两种检测系统测定糖化血红蛋白的比对分析

Analyses and comparison of two assay systems for glycosylated hemoglobin measurement

目的对两种检测系统测定糖化血红蛋白所得结果进行相关性分析及偏倚评估。方法分别使用TOSOH G8糖化血红蛋白分析仪采用离子交换高效液相色谱法(HPLC)和雅培AEROSET全自动生化分析仪以酶化学法检测40例血液样本的糖化血红蛋白,对两检测系统的结果进行比对分析,检查离群点,计算线性相关系数、直线回归方程和预期偏倚评估。结果离子交换高效液相色谱法(TOSOH G8糖化血红蛋白分析仪)的测定均值为7.31%,酶化学法(雅培AEROSET生化仪)的测定均值为7.07%,线性回归方程为Y=1.047 4 X-0.587 2,r2=0.954 4,糖化血红蛋白可接受偏倚大于预期偏倚可信区间上限。结论酶化学法与离子交换高效液相色谱法结果相当,酶化学法结果可接受,可满足临床要求。

Objective To evaluate two kinds of assay systems for glyeosylated hemoglobin measurement. Methods Ion-ex- change high performance liquid chromatography（HPLC） by TOSOH G8 glycosylated hemoglobin analyzers and enzyme chemistry method by Abbott AEROSET automatic biochemical analyzer were applied to test glycosylated hemoglobin in 40 cases of blood sample. The results went through comparative analysis, the outlier checking, the linear correlation coefficient calculating, getting ex- pected bias estimation of linear regression equation. Results The determination averages was 7.31% by HPLC（TOSOH G8 glycat- ed hemoglobin analyzers） and 7.07 % by enzyme chemistry method（Abbott AEROSET biochemical Analyzer）. The linear regres- sion equation was Y= 1. 0474X--0. 5872 ,R^2 = 0. 954 4, and glycosylated hemoglobin acceptable bias was greater than the upper lim- it of expected bias confidence interval. Conclusion Glyeosylated hemoglobin results by enzyme chemical method is equivalent to ion- exchange high performance liquid chromatography which means enzyme chemistry method is acceptable to meet the clinical require- ment.