血红蛋白毛细管采集系统贮存血样用于测定糖化血红蛋白的稳定性研究  

Stability study of the hemoglobin A1c determination in blood samples stored in the hemoglobin capillary collection system

作　　者：张军[1] 李彩娜[2] 陈歆琦 高凤芝[1] 蒋玲敏[2] 李铭[1] 李怡[1] 王玉洁 刘玉玲[2] 申竹芳[2] ZHANG Jun;LI Cai-na;CHEN Xin-qi;GAO Feng-zhi;JIANG Ling-min;LI Ming;LI Yi;WANG Yu-jie;LIU Yu-ling;SHEN Zhu-fang(National Center of Gerontology, Beijing Hospital, Beijing 100730, China;Diabetes Research Center of Chinese Academy of Medical Sciences, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050, China;Laboratory of Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China)

机构地区：[1]北京医院国家老年医学中心,北京100730 [2]中国医学科学院北京协和医学院药物研究所中国医学科学院糖尿病研究中心,北京100050 [3]中国医学科学院北京协和医学院北京协和医院检验科,北京100730

出　　处：《中国临床药理学杂志》2019年第6期567-570,共4页The Chinese Journal of Clinical Pharmacology

基　　金：中国医学科学院医学与健康科技创新工程资助项目(2016-I2M-2-006)

摘　　要：目的研究血红蛋白毛细管采集系统(HCCS)贮存血样在冷藏、冷冻及超低温冷冻等条件下,保存不同时间后对糖化血红蛋白(Hb A1c)测定值稳定性的影响。方法用HCCS分装保存糖尿病患者和健康体检者的全血样本共计20例,分别于冷藏(2～8℃)保存14周、冷冻(-18～-22℃)和超低温冷冻(≤-70℃)保存28周,于保存不同时间取样,冻融后用VARIANTⅡTURBO糖化血红蛋白仪(HPLC法)测定Hb A1c水平,以绝对偏差和平均百分偏差为指标,比较分析保存温度和时间对Hb A1c测定结果的影响。同时考察冻融对HCCS贮存样品测定Hb A1c的影响及样品冻融后于室温放置的稳定性。结果冻融对HCCS贮存样品的Hb A1c测定无影响,冻融后的血样可于室温至少放置24 h。与基础值相比,HCCS贮存样品在3种条件下分别保存不同时间后,Hb A1c测定值间的差异均无统计学意义(均P> 0. 05),偏差均在0. 26%以内,平均百分偏差均小于4%。结论 HCCS贮存血样用于Hb A1c测定,在2～8℃可稳定保存至少14周,在-18～-22℃和≤-70℃可稳定保存至少28周。Objective To evaluate the effect of storage time on the determination of hemoglobin A1 c( HbA1 c) in blood samples stored in the hemoglobin capillary collection system( HCCS) at 2-8 ℃,-18--22 ℃ and ≤-70 ℃,respectively. Methods Twenty blood samples from healthy subjects and patients with type 2 diabetes were separately divided and stored using HCCS at 2-8 ℃ for 14 weeks,and at-18--22 ℃ and ≤-70 ℃ for 28 weeks,then the Hb A1 c levels were determined at different times using the VARIANT Ⅱ TURBOHbA1 c analyzer( HPLC method),ultimately to assay the influences of storage time and temperature on the determination of Hb A1 c according to the deviation and diff%. The effect of freeze-thaw on Hb A1 c determination in samples stored in HCCS and the stability of samples in room temperature were also observed. Results Freeze-thaw had no effect on the determination of HbA1 c and the sample after freeze-thaw could be stably stored in room temperature for at least 24 h. In comparison to the baseline of HbA1 c,there were no statistical differences of the Hb A1 c levels determined using samples stored at 2-8 ℃,-18--22 ℃ and ≤-70 ℃for different times( all P>0.05),and the deviation and diff% were separately less than 0. 26% and 4%. Conclusion Samples stored in HCCS for Hb A1 c determination could be stably kept for at least 14 weeks at 2-8 ℃ and at least 28 weeks at-18--22 ℃ and ≤70 ℃.

关 键 词：血红蛋白毛细管采集系统 糖化血红蛋白 保存温度 保存时间 稳定性 

分 类 号：R97[医药卫生—药品]