Chang Zhenglin, Deng Jiwang, Zhang Jinhu, Wu Haojie, Wu Yuanyuan, Bin Lai, Li Danmei, Liu Jingxing, Yu Rixia, Lin Huaming, An Lingyue, 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, 510120, China; Guangzhou National Laboratory, XingDaoHuanBei Road, Guangzhou International Bio Island, Guangzhou 510005, Guangdong, China.
Department of Urology, Guangdong Provincial People's Hospital, Southern Medical University, Guangzhou 510080, China.
J Infect. 2025 Apr;90(4):106459. doi: 10.1016/j.jinf.2025.106459. Epub 2025 Mar 7.
Urinary tract infections (UTIs) rank among the most prevalent bacterial infections globally. Traditional urine culture methods have significant limitations in detection time and sensitivity, prompting the need to evaluate targeted next-generation sequencing (tNGS) as a potential diagnostic tool.
The study included a discovery cohort of 400 suspected UTI patients (202 analyzed) and a validation cohort of 200 patients (110 analyzed). The study assessed detection time, concordance rates, ability to identify polymicrobial infections, and antibiotic resistance genes (ARGs). Both clear and turbid urine samples were evaluated across different clinical settings.
In the discovery cohort, tNGS demonstrated 96.5% concordance with culture-positive samples, while showing superior specificity in culture-negative specimens (53.1% vs 28.1% for mNGS). Detection time for tNGS (12.89 h) was notably shorter than mNGS (17.38 h) and traditional culture (61.48 h). tNGS exhibited remarkable capability in identifying polymicrobial infections (55.4% of samples), significantly outperforming both mNGS (27.7%) and traditional culture methods, which failed to detect any co-infections. The method showed particular strength in detecting fastidious organisms like Ureaplasma parvum and fungal species such as Candida tropicalis. For antibiotic resistance prediction, tNGS detected more ARGs (52.67% vs 41.22% for mNGS) and achieved 100% sensitivity for vancomycin and methicillin resistance in Gram-positive pathogens. The validation cohort confirmed tNGS's robust performance, maintaining high concordance rates for both culture-positive (90.00%) and culture-negative samples (55.00%), demonstrating consistent reliability across different clinical settings CONCLUSIONS: tNGS demonstrates advantages in rapid and accurate UTI diagnosis, particularly in detecting polymicrobial infections and analyzing antibiotic resistance genes. It shows promise as an effective complementary tool for UTI diagnostics.
尿路感染（UTIs）是全球最常见的细菌感染之一。传统的尿培养方法在检测时间和灵敏度方面存在显著局限性，这促使人们需要评估靶向新一代测序（tNGS）作为一种潜在的诊断工具。
该研究包括一个由400名疑似UTI患者组成的发现队列（分析了202例）和一个由200名患者组成的验证队列（分析了110例）。该研究评估了检测时间、符合率、识别混合微生物感染的能力以及抗生素耐药基因（ARGs）。在不同的临床环境中对清亮和浑浊的尿液样本进行了评估。
在发现队列中，tNGS与培养阳性样本的符合率为96.5%，而在培养阴性样本中显示出更高的特异性（mNGS为28.1%，tNGS为53.1%）。tNGS的检测时间（12.89小时）明显短于mNGS（17.38小时）和传统培养（61.48小时）。tNGS在识别混合微生物感染方面表现出显著能力（55.4%的样本），明显优于mNGS（27.7%）和传统培养方法，传统培养方法未能检测到任何合并感染。该方法在检测诸如微小脲原体等苛养菌和热带念珠菌等真菌物种方面表现出特别的优势。对于抗生素耐药性预测，tNGS检测到更多的ARGs（mNGS为41.22%，tNGS为52.67%），并且对革兰氏阳性病原体中的万古霉素和甲氧西林耐药性实现了100%的灵敏度。验证队列证实了tNGS的强大性能，培养阳性样本（90.00%）和培养阴性样本（55.00%）均保持了较高的符合率，表明在不同临床环境中具有一致的可靠性。结论：tNGS在快速准确的UTI诊断中显示出优势，特别是在检测混合微生物感染和分析抗生素耐药基因方面。它有望成为UTI诊断的一种有效的补充工具。
