比较两种自动化免疫分析仪对血清25-羟维生素D的测定  

A comparison study between two automated immunoassays for determining serum 25-OH vitamin D

作　　者：叶蕾[1] 李莹莹[1] 颜子乙 颜灵逸 陈岚[1] 江咏梅[1,2] YE Lei;LI Ying-ying;YAN Zi-yi;YAN Ling-yi;CHEN Lan;JIANG Yong-mei(Laboratory Department of West China Second Hospital of Sichuan University,Chengdu,Sichuan 610041,China)

机构地区：[1]四川大学华西第二医院检验科 [2]四川大学出生缺陷与相关妇儿疾病教育部重点实验室,四川成都610041

出　　处：《现代预防医学》2020年第7期1285-1290,共6页Modern Preventive Medicine

基　　金：四川省科技厅重点研发项目(2017SZ0122);四川省科技厅支撑课题(2016SZ0021)。

摘　　要：目的比较Architect I2000和DiaSorin LIAISON两种自动化免疫分析仪对血清25-羟维生素D[25(OH)D]测定的相关性及差异,为临床诊疗提供参考依据。方法根据美国临床实验室标准化委员会(NCCLS)的EP9-A2文件,分别在两个系统检测三个水平(L1,L2,L3)的25(OH)D质控品,通过Excel 2007软件分析两个系统测定25(OH)D的不精密度。收集266份临床样本进行25(OH)D检测,将样本分成两份在本实验室Architect I2000和DiaSorin LIAISON系统同时进行检测。采用MedCalc软件进行统计学分析,以Passing-Bablok回归和Pearson相关系数分析两种方法测定结果之间的相关性,以Bland-Altman比较它们之间的差异。结果在不精密度评估中,两个系统(DiaSorin LIAISON vs Architect I2000)三个质控水平(L1,L2,L3)的总不精密度分别为L1:8.86%vs 7.89%,L2:5.82%vs 4.67%,L3:6.66%vs 5.71%。Passing-Bablok和Pearson分析显示Architect I2000和DiaSorin LIAISON间相关系数为r=0.98。Bland-Altman分析结果显示,Architect I2000检测的25(OH)D比DiaSorin LIAISON的平均高7.2 ng/ml,随着25(OH)D的增高,两者的差值越来越大,最大差值可达43.3 ng/ml。结论Architect I2000和DiaSorin LIAISON两个系统检测的25(OH)D相关性较好。Architect I2000精密度优于DiaSorin LIAISON,Architect I2000系统得到25(OH)D的结果更为准确,与临床诊断更相符。Objective To compare the relationships and differences of the determination results between Architect I2000 and the DiaSorin LIAISON,two automated immunoassays used to test 25-hydroxyvitamin D[25(OH)D],so as to provide a reliable basis for clinical diagnosis and treatment of related diseases Methods Imprecision studies were performed using 25(OH)D control materials of three levels(L1,L2,L3)in two immunoassays,according to a modified form of the EP9-A2 protocol of the National Committee for Clinical Laboratory Standards.Imprecision studies were performed in two automated immunoassays by Excel 2007 software.266 clinical samples were selected from routine 25(OH)D tests.Two of the serum aliquots were analyzed at the Abbott Architect I2000 and the DiaSorin LIAISON in our laboratory at the same time.Statistical analysis was performed by MedCalc software,where the Passing-Bablok regression analysis and Pearson’s correlation coefficient test were used to evaluate the relationships of the two groups of data,and the Bland-Altman was used to compare the differences of them.Results In imprecision studies,total coefficient of variation were L1:8.86%vs 7.89%,L2:5.82%vs 4.67%,and L3:6.66%vs 5.71%in the DiaSorin LIAISON and Architect I2000.The Architect I2000 correlated well with the DiaSorin LIAISON with Pearson’s correlation coefficients(r)of 0.98.In the Bland-Altman plot,the average value of 25(OH)D detected by Architect I2000 was 7.2 ng/mL,which was higher than that of DiaSorin LIAISON.The difference of 25(OH)D between them tended to increase as 25(OH)D concentration increased,and the maximal difference was 43.3 ng/mL.Conclusion Though there is good overall correlation between the results of the Architect I2000 and the DiaSorin LIAISON,the Architect I2000 assay demonstrates better performance than the DiaSorin LIAISON in imprecision studies.And the Architect I2000 is more consistent with the clinical diagnosis.

关 键 词：25-羟维生素D 自动化免疫分析仪 相关性 

分 类 号：R446.6[医药卫生—诊断学]