Inulin immunoassay for kidney function

描述（申请人提供）：在动物模型和临床中缺乏广泛接受的可商购获得的方法来测量肾小球滤过率（GFR）对（i）开发用于治疗肾病的方法和药物，（ii）准确评估肾移植受体和供体，（iii）校准年轻人和老年人的药物剂量，（iv）在药物开发过程中最小化肾毒性，以及（v）在临床环境中准确评估肾毒性。菊粉是测量GFR的金标准。一种灵敏、特异、简便的菊糖测定方法最有可能被一般研究、临床研究和临床所接受。菊粉是免费的任何争议与钆螯合物往往提出作为GFR探针。我们已经完成了第一阶段申请中概述的所有具体目标，产生了菊粉的研究免疫测定和测量肾小球滤过率的诊断测试。我们的菊粉ELISA避免了 该方法克服了其他菊粉测定的缺点，易于进行，成本有效，高度特异性，并且比目前可用的菊粉测定灵敏得多。所有试剂均稳定，菊粉检测下限小于10 ng/ml，菊粉抗体的特异性允许将菊粉与所有常见糖和多糖区分开。第二阶段完成后，将推出两种产品和一种服务。这两种产品是菊粉氯化钠注射液（USP）和cGMP FIT-GFR菊粉试剂盒。该服务提供了一个CLIA许可的实验室，配备测量和报告GFR（mGFR）测定从研究实验室，兽医和医疗实践中获得的样本。 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。该测试将利用众所周知和广泛可用的分析技术，并将利用“金标准”来衡量肾功能。因此，这种测试将有助于迅速进入市场。

DESCRIPTION (provided by applicant): The absence of a widely accepted commercially available method to measure glomerular filtration rate (GFR) in animal models and in the clinic has had profoundly negative effects on (i) developing methods and drugs for treating kidney disease, (ii) accurately assessing kidney transplant recipients and donors, (iii) calibrating drug dosing in the young and elderly, (iv) minimizing nephrotoxicity in the drug development process, and (v) accurately assessing nephrotoxicity in the clinical setting. Inulin is the gold standard fo measuring GFR. A sensitive, specific and easy assay to measure inulin is most likely to be accepted for general research, clinical research, and in the clinic. Inulin is free of any controversy associated with gadolinium chelates often proposed as GFR probes. We have completed all specific aims outlined in our Phase I application yielding a research immunoassay for inulin and a diagnostic test to measure glomerular filtration rate. Our inulin ELISA avoids the shortcomings of other inulin assays, is easy to perform, cost effective, highly specific, and far more sensitive than currently available inulin assays. All reagents are stable, the lower limit of inulin detection is less than 10ng/ml, the specificity of the antibody for inulin allows discrimination between inulin and all common sugars and polysaccharides. Completion of Phase II will see the launch of two products and one service. The two products are inulin in sodium chloride injection, USP, and a cGMP FIT-GFR inulin kit. The service provides a CLIA licensed laboratory equipped to measure and report GFR (mGFR) determinations from samples obtained from research laboratories, veterinary and medical practices. 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 the "gold standard" for the measure of kidney function. Therefore, this test will be ale to quickly enter the market-place.