Glycated albumin (GA) in human serum is tested clinically as a short-term indicator for glucose monitoring. Here, we evaluated a candidate serum reference material (RM) at three different GA concentrations to help standardize serum GA measurements. Both albumin and GA were quantitatively determined using isotope-dilution liquid chromatography/tandem mass spectrometry with lysine―4,4,5,5-D₄·2HCl (D₄-lysine) and N^ε-^l3C₆-(l-deoxy-d-fructose-1-yl)-l-lysine (¹³C₆-DOF-lysine) as internal standards and lysine and synthetic DOF-lysine as calibration standards. The method was evaluated with the RM, JCCRM611-1, from the Reference Material Institute for Clinical Chemistry Standards. The homogeneity and stability of the candidate RMs were examined using a commercial biochemical analyzer. Fifteen units were randomly selected, and statistical analysis showed no inhomogeneity. The candidate RMs were stable for at least 6 months at −80 °C. The coefficients of variation (CVs) for the JCCRM611-1 RM ranged from 3.2% to 2.3%, and the biases ranged from 4.12% to −1.84%. GA was tested at low, medium, and high concentrations, which were quantified as 249.53 ± 13.29, 408.02 ± 11.70, and 637.22 ± 17.03 mmol/mol, respectively. The overall CVs ranged from 0.99% to 2.51%. The candidate RMs can potentially be used to develop a traceability chain to improve the accuracy of GA measurements.

人血清中的糖化白蛋白 (GA) 在临床上作为葡萄糖监测的短期指标进行了测试。在这里，我们评估了三种不同 GA 浓度的候选血清参考物质 (RM)，以帮助标准化血清 GA 测量。白蛋白和 GA 均使用同位素稀释液相色谱/串联质谱法与赖氨酸―4,4,5,5-D ₄ ·2HCl（D ₄ -赖氨酸）和 N ^ε - ^l3 C ₆ -（l-脱氧）定量测定- d -fructose-1-yl)- l -赖氨酸 ( ¹³ C ₆-DOF-赖氨酸）作为内标，赖氨酸和合成 DOF-赖氨酸作为校准标准。使用来自临床化学标准参考材料研究所的 RM JCCRM611-1 对该方法进行了评估。使用商业生化分析仪检查候选 RM 的同质性和稳定性。随机抽取十五个单位，统计分析显示无异质性。候选 RM 在 -80 °C 下至少稳定 6 个月。JCCRM611-1 RM 的变异系数 (CV) 范围为 3.2% 至 2.3%，偏差范围为 4.12% 至 -1.84%。GA 在低、中和高浓度下进行了测试，分别量化为 249.53 ± 13.29、408.02 ± 11.70 和 637.22 ± 17.03 mmol/mol。整体 CV 介于 0.99% 和 2.51% 之间。