【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。更多还原

【Abstract】 Objective To investigate the stability time of HbA1c samples in 4 different storage temperature conditions.Methods 20 samples with different HbA1c levels were collected.Each sample is thoroughly mixed and distributed into 45 parts.In each level group,a random selected sample was measured immediately,and the remaining samples were immediately grouped and stored at room temperature(22~25 ℃),refrigerated(2~8 ℃),frozen(≤-20 ℃),cryopreservation(≤-70 ℃),which were measured at 1,2,3,7,15,20 day and 1,2,3,6 month and 1y respectively.HbA1c levels were detected by HPLC method.The changes of average level of HbA1c versus time with 4 different temperatures were observed and the stability of HbA1c was evaluated by different method or judgment.Results Based on a defined bias less than 6%,HbA1c was stable for one year at-70 ℃;HbA1c in low concentration levels was stable for 7 days at-20 ℃,while in high concentration levels could be stable for 20 days with 11.2% average annual decline rate.HbA1c at room temperature and refrigerated storage conditions could be stable for 3 days,till 7 days,HbA1c level dropped by average-9.1% and-7.1% respectively.Conclusions This study provides a basis to formulate and improve HbA1c specimens preservation conditions. The Cryopreservation is more favorable for large-scale epidemiological studies of HbA1c.更多还原