Glomerular filtration rate test

描述（由申请人提供）：肾脏疾病在美国被描述为流行病。超过2000万患者患有慢性肾脏疾病（CKD），并且这些数字每年都在增加。因此，终末期肾病患者的人数预计在1999年至2010年期间将翻一番。CKD和ESRD的这些增加与显著的发病率、死亡率和医疗保健成本相关。肾脏疾病的早期诊断和治疗已被证明可以改善预后，但肾脏疾病往往诊断不足，导致失去治疗机会。肾脏疾病早期诊断和治疗的重要性已被广泛审查，并由国家肾脏基金会作为K/DOQI临床实践指南出版。监测肾小球滤过率（GFR）的变化为早期发现肾脏疾病提供了最佳手段。在美国最广泛用于筛查GFR异常的测试是血清肌酐。然而，与使用理想过滤标记物（例如菊糖）直接测量GFR的方法相比，使用血清肌酸酐估计的GFR值的诊断价值有限。该II期申请寻求支持，以进一步开发基于免疫测定技术的新型读出系统，以直接测量GFR。正如第一阶段所证明的那样，我们的测试是准确的，简单易用，价格低廉，可以广泛评估。该测试利用FDA批准的化合物，已知是GFR标志物。因此，我们提出的GFR测试将能够更快地进入市场。 公共卫生相关性：该项目将进一步开发一种测量肾功能的诊断测试。该试验将利用众所周知和广泛可用的分析技术，并将利用临床可用的化合物。因此，这种测试将能够迅速进入市场。

DESCRIPTION (provided by applicant): 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 II application seeks support to further develop a novel readout system, based on immunoassay technology, to directly measure GFR. As demonstrated during Phase I, our test is accurate, simple-to-use, inexpensive and can be widely assessable. The test utilizes 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. PUBLIC HEALTH RELEVANCE: The project will further develop a diagnostic test to measure kidney function. The test will utilize well-known and widely available analytical technology and will utilize clinically available compounds. Therefore, this test will be able to quickly enter the market-place.