Inulin immunoassay for kidney function

描述（由申请人提供）：缺乏一种广泛接受的商业上可用的方法来测量动物模型和临床中的肾小球滤过率（GFR），这对以下方面产生了深远的负面影响：(i)开发治疗肾脏疾病的方法和药物，（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）在药物开发过程中尽量减少肾毒性，以及(v)在临床环境中准确评估肾毒性。菊粉是测定GFR的金标准。一种灵敏、特异和简便的测定菊粉的方法最有可能被一般研究、临床研究和临床应用所接受。菊粉与经常被提议作为GFR探针的钆螯合物没有任何争议。我们已经完成了I期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。我们的胰岛素酶联免疫吸附试验避免了

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.