Integrated iPRISM Direct-on-Urine Platform for Rapid UTI Diagnosis in a Double-Blind Clinical Trial.

Rapid point-of-care (POC) diagnostics for urinary tract infections (UTIs) are critical for targeted therapy and antibiotic stewardship. We report the first double-blind study of a POC diagnostic system for UTI detection and phenotypic antimicrobial susceptibility testing (AST), using the label-free, real-time iPRISM platform (intensity-based phase-shift reflectometric interference spectroscopic measurement), which traps and grows bacteria on photonic silicon chips. In this near-patient study, unprocessed urine samples were tested in a single-use microfluidic device that integrates both infection screening and AST. Infection screening achieved 97% sensitivity and 60% specificity within 90 min; threshold optimization at 75 min improved performance to 81% specificity and 82% sensitivity. For AST, iPRISM correctly classified 100% of gentamicin-exposed samples in just 30 min and achieved 62% sensitivity and 87% specificity for ciprofloxacin within 90 min. Notably, our preliminary data also demonstrate the potential to differentiate between fungal and bacterial infections, thereby broadening its diagnostic applicability. iPRISM delivers clinically actionable results within a relevant time frame, enabling single-visit prescriptions and supporting personalized, data-driven UTI management.