全血糖化血红蛋白用常规方法测定的稳定性研究

摘要

目的 探讨全血糖化血红蛋白HbA1c在不同储存条件下分别用Tosoh G7、罗氏/日立7170A和NycoCard READERⅡ测定的稳定性.方法 收集3个糖化血红蛋白水平的乙二胺四乙酸抗凝及1个水平的肝素抗凝全血样本,冻存管分装,分别储存在-80℃、-20℃、4℃、室温(15～25 ℃)和37℃.分别在第1、2、5、7、9、14、21、28、35、42、49、56、63和70 d用3种方法进行测定.结果在-80℃储存的全血样本在研究期间无论是用东曹G7方法还是用罗氏/日立7170A方法测定结果稳定,东曹G7的变异系数(CV)为0.54%～1.22%;罗氏/日立7170A的CV为0.86%～1.82%;样本用东曹G7测定的稳定性为:-20℃可稳定14 d,4 ℃ 63 d,室温5 d,37 ℃少于1 d;罗氏/日立7170A方法 为:-20℃21 d,4 ℃ 42 d,室温7 d,37℃少于1 d;NycoCard READER Ⅱ:4℃9 d,室温少于1 d.结论 不同方法测定全血样本的稳定性是特异的,不同温度下允许保存时间不同.%Objective To investigate the stability of glycated hemoglobin HbA1c in whole blood sample measured by Tosoh G7, Roche/Hitachi 7170A and NycoCard READER Ⅱ under different storage conditions. Methods Three whole blood samples (EDTA anticoagulated) with different glycated hemoglobin levels and one whole blood sample (heparin anticoagulated) were collected and stored at -80 ℃, -20 ℃, 4 ℃,room temperature(15 -25 ℃), and 37 ℃ HbA1c was analyzed by each method on days 1, 2, 5, 7, 9, 14, 21,28, 35, 42, 49, 56, 63 and 70 respectively. Results The results of sample stored at -80 ℃ appear to be stable for Tesoh G7 and Roche/Hitachi 7170A method. The coefficients of variation (CV) for Tosoh G7 was 0.54%-1.22%. The CV for Roche/Hitachi 7170A was 0.86% -1.82%. When samples was detected with Tosoh G7 method, the results was consistent when the sample was stored at -20 ℃ for 14 days, 4 ℃ for 63 days, room temperature for 5 days, and 37 ℃ for less than 1 day. When samples was detected with Roche/Hitachi 7170A method, the results was consistent when the samples was stored at -20 ℃ for 21 days, 4 ℃ for 42 days, room temperature for 7 days, and 37 ℃ for less than 1 day. The NycoCard READER Ⅱ showed stability at 4 ℃ for 9 days, and room temperature for less than 1 days. Conclusions The stability of whole blood samples is dependent on different methods. Storage time under different temperatures is different.