Abstract
BACKGROUND: Urinary tract infections (UTIs) are among the most prevalent bacterial infections worldwide, impacting millions annually. Traditional urine culture, the gold standard for UTI diagnosis, is associated with limitations such as lengthy culture times (24-48 hours), which can delay treatment. Additionally, the increasing prevalence of antibiotic resistance further emphasizes the need for rapid diagnostic methods to enhance clinical decision-making and reduce the unnecessary use of antibiotics. The HB&L system, developed by ALIFAX, presents a promising alternative that could potentially shorten diagnostic times, improving both treatment speed and patient outcomes. This study aims to evaluate the efficacy of the HB&L system for the rapid diagnosis of UTIs, comparing its performance with traditional urine culture methods, and to explore its feasibility and potential advantages in clinical practice. METHODS: From June 2023 to February 2024, midstream urine samples were collected from 409 suspected UTI patients treated at The First Affiliated Hospital of Guangzhou Medical University. The samples were analyzed using both traditional urine culture methods and the HB&L system, with concurrent urinalysis results obtained from the same specimens. Traditional urine culture served as the reference standard to evaluate the diagnostic performance of the HB&L system and urinalysis for detecting UTIs. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated to assess the agreement between the methods. The Kappa coefficient was used for statistical analysis to determine the level of concordance. RESULTS: The HB&L system demonstrated a sensitivity of 89.77%, specificity of 96.88%, PPV of 88.76%, NPV of 97.19%, and a Kappa coefficient of 0.86, indicating a high degree of concordance with traditional culture methods. In contrast, the Kappa coefficients for urinalysis parameters were 0.11 for protein, 0.08 for leukocyte esterase, and 0.44 for nitrite. The combined Kappa coefficient for these three infection-related urinalysis indicators was 0.11. The HB&L system provides results within 4.5 hours, whereas traditional methods typically require 24-48 hours. Overall, the diagnostic performance of urinalysis was inferior to that of the HB&L system. CONCLUSIONS: The HB&L system has significant advantages in the rapid and accurate diagnosis of UTIs, making it a potential alternative or complement to traditional urine culture methods.