Keleş Murat, Ünver Şeker Gönül
Alanya Alaaddin Keykubat University Alanya Education And Research Hospital, Antalya, Turkey.
Bursa Public Health Laboratory, Bursa, Turkey.
Scand J Clin Lab Invest. 2024 Nov-Dec;84(7-8):535-539. doi: 10.1080/00365513.2024.2439394. Epub 2024 Dec 16.
HbA plays an important role in the diagnosis and treatment of diabetes and is a valuable biomarker for evaluating glycemic control and predicting the risk of vascular complications. The study aimed to determine the biological variation (BV) for HbA and thereby contribute to analytical performance specifications, reference change values, and index of individuality. Fasting venous whole blood samples were collected from 38 presumably healthy subjects (20 females, 18 males) once a week for ten weeks, and analyzed in duplicate using the Roche Cobas c501 analyzer. BioVar, an online R-based biological variation analysis tool, was used for the statistical analysis. BV values were obtained by analysis of variance (ANOVA) after outlier detection, normality tests, steady-state, and homogeneity checks. The within-subject biological variation for HbA was 2.9%, and the between-subject biological variation was 7.9%. The index of the individuality of HbA was 0.37. Derived desirable analytical goals for imprecision, bias, total allowable error, and maximum expanded allowable measurement uncertainty were 1.4%, 1.8%, 4.2%, and 2.9% respectively. The reference change value is more appropriate for interpreting HbA1c results than a population-based reference interval.
糖化血红蛋白（HbA）在糖尿病的诊断和治疗中发挥着重要作用，是评估血糖控制和预测血管并发症风险的重要生物标志物。本研究旨在确定HbA的生物学变异（BV），从而为分析性能规范、参考变化值和个体指数提供依据。从38名可能健康的受试者（20名女性，18名男性）中每周采集一次空腹静脉全血样本，共采集十周，并使用罗氏Cobas c501分析仪进行双份检测。使用基于R语言的在线生物变异分析工具BioVar进行统计分析。在进行异常值检测、正态性检验、稳态和同质性检查后，通过方差分析（ANOVA）获得BV值。HbA的个体内生物学变异为2.9%，个体间生物学变异为7.9%。HbA的个体指数为0.37。推导得出的不精密度、偏倚、总允许误差和最大扩展允许测量不确定度的理想分析目标分别为1.4%、1.8%、4.2%和2.9%。与基于人群的参考区间相比，参考变化值更适合解释糖化血红蛋白（HbA1c）结果。
