Microchip Assay for Serum Creatinine

血清肌酐的微芯片测定

• 批准号: 7157530
• 负责人: Dale M Willard
• 金额: $ 9.97万
• 依托单位: ADVANCED MICROLABS, LLC
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7157530
• 关键词: biomedical equipment development; blood chemistry; capillary electrophoresis; clinical biomedical equipment; creatinine; diagnosis design /evaluation; diagnostic tests; electrochemistry; human tissue; kidney disorder diagnosis; kidney function; microprocessor /microchip; miniature biomedical equipment

DESCRIPTION (provided by applicant): Project Summary/Abstract: Currently, an estimated 8 million Americans have substantial kidney impairment and this number is growing. More people die annually from kidney failure than from either colon cancer, breast cancer, or prostate cancer. Estimated medical and other economic costs of chronic kidney disease are expected to approach $28 billion annually by 2010, with an additional $90 billion in annual costs related to increased cardiovascular disease, infections, and hospitalizations. The most commonly measured species for renal function assessment is creatinine, measured in blood serum (Scr). A variety of methods exist that allow for Scr determination. The least expensive variety rely on indirect detection: a reagent is added that specifically reacts with Scr to give an easily detected compound. Without exception, indirect methods suffer interferences from other specimen species resulting in less confident assessments. Direct detection of Scr is possible, but requires expensive and complicated instrumentation, such as, High Performance Liquid Chromatography (HPLC). Advanced MicroLabs, LLC (AML) is dedicated to the development of our unique Microchip Capillary Electrophoresis with Electrochemical Detection (Microchip CE-EC) technology for tomorrow's monitoring devices. Our device will be capable of measuring hundreds of assays on a single, disposable chip about the size of a matchbook. Analysis will be quick (ca. 3 min) and inexpensive. The device will be user-friendly, operate in a point of care or clinical situation. Most importantly, because our device detects Scr directly, it will suffer little interference. While this proposal focuses on a Scr assay, our system is amendable to simultaneous determination of multiple renal disease markers. Phase I results will establish a sampling protocol for Microchip CE-EC detection of Scr starting with a whole blood sample. Using dilutions, filtering, and chromatography, Scr will be uniquely detected. In Phase II, all procedures will be combined into a self-contained, integrated, microchip format. Project Narrative: Currently, an estimated 8 million Americans have substantial kidney impairment and this number is growing. Our proposed medical device will allow medical practitioners to diagnose kidney impairment faster, more accurately, more reliably, and less intrusively.

描述（由申请人提供）： 项目概要/摘要：目前，估计有 800 万美国人患有严重的肾损伤，而且这个数字还在不断增长。每年死于肾衰竭的人数多于死于结肠癌、乳腺癌或前列腺癌的人数。预计到 2010 年，慢性肾病的医疗和其他经济费用每年将接近 280 亿美元，其中与心血管疾病、感染和住院治疗增加相关的每年额外费用达 900 亿美元。肾功能评估最常测量的物质是肌酐，在血清 (Scr) 中测量。有多种方法可以测定 Scr。最便宜的品种依赖于间接检测：添加一种与 Scr 发生特异性反应的试剂，生成易于检测的化合物。无一例外，间接方法都会受到其他标本物种的干扰，导致评估的可信度较低。直接检测 Scr 是可能的，但需要昂贵且复杂的仪器，例如高效液相色谱 (HPLC)。 Advanced MicroLabs, LLC (AML) 致力于开发用于未来监测设备的独特的 Microchip 毛细管电泳电化学检测 (Microchip CE-EC) 技术。我们的设备将能够在一个火柴盒大小的一次性芯片上测量数百次测定。分析速度快（约 3 分钟）且成本低廉。该设备将用户友好，可在护理点或临床情况下操作。最重要的是，由于我们的设备直接检测Scr，因此受到的干扰很小。虽然该提案侧重于 Scr 测定，但我们的系统可修改为同时测定多种肾脏疾病标志物。第一阶段的结果将为 Microchip CE-EC 从全血样本开始检测 Scr 建立采样方案。通过稀释、过滤和色谱法，可以独特地检测 Scr。在第二阶段，所有程序将被组合成一个独立的、集成的微芯片格式。项目叙述：目前，估计有 800 万美国人患有严重的肾损伤，而且这个数字还在增长。我们提出的医疗设备将使医生能够更快、更准确、更可靠、更少侵入地诊断肾损伤。