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）：项目摘要/摘要：目前，估计有800万美国人有严重的肾功能损害，这个数字正在增长。每年死于肾衰竭的人数多于结肠癌、乳腺癌或前列腺癌。预计到2010年，慢性肾脏疾病的估计医疗和其他经济成本每年将接近280亿美元，另外每年与心血管疾病、感染和住院治疗增加有关的成本为900亿美元。肾功能评估中最常测量的种属是肌酐，在血清（Scr）中测量。存在允许Scr测定的多种方法。最便宜的品种依赖于间接检测：加入一种试剂，与Scr特异性反应，得到一种容易检测的化合物。无一例外，间接方法受到其他样品物种的干扰，导致评估的置信度较低。直接检测Scr是可能的，但需要昂贵且复杂的仪器，例如高效液相色谱法（HPLC）。Advanced MicroLabs，LLC（AML）致力于为未来的监测设备开发我们独特的微芯片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个检测。分析将是快速的（CA。3分钟）和便宜。该器械将是用户友好型的，可在床旁或临床情况下操作。最重要的是，由于我们的设备直接检测Scr，因此几乎不会受到干扰。虽然该建议侧重于Scr测定，但我们的系统可同时测定多种肾脏疾病标志物。I期结果将建立从全血样本开始的Scr微芯片CE-EC检测的采样方案。使用稀释、过滤和色谱法，可唯一检测Scr。在第二阶段，所有程序将被合并成一个独立的，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允许医生更快，更准确，更可靠，更少侵入性地诊断肾损伤。