Abstract: Objective To analyze the influencing factors of temperature-time, concentration, freeze thawing, transportation conditions and different strain sources in malic enzyme-1 and isocitrate dehydorgenase-1 standard samples. Method C57BL / 6, BALB / c and CBA inbred mice were used to prepare standard samples. After homogeneity test, random samples were collected and tested according to GB / T 14927. 1—2008. We used 4 ℃ , room temperature ( RT) and 37 ℃ as horizontal ordinate, and day 1, day 2, day 3, day 7, day 14 and day 21 as ordinate to analyze temperature-time factors. At each coordinate point, two tubes are randomly selected from each strain. The concentration factors were measured by the gradient of original, 1 / 2, 1 / 4 and 1 / 8 concentration samples in 1 tube per strain. In the factors of freeze thawing analysis, we tested samples (3 tubes per strain) for 3 times under the conditions of 2 hour storage at - 20 ℃ and thawing at room temperature. The transportation condition were 3 round-trip test from Beijing to Shenyang, Xi’ an and Chengdu using dry ice in cold chain. Result There were no significant differences in temperature-time, concentration, freeze-thaw and transportation conditions among the standard samples from different strains. Each standard sample could exist stably in condition of 4 ℃ , RT for 21 days, and only 2 days at 37 ℃ . After dilution to 1 / 8 concentration, 3 times freeze-thaw and dry ice transportation, the samples can still be stable. Conclusion The malic enzyme-1 and isocitrate dehydorgenase-1 standard samples are homogeneous, stable and comparable, whIch can meet the requirements of the proficiency testing program.

Key words: malic enzyme-1, isocitrate dehydorgenase-1, uniformity, stability, influence factors

摘要： 目的 分析温度-时间、浓度、冻融、运输条件和不同品系来源对苹果酸酶-1( malic enzyme-1,ME-1) 和异柠檬酸脱氢酶-1( isocitrate dehydorgenase-1,IDH-1)标准样品的影响。 方法 制备 C57BL / 6、BALB / c 和 CBA 三种近交系小鼠来源的标准样品,经均匀性测定后,随机抽样按照 GB / T 14927. 1—2008 中的检测方法进行测试。 温度-时间因素以 4 ℃ 、室温( RT)和 37 ℃ 这 3 个温度为观测纵坐标,1、2、3、7、14 和 21 d 为观测纵坐标。 在每个坐标交点,每品系分别随机抽取两管。 浓度因素按照每品系一管进行原倍、1 / 2、1 / 4 和 1 / 8 倍进行梯度测试。 冻融因素,每品系 3管,-20 ℃ 冻存 2 h 至室温融化 3 次为条件测试。 所有实验均为相同的运输条件、干冰冷链及北京往返沈阳、西安、成都三地测试。 结果 不同品系来源标准样品在温度-时间、浓度、冻融和运输条件下无显著差异。 各标准样品21 d 内在 4 ℃ 及室温( RT)条件下,均能稳定存在,但 37 ℃ 仅能稳定存在 2 d。 原倍稀释至 1 / 8 浓度、3 次冻融和干冰运输三地往返后,样品检测结果显示稳定。 结论 制备的 ME-1 和 IDH-1 标准样品具备均一性、稳定性和可比性,满足能力验证计划需求。

关键词: 苹果酸酶-1, 异柠檬酸脱氢酶-1, 均匀性, 稳定性, 影响因素