Wu Rui, Zhou Huijuan, Nizhamnuding Xiaerbanu, Pan Anqi, Zheng Hao, Zhang Jiangtao, Zhao Haijian, Wang Jing, Zhang Tianjiao, Zhang Chuanbao
National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology, Beijing, P.R. China.
Chinese Academy of Medical Sciences, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P.R. China.
Clin Chem Lab Med. 2025 May 28. doi: 10.1515/cclm-2025-0507.
In clinical practice, glycated albumin (GA), as a key biomarker reflecting the level of blood glucose control in the short and medium term, has been widely used in the diagnosis and efficacy monitoring of diabetes. However, the consistency of GA results between different detection systems remains one of the current challenges in laboratory medicine. we evaluated the commutability of 10 evaluated samples to identify candidate EQA materials for GA measurement.
According to the Clinical and Laboratory Standards Institute (CLSI) document EP14-A3 and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) commutability evaluation program, we used the established isotope dilution liquid chromatography-tandem mass spectrometry (ID LC-MS/MS) method for serum glycated albumin determination as the comparative method, and six different commercial kits used enzyme assay as the evaluating method. A total of 40 clinical sample serums, 9 pregnancy sample serums, and 10 evaluated samples were analyzed.
For the CLSI approach, pooled serum samples (cRM1-3) at medium concentrations (cRM2) are commutable in 5/6 kits. For the IFCC approach, none of samples commutable.
The commutability evaluation results of the two approaches were different, and the cRM2 has commutability in most enzymatic kits. It can be a commutable material for the EQA project.
在临床实践中，糖化白蛋白（GA）作为反映短期和中期血糖控制水平的关键生物标志物，已广泛应用于糖尿病的诊断和疗效监测。然而，不同检测系统之间GA结果的一致性仍然是检验医学当前面临的挑战之一。我们评估了10个评估样品的互换性，以确定用于GA测量的候选EQA材料。
根据临床和实验室标准协会（CLSI）文件EP14-A3和国际临床化学与检验医学联合会（IFCC）互换性评估程序，我们使用已建立的同位素稀释液相色谱-串联质谱（ID LC-MS/MS）法测定血清糖化白蛋白作为比较方法，使用六种不同的商业试剂盒采用酶法作为评估方法。共分析了40份临床样本血清、9份妊娠样本血清和10份评估样本。
对于CLSI方法，中等浓度（cRM2）的混合血清样本（cRM1-3）在5/6的试剂盒中具有互换性。对于IFCC方法，没有样本具有互换性。
两种方法的互换性评估结果不同，cRM2在大多数酶试剂盒中具有互换性。它可以作为EQA项目的可互换材料。
