Glomerular Filtration Rate Test

摘要 在美国，肾脏疾病被描述为一种流行病。超过20个 数以百万计的患者患有慢性肾脏疾病(CKD)，而且这些数字还在增加 每年一次。因此，患有终末期肾病(ESRD)的患者数量为 预计在1999至2010年间将翻一番。CKD和ESRD的这些增加是 与严重的发病率、死亡率和医疗费用有关。早期发现和 肾脏疾病的治疗已被证明可以改善结果，但肾脏疾病 往往诊断不足，导致失去治疗机会。及早行动的重要性 肾脏疾病的诊断和治疗已被广泛回顾和发表。 作为国家肾脏基金会的K/DOQI临床实践指南。监控 肾小球滤过率(GFR)的变化为早期检测肾小球滤过率(GFR)提供了最佳手段 肾脏疾病。在美国被最广泛使用的一种检查异常的方法 肾小球滤过率是指血清肌酐。然而，使用血清肌酐估计的GFR值有 与直接测量肾小球滤过率的方法相比，理想方法的诊断价值有限 过滤标记，如菊粉。此第一阶段申请寻求支持，以进一步 开发一种基于免疫分析技术的新型读出系统，以直接 测量肾小球滤过率。我们建议的测试将是准确的，简单易用，廉价，并将 具有广泛的可评估性。这项测试将使用FDA批准的化合物，这些化合物已知是 GFR标志物。因此，我们建议的GFR测试将能够更快地进入 集市。

ABSTRACT Kidney disease in the United States has been described as an epidemic. More than 20 million patients have chronic kidney disease (CKD) and these numbers are increasing annually. As a result, the number of patients with end-stage renal disease (ESRD) is expected to double between 1999 and 2010. These increases in CKD and ESRD are associated with significant morbidity, mortality and healthcare costs. Early detection and treatment of kidney disease has been shown to improve outcomes, but kidney disease is often under diagnosed resulting in lost opportunities to treat. The importance of early diagnosis and treatment of kidney disease has been extensively reviewed and published as a K/DOQI clinical practice guideline by the National Kidney Foundation. Monitoring changes in glomerular filtration rate (GFR) provides the best means for early detection of kidney disease. The test that is most widely used in the US to screen abnormalities in GFR is serum creatinine. However, estimated GFR values using serum creatinine have limited diagnostic value over methods that directly measured GFR using an ideal filtration marker, such as inulin. This Phase I application seeks support to further develop a novel readout system, based on immunoassay technology, to directly measure GFR. Our proposed test will be accurate, simple-to-use, inexpensive and will be widely assessable. The test will utilize FDA-cleared compounds that are known to be GFR markers. As a result, our proposed GFR test will be able to more quickly enter the marketplace.