POINT OF CARE DIAGNOSTICS FOR URINARY TRACT INFECTION

描述（由申请人提供）：尿路感染（UTI）是一种非常常见的疾病，发生在所有年龄段的男性和女性以及儿童中。尿路感染是美国最常见的泌尿系统疾病，也是所有器官系统中第二常见的细菌感染。尿路感染（UTI）的定义是，无症状个体每毫升尿液中细菌菌落形成单位（CFU）超过105个，有症状个体每毫升尿液中细菌菌落形成单位（CFU）要低得多（~103 CFU/mL）。尿路感染诊断的“金标准”是微生物尿培养。然而，尿液培养系统的一个主要缺点是标本收集和病原体鉴定之间大约有2天的时间滞后。目前可用的快速诊断测试对尿路感染的敏感性和/r特异性较差。一种快速、灵敏、易于使用的基于POC的分子方法可以准确、可靠地检测和鉴定临床尿液标本中具有临床意义的细菌病原体浓度，这将是相当有益的。该SBIR项目的总体目标是开发一种成本效益高、灵敏度高、易于使用的设备，用于在护理点（POC）诊断尿路感染（UTI）。我们提出的技术将用于开发一种传感器阵列，专门用于与UTI最常见的微生物，包括大肠杆菌和凝固酶阴性葡萄球菌。在第二阶段，我们将扩大菜单，包括其他生物的检测，包括肺炎克雷伯菌、奇迹变形杆菌、肠球菌、铜绿假单胞菌。

DESCRIPTION (provided by applicant): Urinary tract infection (UTI) is an extremely common condition that occurs in both males and females of all ages and in children. UTI is the most common urological disease in the United States and the second most common bacterial infection of any organ system. Urinary tract infection (UTI) is defined by the presence of a growth of more than 105 colony forming units (CFU) of bacteria per mL of urine for asymptomatic individual and much lower for symptomatic individuals (~103 CFU/mL). The "gold standard" for UTI diagnosis is microbiological urine culture. However, a major drawback of urine culture systems is the time lag of approximately 2 days between specimen collection and pathogen identification. Currently available rapid diagnostic tests exhibit poor sensitivities and/r specificities for UTI. A rapid, sensitive, easy to use POC based molecular approach for accurate and reliable detection and identification of clinically significant concentrations of bacterial pathogens in clinical urine specimens would be of considerable benefit. The overall goal of this SBIR project is to develop a cost effective, sensitive, easy to use device for diagnosing Urinary Tract Infection (UTI) at the Point Of Care (POC). The application of our proposed technology will be directed towards the development of a sensor array specifically for the microorganisms most commonly associated with UTI including E. coli, and coagulase negative Staphylococcus. During PHASE II we will expand the menu to include for the detection of other organisms including Klebsiella pneumoniae, Proteus mirabilis, Enterococcus sp., Pseudomonas aeruginosa. PUBLIC HEALTH RELEVANCE: Urinary tract infection (UTI) is an extremely common condition that occurs in both males and females of all ages and in children. Currently available rapid diagnostic tests exhibit poor sensitivities and/or specificities for UTI. A rapid, sensitive, easy o use POC based molecular approach for accurate and reliable detection and identification of clinically significant concentrations of bacterial pathogens in clinical urine specimens would be of considerable benefit.