HbA1 c在三种检测系统及不同储存条件下结果的稳定性

摘要

Objective To investigate the stability differences of glycosylated hemoglobin A1c (HbA1c )measurement by 3 detection systems under different storage conditions.Methods Three whole blood samples anti-coagulated by ethylene diamine tetraacetic acid-K2(EDTA-K2)at 3 HbA1c levels were collected and stored at room temperature(20-25℃),4℃,-30℃ and -70℃.One aliquot from each temperature was analyzed by each method on day 1,3,5,7, 14,21,28,35,42,56 and 84.The 3 detection systems were Bio-Rad variant Ⅱ Turbo HbA1c analyzer (positive ion exchange high performance liquid chromatography,Bio-Rad variant Ⅱ Turbo),Primus Ultra2 HbA1c analyzer (affinity high performance liquid chromatography,Primus Ultra2 )and Roche Modular PPI automatic biochemistry analyzer and its reagents (inhibition immunoturbidimetry,Roche Modular PPI).Results The results of samples stored at -70℃were similar at different days.The coefficient of variation (CV)for Bio-Rad variantⅡTurbo was 2.12%-2.80%.The CV for Primus Ultra2 was 2.19%-2.71%.The CV for Roche Modular PPI was 2.28%-2.91%.The Bio-Rad variantⅡTurbo showed having stabilities at room temperature for 7 d,4 ℃ for 14 d and -30℃ for 35 d.The Primus Ultra2 showed having stabilities at room temperature for 14 d,4℃ for 56 d and -30℃ for 84 d.The Roche Modular PPI showed having stabilities at room temperature for 14 d,4℃ for 84 d and -30℃ for 84 d.Conclusions The HbA1c measurement is differently detected by different systems under different storage conditions.%目的：探讨在3种不同检测系统及不同的储存条件下全血糖化血红蛋白A1c （HbA1c ）检测结果的稳定性差异。方法选取3支用乙二胺四乙酸二钾（EDTA-K2）抗凝的不同HbA1c浓度的全血样本，分装后分别置常温（20～25℃）、4℃、-30℃、-70℃保存。分别于第1、3、5、7、14、21、28、35、42、56、84天用3种HbA1c检测系统[Bio-Rad variant ⅡTurbo HbA1c检测仪（阳离子离子交换高效液相色谱法），简称Bio-Rad variant ⅡTurbo；Primus Ultra2 HbA1c检测仪（亲和层析高效液相色谱法），简称Primus Ultra2；Roche Modular PPI全自动生化分析仪及配套试剂（免疫抑制比浊法），简称Roche Modular PPI]进行测定。结果-70℃保存样本不同时间测定结果的差异较小，其中Bio-Rad variant ⅡTurbo测定样本的变异系数（CV）为2．12％～2．80％；Primus Ultra2的CV为2．19％～2．71％；Roche Modular PPI的CV为2．28％～2．91％。Bio-Rad variant ⅡTurbo测定的样本常温可稳定7 d，4℃可稳定14 d，-30℃可稳定35 d；Primus Ultra2测定的样本常温可稳定14 d，4℃可稳定56 d，-30℃可稳定84 d；Roche Modular PPI测定的样本常温可稳定14 d，4及-30℃可稳定84 d。结论不同的检测系统及不同的样本存放条件HbA1c检测结果存在差异。