摘要
目的探讨免疫抑制透射比浊法（TINIA）和离子交换高效液相色谱法（HPLC）测定糖化血红蛋白（HbAlc）的相关性及其临床应用。方法根据美国临床实验室标准化委员会（NCCLS）实验评价方案进行精密度、线性、方法比对及偏倚实验，结果采用回归方程和t检验进行统计分析。结果HbAlc浓度在3．9％-15．2％范围时无论是TINIA还是HPLC法，都有良好的重复性和线性关系，但以HPLC法更佳。偏倚对比分析显示在高水平TINIA与HPLC成负偏倚，低水平时成正偏倚。在方法比对实验中的两组数据没有统计学意义（P〉0．05），以TINIA测定结果为Y轴、HPLC的为X轴进行相关性分析：y=0．7857x＋1．264，r=0．89两者呈正相关。结论通过方法学评价，本实验室两种方法测定HbAlc的精密度、线性范围符合临床要求，结果具有可比性；HPLC法的重复性更住、更适合临床用于糖尿病的治疗监测。
Objective To explore the correlation and clinical application of turbidimetric inhibition im- munoassay （TINIA） and ion-exchange high-performance liquid chromatography （HPLC） for detecting glycosy- lated hemoglobin （HbA1C）. Methods According to the criteria on NCCLS, experiments of precision, linearity , method comparison, and bias were conducted. The results were analyzed by regression equation and t test. Re- suits The concentration of HbAlc at a range of 3.9%-15.2% had good repeatability and linearity for TIN1A or HPLC. Bias analysis showed TINIA and HPLC were negative bias as HbAlc was at higher level, and were posi- tive bias at lower level. The data in the two groups had no statistical significance in method comparison （P〉0,05）. The correlation analysis with the result of TINIA determination as Y axis and that of HPLC as X axis revealed y = 0.7857x ＋1.264 and r =0.89, being positively related. Conclusions Through methodological evaluation, these two methods for determining HbA1C precision and linear range meets clinical requirement, with comparable re- suits. HPLC, which has better repeatability, is more suitable for clinical monitoring in the treatment of diabetes mellitus.
出处
《国际医药卫生导报》
2013年第1期18-21,共4页
International Medicine and Health Guidance News
关键词
糖化血红蛋白
免疫抑制透射比浊法
离子交换高效液相色谱法
Glycated hemoglobin
lmmunosuppressive Turbidimetry
Ion exchange high performance liquid chromatography
