Rapid Point-of-Care Diagnostic Device for UTIs: User-Informed Design to Transform 3-Day Urine Culture Tests into a 10-Minute Clinical Solution

**Project Overview** Each year, over 1.1 billion people worldwide are diagnosed with microbial diseases, facing an average delay of eight days from the onset of symptoms to effective treatment. In public health systems like the NHS (National Health Service), long GP (General Practitioner) wait times and centralised diagnostic services lead to significant treatment delays. In privatised healthcare systems such as those in the US and India, the high cost of technicians and diagnostic procedures further hampers timely treatment. Consequently, 96% of microbial disease cases receive first-line antibiotics based on empirical observations, often without critical pathogen or antibiotic resistance information. This delay and barrier to effective treatment result in approximately 8.5 million preventable deaths annually. **Challenges with Existing Technologies** Current pathogen and antimicrobial drug susceptibility testing primarily rely on laboratory-based microbial culture, which has a turnaround time of 3-5 days and costs over £80\. Existing point-of-care tests, like dipsticks for urinary tract infections (UTIs) and lateral flow tests (LFT) for syphilis, do not provide comprehensive pathogen identification or antimicrobial susceptibility testing (AST). Recognising this gap, the National Institute of Healthcare Research (NIHR) and the World Health Organisation (WHO) have called for a low-cost, portable, point-of-care test that can identify pathogens and determine drug resistance. **Innovative Solution** Our project introduces an advanced infectious disease detection platform that significantly reduces treatment delays from eight days to under 30 minutes. Utilising lasers and nanoparticles, our machine rapidly thermocycles samples to amplify and identify specific sequences of pathogen DNA and RNA within 10 minutes. This innovative approach allows for direct processing of unprocessed samples with accuracy equivalent to gold-standard laboratory methods, eliminating the need for technicians and complex microfluidics. This streamlined, technician-free workflow can reduce treatment delays for microbial diseases by 200-fold, potentially saving millions of lives and preventing long-term health complications for hundreds of millions of patients. **Project Goals and Progress** Building on our ICURe (Innovation to Commercialisation of University Research) Explore, Exploit, and subsequent market discovery journey, our team has established strong connections with over 50 hospitals globally. Our primary project goal is to advance from single-pathogen testing (TRL-4/5) to a clinically-validated UTI test (TRL-7), pending regulatory approval. This step-change in technological readiness aims to provide a reliable, rapid diagnostic tool for widespread clinical use, transforming the landscape of microbial disease management.