三种不同方法测定糖化血红蛋白的结果比对和偏移评估分析

Comparison and bias estimation of three methods in determination of glycated hemoglobin A1 c

目的对3种不同原理测定糖化血红蛋白（HbA1c）的结果进行比对和偏移评估。 方法根据美国临床和实验室标准协会（CLSI） EP9－A3文件，应用Roche Tina－quant免疫比浊法、Sebia Minicap FP毛细管电泳法和Trinity Biotech Premier Hb 9210？高效液相色谱法（HPLC）3种不同原理的检测系统分别单次测定40份线性范围内静脉血标本的HbA1c，其结果进行两两比较，绘制散点图和偏差图。并对结果进行极端学生化偏差（ESD）法离群值检验，选取最佳回归模型拟合回归方程，并计算医学决定水平处的偏移，以1/2允许总误差（Tea）为可接受标准。 结果通过目测散点图及ESD法确认40份样本HbA1c检测结果具有良好的相关性，未发现离群值点。根据百分比差值偏差图、百分比差值排序偏差图、数值偏差图和排序偏差图特征选取了普通线性回归（OLR）[Roche（X）和sebia（Y1）]、加权最小二乘法（WLS）[ Roche（X）和Trinity （Y2）]以及戴明回归（Deming）[Sebia（Y1）和Trinity（Y2）]4种回归分析模型进行拟合，其回归方程分别为Y1＝－0.420 3＋1.052 7X，Y2＝－0.174 0＋1.027 0X，Y2＝0.423 1＋0.959 0Y1。并将HbA1c两个医学决定水平10%、16%分别代入方程中，Roche（X）和sebia（Y1）比对系统偏移为1.06%、2.61%；Roche（X）和Trinity （Y2）比对系统偏移为0.96%、1.60%；Sebia（Y1）和Trinity（Y2）比对系统偏移为0.13%、－1.47%，其偏移均小于可接受标准。 结论Sebia Minicap FP全自动毛细管电泳法、Trinity Biotech Premier Hb 9210？ HPLC法与Roche Tina－quant免疫比浊法3种不同方法测定HbA1c的结果具有可比性。

ObjectiveTo evaluate the bias of three different methods in determination of glycated hemoglobin A1c （HbA1c）. MethodsAccording to Clinical and Laboratory Standards Institute（CLSI）EP9-A3 document, 40 serum specimens among linear range were tested by immunoturbidimetry assay （Roche Tina-quant）, capillary electrophoresis （Sebia Minicap FP）, high performance liquid chromatography system （HPLC, Trinity Biotech Premier Hb 9210？）. Results were analyzed by pairwise comparision. The difference plots and scatter plots were analyzed. The results of outliers were examined by extreme studentized deviate （ESD） method. The best regression model was chosen to fit the regression equation and the biases were calculated at the level of medical decision and judged the comparability according to the half of Tea acceptance standard. ResultsScatter plots and ESD results showed good correlation among test results of 40 samples, no abnormal values were found. Based on proportional difference deviation plots, proportional difference rank order deviation plots, numerical deviation plots and ranked order difference plots, weighted least squares（WLS）（Roche（X）vs sebia（Y1））, ordinary linear regression （OLR）（Roche（X）vs Trinity （Y2）） and Deming （Sebia（Y1）vs Trinity（Y2））were chosen to fit regression analysis model. The regression equations were Y1 =-0.420 3＋ 1.052 7X, Y2 =-0.174 0＋ 1.027 0X, Y2=0.423 1＋ 0.959 0Y1, respectively. Assuming the HbA1c medical decision points of 10%, 16% to regression equation, the proportional biases were 1.06% and 2.61% at Roche（X）and sebia（Y1） system, 0.96% and 1.60% at Roche（X）and Trinity （Y2） system, 0.13% and -1.47% at Sebia（Y1）and Trinity（Y2）system respectively, which were all lower than the acceptable values. ConclusionThe measurement values of HbA1c by capillary electrophoresis （Sebia Minicap FP）, HPLC （Trinity Biotech Premier Hb 9210？ ） and immunoturbidimetry assay （Roche Tina-quant ）, are comparable.