【摘要】： 目的 评价离子交换高效液相层析(IE-HPLC)法与酶化学法测定HbA1c结果的一致性。 方法 参照美国国家临床实验室标准化委员会(NCCLS) EP9-A2文件实验设计方法进行比对试验。结果 两种方法批内及批间CV均﹤3%，相关回归分析：Y=1.033X—0.0748，r=0.9927,预期相对偏倚分别为1.43%(4.0%)、2.53%(10.0%)、2.88%(16.0%)。结论 酶法与IE-HPLC法精密度高、相关性好，测定HbA1c结果的系统误差属临床可接受水平，具有可比性。

　　【关键词：】 糖化血红蛋白;高效液相层析法;酶化学法;

　　Evaluation by NCCLS-EP9-A2 on consistency of two methods for glycosylated hemoglobin determination JIANG Chun-shan, JIN Chun-hua(. Department of Laboratory, Yanbian University Hospital, Yanji 133000, China

　　【Abstract】Objective To compare the results of glycosylated hemoglobin (HbAlc) detected by the ion-exchange high-performance liquid chromatography (IE-HPLC) method and enzyme chemical method. Methods The experimental methodology mentioned in the document EP9-A2 of National Committee for Clinical Laboratory Standards (NCCLS) was used for comparison and analysis. Results The intra- and inter- average coefficients of variation were all below 3%. In the regression analysis, the results of two groups were correlated, Y = 1.033X - 0.0748, r = 0.9927, and the expected biases were 1.43% at 4%, 2.53% at 10%, and 2.88% at 16% respectively. Conclusion The correlation and precision of HbAlc determination by IE-HPLC and enzymatic methods are fine and comparable.

　　【Keywords】 Glycosylated hemoglobin; High-performance liquid chromatography; Enzymatic chemical method