OXALOBACTER FORMIGENES DIAGNOSTIC KIT DEVELOPMENT

产草酸杆菌诊断试剂盒的开发

• 批准号: 6647746
• 负责人: Robert G Harris
• 金额: $ 38.73万
• 依托单位: IXION BIOTECHNOLOGY, INC.
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-01 至 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6647746
• 关键词: anaerobic bacteria; bacterial genetics; clinical research; colorimetry; diagnosis design /evaluation; diagnostic tests; enzyme linked immunosorbent assay; genetic screening; gram negative bacteria; human subject; metabolism disorder diagnosis; nephrocalcinosis; nucleic acid probes; oxalates; polymerase chain reaction; primary hyperoxalurias

DESCRIPTION (provided by applicant): Absence of Oxalobacter formigenes (Oxf) from the GI-tract is a risk factor for development of hyperoxaluria and calcium oxalate kidney stones. Recent data now indicate that patients with recurrent urolithiasis have a lower prevalence rate of Oxf in their stools than non-stone forming individuals. In addition, urinary oxalate levels are higher in non-colonized individuals as compared to colonized individuals. This indicates a clinical need for a test that can identify non-colonized individuals. Phase I of this grant resulted in the development of a reliable and rapid PCR ELISA-based microtiter plate assay for the detection of Oxf in human fecal samples. Pre-clinical performance data for the test (Le. its analytical sensitivity, analytical specificity, precision and reproducibility) were obtained as per the NCCLS guidelines. In Phase II of this project, we propose to complete the development of a production prototype of the XEntrix(TM) O. formigenes Monitor Kit. Analytical and clinical performance of the prototypic test kit will be determined in a multicentre clinical trial. The clinical studies have been designed not only to validate the test kit but also to strengthen the utility of Oxf determination as a diagnostic tool for the assessment of risk for calcium oxalate urolithiasis. By end of the proposed Phase II studies, we will have sufficient analytical and clinical performance data on this diagnostic kit to seek a pre-market approval under section 510K of the Food Drugs and Cosmetic Act, from the Center for Devices and Radiological Health.

描述（由申请人提供）：胃肠道中不存在产草酸杆菌（Oxf）是发生高草酸尿症和草酸钙肾结石的危险因素。最近的数据表明，复发性尿石症患者粪便中 Oxf 的患病率低于未形成结石的患者。此外，与定植个体相比，非定植个体的尿草酸盐水平较高。 This indicates a clinical need for a test that can identify non-colonized individuals.该资助的第一阶段开发了一种可靠、快速的基于 PCR ELISA 的微量滴定板测定法，用于检测人类粪便样本中的 Oxf。该测试的临床前性能数据（即分析灵敏度、分析特异性、精密度和重现性）是根据 NCCLS 指南获得的。在该项目的第二阶段，我们建议完成 XEntrix(TM) O. formigenes Monitor Kit 生产原型的开发。原型测试套件的分析和临床性能将在多中心临床试验中确定。临床研究的目的不仅是为了验证检测试剂盒，而且是为了加强 Oxf 测定作为评估草酸钙尿石症风险的诊断工具的实用性。在拟议的 II 期研究结束时，我们将获得有关该诊断试剂盒的足够的分析和临床性能数据，以便根据《食品药品和化妆品法》第 510K 条从设备和放射健康中心寻求上市前批准。