A newly published protocol paper from researchers at the NIHR HealthTech Research Centre in Community Healthcare at Oxford outlines an innovative approach to evaluating rapid diagnostic tests for urinary tract infections (UTIs), just as the groundbreaking study nears its recruitment target for its first tranche of tests.
The TOUCAN (plaTform fOr Urinary tract infection diagnostiC evAluatioN) study represents a significant shift in how new diagnostic technologies are evaluated for primary care use.
"Traditional approaches to diagnostic evaluation can be slow and inefficient, with each new technology requiring its own separate study," explains Professor Gail Hayward, Clinical Director of the NIHR HealthTech Research Centre and TOUCAN Chief Investigator. "TOUCAN's platform design allows us to evaluate multiple promising technologies simultaneously, significantly accelerating the generation of evidence required before patients can be safely offered these tests."
The study, which has already recruited hundreds of patients across primary care sites in England, is evaluating technologies including the Sysmex PA-100 AST System – winner of the £10 million Longitude Prize for rapid diagnostics to combat antimicrobial resistance. The PA-100 system aims to provide results within 15 - 45 minutes, potentially enabling evidence-based prescribing decisions during a single consultation.
The need for better diagnostic tools for acute UTI is pressing. Around half of all women experience a UTI in their lifetime, with a quarter of infections associated with antibiotic resistant organisms. Current testing methods are either too inaccurate or take days to provide results and can be confounded by sample contamination, so contribute little to immediate decision making.
Valerie Tate, public co-investigator on the study, explains: "Anyone who has experienced a UTI knows how distressing and disruptive they can be. The current uncertainty around diagnosis and treatment only adds to that stress. Having a rapid, accurate test could make a real difference to patients' experiences and outcomes."
"The platform approach isn't just about efficiency," says Dr Philip Turner, study lead. "By evaluating these technologies in real primary care settings, with real clinical users, we can understand not just their accuracy but also their practical usability and implementation requirements. This is crucial information for both clinicians and commissioners."
The protocol's publication in BMJ Open details innovative aspects of the study design, including:
- A flexible ‘Platform’ structure allowing new diagnostic technologies to be added as they become available
- Mechanisms to evaluate both developed and early-stage technologies
- Evaluation of both diagnostic accuracy and real-world implementation considerations
- Collection of qualitative data on clinician experiences of test use
- Use of common samples across multiple tests to address challenges associated with imperfect laboratory methods
"The protocol's publication marks an important milestone," adds Professor Hayward. "While we're already well advanced in recruitment, sharing our methodology allows other researchers to learn from and build upon this approach to diagnostic evaluation."
The TOUCAN platform continues to welcome discussions with diagnostic companies developing rapid UTI tests. The study team is also exploring how this innovative platform approach could be applied to diagnostic evaluation in other clinical areas.
For more information about TOUCAN or to discuss technology evaluation, contact toucan@phc.ox.ac.uk
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TOUCAN is a collaboration involving the NIHR SPCR centres at Oxford (NIHR HRC in Community Healthcare), Bristol and Southampton, the Specialist Antimicrobial Chemotherapy Unit at Public Health Wales, the University of Leeds, and the Primary Care Clinical Trials Unit at the University of Oxford.