotic sensitivity testing in one step. This system enables rapid detection of bacteria and their sensitivity to certain antibiotics, thus reducing the time to a positive result from days to hours. This could potentially enable more rapid and appropriate antibiotic treatment for patients with UTI.
The aim of this project to is compare the performance of UTI-Scope with standard laboratory tests for the diagnosis of UTI (microscopy, culture, and antibiotic sensitivity testing).
This is a laboratory based study and will not involve direct contact with NHS patients. Urine samples (N=4000) that have been collected from patients with suspected UTI and processed in the diagnostic microbiology laboratory at Addenbrooke's Hospital will be included in the study.
Urine samples will be identified using a daily automated search of the microbiology laboratory database. Samples will be assigned a unique anonymised study identification code and transferred to the Department of Medicine laboratory for testing with the UTI Scope system.
Data will be analysed to compare the accuracy and time to result for the UTI-Scope system compared with standard laboratory diagnostic tests for UTI.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
20/SC/0265
Date of REC Opinion
3 Jul 2020
REC opinion
Favourable Opinion