Multi-center determination of galectin-3 assay performance characteristics: Anatomy of a novel assay for use in heart failure
Multi-center determination of galectin-3 assay performance characteristics: Anatomy of a novel assay for use in heart failure
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DOI：
10.1016/j.clinbiochem.2010.02.001
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发表时间：
2010-05-01
影响因子：
2.8
通讯作者：
Gardiner, Peter
中科院分区：
文献类型：
--
作者：
Christenson, Robert H.;Duh, Show-Hong;Gardiner, Peter
背景：半乳糖凝集素-3是一种糖结合蛋白，在炎症、免疫和肿瘤中起着重要的调节作用。最近的研究表明，半乳糖凝集素-3是心力衰竭发展和进展的介质。开发用于半乳糖凝集素-3测量的改进的测定法对于适当的临床评估是必要的。定义了关键的分析性能特征、半乳糖凝集素-3水平的参考分布和与心力衰竭患者临床结局的相关性。检查了双位点ELISA试验的测量基质、不精密度、空白限、检测限和定量限，以及线性、高剂量钩状效应、储存稳定性、与9种类似化合物的交叉反应性，干扰22种常见药物和黄疸、脂血和溶血，均符合CLSI指南。还研究了人抗小鼠抗体和类风湿因子对半乳糖凝集素-3回收率的影响。确定了1092名表面健康个体的参考区间。在129例急性失代偿性心力衰竭patients.Results的初步分析中，半乳糖凝集素-3浓度与死亡率结果的相关性进行了研究：半乳糖凝集素-3结果在血清或EDTA血浆中测量时是等效的。不精密度研究表明，总CV为
Background: Galectin-3 is a carbohydrate binding protein that plays many important regulatory roles in inflammation, immunity and cancer. Recent studies indicate that galectin-3 is a mediator of heart failure development and progression. Development of an improved assay for galectin-3 measurement was necessary for appropriate clinical assessment. Key analytical performance characteristics, the reference distribution and association of galectin-3 levels with clinical outcome in heart failure patients are defined.Methods: A two-site ELISA test was examined for measurement matrix, imprecision, limits of blank, detection, and quantitation, as well as linearity, high-dose hook effect, storage stability, cross-reactivity with nine similar compounds, interference with 22 common medications and icterus, lipemia and hemolysis, all in accordance with CLSI guidance. Also the effects of human anti-mouse antibodies and rheumatoid factor on recovery of galectin-3 were investigated. The reference interval was determined for 1092 ostensibly healthy individuals. The association of galectin-3 concentrations with an outcome of mortality was examined in a preliminary analysis of 129 acute decompensated heart failure patients.Results: Galectin-3 results were equivalent when measured in serum or EDTA plasma. Imprecision studies demonstrated that the total CV was