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POINT OF CARE DIAGNOSTICS FOR URINARY TRACT INFECTION

尿路感染的护理点诊断

基本信息

批准号：
8394577
负责人：
KUMAR SUBRAMANIAN
金额：
$ 29.49万
依托单位：
PHOENIX BIOSYSTEM, INC.
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-07-02 至 2014-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8394577
关键词：
Accident and Emergency department Age Antimicrobial susceptibility Bacteria Bacterial Infections Biological Assay Buffers Caring Child Clinical Coagulase Colony-forming units Communicable Diseases Detection Development Devices Diagnosis Diagnostic Diagnostic tests Disease Doctor of Philosophy Enterococcus Escherichia coli Exhibits Female Genus staphylococcus Goals Gold Growth Hour Hypersensitivity Individual Infection Kinetics Klebsiella pneumonia bacterium Label Laboratories Life Marketing Medicine Microfluidics Molecular Nucleic Acid Probes Organism Patients Pattern Peptide Nucleic Acids Proteus mirabilis Pseudomonas aeruginosa Pump Reproducibility Resources Ribosomal RNA Running Sampling Sepsis Sexually Transmitted Diseases Small Business Innovation Research Grant Specificity Specimen System Technology Testing Time TimeLine United States Universities Urinary tract infection Urine Urologic Diseases Washington assay development base body system clinically significant cost effective design electric impedance innovation male meter microorganism nucleic acid detection pathogen point-of-care diagnostics professor sample collection sensor

项目摘要

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.

描述（由申请人提供）：尿路感染（UTI）是一种极其常见的疾病，发生在所有年龄段的男性和女性以及儿童中。UTI是美国最常见的泌尿系统疾病，也是任何器官系统中第二常见的细菌感染。尿路感染（UTI）定义为无症状个体每mL尿液中细菌生长超过105个菌落形成单位（CFU），而有症状个体的细菌生长更低（约103 CFU/mL）。尿路感染诊断的“金标准”是尿微生物培养。然而，尿培养系统的一个主要缺点是样本采集和病原体鉴定之间约2天的时间滞后。目前可用的快速诊断测试对UTI表现出差的灵敏度和/或特异性。一种快速、灵敏、易于使用的基于POC的分子方法，用于准确和可靠地检测和鉴定临床尿液样本中临床显著浓度的细菌病原体，将是相当有益的。该SBIR项目的总体目标是开发一种具有成本效益、灵敏、易于使用的设备，用于在护理点（POC）诊断尿路感染（UTI）。我们所提出的技术的应用将针对于开发一种传感器阵列，该传感器阵列专门用于最常见的与UTI相关的微生物，包括大肠杆菌。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，包括检测其他微生物，包括肺炎克雷伯菌，奇异变形杆菌，肠球菌，绿脓杆菌。公共卫生相关性：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。目前可用的快速诊断测试对UTI表现出较差的灵敏度和/或特异性。一种快速、灵敏、易于使用的基于POC的分子方法，用于准确和可靠地检测和鉴定临床尿液样本中临床显著浓度的细菌病原体，将是相当有益的。