A Novel Device for Determination of GFR Markers

一种测定 GFR 标志物的新型装置

• 批准号: 7405479
• 负责人: BIKAS VAIDYA
• 金额: $ 48.61万
• 依托单位: LYNNTECH, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-08-01 至 2010-12-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7405479
• 关键词: Acetic Acid; Acetic Acids; American; Analytical Chemistry; Appearance; Automation; Biological Assay; Bismuth; Blood; Capillary Electrophoresis; Chemicals; Chronic Kidney Failure; Clinical; Clinical Data; Clinical Trials; Complex; Computer software; Contrast Media; Creatinine; Data; Detection; Development; Devices; Diabetes Mellitus; Diagnostic; Dialysis procedure; Dissociation; Doctor of Medicine; Doctor of Philosophy; Edetic Acid; Electrochemistry; Electrodes; End stage renal failure; Engineering; Evaluation; Fluorescence; Functional disorder; Funding; Glomerular Filtration Rate; Goals; Government; Health Personnel; Health Professional; High Pressure Liquid Chromatography; Human Resources; Hypertension; I125 isotope; Impaired Renal Function; In Vitro; Indiana; Inulin; Iodides; Iodine; Iohexol; Iothalamate; Kidney; Kidney Diseases; Kidney Failure; Kidney Function Tests; Kidney Transplantation; Label; Laboratories; Lupus Erythematosus; Maintenance; Measurement; Measures; Membrane; Methods; Microfluidics; Monitor; Numbers; Patients; Performance; Persons; Phase; Physical Dialysis; Plasma; Povidone; Povidone-Iodine; Process; Purpose; Radiation; Radio; Radioactive; Radioactive Iodine; Radioactivity; Radioisotopes; Radiolabeled; Reaction; Renal function; Research; Research Personnel; Risk; Roentgen Rays; Sampling; Scientist; Serum; Services; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Staging; Standards of Weights and Measures; System; Technology; Testing; Therapeutic Intervention; Training; United States Food and Drug Administration; United States National Institutes of Health; Universities; Urine; Work; analytical method; base; cancer immunotherapy; commercialization; data management; design; experience; indexing; innovation; instrumentation; medical schools; novel; oxidation; pre-clinical; prevent; radiotracer; rapid technique

DESCRIPTION (provided by applicant): About 20 million Americans have chronic kidney disease while an additional 20 million are at risk. Over the next 10 years, the number of patients in the U.S. with end stage renal disease is expected to double. Some major causes of kidney dysfunction include hypertension, diabetes, lupus erythematosus, chemotherapy and immuno-suppression therapy. In all these instances, it is essential to have an accurate test of kidney function to determine the most appropriate therapeutic intervention. Preventing or slowing the progression of renal disease through early recognition of impaired renal function will reduce the number of patients with end stage renal disease and also prevent or reduce the need for dialysis and kidney transplantation. Glomerular Filtration Rate (GFR) is one of the best indexes of kidney function and it is determined by measuring the disappearance of certain agents from the blood and their appearance in urine. Although commonly used, the accurate estimation of GFR from serum creatinine is unreliable and insensitive as a marker of chronic kidney disease. Conversely, Inulin and radiolabeled Iothalamate provide an accurate measurement of GFR but Inulin is too expensive for common use and Iothalamate is difficult to assay because it requires either iodine-125 radiolabeling or expensive and cumbersome HPLC analysis. This Phase II SBIR proposal describes the development of a small bench-top device that can accurately, rapidly (5 minutes), and conveniently measure "cold" (non-radioactively labeled) Iothalamate in blood and urine samples that will render the usage of radioactively labeled Iothalamate and burdensome HPLC assays obsolete. During the Phase I project, Lynntech designed, fabricated, assembled, and tested a breadboard Iothalamate detection system from commercially available, off-the-shelf components. The system demonstrated sufficient sensitivity (< 20 ppm) in plasma and urine and sample analysis was complete in 5 minutes with minimal sample manipulation. The Phase II workplan describes the optimization of the detection method and the design, assembly, and testing of a fully-integrated bench-top device. The performance of the bench-top device will be compared to an HPLC method developed by our collaborator at the Indiana School of Medicine. The Phase II research also includes the identification of disposable components and process automation in the bench-top system. Glomerular Filtration Rate (GFR) is one of the best indexes of kidney function and it is determined by measuring the disappearance of certain agents from the blood and their appearance in urine. Currently available methods for determination of GFR markers are either too expensive, difficult to assay or require the use of radio-labeled markers. Lynntech's inexpensive and easy to use system can accurately detect non- radiolabeled GFR markers in plasma and urine which will enable the rapid and convenient determination of GFR.

描述（由申请人提供）：约有2000万美国人患有慢性肾脏疾病，而另外2000万人处于危险之中。在接下来的10年中，预计美国患有末期肾脏疾病的患者人数将翻一番。肾功能障碍的一些主要原因包括高血压，糖尿病，狼疮红肿，化学疗法和免疫抑制疗法。在所有这些情况下，必须对肾脏功能进行准确的测试，以确定最合适的治疗干预措施。通过早期识别肾功能受损的肾脏疾病的肾脏疾病的进展将减少或减缓肾脏疾病的进展，这将减少末期肾脏疾病的患者数量，并防止或减少或减少透析和肾脏移植的需求。肾小球过滤率（GFR）是肾功能的最佳指数之一，它是通过测量某些药物从血液中的消失及其在尿液中的外观而确定的。尽管通常使用，但从血清肌酐中对GFR的准确估计是不可靠的，并且是慢性肾脏疾病的标志物。相反，菊粉和放射性标记的艾硫胺盐可提供准确的GFR测量，但对于常用使用含量太昂贵了，易甲酰胺很难进行测定，因为它需要碘125-225放射性标记或昂贵且昂贵且笨拙的HPLC分析。该II期SBIR提案描述了一个小型基准设备的开发，该设备可以准确，快速（5分钟），并方便地测量血液和尿液样品中的“冷”（非放射性标记）的iothalamate，可以使iothalamate和burdensome hplc的放射性标记的使用，并使您使用放射性标记。在I阶段项目中，Lynntech设计，制造，组装和测试了面包板的iothalamate检测系统，从市售的，现成的组件中。该系统在血浆和尿液中表现出足够的灵敏度（<20 ppm），并且样品操作最少，在5分钟内完成了样品分析。 II期工作计划描述了检测方法的优化以及完全集成的基准设备的设计，组装和测试。台式设备的性能将与我们印第安纳州医学院合作者开发的HPLC方法进行比较。 II期研究还包括鉴定台式系统中一次性组件和过程自动化。肾小球过滤率（GFR）是肾功能的最佳指数之一，它是通过测量某些药物从血液中的消失及其在尿液中的外观而确定的。当前用于确定GFR标记的方法要么太昂贵，难以测定或需要使用无线电标记的标记。 Lynntech廉价且易于使用的系统可以准确检测血浆和尿液中的非放射性标记的GFR标记，这将使GFR的快速和方便测定。