Comparison of the Consistency and Difference of Three Detection Methods in Blood Concentration Monitoring of Mycophenolic Acid / 中国药房

ABSTRACT

OBJECTIVE：To investigate the consistency and difference of f luorescence immunochromatographic and liquid chromatography-tandem mass spectrometry （LC-MS/MS）and enzyme multiplied immunoassay technique （EMIT）in the blood concentration monitoring of mycophenolic acid. METHODS ：Fluorescence immunochromatography ，LC-MS/MS and EMIT were used to detect the blood concentration of mycophenolic acid in 61 blood samples of children treated with mycophenolate mofetil ester orally at different time points. Kolmogorov-Smirnov method ，Wilcoxon pairing test ，Passing-Bablok regression ，Cusum method，Spearman correlation analysis ，Bland-Altman scatter diagram were adopted for statistical analysis. RESULTS ：Blood concentrations of mycophenolic acid ，which were determined by fluorescence immunochromatography ，LC-MS/MS and EMIT ， showed non-normal distribution. Passing-Bablok regression analysis showed that regression equation of fluorescence immunochromatography and LC-MS/MS ，fluorescence immunochromatographic method and EMIT were CFI=0.928 3CLC-MS/MS+0.961 7 and CFI＝0.880 7CEMIT－0.488 2（FI means fluorescence immunochromatographic ）. Spearman correlation analysis showed that the correlation coefficients between fluorescence immunochromatography and LC-MS/MS ，fluorescence immunochromatography and EMIT were 0.968 and 0.929， respectively （P＜0.000 1）. Bland Altman scatter plot analysis showed that 3.28％ of the 358341451@qq.com difference between fluorescence immunochromatography and LC-MS/MS was outside the consistency limit （±1.96SD）， and 1.64％ of the difference between fluorescence immuno- chromatography and EMIT was outside the consistency limit （± 1.96SD）. Wilcoxon pairing test showed that the results of fluorescence immunochromatography were higher than those of LC-MS/MS （Z＝3.76，P＝0.000 2）and lower than those of EMIT （Z＝－5.96，P＜0.000 1）. CONCLUSIONS ：Fluorescence immunochromatography shows good consistency and correlation with LC-MS/MS and EMIT ；the blood concentrations of mycophenolic acid detected by fluorescence immunochromatography were higher than those by LC-MS/MS and lower than those by EMIT . It can be used for bedside rapid detection. When using the test results of different methods for clinical medication ，the differences of test methods need to be considered.