液相色谱串联质谱法和化学发光微粒子免疫法测定人血清中卡马西平血药浓度的一致性评价  

Consistency evaluation between LC-MS/MS and ECLIA in detecting carbamazepine in humanserum

作　　者：赵柯 邓雅妮 王亚南 朱晶晶 代冰 丁利霞 ZHAO Ke;DENG Yani;WANG Yanan;ZHU Jingjing;DAI Bing;DING Lixia(Zhengzhou Kingmed Clinical Laboratory Inc.,Zhengzhou,Henan 450000,China;Changsha Kingmed Center for Clinical Laboratory Co.,Ltd.,Changsha,Hunan 410000,China)

机构地区：[1]郑州金域临床检验中心有限公司,河南郑州450000 [2]长沙金域医学检验实验室有限公司,湖南长沙410000

出　　处：《国际检验医学杂志》2024年第S01期103-108,共6页International Journal of Laboratory Medicine

摘　　要：目的比较液相色谱串联质谱法(LC-MS/MS)与化学发光微粒子免疫法(CMIA)两种方法检测人血清中卡马西平浓度的一致性。方法收集118例临床血清样本,分别用LC-MS/MS和CMIA两种方法检测卡马西平。采用Passing-Boblok回归分析两种方法之间的相关性,采用Bland-Altman及Mountain plot评估两种方法的一致性,使用Kappa分析判断两种方法检测卡马西平浓度是否在有效范围的符合率。结果LCMS/MS与CMIA法检测卡马西平结果分别为(5.68±2.36)μg/mL和(6.45±2.69)μg/mL,Passing-Bablok回归分析显示两种方法检测卡马西平浓度的回归方程为yCMIA=-0.04885+1.1538xLC-MS/MS,斜率为1.1538(95%CI:1.0887~1.2244)不包含1,截距为-0.04885(95%CI:-0.4559~0.2792)包含0,P>0.1,线性度无明显偏差。Bland-Altman图显示两种方法差值的均值为-0.77,界外点数(比率)为5.08%;山形图的山顶值为-0.74μg/mL,偏离0较小,表明两种方法测量的结果一致性较好。两种方法判断卡马西平治疗浓度水平Kappa系数为0.693,诊断符合率为89.93%。结论CMIA与LC-MS/MS两个检测系统检测结果一致性较好。Objective To compare the correlation and consistency between liquid chromatogram tandem mass spectrum(LC-MS/MS)and chemiluminescence micropaticle immuno saasy(CMIA)for the determination of carbamazepine in human serum.Methods The concentrations of carbamazepine in collected 118 serum samples were determined by LC-MS/MS and CMIA,respectively.The correlation between the two methods was analyzed by Passing-Boblok regression,using Bland-Altman and Mountain plot to evaluate the consistency of the two methods.The consistency rates was judged using Kappa analysis.Results The average concentrations of carbamazepine in 118 samples by LC-MS/MS and CMIA method were(5.68±2.36)and(6.45±2.69)ng/mL.Passing-Boblok regression shows that the result equation was yCMIA=-0.04885+1.1538xLCMS/MS.The slope was 1.1538(95%confidence interval 1.0887 to 1.2244),exclusive of 1.The intercept was-0.04885(95%confidence interval-0.4559 to 0.2792),including 0.There was no significant deviation in the linearity.Bland-Altman consistency analysis shows that the maximum points out(ratio)is 5.08%,the arithmetic mean was-0.77.The median of Mountain plot was-0.74 ng/mL.The result of Bland-Alt-man and Mountain plot analysis indicated that there was a decent consistency.The Kappa coefficient between the two methods of concentration level of carbamazepine was 0.693,the consistency rates was 89.93%.Con-clusion There was good correlation between LC-MS/MS and CMIA for the determination of carbamazepine in human serum.

关 键 词：液相色谱串联质谱法 电化学发光免疫分析法 卡马西平 血药浓度 方法比对 

分 类 号：R446.6[医药卫生—诊断学]