Development of a rapid antimicrobial susceptibility test to assist the treatment of UTI in primary and urgent care settings.

Urinary Tract Infection (UTI) is one of the most common bacterial infections managed by primary healthcare. Despite the prevalence, definitive diagnostics remain a challenge. With rising antimicrobial resistance, suboptimal diagnosis and initial management can have serious consequences for those clinical vulnerabilities. Current bacterial culture tests take between 36-72 hours, which is particularly problematic for vulnerable patients at high risk of rapid deterioration. As antibiotics are frequently prescribed without a confirmed diagnoses or knowledge of the bacterial resistance profile, treatment delays, increased hospitalisation rates, greater costs and elevated morbidity and mortality can all result. Current first-line tools like urine dipstick tests lack specificity and sensitivity and don't indicate antibiotic susceptibility. A recent national horizon-scanning exercise indicated there were no cost-effective rapid antimicrobial susceptibility tests suitable for informing immediate clinical care decisions. Consequently, there remains a pressing need for new technologies to underpin effective solutions to antibiotic resistance. Our technology, subcellular fluctuation imaging (SCFI) (a light scattering measurement technique), can detect bacterial susceptibility to antibiotics rapidly. With its current status at Technology Readiness Level (TRL) 3, SCFI has shown promising preliminary results in discerning bacterial resistance profiles within 30-60 minutes in key species. This project aims to refine the technology and develop a co-designed, user-friendly prototype suited for community clinical settings. Objectives include creating a single-use cartridge for the system, automating data collection and analysis, and building an effective image classifier to identify resistance across clinically-relevant species. We can achieve a validated SCFI prototype suitable for clinical settings to make immediate, informed antibiotic prescription decisions. The project builds on an established industry partnership (FluoretiQ) to develop a viable route to market with a portable device to transform UTI management in the community. We propose six interconnected work packages aimed at developing and validating an automated SCFI device for UTIs in community settings: WP1 - Management and Advisory: Overall project management and establishment of key stakeholder groups to guide the project, including patient representatives and health professionals. WP2 Development of SCFI subsystems: Transition SCFI to TRL5 for clinical use. Goals encompass developing subsystems for sample collection, image acquisition, and testing optimisation. WP3 Validation using Clinical Samples and Product Development: This involves testing the device with various additional isolates/strains, and actual clinical samples. This component will progress the commercialisation aspects of a unit (and consumables) towards regulatory approval. WP4 Device Utility in Community Workflows: Exploration of the device's usage and integration into community pathways, using a co-design approach. WP5 Health Economics: Analysis of the cost-effectiveness of the device in routine NHS community care, including cost-effectiveness models and optimisation for different patient pathways. WP6 Involvement of Target Groups: Engaging key groups, especially individuals over 75 and parents of children under 5, to provide critical research direction, ensuring the developed device is well-suited for its intended audience. Overall, the research plan presents a comprehensive approach to device development, validation, implementation, and commercialisation, with a focus on stakeholder engagement and cost-effectiveness. Outcomes include a clinically valid prototype device, regulatory approval, and reports on usability and economic impact.