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）：该提案描述了快速即时检测试剂盒开发的第一阶段，该试剂盒用于直接测量菌尿作为尿路感染（UTI）的诊断。虽然菌尿水平为 105 CFU/ml 是 UTI 诊断的金标准，但实际上，由于通常要延迟 2 天才能获得结果，因此所需的尿培养是不可行的。尿路感染的诊断需要其他诊室尿液分析试纸的帮助，但研究表明，误诊率很高，从而导致抗生素过度治疗。拟议的测试套件将首次允许在 10 分钟内直接“试纸”测量尿液中的细菌浓度，以便在初次就诊时及时帮助诊断 UTI。拟议的测试套件将是侧流免疫分析，类似于家庭妊娠测试。在测试设计中，抗细菌单克隆抗体 (MAb) 将用于直接与尿液样本中的细菌细胞结合，产生校准至 105 CFU/ml 的视觉结果。测试形式将基于申请人公司专有的Watersafe(r)细菌测试，这是一种针对游泳池细菌的快速免疫测定法，目前由该公司制造和销售。据我们所知，该测试是唯一不需要培养或样品浓缩的细菌快速免疫测定。此外，该公司已经开发了超过 60 种用于广谱细菌检测的单克隆抗体，这些抗体也将用于拟议的检测试剂盒中。在第一阶段，申请人将开发一个原型测试套件，并确定其对几种泌尿道致病性大肠杆菌菌株和其他物种在 105 CFU/ml 水平的敏感性。在第二阶段，将使用加标样品和临床样品进一步优化检测试剂盒的灵敏度和特异性，并将进行验证研究以确定产品的实际性能。第二阶段成功结束后，测试套件将准备好进行制造、FDA 审查和营销。最终用户每次测试的估计成本为 2.00 - 5.00 美元，远低于尿培养的成本，并且与当前尿液试纸的成本一致。测试套件符合当前尿培养指南（尿路感染诊断的黄金标准）规定的性能规格。 公共卫生相关性：尿路感染是医生就诊的最常见原因之一，在美国每年就诊的人数超过 8,000,000 人次。 UTI 的金标准诊断方法（即尿液培养来检测细菌）目前无法作为常规程序，因为获得结果会延迟 2 天。该提案旨在开发一种简单、廉价的 10 分钟“试纸”测试尿液中的细菌，使医生能够在患者初次就诊时准确诊断尿路感染。