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

描述(由申请人提供)：这项建议描述了开发一种用于直接测量菌尿作为尿路感染(UTIs)诊断的快速护理点检测试剂盒的第一阶段。虽然细菌尿达到105cfu/ml是尿路感染诊断的金标准，但在实践中，所需的尿液培养是不可行的，因为典型的结果延迟了2天。尿路感染的诊断得到了其他办公室尿检试纸的辅助，但研究表明，误诊率很高，因此过度使用抗生素。拟议的检测试剂盒将首次允许在10分钟内直接测量尿液中的细菌浓度，以便在最初的办公室就诊时及时诊断尿路感染。拟议的试剂盒将是一种侧向流动免疫分析，类似于家庭怀孕测试。在测试设计中，抗细菌单抗(MAb)将被用来直接与尿样中的细菌细胞结合，产生校准到105cfu/ml的可视结果。测试格式将基于申请公司专有的Water Safe(R)细菌测试，这是该公司目前制造和销售的一种游泳池细菌快速免疫分析方法。据我们所知，这项测试是唯一一种不需要培养或样本浓缩的细菌快速免疫分析方法。此外，该公司已经开发了用于广谱细菌检测的&gt；60单抗，这些抗体也将用于拟议的检测试剂盒。在第一阶段，申请者将开发一种原型检测试剂盒，并确定其对几种致病性大肠杆菌和其他物种的敏感性为105 cfu/ml。在第二阶段，检测试剂盒将进一步优化敏感性和特异性，使用添加的样本和临床样本，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，检测试剂盒将准备好用于制造、FDA审查和营销。对最终用户来说，每项测试的估计成本将为2.00-5.00美元，远远低于尿液培养的成本，与目前尿液试纸的成本一致。测试试剂盒符合当前尿液培养指南规定的性能规范-尿路感染的黄金诊断标准。 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，每年就诊人数超过800万人次。尿路感染的金标准诊断方法，即尿液培养检测细菌，目前作为常规程序不可行，因为获得结果的时间延迟了2天。这项提议旨在开发一种简单、廉价、10分钟的尿液细菌“试纸”，使医生能够在患者首次就诊时准确诊断尿路感染。

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.