离子交换高效液相层析法与酶化学法测定糖化血红蛋白的比对分析

目的对离子交换高效液相层析（IE-HPLC）法与酶化学法测定糖化血红蛋白（HbA1c）进行方法学比较。方法依据美国国家临床实验室标准化委员会（NCCLS）有关文件对IE-HPLC法与酶化学法测定HbA1c进行相关性比较、精密度评价。结果 IE-HPLC法与酶化学法测定HbA1c相关性良好（Y=0.962 2X＋0.045,r=0.994 0,P〉0.05）,预期相对偏差在低值（4.0%）时为2.66%;在中值（6.5%）时为3.09%;在高值（16.0%）时为3.50%。IE-HPLC法批内变异系数（CV）为1.23%~2.17%,批间CV为1.87%~2.99%;酶化学法批内CV为0.93%~1.72%,批间CV为1.65%~2.71%。结论 IE-HPLC法与酶化学法测定HbA1c的相关性、精密度均很好,具有可比性。酶化学法测定HbA1c可用于自动生化分析仪,适合检验科使用。

The comparison analysis of glycosylated hemoglobin detection by ion exchange high performance liquid chromatography and enzymatic method

Objective To compare the ion exchange high performance liquid chromatography（IE-HPLC） and enzymatic method in glycosylated hemoglobin（HbA1c） detection.Methods According to the National Committee for Clinical Laboratory Standards（NCCLS） documents,the correlation and precision of HbA1c detection by IE-HPLC and enzymatic method were compared and analyzed.Results The correlation of HbA1c detection by IE-HPLC and enzymatic method was fine（Y=0.962 2X＋0.045,r=0.994 0,P0.05）,and the predicted bias was 2.66% at 4.0%,3.09 % at 6.5% and 3.50% at 16.0% respectively.The within-run coefficient of variation（CV） was 1.23%-2.17%,and the between-run CV was 1.87%-2.99% in IE-HPLC.The within-run CV was 0.93%-1.72%,and the between-run CV was 1.65%-2.71% in enzymatic method.Conclusions The correlation and precision of HbA1c detection by IE-HPLC and enzymatic method are fine and comparable.Enzymatic method can be tested by biochemical auto analyzer and applied on automatic diagnosis.