3种检测系统测定糖化血红蛋白测量不确定度的评估-现代医学

3种检测系统测定糖化血红蛋白测量不确定度的评估

单位：南京同仁医院

分类号：R446.1

出版年·卷·期（页码）：2012·40·第五期（520-523）

摘要：

目的对3种不同检测系统测定糖化血红蛋白的测量不确定度进行评估，探讨3种检测系统测定HBA1c结果的可比性及各自检测性能的差异。方法分别以离子交换高效液相色谱法（HPLC）为检测原理的Bio-Rad D-10糖化血红蛋白分析仪，Affinion AS100与Roche Modular 全自动生化分析仪为实验检测系统，应用正常和异常水平的糖化血红蛋白质控品进行批内、批间精密度测定，选用有证定值HbA1c参考物评价不同检测系统的方法偏倚，综合以上主要变量评估3种检测系统测定HbA1c的测量不确定度。结果 Bio-Rad D-10糖化血红蛋白分析仪、Affinion AS100分析仪和Roche Modular生化分析仪测定糖化血红蛋结果在正常水平浓度测量不确定度分别为4.73-6.15 %；在异常水平浓度测量不确定度分别为3.14－5.59%。结论 3种检测系统测定HbA1c精密度高，准确性好，测量合成不确定度之间无明显差异并均在6.5%范围内，能满足临床需求。

Objective To evaluation of the uncertainty of three glycated hemoglobin measurement systems, to investigate the comparability and difference among three measurement systems. Methods The uncertainty of three HbA1c measurement systems (Bio-Rad D-10 Hemoglobin Testing System, Affinion AS100 analyzer System and Roche Modular analyzer)were evaluated by within-run and between-run precisions that evaluated through two levels HbA1c control and bias that evaluated by the difference between the test result and the assayed reference value respectively. Results The uncertainty of three measurement systems were 4.73-6.15% in normal level of HbA1c and 3.14－5.59% in abnormal level of HbA1c.Conclusions There is no significant difference among the uncertainty of three systems and three measurement systems on detecting the level of HbA1c have good performance of precision and trueness that meet the clinical requirement.

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