参照NCCLS-EP9-A2文件评价两种糖化血红蛋白测定方法的一致性  

Evaluation by NCCLS-EP9-A2 on consistency of two methods for glycosylated hemoglobin determination

作　　者：王玉环[1] 姜春善[1] 金春花[1] 

机构地区：[1]延边大学附属医院检验科,延吉133000

出　　处：《中国糖尿病杂志》2013年第2期152-153,共2页Chinese Journal of Diabetes

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%)。结论酶化学法与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。Objective To compare the results of HbA1c 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-assay 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 HbA1c determination by IE-HPLC and enzymatic methods are fine and comparable.

关 键 词：糖化血红蛋白 高效液相层析法 酶化学法 

分 类 号：R446.11[医药卫生—诊断学]