高效液相色谱串联质谱法与化学发光法在血清雌二醇水平检测中的效果分析  

Effect analysis of high performance liquid chromatography tandem mass spectrometry and chemiluminescence in detection of serum estradiol levels

作　　者：刘冰[1] 韩雪[2] LIU Bing;HAN Xue(Department of Laboratory Medicine,Tonghua Central Hospital,Tonghua 134001,China;Department of Neurology,Tonghua Central Hospital,Tonghua 134001,China)

机构地区：[1]通化市中心医院检验科,通化134001 [2]通化市中心医院神经内科,通化134001

出　　处：《实验室检测》2024年第12期139-141,共3页Laboratory Testing

摘　　要：目的 比较高效液相色谱串联质谱法(LC-MS/MS)与化学发光法(CLIA)测定血清雌二醇(E2)水平的结果。方法 选择2023年1月至2024年1月于医院门诊就诊及住院的患者100例作为研究对象,采集全部研究对象当天新鲜的血液标本,分别应用LC-MS/MS与CLIA测定血清E2水平。结果 CLIA测定血清E2水平显著高于LCMS/MS,具有统计学差异(P<0.05);Pearson相关检验结果显示,LC-MS/MS与CLIA测定血清E2水平呈显著相关(r=0.866,P<0.05);LC-MS/MS与CLIA测定血清E2水平呈线性相关,线性回归方程为:Y=1.161X-6.574(r=0.973,n=100);Bland-Altman分析结果显示,LC-MS/MS与CLIA测定血清E2水平的差值平均为0.078 nmol/L(95%CI:0.069~0.086 nmol/L),一致性界限范围为(-0.011,0.143),存在5%(5/100)的点位于95%一致性界限范围之外,在95%一致性界限范围之内,LC-MS/MS与CLIA测定血清E2水平的差值最大为0.156 nmol/L,LCMS/MS与CLIA测定血清E2水平的平均值为0.152 nmol/L,提示两种测定方法的一致性欠佳。结论 通过CLIA测定的血清E2水平较LC-MS/MS测定偏高,两种方法测定血清E2水平具有一定的相关性,但一致性欠佳,CLIA测定血清E2水平更适合于快速筛查,在需要准确进行临床诊断时,则需要应用LC-MS/MS测定血清E2水平。Objective To compare the results of high-performance liquid chromatography tandem mass spectrometry(LC-MS/MS)and chemiluminescence immunoassay(CLIA)in the determination of serum estradiol(E2)level.Methods From January 2023 to January 2024,100 patients who were treated in outpatient department and hospitalized in the hospital were selected as the research subjects.Fresh blood samples were collected from all study subjects on the same day,and serum E2 levels were measured by LC-MS/MS and CLIA respectively.Results Serum E2 level measured by CLIA was significantly higher than that of LC-MS/MS(P<0.05).Pearson correlation test results showed that LC-MS/MS was significantly correlated with CLIA in measuring serum E2 level(r=0.866,P<0.05).There was a linear correlation between serum E2 level measured by LC-MS/MS and CLIA,and the linear regression equation was manifested as Y=1.161X-6.574(r=0.973,n=100).Bland-Altman analysis revealed that the average difference between LC-MS/MS and CLIA in measuring serum E2 level was 0.078 nmol/L(95%CI:0.069~0.086 nmol/L),and the consistency limit range was(-0.011,0.143).There were 5%(5/100)points outside the 95%consistency limit range,and within the 95%consistency limit range,and the maximum difference between LC-MS/MS and CLIA was 0.156 nmol/L.The average value of serum E2 level measured by LC-MS/MS and CLIA was 0.152 nmol/L,suggesting that the consistency of the two methods was poor.Conclusion Serum E2 level determined by CLIA is higher than that determined by LC-MS/MS.There is a certain correlation between the two methods for the determination of serum E2 level,but the consistency is not good.The determination of serum E2 level by CLIA is more suitable for rapid screening.When accurate clinical diagnosis is needed,it is necessary to apply LC-MS/MS to measure serum E2 level.

关 键 词：雌二醇 高效液相色谱串联质谱法 化学发光法 一致性 

分 类 号：R446.1[医药卫生—诊断学]