Multiplex Pathogen Identification for Polymicrobial Urinary Tract Infections Using Biosensor Technology: A Prospective Clinical Study
Multiplex Pathogen Identification for Polymicrobial Urinary Tract Infections Using Biosensor Technology: A Prospective Clinical Study
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DOI：
10.1016/j.juro.2009.08.028
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发表时间：
2009-12-01
影响因子：
6.6
通讯作者：
Liao, Joseph C.
中科院分区：
文献类型：
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作者：
Mach, Kathleen E.;Du, Christine B.;Liao, Joseph C.
目的：尿路感染的快速诊断对临床治疗有重要意义，特别是对尿路结构或功能异常的患者，这些患者对反复发生的多菌感染具有高度易感性。在一项神经源性膀胱患者的前瞻性临床研究中，我们检验了电化学生物传感器阵列用于尿路感染快速分子诊断的分析有效性。材料和方法：电化学生物传感器阵列用针对最常见的尿路病原体16S rRNA的DNA探针功能化。退伍军人事务部医院的脊髓损伤患者被招募到这项研究中。尿样通常在采集后1至2小时内在生物传感器上进行检测。结果：成功建立了一种1小时的病原菌多重鉴定生物传感器方法。从2007年7月至2008年12月，我们招募了116名患者，总共产生了109份适合分析的尿样，并将其与标准尿培养法进行了比较。74%的标本为阳性，其中42%为多菌。共鉴定出细菌20株，其中以大肠埃希菌、铜绿假单胞菌和肠球菌最常见。生物传感器检测的特异性和阳性预测值均为100%。病原体检测灵敏度为89%，阴性预测值为76%。结论：据我们所知，我们报道了第一项使用电化学生物传感器平台在护理时间范围内成功识别病原体的前瞻性临床研究。为了进一步提高检测灵敏度，还需要做出更多的努力来改进检测极限和探针设计。
Purpose: Rapid diagnosis of urinary tract infection would have a significant beneficial impact on clinical management, particularly in patients with structural or functional urinary tract abnormalities who are highly susceptible to recurrent polymicrobial infections. We examined the analytical validity of an electrochemical biosensor array for rapid molecular diagnosis of urinary tract infection in a prospective clinical study in patients with neurogenic bladder.Materials and Methods: The electrochemical biosensor array was functionalized with DNA probes against 16S rRNA of the most common uropathogens. Spinal cord injured patients at a Veterans Affairs hospital were recruited into the study. Urine samples were generally tested on the biosensor within 1 to 2 hours of collection. Biosensor results were compared with those obtained using standard clinical microbiology laboratory methods.Results: We successfully developed a 1-hour biosensor assay for multiplex identification of pathogens. From July 2007 to December 2008 we recruited 116 patients, yielding a total of 109 urine samples suitable for analysis and comparison between biosensor assay and standard urine culture. Of the samples 74% were positive, of which 42% were polymicrobial. We identified 20 organisms, of which Escherichia coli, Pseudomonas aeruginosa and Enterococcus species were the most common. Biosensor assay specificity and positive predictive value were 100%. Pathogen detection sensitivity was 89%, yielding a 76% negative predictive value.Conclusions: To our knowledge we report the first prospective clinical study to successfully identify pathogens within a point of care time frame using an electrochemical biosensor platform. Additional efforts to improve the limit of detection and probe design are needed to further enhance assay sensitivity.