USENSE: A proof‐of‐concept self‐screening tool for home‐based recurrent urinary tract infection management

Abstract

In this work, we report a novel proof‐of‐concept biosensing diagnostic tool for the multiplexed electrochemical quantitation of a unique combination of three UTI‐relevant biomarkers, Prostaglandin E2 (PGE2), Interleukin‐8 (IL‐8), and Lipopolysaccharide (LPS), in unfiltered human urine. The proposed device, called USENSE, integrates lateral flow microfluidic channels, a gold‐based sensor array for quantifying PGE2, IL‐8, and LPS levels, and a random forest machine learning model for reliable diagnosis of UTI. The device is unique as it not only acts as a diagnostic device but also provides information on UTI by providing a risk score for UTI recurrence. USENSE is culture‐free and label‐free, requires no sample preparation at the user end, and can be adapted for use in home‐based self‐screening. In less than 5 minutes, USENSE directly measures the urinary concentration of PGE2, IL‐8, and LPS and provides a UTI severity state classification: 0 = Healthy, 1 = Asymptomatic Bacteriuria, 2 = Symptomatic; low risk of relapse, 3 = Symptomatic; high risk of UTI relapse. In postmenopausal women, the PGE2, IL8, and LPS concentrations measured via the device correlated well with the levels measured using traditional enzyme‐linked immunosorbent assay (ELISA). Our machine learning diagnostic model allowed for UTI diagnosis with 93% test accuracy and UTI prognosis state classification with >84% accuracy for the human urine samples tested. Further development of USENSE for clinical and home‐based use could create a paradigm shift in point‐of‐care UTI diagnostics by allowing timely intervention and minimizing unwarranted empirical administration of antibiotics.