电化学发光免疫分析法与衍生化液相色谱串联质谱法25-羟基维生素D检测结果的一致性评价  

A Consistency Evaluation of 25-Hydroxyvitamin D Results from Electrochemiluminescence Immunoassay and Derivatization Liquid Chromatography Tandem Mass Spectrometry Method

作　　者：罗保斌 张晓红[1] 白晶[1] 周学红[1] 耿红艳[1] 刘向祎[1] LUO Baobin;ZHANG Xiaohong;BAI Jing;ZHOU Xuehong;GENG Hongyan;LIU Xiangyi(Department of Clinical Laboratory,Beijing Tongren Hospital,Capital Medical University,Beijing 100730,China)

机构地区：[1]首都医科大学附属北京同仁医院检验科,北京100730

出　　处：《标记免疫分析与临床》2025年第2期407-410,共4页Labeled Immunoassays and Clinical Medicine

基　　金：首都卫生发展科研专项(编号:2020-1-4040)。

摘　　要：目的比较电化学发光免疫分析法与衍生化液相色谱串联质谱法25-羟基维生素D检测结果的一致性。方法方法学比对,电化学发光免疫分析法为评估方法,衍生化液相色谱串联质谱法为参比方法。收集北京同仁医院2024年1月至2024年6月健康体检者剩余血清321份,分别由两种方法检测。采用SPSS 25.0及MedCalc20.2进行统计学分析,配对t检验分析两种方法检测结果的差异是否有统计学意义,一致性相关系数(CCC)评估结果的一致性,Passing-Bablok回归分析两种方法之间的相关性,Bland-Altaman图比较两种方法的平均相对差异。以25(OH)D≥20ng/mL、12~20ng/mL和<12ng/mL作为临床判定维生素充足、不足和缺乏的标准,分析两种方法的符合率。结果配对t检验显示两种方法检测结果的差异有统计学意义(t=-19.3,P<0.001)。两种方法的一致性相关系数为0.615,一致性较差。Passing-Bablok回归方程为Y=0.189+0.709 X,斜率为0.709(95%CI:0.667~0.755),截距为0.189(95%CI:-0.674~1.167),斜率不包括1,提示两种检测方法存在比例差异。Bland-Altaman分析显示两种方法检测结果平均相对偏差为-30.2%。25-羟基维生素D营养状况判断总体符合率为65.1%,缺乏符合率为96.4%。结论两种方法25-羟基维生素D检测结果偏差较大,但临床营养状况判断中缺乏符合率较高。Objective To evaluate the consistency of 25(OH)D results from electrochemiluminescence immunoassay and derivatization liquid chromatography tandem mass spectrometry method.Methods A methodological evaluation was conducted.Specifically,ECLIA was the evaluation method,while LC-MS/MS was the reference method.321 residual serum samples from routine health examination participants were collected.Statistical analysis was performed by SPSS 25.0 and MedCalc 20.2 software.Paired t-test,concordance correlation coefficient,Passing-Bablok regression,Bland-Altaman plots were performed to evaluate the differences of the two methods.Results The paired t-test revealed significant differences between the two methods(t=-19.3,P<0.001).The concordance correlation coefficient(CCC)showed a poor agreement(CCC=0.615).Passing-Bablok regression equations for both methods was:Y=0.189+0.709 X(Y:LC-MS/MS,X:ECLIA).The regression slope was significantly different from 1,suggested that there were proportional differences between the two methods.Bland-Altman plot showed that the average deviation between the two methods was-30.2%.The overall agreement was 65.1%for the judgment of vitamin D nutritional status,and 96.4%for the judgment of vitamin D deficiency rate.Conclusion There are significant differences between the two methods of 25(OH)D results,but the concordance of vitamin D deficiency rate is high.

关 键 词：25-羟基维生素D 电化学发光法 液相色谱串联质谱法 方法学比对 

分 类 号：Q565[生物学—生物化学] R446[医药卫生—诊断学]