三种检测系统测定糖化血红蛋白相关性分析及偏倚评估

目的比较三种检测系统测定糖化血红蛋白（HbA1c）结果的差异并评价其偏倚度。方法分别使用Bio-Rad D-10糖化血红蛋白分析仪应用高压液相层析法（HPLC）、Roche Cobas全自动生化分析仪以免疫法、Afinion AS100分析仪以亲和色谱法测定HbA1c,对64例血液样本作比对测定,评估各检测系统之间测定结果的相关性和偏倚;应用高低两个水平质控品分别测定三种检测系统的不精密度。结果三种不同检测系统测定糖化血红蛋白的结果有良好的相关性（P〈0.01）,HPLC和亲和色谱法的总不精密度〈2.0%,免疫法总不精密度接近4.0%,符合临床测定的性能要求。以D-10 HPLC为参考检测系统,Afinion亲和色谱法和Roche免疫法测定结果的相对偏倚分别为0.17%和0.13%。结论 D-10 HPLC法、Afinion亲和色谱法和Roche免疫法测定糖化血红蛋白的准确度、精密度和偏倚符合临床要求,Roche免疫法测定HbA1c结果变异系数较大,应以HPLC法作为参考检测系统定期作比对分析。

Comparison research on HbA1c results among three kinds of assay systems

Objective To discuss the comparability of HbA1c results among three kinds of different assay systems.Methods The CLSI protocol EP-9 was applied to investigate imprecision,accuracy,and bias.64 whole blood specimens were measured for HbA1c with HPLC method on Bio-Rad D-10 automated analyzer,with immunoassay method on the Roche Modular automated biochemical analyzer;and with affinity chromatography method on Afinion AS100 analyzer.Two different level control samples were measured to evaluate their analytical variances.Results The results of HbA1c were analyzed with the three kinds of assay systems showed that the correlation between D-10 HPLC and Afinion AS100 analyzer was excellent（Y=1.032X-0.061,r=0.996,P0.01）;meanwhile the correlation between D-10 HPLC and Roche immunoassay method was excellent（Y=0.9704X＋0.3545,r=0.992,P0.01）.The total CVs for the different detection systems were ： D-10 HPLC 2.0% and 1.6%,Afinion HbA1c assay 1.7% and 1.3%,and Roche Modular HbA1c assay 4.1%,3.7%.Conclusion The analytic bias,imprecision and accuracy on HbA1c measurement with the three kinds of assay systems met the acceptance criteria in the clinically relevant range.Roche immunoassay was proved larger variance on HbA1c assay,which should be performed regularly comparison tests with reference method.