高效液相层析法与免疫比浊法测定HbA1c结果一致性评估

Evaluation of testing results of Hb Alc from HPLC and ITM

目的对Hb A1c在2种不同检测系统中结果的一致性进行比对和偏倚评估,探讨不同检测系统间同一项目结果的可比性,为实验室结果互认提供依据。方法分别取质控血清在罗氏Cobas 8000全自动生化分析系统和Bio D-10高压液相色谱分析系统进行批内、日间精密度检测,以厂商声明和实验室规定的精密度要求为评价标准。参考美国临床实验室标准化委员会的EP9—A2文件,以Bio D-10高压液相色谱分析仪为比较方法,罗氏Cobas 8000全自动生化分析仪为实验方法,在2种检测系统上分别检测40份样本的Hb A1c结果,并进行比对分析。结果 2种检测系统测定Hb A1c批内及日间CV均低于厂商声明的3.0%和实验室规定的2.8%精密度要求,相关回归方程为y=0.122x+1.004,r=0.999 9,相对偏倚<3.5%。结论罗氏Cobas 8000全自动生化分析系统和Bio D-10高压液相色谱分析系统测定Hb A1c结果具有显著的相关性,2种检测系统的比对和偏倚评估一致性较好,检测结果具有可比性。

Objective To compare and to evaluate the testing results of Hb A1 c which was obtained from two different detecting systems,investigating the comparability of the testing results,so as to provide basis for the testing results from different detecting systems to recognize each other. Methods Quality control serum were taken for precision detection in batch and the day in,Rocher Cobas 8000 biochemical analysis system and roche Cobas Bio-10 D high pressure liquid chromatography（ HPLC） analysis system,and the precision was stipulated in the manufacturer＇s declaration and laboratory evaluation criteria. Reference for the clinical laboratory standardization committee EP9—A2 files,using Bio-10 D high pressure liquid chromatography analyzer as comparative method,Roche Cobas 8000 biochemical analyzer for experimental methods,respectively on two kinds of detection system to detect 40 samples of Hb A1 c results,and to compare analysis. Results The CV of Hb A1 c batch and daytime determined with the two kinds of test system were less than 3. 0% and 2. 8% of precision requirements respectively of the manufacturer＇s declaration and laboratory,relevant regression equations： y = 0. 122 x ＋ 1. 004,r = 0. 999 9,the relative bias was less than 3. 5%. Conclusion There are good correlations between the results of Hb A1 c from the Roche Cobas 8000 biochemical analysis system and the Bio D-10 high pressure liquid chromatography system. The comparison and evaluation of the testing results from the two systems are shown in well agreement with each other; The testing results are comparable.