Rapid Point-of-Care Test to Detect Bacteriuria & Confirm Urinary Tract Infection

用于检测菌尿的快速护理点测试

• 批准号: 8293081
• 负责人: MARK GEISBERG
• 金额: $ 50.77万
• 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 2014-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8293081
• 关键词: Accounting; Antibiotics; Antibodies; Bacteria; Bacteriuria; Bedside Testings; Benchmarking; Binding; Biological Assay; Cells; Clinical; Clinical Research; Collaborations; Collection; Cyclic GMP; Data Set; Detection; Development; Devices; Diagnosis; Diagnostic; Diagnostic Procedure; Escherichia coli; Future; Goals; Gold; Home environment; Immunoassay; Instruction; Lateral; Marketing; Measurement; Methods; Modification; Monoclonal Antibodies; Office Visits; Patients; Performance; Phase; Physicians; Pregnancy Tests; Procedures; Protocols documentation; Reporting; Sampling; Sensitivity and Specificity; Testing; Time; Urinalysis; Urinary tract infection; Urine; Uropathogen; Validation; Visit; Visual; Washington; Work; base; cost; design; improved; prototype; validation studies

DESCRIPTION (provided by applicant): This proposal describes Phase II 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, multiple 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. These MAbs will be selected from the Company's existing collection of >80 such antibodies. The test utilizes the Company's proprietary SandwichPLUS" format, which allows the simultaneous use of multiple antibodies in a single assay and radically shortens development time. In Phase I, the applicant developed a proof-of- concept prototype which was shown to detect six uropathogenic bacteria strains at the target level of 104 - 105 CFU/ml. In Phase II, the test kit will be further optimized for sensitivity and specificity using a much broader range of uropathogenic isolates, and test procedure will be further improved and simplified. Clinical 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.

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II阶段，用于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，多种抗细菌单克隆抗体（MAB）将用于直接与尿液样品中的细菌细胞结合，从而产生视觉+/-结果校准至〜105 cfu/ml。这些mAB将从公司现有> 80种此类抗体的现有集合中选择。该测试利用公司的专有夹层“格式”，该格式允许在单个测定中同时使用多种抗体，并从根本上缩短了开发时间。在第一阶段，申请人开发了一种概念证明的原型，该原型可检测到六个尿道疾病的启发性，以在104-105 cfu/ml的目标水平上检测到六个尿道疾病的效果。使用更广泛的尿道病隔离株，将进一步改进和简化临床验证研究，以确定产品的现实性能。尿液尺。