Functional immunoassay technology (FIT), a new approach for measuring physiological functions: application of FIT to measure glomerular filtration rate (GFR).

Functional immunoassay technology (FIT), a new approach for measuring physiological functions: application of FIT to measure glomerular filtration rate (GFR).
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功能免疫分析技术(FIT),一种测量生理功能的新方法:应用FIT测量肾小球滤过率(GFR)。

DOI:
10.1152/ajprenal.90354.2008
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发表时间:
2008
期刊:
American journal of physiology. Renal physiology
影响因子:
--
通讯作者:
Vaccaro,DennisE
Vaccaro,DennisE
中科院分区:
--
文献类型:
--
作者:
Reinhardt,ChristopherPeter;Germain,MichaelJ;Groman,ErnestV;Mulhern,JeffreyG;Kumar,Rajesh;Vaccaro,DennisE

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这是功能免疫分析技术 (FIT) 的首次描述,该技术作为一种诊断工具,在整个生理测量领域具有广泛的应用。在本文中,FIT 用于测量临床可用造影剂超低剂量给药的肾脏清除率,以获得准确的肾小球滤过率 (GFR) 测量结果。基于生物标志物的 GFR 估计提供了便利,但并不准确,而且常常具有误导性。 FIT 克服了之前与获得准确 GFR 测量相关的分析障碍。我们介绍了该诊断测试的性能特征,并通过直接比较 FIT 获得的 GFR 值与 FDA 批准的 20 名成人核测试获得的 GFR 值来演示该方法。两名受试者是健康志愿者,其余 18 名受试者被诊断为慢性肾脏病,其中 12 名是肾移植受者。测量的 GFR 值通过经典 UV/P 方法和血液清除率方法计算。 FIT 获得的 GFR 和核试验在较宽的 GFR 值范围内 (10.9–102.1 ml·min−1·1.73 m−2) 密切相关。该研究表明 FIT-GFR 提供了准确且可重复的测量结果。这种基于非放射性、免疫测定的方法具有许多优点,主要是大多数实验室已经拥有运行 ELISA 所需的设备和训练有素的人员,因此可以更容易地获得这种重要的诊断测量结果。 FIT-GFR 测试可用于整个药物开发流程:临床前和临床试验。
This is the first description of functional immunoassay technology (FIT), which as a diagnostic tool has broad application across the whole spectrum of physiological measurements. In this paper, FIT is used to measure the renal clearance of an ultra low-dose administration of a clinically available contrast reagent for the purpose of obtaining an accurate glomerular filtration rate (GFR) measurement. Biomarker-based GFR estimates offer convenience, but are not accurate and are often misleading. FIT overcomes previous analytic barriers associated with obtaining an accurate GFR measurement. We present the performance characteristics of this diagnostic test and demonstrate the method by directly comparing GFR values obtained by FIT to those obtained by an FDA approved nuclear test in 20 adults. Two subjects were healthy volunteers and the remaining 18 subjects had diagnosed chronic kidney disease, with 12 being kidney transplant recipients. Measured GFR values were calculated by the classic UV/P method and by the blood clearance method. GFR obtained by FIT and the nuclear test correlated closely over a wide range of GFR values (10.9–102.1 ml·min−1·1.73 m−2). The study demonstrates that FIT-GFR provides an accurate and reproducible measurement. This nonradioactive, immunoassay-based approach offers many advantages, chiefly that most laboratories already have the equipment and trained personnel necessary to run an ELISA, and therefore this important diagnostic measurement can more readily be obtained. The FIT-GFR test can be used throughout the pharmaceutical development pipeline: preclinical and clinical trials.
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