荧光免疫层析法和酶联免疫吸附法检测英夫利西单抗血药浓度的比较研究

目的:探讨荧光免疫层析法(fluorescence immunochromatography assay,FICA)与酶联免疫吸附法(ELISA)检测英夫利西单抗(infliximab,IFX)血药浓度结果的相关性与一致性。方法:采用已上市的IFX药物浓度测定试剂盒(荧光免疫层析法)与实验室建立的检测IFX浓度的ELISA方法测定克罗恩病患者血液样本IFX浓度。通过Spearman相关分析、Passing-Bablok回归、单样本t检验、Bland-Altman散点图和Cohen's Kappa系数等对检测结果统计分析。结果:共收集到44份血液样本,FICA和ELISA法检测IFX结果的Spearman系数为0.87(P＜0.01)。Passing-Bablok回归分析显示,FICA和ELISA法检测IFX结果的回归方程为C_FICA＝0.5071C_ELISA+0.6230。单样本t检验提示2种方法检测IFX结果差值与0有显著差异。Bland-Altman散点图显示FICA与ELISA法所测IFX血药浓度的差值中有91.43%(32/35)在一致性界限内(差值均值±1.96 SD)。对2种分析方法检测IFX结果定性分析表明一致性为68.18%(30/44),Cohen's KAppa系数为0.51。结论:FICA与ELISA法检测IFX结果高度相关,但一致性存在差异。ELISA法所测IFX浓度结果高于FICA,提示运用IFX检测结果进行临床决策时要关注检测方法。

Comparison for blood concentration monitoring of infliximab between fluorescence immunochromatography and enzyme-linked immunosorbent assay

OBJECTIVE To investigate the correlation and consistency of the blood concentration of infliximab(IFX)detected by fluorescence immunochromatography assay(FICA) and enzyme-linked immunosorbent assay(ELISA).METHODS The concentration of IFX in blood samples from patients with Crohn’s disease were determined by using the marketed IFX drug concentration assay kit(FICA) and the ELISA method by laboratory developed test.Spearman correlation analysis,Passing-Bablok regression,one-sample t-test,Bland-Altman scatter plot and Cohen’s Kappa were used for statistical analysis.RESULTS A total of 44 blood samples were collected.The Spearman coefficient was 0.87(P＜0.01),the Passing-Bablok regression equation was C_FICA=0.507 1C_ELISA+0.623 0,one-sample t-test indicates that the difference between the two methods for detecting IFX results is significantly different from 0 and the Bland-Altman scatter plot showed that 91.43%(32/35)were in the consistency limit(x±1.96 SD).Qualitative analysis of the IFX results of the two analytical methods showed that the consistency was 68.18%(30/44),and the Cohen’s Kappa coefficient was 0.51.CONCLUSION FICA and ELISA show good correlation,but there is a difference in consistency.The concentration of IFX measured by ELISA was higher than that by FICA.It is suggested to pay attention to the detection method when using IFX test results for clinical decision-making.