冻存时间对ALT干粉质控品检测的影响分析

The Effect of Freezing Time on the Detection of ALT Dry Powder Quality Control Products

摘要: 目的：分析冻存时间对转氨酶干粉质控品检测结果的影响，了解干粉质控品复溶后的均一与稳定性，从而优化血站ALT检测中室内质控品使用方案。方法：将转氨酶干粉质控品中值及高值复溶后分装，各浓度取6支共重复检测20次，其他−20℃冰箱保存。自第2天起至第38天，每天取出2支置室温，由同一人重复操作共检测4次，计算均值(X)、标准差(SD)和变异常数(CV)。将第一天的值作为实验对照组，第2~15天为第二组，第16~29天为第三组，第30~38天为第四组。采用多重比较Dunnett-t检验比较后三组与第一组检测结果有无差异性。连续观察152天，制作结果折线图观察有无趋势变化。结果：每天重复检测的CV < 3%，一天内精密度高，均一性较好；中值及高值冷冻条件下复溶的均值与对照组比较，均无统计学差异(p > 0.05)；ALT质控品152天检测趋势显示，CV小于允许总误差值的1/3 (6.67%)，折线图显示无明显趋势变化。结论：−20℃保存的朗道ALT质控品分装37支较为合理，能最大限度发挥其使用效能。

Abstract: Objective: The influence of frozen time on the test results of ALT quality control products, was analyzed to understand the uniformity and stability, so as to optimize the use scheme of indoor quality control in ALT test of blood station. Methods: The medium value and high value of ALT dry powder were dissolved in water and then divided into different packs. 6 packs of each concentration were taken for 20 times repeated testing, and the others were stored at −20˚C. From the 2nd day to the 38th day, 2 packs were taken out at room temperature every day. The operation was repeated by the same person for a total of 4 times, and the mean value (X), standard deviation (SD) and variation constant (CV) were calculated. The results of the first day were used as the control group, the second group on days 2~15, the third group on days 16~29, and the fourth group on days 30~38. The multiple comparison Dunnett-T test was used to compare the results of the last three groups and the first group. After 152 days of continuous observation, a line chart was made to observe whether there was a trend change. Results: CV of daily repeated detection is less than 3%, which had high precision and good uniformity within days. Compared with the control group, under the freezing condition of the medium and high value both showed no statistical difference (p > 0.05). The test trend of ALT quality control products in 152 days showed CV was less than 1/3 (6.67%) of the total allowable error value, and the line chart had no obvious trend change. Conclusion: It is reasonable to pack 37 pieces of Landau ALT quality control products stored at -20 ℃, which can maximize the use efficiency of quality control serum.