朗道ACTH室内质控品在不同储存条件下的稳定性评价  

Stability evaluation of randox acth internal quality control under different storage conditions

作　　者：王淇泓 赵晓君 周琳 吴洪坤 WANG Qihong;ZHAO Xiaojun;ZHOU Lin;WU Hongkun(Department of Clinical Laboratory,The Second Affiliated Hospital of Naval Medical University,Shanghai 200003,China;Department of Immunology,Shanghai Clinical Laboratory Center,Shanghai 200126,China)

机构地区：[1]海军军医大学第二附属医院检验科,上海200003 [2]上海市临床检验中心免疫室,上海200126

出　　处：《检验医学与临床》2024年第S01期1-4,共4页Laboratory Medicine and Clinic

基　　金：国家自然科学基金委员会面上项目(82272390),上海市科委自然科学基金项目(21ZR1478200)。

摘　　要：目的探讨不同储存条件下朗道促肾上腺皮质激素(ACTH)室内质控品的稳定性,以保证ACTH的检测质量。方法将新鲜配制的质控品作为对照组,-40℃、4℃冷藏、室温条件下储存的质控品分别作为观察组,采用全自动电化学发光免疫分析仪进行检测,计算对照组和多个观察组的检测均值及变异系数(CV),计算不同条件储存下的质控品的平均偏移(Bias)及平均累计CV。结果-40℃保存条件下,观察组和对照组均值的Bias%均<25%,且0~14 d累计中间精密度CV值均<8.33%;4℃保存条件下,观察组和对照组均值的Bias%均<25%,且0~300 min累计中间精密度CV值均<8.33%;室温保存条件下,中值质控品在60 min时其均值的Bias%>25%,60 min累计中间精密度CV>10%。结论ACTH质控品在不同储存条件下稳定性存在显著差异,选择合适的储存条件有助于提高ACTH的室内质量质控水平、降低成本。Objective To investigate the stability of Randox adrenocorticotropic hormone(ACTH)internal quality control under different storage conditions to ensure the quality of ACTH testing.Methods Freshly prepared quality control materials were used as the control group,and quality control materials stored at-40℃,4℃refrigeration,or room temperature were used as the observation group respectively.Automatic electrochemical luminescence immunoanalyzer was used for detection,and the mean values and coefficient of variation(CV)of the control group and multiple observation groups were calculated.The average bias(Bias)and average cumulative CV of the quality control materials under different storage conditions were calculated.Results Under-40℃storage conditions,the Bias of the observation group and control group mean values were both<25%,and the cumulative intermediate precision CV value of 0 to 14 days was<8.33%,and cumulative intermediate precision CV of 0 to 14 days was<8.33%;Under 4℃storage conditions,the Bias of the observation group and control group mean values were both<25%,and the cumulative intermediate precision CV value of 0 to 300 minute was<8.33%;Under room temperature storage conditions,the Bias of medium value control materials was>25%at 60 minute and cumulative intermediate precision CV was>10%at 60 minute.Conclusion The stability of ACTH quality control varies significantly under different storage conditions.Choosing appropriate storage conditions can help improve the level of internal quality control of ACTH and reduce costs.

关 键 词：促肾上腺皮质激素 质控品 室内质量控制 存储方式 稳定性 

分 类 号：R446[医药卫生—诊断学] R4[医药卫生—临床医学]