保存温度和时间对糖化血红蛋白A1c样本稳定性的影响  

Stability of haemoglobin A1c in different Storage temperature and time

作　　者：迟书玲[1] 邱玲[1] 郝英英[1] 张麟[1] 赵芳[1] 徐二木[1] 陈雨[1] 朱广瑾[2] 

机构地区：[1]中国医学科学院北京协和医院检验科,北京100730 [2]中国医学科学院基础医学研究所,北京100730

出　　处：《基础医学与临床》2013年第6期704-707,共4页Basic and Clinical Medicine

基　　金：国家科技部科技基础性专项重点项目(2006FY110300)

摘　　要：目的探讨4种保存温度下糖化血红蛋白A1c(HbA1c)样本稳定时间。方法收集20例HbA1c水平不同的受试者样本,每例样本充分混匀后分装成45管,随机抽取一管样品立即测定,其余样本分组保存在室温(22～25℃)、冷藏(2～8℃)、低温冷冻(≤-20℃)、超低温冷冻(≤-70℃)条件下,并于保存第1、2、3、7、15和20天,第1、2、3和6个月及1年测定。HbA1c检测采用高效液相色谱(HPLC)法。观察4种保存条件下HbA1c平均水平随时间变化率,并采用不同统计方法和判别标准评价样本稳定性。结果按偏差小于6%判定,-70℃保存HbA1c可稳定1年;-20℃保存时,低浓度水平可稳定7 d,高浓度水平可稳定20 d,1年平均下降率为11.2%。室温及冷藏保存均可稳定3 d,至第7天HbA1c分别平均下降-9.1%和-7.1%。结论本研究为临床检验制定完善的HbA1c标本保存条件提供了依据,同时超低温冷冻保存更适用于开展HbA1c的大规模流行病学研究。Objective To investigate the stability time of HbA1 c samples in 4 different storage temperature condi- tions. Methods 20 samples with different HbA1 c levels were collected. Each sample is thoroughly mixed and dis- tributed into 45 parts. In each level group, a random selected sample was measured immediately, and the remai ning samples were immediately grouped and stored at room temperature（22 -25 ℃ ）, refrigerated（2 -8℃ ） , fro- zen （≤ -20 ℃ ）, cryopreservation （ ≤ -70 ℃ ）, which were measured at 1,2,3,7,15,20 day and 1,2,3,6 month and ly respectively. HbAlc levels were detected by HPLC method. The changes of average level of HbAlc versus time with 4 different temperatures were observed and the stability of HbAlc was evaluated by different meth od or judgment. Results Based on a defined bias less than 6%, HbAlc was stable for one year at -70 ℃ ; HbA1 c in low concentration levels was stable for 7 days at -20℃, while in high eoncentration levels could be sta ble for 20 days with 11.2% average annual decline rate. HbAlc at room temperature and refrigerated storage con ditions could be stable for 3 days, till 7 days, HbA1 c level dropped by average -9.1% and -7.1% respective ly. Conclusions This study provides a basis to formulate and improve HbA1 c specimens preservation conditions.The Cryopreservation is more favorable for large-scale epidemiological studies of HbA1 c.

关 键 词：糖化血红蛋白A1C 稳定性 

分 类 号：R446.1[医药卫生—诊断学]