三种一致性分析法在糖化血红蛋白测定系统临床评价中的应用

Application of three consistency analysis methods in clinical evaluation of glycohemoglobin test systems

目的对国产和进口的两种糖化血红蛋白(Hb A1c)测定系统检测结果的一致性进行评估。方法 110份抗凝全血样本同时在美国Bio-Rad D-10型和某国产TH3600型Hb A1c分析仪进行检测。对两组测定结果分别采用回归分析、Kappa检验和Bland-Altman分析法比较一致性。结果回归分析显示两组结果有很好的线性相关;以回归方程作医学决定水平的偏倚分析,结果明显小于CAP室间质评允许的误差。Kappa检验显示两组结果几乎完全一致。两组结果差值的BlandAltman分析显示:在95%一致性界限以外,最大差值和最大相对误差可为临床接受。结论研究表明该国产设备与进口测试系统的Hb A1c检测结果具有很好的一致性,可作为临床实验室常规使用的选择。

Objective To evaluate the consistency of the results between a domestic HbA1c determination system and an imported one.Methods One hundred and ten anticoagulant whole blood samples were simultaneously assayed in a Bio-Rad D-10 hemoglobin test system and a domestic TH3600 HbA1c analyzer.Then,linear regression analysis,Kappa test and Bland-Altman analysis were performed to analyze the consistency between the two sets of the results.Results The regression analysis showed a good linear correlation between the two sets of results.The biases of the medical decision levels were significantlyyy less than the requirement of external quality assessment in the College of American Pathologists(CAP).Kappa test showed that the two sets of the results were almost identical.The Bland-Altman analysis of the difference between the two sets of results showed that the outside the scope of 95%consistency,the maximum difference and the maximum relative error can be clinically accepted.Conclusion Our research shows that the domestic equipment and the imported test system used in the study have a good consistency for HbA1c test that can be used as a routine test for clinical laboratory practice.