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冻存时间对ALT干粉质控品检测的影响分析
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Abstract:
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。
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.
[1] | 中华人民共和国国家卫生健康委员会. 血站技术操作规程(2019版) [S]. 北京: 中华人民共和国国家卫生健康委员会, 2019. |
[2] | 徐超. 重组人转氨酶标准物质及人巨细胞病毒IgG抗体国家参考品的研制[D]: [硕士学位论文]. 北京: 中国食品药品检定研究院, 2013. |
[3] | 李全双, 许靖, 吴燕, 等, 朗道血清质控品作为ELISA法检测血清可溶性ST2室内质控物的可行性探讨[J]. 现代检验医学杂志, 2022, 37(5): 190-193. |
[4] | 常乐, 闫颖, 姬慧敏, 王露楠. 我国血站血液检测实验室检测能力基本情况分析[J]. 中国输血杂志, 2022, 35(7): 731-736. |
[5] | 中国输血协会. T/CSBT 004-2019血站血液检测实验室质量监测指标[S]. 北京: 中国输血协会, 2019. |
[6] | 刁丽波, 梁艳娇. 血站酶免检测实验室质量监控指标分析方法探讨[J]. 大理大学学报, 2021, 6(2): 82-85. |
[7] | 王露楠. 血站实验室能力建设[J]. 中国输血杂志, 2018, 31(2): 99-100. |
[8] | 蔡茵, 郑岚, 翁逸峰, 等. 血液筛查实验室检测前哨兵指标的建立与应用[J]. 中国输血杂志, 2021, 34(11): 1269-1273. |
[9] | 沈荣静. 实验室能力验证影响最终结果的几种因素[J]. 中国标准化, 2018(4): 216-221. |
[10] | 中国合格评定国家认可委员会. CNAS-GL005: 2018实验室内部研制质量控制样品的指南[S]. 北京: 中国合格评定国家认可委员会, 2018. |
[11] | 刘瑞来, 张晨, 林炜炜, 等. 不同生化血清非定值质控品性能的应用评估[J]. 中华检验医学杂志, 2019, 42(9): 787-792. |
[12] | Chua, C., Tifigiu, E., Boroujeni, A.M., et al. (2018) Stability of Values for the Activities of Critical Enzymes Assayed in Serum Frozen for Prolonged Time Periods. Annals of Clinical & Laboratory Science, 48, 618-626. |
[13] | 黄敏, 张立波, 庞蓉蓉, 等. ELISA室内质控品在冷藏条件下的时间稳定性分析[J]. 临床血液学杂志(输血与检验), 2019, 32(6): 934-939. |
[14] | 中国合格评定国家认可委员会. CNAS-GL003: 2018能力验证样品均匀性和稳定性评价指南[S]. 北京: 中国合格评定国家认可委员会, 2018. |
[15] | 中国合格评定国家认可委员会. CNAS-GL017: 2018标准物质/标准样品定值的一般原则和统计方法[S]. 北京: 中国合格评定国家认可委员会, 2018. |
[16] | 彭南海, 李培, 倪元红. 不同存放方式对肠外营养液稳定性影响的研究[J]. 肠外与肠内营养, 2015, 22(5): 295-299. |
[17] | 王全慧. 血站实验室全自动生化分析仪ALT项目的检测性能分析[J]. 检验医学与临床, 2020, 17(6): 820-823. |
[18] | Kachhawa, K., Kachhawa, P., Varma, M., et al. (2017) Study of the Stability of Various Biochemical Analytes in Samples Stored at Different Predefined Storage Conditions at an Accredited Laboratory of India. Journal of Laboratory Physicians, 9, 11-15. https://doi.org/10.4103/0974-2727.187928 |
[19] | dos Santos, D.R., Souza, R.O., Dias, L.B., et al. (2018) The Effects of Storage Time and Temperature on the Stability of Salivary Phosphatases, Transaminases and Dehydrogenase. Archives of Oral Biology, 85, 160-165.
https://doi.org/10.1016/j.archoralbio.2017.10.016 |