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plaTform fOr Urinary tract infection diagnostiC evAluatioN (TOUCAN): a protocol for a prospective diagnostic accuracy study of point-of-care testing in patients suspected of acute uncomplicated urinary tract infection in primary care clinics in England

Title: plaTform fOr Urinary tract infection diagnostiC evAluatioN (TOUCAN): a protocol for a prospective diagnostic accuracy study of point-of-care testing in patients suspected of acute uncomplicated urinary tract infection in primary care clinics in England
Authors: Turner, PJ; Fanshawe, TR; Freeman, J; Glogowska, M; Hay, AD; Kenealy, N; Llion, O; Lowe, R; Lown, M; Moore, M; Tate, V; Wilcox, MH; Wootton, M; Butler, CC; Hayward, GN
Publisher Information: BMJ Publishing Group
Publication Year: 2026
Collection: Oxford University Research Archive (ORA)
Description: Introduction Acute uncomplicated urinary tract infection (UTI) is a common condition with potentially serious sequelae that is mostly diagnosed and managed in primary care settings. Around half of all women have a UTI in their lifetime, and a quarter experience an infection caused by organisms resistant to more than one antibiotic. Reducing inappropriate prescribing of antibiotics is a core tenet of antimicrobial stewardship. However, current diagnostics for UTI are unfit for purpose in acute (highest prescribing) settings, being too slow to inform the required immediate decision-making and often confounded by sample contamination. Rapid point-of-care diagnostic tests (POCTs) that facilitate timely decision-making are potential solutions to this problem. Several such tests have reached advanced stages of technology readiness, but their diagnostic performance has not been evaluated in primary care with clinical users. To progress novel tests towards implementation, a diagnostic field study is required, to allow for parallel and sequential evaluation of multiple tests in a primary care population. Methods and analysis We will recruit participants assigned female at birth from primary care clinics in England who contact their clinic with symptoms of acute uncomplicated UTI. Eligible participants will complete a short questionnaire to capture symptoms and symptom severity and will provide a urine sample. Samples will be split and initially tested using novel index tests (POCTs) and conventional urinalysis ‘dipstick’ at the primary care clinic. The second part of the sample will be processed at a National Health Service-based reference laboratory using a modified reference standard including microscopy, microbiological culture, pathogen speciation and antimicrobial susceptibility testing. The UTI reference standard culture, although based on the national methods, is modified to provide accurate bacterial counts, better to define a microbiological diagnosis of UTI. Susceptibility testing will be performed using ...
Document Type: article in journal/newspaper
Language: English
DOI: 10.1136/bmjopen-2024-090012
Availability: https://doi.org/10.1136/bmjopen-2024-090012; https://ora.ox.ac.uk/objects/uuid:8d1c2a3f-7a03-4a28-b6f8-5d5ea95fb556
Rights: info:eu-repo/semantics/openAccess ; CC Attribution (CC BY)
Accession Number: edsbas.AE8B95B1
Database: BASE