糖化血红蛋白不同测定法的评价及标准化
Evaluation and Standardization of HbA1c with different Test Method
黄驰 1张稳健 1马杰1
作者信息
- 1. 湖北省中西医结合医院检验科，湖北 武汉，430015
- 折叠
摘要
目的：对3种通过美国国家糖化血红蛋白标准化计划（NGSP）认证的检测方法进行方法学评价以及探讨糖化血红蛋白检测标准化的意义。方法用离子交换高效液相层析（HPLC）法（X）、硼酸亲和色谱层析法（Y1）、酶法（Y2）测定40例糖化血红蛋白样本，进行精密度分析、偏倚分析、回归分析。结果X、Y1、Y2方法测定的精密度均不大于2%；X-Y1、X-Y2中都不存在离群值、所有的数据偏差都在6%的范围内；X-Y1的回归方程为y=0.9968x+0.1785（r=0.9981，Syx=0.092），X-Y2的回归方程为y=0.9569x+0.2449（r=0.9862，Syx=0.243）。结论和HPLC法相比，硼酸亲和色谱层析法以及酶法的精密度均可以接受，糖化血红蛋白检测标准化使采用不同厂商、不同方法、不同试剂测定同一份样本的结果应该是可比的。
Abstract
Purpose Evaluate 3 methods that obtains NGSP certification and discuss about the significance of the standardization of HbA1c tests. Method Test 40 HbA1c samples by using HPLC (X), boronic affinity chromatography (Y1) and enzymic method (Y2) to analyze their precision, bias and regression. Results The precision using X, Y1, Y2 are all no more than 2%; no outlier exists in X-Y1 or X-Y2, and data deviation are within 6%;the regression equation of X-Y1 is y=0.9968x+0.1785 (r=0.9981,Syx=0.092)and the regression equation of X-Y2 is y=0.9569x+0.2449 (r=0.9862,Syx=0.243).Conclusion Compared to HPLC, the precision of boronic affinity chromatography and enzymic method are acceptable.The standardization of HbA1c test makes result of which test the same sample using different manufacturers, different methods and different reagents comparable.
关键词
糖化血红蛋白/高效液相色谱法/硼酸亲和色谱层析法/酶法/NGSPKey words
HbA1c/HPLC/boronic affinity chromatography/enzymic method/NGSP引用本文复制引用
出版年
2016
NETL
NSTL
维普
万方数据