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Background <p>Preoperative urinary tract infections in urolithiasis patients represent a significant clinical challenge, with infection rates of 7–28% increasing hospitalization duration and complicating surgical management. Rapid diagnostic platforms are needed to replace traditional culture-based methods that delay targeted therapy.</p> Methods <p>This study evaluated 158 urolithiasis patients’ urine specimens using both the HB&amp;L rapid detection system and traditional culture methods. The HB&amp;L system utilized 500 µL of urine incubated for 4.5&#xa0;h, while conventional culture used 10 µL inoculated onto Columbia agar plates incubated for 24–48&#xa0;h. Samples were divided into discovery (<i>n</i> = 86) and validation (<i>n</i> = 74) cohorts. Statistical measures including sensitivity, specificity, positive/negative predictive values, and Kappa coefficients assessed agreement between methods. Statistical validity was ensured by reporting the 95% Confidence Intervals for all key diagnostic metrics, including the Kappa coefficient.</p> Results <p>In the total cohort, culture-positive patients showed significant differences in sex distribution (73.5% females vs. 47.6% males, <i>p</i> = 0.013), leukocyte esterase (<i>p</i> = 0.023), nitrites (<i>p</i> &lt; 0.001), and urinary leukocytes (<i>p</i> = 0.019). Gender-based analysis revealed female patients had higher prevalence of urinary tract hydronephrosis (83.3% vs. 82.4%) and renal insufficiency (14.3% vs. 8.1%), while males demonstrated significantly higher rates of benign prostatic hyperplasia (12.2% vs. 0%, <i>p</i> = 0.003). Pathogen distribution analysis revealed Escherichia coli as the predominant pathogen, especially in female patients, while male patients showed greater representation of Staphylococcus aureus, Morganella morganii, and Enterococcus faecalis. The HB&amp;L system demonstrated outstanding performance metrics with 100% sensitivity (95% CI: 89.1–100.0%), 98.41% specificity (95% CI: 94.7–99.8%), 94.12% positive predictive value, and 100% negative predictive value. Multivariate logistic regression analysis confirmed that its superior diagnostic performance remained consistent in key patient-related comorbidity subgroups. The system maintained excellent concordance across varying urine sample conditions, with a Kappa coefficient of 0.96 (95% CI: 0.89-1.00)reflecting very high consistency with traditional culture results while reducing detection time from 48 to 72&#xa0;h to 2–5&#xa0;h.</p> Conclusions <p>The HB&amp;L system provides rapid, accurate UTI diagnosis for urolithiasis patients, significantly reducing detection time while maintaining high diagnostic accuracy. Its ability to quickly rule in or rule out a bacterial etiology helps distinguish UTIs from other non-infectious causes of symptoms, enabling timely targeted therapy and potentially improving surgical outcomes.</p> Clinical Trial <p>Not applicable.</p>

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Rapid and accurate preoperative diagnosis of urinary tract infections in urolithiasis patients: clinical validation of the HB&L system

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月6日

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  • Zhenglin Chang,
  • Jierong Chen,
  • Zhaozhang Wang,
  • Ying Liang,
  • Siyu She,
  • Suilin Wang,
  • Xianbin Huang,
  • Haojie Wu,
  • Xiujing Han,
  • Lingjian Luo,
  • Qianjun Li,
  • Baoqing Sun,
  • Guohua Zeng

摘要

Background

Preoperative urinary tract infections in urolithiasis patients represent a significant clinical challenge, with infection rates of 7–28% increasing hospitalization duration and complicating surgical management. Rapid diagnostic platforms are needed to replace traditional culture-based methods that delay targeted therapy.

Methods

This study evaluated 158 urolithiasis patients’ urine specimens using both the HB&L rapid detection system and traditional culture methods. The HB&L system utilized 500 µL of urine incubated for 4.5 h, while conventional culture used 10 µL inoculated onto Columbia agar plates incubated for 24–48 h. Samples were divided into discovery (n = 86) and validation (n = 74) cohorts. Statistical measures including sensitivity, specificity, positive/negative predictive values, and Kappa coefficients assessed agreement between methods. Statistical validity was ensured by reporting the 95% Confidence Intervals for all key diagnostic metrics, including the Kappa coefficient.

Results

In the total cohort, culture-positive patients showed significant differences in sex distribution (73.5% females vs. 47.6% males, p = 0.013), leukocyte esterase (p = 0.023), nitrites (p < 0.001), and urinary leukocytes (p = 0.019). Gender-based analysis revealed female patients had higher prevalence of urinary tract hydronephrosis (83.3% vs. 82.4%) and renal insufficiency (14.3% vs. 8.1%), while males demonstrated significantly higher rates of benign prostatic hyperplasia (12.2% vs. 0%, p = 0.003). Pathogen distribution analysis revealed Escherichia coli as the predominant pathogen, especially in female patients, while male patients showed greater representation of Staphylococcus aureus, Morganella morganii, and Enterococcus faecalis. The HB&L system demonstrated outstanding performance metrics with 100% sensitivity (95% CI: 89.1–100.0%), 98.41% specificity (95% CI: 94.7–99.8%), 94.12% positive predictive value, and 100% negative predictive value. Multivariate logistic regression analysis confirmed that its superior diagnostic performance remained consistent in key patient-related comorbidity subgroups. The system maintained excellent concordance across varying urine sample conditions, with a Kappa coefficient of 0.96 (95% CI: 0.89-1.00)reflecting very high consistency with traditional culture results while reducing detection time from 48 to 72 h to 2–5 h.

Conclusions

The HB&L system provides rapid, accurate UTI diagnosis for urolithiasis patients, significantly reducing detection time while maintaining high diagnostic accuracy. Its ability to quickly rule in or rule out a bacterial etiology helps distinguish UTIs from other non-infectious causes of symptoms, enabling timely targeted therapy and potentially improving surgical outcomes.

Clinical Trial

Not applicable.