Yun Seung Gyu, Kim Sang-Wook, Shin Gyeong Hee, Lee Chang Kyu, Ko Sun-Young, Kim Dae Won, Cho Yunjung
Clin Lab. 2020 Oct 1;66(10). doi: 10.7754/Clin.Lab.2020.200213.
The measurement of glycemic control among patients with diabetes mellitus is important for predicting the risk of diabetic complications. Glycated hemoglobin (HbA1c) measurements have been used for long-term glycemic control in clinical practice. However, glycated albumin (GA) or glycated serum protein (GSP) is a more reliable indicator of glycemic control in the short term (2 - 4 weeks) and an alternative marker of HbA1c in clinical situations with changing red blood cell (RBC) lifespan. Here, we evaluated an analytical performance of the two enzymatic assays commercially available, Lucica GA-L and Autolab GA, for the determination of GA (%).
For each assay, the imprecision was evaluated based on CLSI EP05-A2. In total, serum samples of 283 subjects were simultaneously tested using the two enzymatic assays for method comparison according to CLSI EP09-A3. Some subjects collected the laboratory data for HbA1c.
The GA (%) value of the Lucica GA-L assay showed highly reproducible results with within-run, between-run, and total coefficient of variations (CVs) below 2.4%. The Autolab GA assay also showed reliable results with within-run, between-run, and total CVs below 3.9%. The Lucica GA-L assay showed a very high correlation with the Autolab GA assay (r = 0.9993). However, at the median decision point (MDP, 14.3%), the estimated bias of the Autolab GA assay was 4.5%, exceeding the allowable bias (2.9%) accounting for the biological variation. For the correlation analysis between HbA1c and GA (%), the two assays demonstrated the same pattern, with no statistical differences between the two independent correlation coefficients.
Both GA assays evaluated in this study showed good precision and excellent correlation, but the comparability at MDP did not meet the acceptance criteria.
糖尿病患者血糖控制的测量对于预测糖尿病并发症风险很重要。糖化血红蛋白（HbA1c）测量已在临床实践中用于长期血糖控制。然而，糖化白蛋白（GA）或糖化血清蛋白（GSP）是短期（2 - 4周）血糖控制的更可靠指标，并且在红细胞（RBC）寿命发生变化的临床情况下是HbA1c的替代标志物。在此，我们评估了两种市售酶法检测Lucica GA-L和Autolab GA用于测定GA（%）的分析性能。
对于每种检测方法，根据CLSI EP05-A2评估不精密度。总共使用这两种酶法检测对283名受试者的血清样本进行同步检测，以根据CLSI EP09-A3进行方法比较。一些受试者收集了HbA1c的实验室数据。
Lucica GA-L检测的GA（%）值显示出高度可重复的结果，批内、批间和总变异系数（CVs）低于2.4%。Autolab GA检测也显示出可靠的结果，批内、批间和总CVs低于3.9%。Lucica GA-L检测与Autolab GA检测显示出非常高的相关性（r = 0.9993）。然而，在中位数决策点（MDP，14.3%），Autolab GA检测的估计偏差为4.5%，超过了考虑生物学变异的允许偏差（2.9%）。对于HbA1c与GA（%）之间的相关性分析，两种检测显示出相同的模式，两个独立相关系数之间无统计学差异。
本研究中评估的两种GA检测均显示出良好的精密度和出色的相关性，但在MDP处的可比性未达到验收标准。
