Sezione di Biochimica Clinica, Dipartimento di Scienze della Vita e della Riproduzione, Università degli Studi di Verona, Italy.
Clin Chim Acta. 2013 Aug 23;423:1-4. doi: 10.1016/j.cca.2013.04.003. Epub 2013 Apr 13.
Glycated albumin (GA) and fructosamine are nonenzymatically glycated proteins still frequently utilized for monitoring glycemic control in diabetics. To investigate the analytical variation and the degree of individuality of these glycemic markers, we have performed an experimental study under a well designed and standardized protocol.
We collected five specimens from each of 18 apparently healthy subjects (9 men and 9 women, ages 26-52 years), on the same day, every two weeks for two months. Samples were stored at -80°C until analysis and assayed in duplicate in a single analytical run. GA and fructosamine were measured using enzymatic (Lucica®GA-L, Asahi Kasei Pharma, AKP, Tokyo, Japan) and colorimetric assays, respectively, on a Modular P Roche system (Roche Diagnostics GmbH, Mannheim, Germany). Data were analyzed by ANOVA.
Analytical coefficient of variation (CVA) was 1.7%, 2.3% and 2.8% for GA, albumin and fructosamine, respectively. Within-subject (CVW) and between-subject (CVG) coefficients of variation were 2.1% and 10.6% for GA, 2.3% and 2.9% for albumin, and 2.3% and 6.3% for fructosamine. The estimated critical difference (CD) was 7.5% for GA, 9% for albumin and 10% for fructosamine.
The good quality achieved by the analytical method for GA assessment and the reduced within-subject biological variation would allow to recommend this test in clinical practice for evaluation of glycemic control along with measurement of glycated hemoglobin.
糖基化白蛋白（GA）和果糖胺是非酶糖化蛋白，在糖尿病患者中仍常被用于监测血糖控制。为了研究这些血糖标志物的分析变异和个体差异程度，我们根据精心设计和标准化的方案进行了一项实验研究。
我们在两个月内，于同一天每隔两周从 18 名健康受试者（9 名男性和 9 名女性，年龄 26-52 岁）每人采集 5 份样本。将样本储存在-80°C，直至分析，并在单个分析运行中进行两次重复测定。使用酶法（Lucica®GA-L，Asahi Kasei Pharma，AKP，东京，日本）和比色法分别测量 GA 和果糖胺，使用 Roche 系统（罗氏诊断公司，曼海姆，德国）。采用方差分析对数据进行分析。
GA、白蛋白和果糖胺的分析变异系数（CVA）分别为 1.7%、2.3%和 2.8%。GA、白蛋白和果糖胺的个体内（CVW）和个体间（CVG）变异系数分别为 2.1%和 10.6%、2.3%和 2.9%、2.3%和 6.3%。GA 的估计临界差异（CD）为 7.5%，白蛋白为 9%，果糖胺为 10%。
GA 评估的分析方法所达到的良好质量和降低的个体内生物学变异，将允许在临床实践中推荐该检测方法，以评估糖化血红蛋白的同时评估血糖控制。
