Diagnostics Department, Asahi Kasei Pharma Corporation, IVD Kit Product Group, Yurakucho, Japan.
J Clin Lab Anal. 2022 Jul;36(7):e24509. doi: 10.1002/jcla.24509. Epub 2022 May 20.
Glycated albumin (GA) is an intermediate-term marker for monitoring glycemic control (preceding 2-3 weeks) in patients with diabetes mellitus. We evaluated the performance of Lucica Glycated Albumin-L, a new GA assay that is traceable to standard reference materials and determined the reference range in healthy subjects without diabetes.
The performance and reference range studies were conducted in accordance with Clinical and Laboratory Standards Institute (CLSI) Guidelines. The traceability was established using reference material recommended by the Japan Society of Clinical Chemistry (JSCC).
The coefficient of variation (CV) of overall repeatability, within-laboratory precision, and overall reproducibility values of GA values were not more than 2.6%, 3.3%, and 1.6%, respectively, among laboratories. The GA values showed good linearity from 173 to 979 mmol/mol (9.4%-54.9%) across the assay range. The GA reference range in 262 healthy subjects was between 183 and 259 mmol/mol (9.9%-14.2%) while that of subjects with diabetes was 217-585 mmol/mol (11.8-32.6%). The reagent was stable for 2 months on the bench at room temperature. The limits of blank, detection, and qualification were 6.9, 7.9, and 9.7 μmol/L for GA concentration, and 3.8, 7.0, and 21.8 μmol/L for albumin concentration, respectively. Hemoglobin slightly affected the assay, while other classical interfering substances had no significant impact.
The present GA assay shows comparable performance to current clinical assays and could be used for intermediate-term monitoring of glycemic control in diabetes patients.
糖化白蛋白（GA）是监测糖尿病患者血糖控制的中期标志物（前 2-3 周）。我们评估了 Lucica Glycated Albumin-L 的性能，这是一种新的 GA 检测方法，可溯源至标准参考物质，并确定了无糖尿病的健康受试者的参考范围。
根据临床和实验室标准协会（CLSI）指南进行了性能和参考范围研究。使用日本临床化学学会（JSCC）推荐的参考物质建立了溯源性。
GA 值的总重复性、实验室内精密度和总再现性的变异系数（CV）分别不超过 2.6%、3.3%和 1.6%。GA 值在整个检测范围内从 173 至 979mmol/mol（9.4%-54.9%）显示出良好的线性关系。262 名健康受试者的 GA 参考范围为 183-259mmol/mol（9.9%-14.2%），而糖尿病患者的 GA 参考范围为 217-585mmol/mol（11.8-32.6%）。试剂在室温下在台面上稳定 2 个月。GA 浓度的空白限、检测限和合格限分别为 6.9、7.9 和 9.7μmol/L，白蛋白浓度的分别为 3.8、7.0 和 21.8μmol/L。血红蛋白对检测略有影响，而其他经典干扰物质无显著影响。
本 GA 检测方法与当前临床检测方法具有可比性，可用于糖尿病患者血糖控制的中期监测。
