滨州医学院学报2025，Vol.48Issue(2)：141-144,4.DOI:10.19739/j.cnki.issn1001-9510.2025.02.007
两种化学发光免疫分析仪检测血清VitB12的评价分析
Evaluationof two chemiluminescence systems for detecting vitamin B12
摘要
Abstract
Objective To evaluate whether there is comparability between the results of serum vitamin B12(VitB12)items detected by the two chemiluminescence detection systems,and to provide a basis for clinical acceptability.Methods Eighty ser-um samples were tested for VitB12 items on EXI1800 chemiluminescence immunoassay analyzer(evaluation system)and Roche cobas e602 analyzer(comparison system).The optimal regression model was selected to fit the regression equation,and the 95％confidence interval(CI)of each parameter and the bias at the medical decision level were calculated.The consistency and comparability of the two test systems were evaluated by 6.25％of ≤1/4 TEa as the acceptable standard.Results No outliers were found after the extreme studentization bias(ESD)method was verified.According to the characteristics of scatter plot,difference deviation plot and percentage difference deviation plot,the difference between the results obtained by the two methods showed a constant SD change and R2 ≥0.95,and the Deming regression model was selected.The regression equation was Y=-21.095 8+1.041 8X,the slope 95％CI was 1.0418(1.008 1,1.075 5),and the intercept 95％CI was-21.095 8(-35.136 9,7.054 7).The estimated value of the medical decision level was substituted into the equation,and the offset was less than 1/4 TEa(6.25％),which met the requirements of the health industry standard.Conclusion The results of the two chemiluminescence immunoassay detection systems for VitB12 in this laboratory are comparable with each other,and the bias is within the clinically acceptable range,which can provide stable and reliable VitB12 test results for the clinic.关键词
维生素B12/一致性检验/对比分析/化学发光免疫检测系统Key words
VitaminB12/consistency testing/comparative study/chemiluminescence immunoassay system分类
医药卫生引用本文复制引用
韩宇晨,郑瑶,毛剑,李海英,安佳佳,陈微微,王蔚琛..两种化学发光免疫分析仪检测血清VitB12的评价分析[J].滨州医学院学报,2025,48(2):141-144,4.基金项目
山东省自然科学基金青年项目(ZR2022QH192) （ZR2022QH192）
滨州医学院附属医院科技基金(KH2020-11,JC2021-01) （KH2020-11,JC2021-01）
