Rapid Point-of-Care Test Kit for the Detection of Bacteriuria Calibrated for Imme

用于检测菌尿的快速护理测试套件，经过即时校准

• 批准号: 7800833
• 负责人: MARK GEISBERG
• 金额: $ 10万
• 依托单位: SILVER LAKE RESEARCH CORPORATION
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-02-08 至 2011-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7800833
• 关键词: Accounting; Antibiotics; Antibodies; Bacteria; Bacteriuria; Bedside Testings; Binding; Cells; Clinical; Detection; Development; Diagnosis; Diagnostic; Diagnostic Procedure; Enzyme-Linked Immunosorbent Assay; Escherichia coli; Gold; Guidelines; Home environment; Hybridomas; Immunoassay; Knowledge; Lateral; Marketing; Measurement; Methods; Monoclonal Antibodies; Office Visits; Patients; Performance; Phase; Physicians; Pregnancy Tests; Procedures; Sampling; Sensitivity and Specificity; Swimming Pools; Testing; Time; Urinalysis; Urinary tract infection; Urine; Visit; Visual; base; cost; design; prototype; public health relevance; validation studies; water sampling

DESCRIPTION (provided by applicant): This proposal describes Phase I of the development of a rapid point-of-care test kit for the direct measurement of bacteriuria as a diagnostic for urinary tract infections (UTIs). While bacteriuria at a level of 105 CFU/ml is the gold standard for UTI diagnosis, in practice the required urine culture is unfeasible due to the typical 2-day delay in obtaining results. UTI diagnosis is aided by other in-office urinalysis dipsticks, but studies have shown that there is a high rate of misdiagnosis and consequent overtreatment with antibiotics. The proposed test kit will allow, for the first time, a direct "dipstick" measurement of bacterial concentration in urine within 10 minutes, in time to aid diagnosis of UTI during the initial office visit. The proposed test kit will be a lateral flow immunoassay, similar to a home pregnancy test. In the test design, anti-bacteria monoclonal antibodies (MAbs) will be used to directly bind to bacterial cells in a urine sample, producing a visual result calibrated to 105 CFU/ml. The test format will be based on the applicant Company's proprietary Watersafe(r) Bacteria Test, a rapid immunoassay for bacteria in swimming pools, which is currently manufactured and marketed by the Company. This test is, to our knowledge, the only rapid immunoassay for bacteria that does not require culture or sample concentration. Additionally, the Company has already developed >60 monoclonal antibodies for broad-spectrum bacterial detection, and these will also be used in the proposed test kit. In Phase I, the applicant will develop a prototype test kit and determine its sensitivity for several uropathogenic strains of E. coli and other species at the level of 105 CFU/ml. In Phase II, the test kit will be further optimized for sensitivity and specificity using spiked and clinical samples, and validation studies will be carried out to determine the real-world performance of the product. At the successful conclusion of Phase II, the test kit will be ready for manufacturing, FDA review, and marketing. The estimated cost of the test to the end user will be $2.00 - $5.00 per test, far less than the cost of urine culture and in line with the cost of current urine dipsticks.test kit matching the performance specifications dictated by current urine culture guidelines - the gold standard diagnostic for UTI. PUBLIC HEALTH RELEVANCE: Urinary tract infections are some of the most common cause of physicians' office visits, accounting for over 8,000,000 visits per year in the US. The gold-standard diagnostic method for UTI, urine culture to detect bacteria, is not currently feasible as a routine procedure due to the 2-day delay in obtaining results. This proposal aims to develop a simple, inexpensive, 10- minute "dipstick" test for bacteria in urine, to give physicians the ability to accurately diagnose UTI during the initial office visit by the patient.

描述（由申请人提供）：该提案描述了开发快速护理测试试剂盒的第一阶段，以直接测量细菌尿症作为尿路感染（UTI）的诊断。虽然105 CFU/mL水平的细菌是UTI诊断的黄金标准，但实际上，由于典型的2天延迟获得结果，所需的尿培养是不可行的。其他办公室内尿液分析量插入式UTI诊断，但研究表明，使用抗生素的误诊率很高，因此过度治疗了。拟议的测试套件将首次允许在10分钟内首次对尿液中细菌浓度进行直接的“尺化”测量，以及时在初次办公室访问期间帮助诊断UTI。拟议的测试套件将是横向流量免疫测定法，类似于家庭妊娠试验。在测试设计中，抗细菌单克隆抗体（MAB）将用于直接与尿液样品中的细菌细胞结合，从而产生校准为105 CFU/mL的视觉结果。测试格式将基于申请人公司专有的水上安全（R）细菌测试，这是游泳池中细菌的快速免疫测定，该测试目前由该公司制造和销售。据我们所知，该测试是细菌的唯一快速免疫测定法，不需要培养或样品浓度。此外，该公司已经开发了60种单克隆抗体用于广谱细菌检测，并且这些抗体也将用于拟议的测试试剂盒中。在第一阶段，申请人将开发一个原型测试试剂盒，并确定其对大肠杆菌和其他物种的几种尿道病菌株的敏感性，在105 CFU/mL的水平上。在第二阶段，将使用尖峰和临床样本进一步优化测试套件，以针对灵敏度和特异性进行优化，并将进行验证研究以确定产品的现实性能。在第二阶段的成功结论中，测试套件将准备好进行制造，FDA审查和营销。每次测试的估计测试成本为$ 2.00- $ 5.00，远低于尿液培养的成本，并且符合当前尿液销料的成本。测试套件符合当前尿液培养指南规定的性能规格 - UTI的金标准诊断。 公共卫生相关性：尿路感染是医师办公室访问的一些最常见原因，在美国，每年有超过8,000,000次就诊。由于获得结果为期2天的延迟，用于尿液培养的UTI，尿培养的尿液培养方法是常规程序，这是尿液培养物的诊断方法。该建议旨在为尿液中细菌的简单，廉价，10分钟的“量油尺”测试，以使医生能够在患者的初步办公室访问期间准确诊断尿液。