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

描述（由申请人提供）：该提案描述了用于直接测量尿路细菌的快速即时检测试剂盒的第一阶段开发，用于诊断尿路感染（uti）。虽然105 CFU/ml水平的细菌尿是尿路感染诊断的金标准，但在实践中，由于获得结果通常需要2天的延迟，所需的尿培养是不可行的。尿路感染的诊断是由其他办公室尿液分析试纸辅助，但研究表明，有很高的误诊率和随之而来的抗生素过度治疗。拟议的检测试剂盒将首次允许在10分钟内直接“试纸”测量尿液中的细菌浓度，及时帮助在初次就诊时诊断尿路感染。拟议的检测试剂盒将是一种侧流免疫测定法，类似于家庭妊娠试验。在测试设计中，抗细菌单克隆抗体（mab）将用于直接结合尿液样本中的细菌细胞，产生校准到105 CFU/ml的视觉结果。测试格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方法，目前由公司生产和销售。据我们所知，该测试是唯一一种不需要培养或样品浓度的细菌快速免疫测定方法。此外，该公司已经开发出bbb60单克隆抗体用于广谱细菌检测，这些抗体也将用于拟议的检测试剂盒。在第一阶段，申请人将开发一个原型测试试剂盒，并确定其在105 CFU/ml水平下对大肠杆菌和其他物种的几种尿路致病性菌株的敏感性。在第二阶段，测试试剂盒将使用加标和临床样品进一步优化灵敏度和特异性，并将进行验证研究以确定产品的实际性能。在第二阶段成功结束后，测试试剂盒将准备好生产，FDA审查和营销。最终用户每次检测的估计成本为2.00 - 5.00美元，远低于尿液培养的成本，与当前尿液试纸的成本一致。符合当前尿培养指南规定的性能规格的测试试剂盒-尿路感染诊断的金标准。

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.