Development of a novel risk score for diagnosing urinary tract infections: Integrating Sysmex UF-5000i urine fluorescence flow cytometry with urinalysis.

Abstract

Urinary tract infections (UTIs) are common globally, and are developing increased antibiotic resistance. Despite being the diagnostic "gold standard," urine culture is limited by slow results and a high rate of false negative findings, leading to treatment delays, higher costs, and overuse of empirical antibiotics. Our study aims to develop a rapid and reliable model to predict clinical outcomes. From January 1st to October 31st, 2023, we enrolled patients with symptoms suggesting UTI from the Outpatient Department of our hospital. Inclusion criteria were patients aged ≥18, initially diagnosed with UTI, available urinalysis, flow cytometry, and urinary culture. Exclusion criteria included failed sample collection and cultures, and pregnant women. A case-control study was conducted, with UTI cases defined as ≥ 10^5 CFU/ µ L and controls as < 10^5 CFU/ µ L, matched for age and sex in a 1:1 ratio. For validation, retrospective cases from July to December 2022 were selected with matching controls. Using urine culture as the gold standard, the predictive model was developed with backward stepwise logistic regression. Model discrimination was assessed using area under the curve (AUC). In our discovery cohort, we included 1,335 UTI cases and 1,282 non-UTI controls, with mean ages of 52.9 ± 17.1 years and 51.9 ± 16.4 years, and females of 76.9% and 77.7%. Using 100 cells/uL as a threshold, bacterial counts demonstrated a sensitivity of 91.0% and specificity of 45.7%. Our novel UTIRisk score, developed from urinalysis and flow cytometry parameters, showed strong discrimination for UTI, with a AUC of 0.82 (95% CI: 0.81-0.84). In the validation cohort, the AUC was 0.77 (95% CI: 0.74-0.80). The UTIRisk score exhibited excellent specificity (96.5%) and high positive predictive value (92.6%). The score performed strongly across subgroups, particularly in males and patients aged ≥65. Our UTIRisk score can improve diagnosis, reduce unnecessary urine cultures, optimize antibiotic use, and help control antibiotic resistance in LMICs. Multicenter, and intervention-based studies are warranted before clinical implementation.