Huang Xianbin, Chang Zhenglin, Jiang Yueting, Chen Yuerong, Wu Haojie, Song Zhenfeng, Qi Defeng, Cheng Zhangkai Jason, Sun Baoqing
Department of Clinical Laboratory, State Key Laboratory of Respiratory Disease, National Center for Respiratory Medicine, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Department of Urology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Transl Androl Urol. 2025 Aug 30;14(8):2346-2357. doi: 10.21037/tau-2025-107. Epub 2025 Aug 26.
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.
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.
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.
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.
尿路感染（UTIs）是全球最常见的细菌感染之一，每年影响数百万人。传统的尿液培养是UTI诊断的金标准，但存在诸如培养时间长（24 - 48小时）等局限性，这可能会延迟治疗。此外，抗生素耐药性的日益普遍进一步凸显了快速诊断方法对于加强临床决策和减少抗生素不必要使用的必要性。由ALIFAX开发的HB&L系统提供了一种有前景的替代方法，有可能缩短诊断时间，提高治疗速度并改善患者预后。本研究旨在评估HB&L系统对UTIs快速诊断的有效性，将其性能与传统尿液培养方法进行比较，并探讨其在临床实践中的可行性和潜在优势。
2023年6月至2024年2月，从广州医科大学附属第一医院治疗的409例疑似UTI患者中收集中段尿样本。样本同时采用传统尿液培养方法和HB&L系统进行分析，并从相同标本中获得尿液分析结果。传统尿液培养作为评估HB&L系统和尿液分析检测UTIs诊断性能的参考标准。计算敏感性、特异性、阳性预测值（PPV）和阴性预测值（NPV）以评估方法之间的一致性。使用Kappa系数进行统计分析以确定一致性水平。
HB&L系统的敏感性为89.77%，特异性为96.88%，PPV为88.76%，NPV为97.19%，Kappa系数为0.86，表明与传统培养方法高度一致。相比之下，尿液分析参数的Kappa系数，蛋白质为0.11，白细胞酯酶为0.08，亚硝酸盐为0.44。这三个与感染相关的尿液分析指标的综合Kappa系数为0.11。HB&L系统在4.5小时内提供结果，而传统方法通常需要24 - 48小时。总体而言，尿液分析的诊断性能低于HB&L系统。
HB&L系统在UTIs的快速准确诊断方面具有显著优势，使其成为传统尿液培养方法的潜在替代或补充方法。
