血清雌二醇和睾酮标准物质候选物同步稳定性研究

Investigation on the isochronous stability of candidate reference materials for serum estradiol and testosterone

目的按照GB/T 15000.3-2008/ISO Guide35(2006)的说明,用同步稳定性实验设计对血清雌二醇和睾酮标准物质候选物在不同保存条件下的稳定性进行研究。方法以实验初始时间为时间零点,-196℃液氮保存为参比温度条件,共设计13种温度时间点计划。将标准物质候选物混合人血清置于-70℃、-20℃、4℃和室温的环境下分别保存1周至28个月。全部储存和转移工作完成后,用常规方法在一个工作日内完成所有样本的测定。结果血清睾酮和雌二醇在-70℃至少稳定保存28个月,在-20℃可稳定保存12个月。在室温保存1个月,4℃下保存2个月,血清中两个项目的浓度存在下降的趋势,经统计学检验该变化具有显著性。结论血清雌二醇和睾酮标准物质候选物长期稳定贮存的条件为-70℃冰冻保存。

Objective To evaluate the stability of serum estradiol and testosterone candidate reference materials under different storage conditions by isochronous stability protocol in coordinate with the national standard GB/T 15000.3-2008/ISOGuide 35 （2006）. Methods The original state of the research was set as the zero point （reference point）, and the liquid nitrogen preservation （ - 196 ℃ ） as the reference storage condition. The candidate materials were stored under - 196℃ , - 70 ℃ , - 20 ℃, 4 ℃ and room tem- perature for 1 week to 28 months, respectively. After the whole storage and transfer process were completed, all the samples were measured in the same working day by a routine method. Results The estradiol and testosterone in pooled human serum candidate ma- terials may be stable at least 28 months at -70℃, 12 months at -20 ℃, 2 months at 4 ℃, and 1 month at room temperature, re- spectively. The levels of serum estradiol and testosterone decreased with increased time and environmental temperature. Conclusion The candidate reference materials for serum estradiol and testosterone should be stored at -70℃ for long-term preservation.