Diaper-based diagnostics: A novel non-invasive method for urine collection and molecular testing of uropathogens.

Urinary tract infections (UTIs) present a global diagnostic challenge, especially in populations where midstream urine collection is impractical. This study evaluates sodium polyacrylate-based diapers as a non-invasive matrix for urine collection, coupled with quantitative PCR (qPCR) for uropathogen detection. Phase I involved 17 samples (7 contrived, 10 from diaper-wearing volunteers), and Phase II analyzed 35 de-identified clinical specimens using a CLIA/CAP-validated qPCR panel targeting 17 bacteria, 4 fungi, 6 antimicrobial resistance genes, and 1 control gene. Diaper-derived samples demonstrated 100 % concordance in positive and negative predictive values with standard urine specimens. Across all clinical samples, mean cycle threshold (Ct) differences ranged from -2.06 to 3.87 (mean absolute difference = 1.43), with lower variability in diaper samples (SD = 4.02 vs. 4.48) and strong correlation in Ct values (r = 0.97). These findings validate the diaper matrix as a clinically robust, non-invasive alternative that maintains diagnostic integrity under simulated transport and storage. This approach enables accurate molecular detection of uropathogens while minimizing invasive procedures, offering immediate applicability for infants, the elderly, and individuals with incontinence-thereby enhancing diagnostic access, accuracy, and antimicrobial stewardship in vulnerable populations.