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    LC-MS/MS与CLIA检测伏立康唑血药浓度的结果比较

    Comparison of Plasma Voriconazole Concentration Using LC-MS/MS and CLIA

      摘要
    • 摘要:
      目的 评价液相色谱-串联质谱法(liquid chromatography-tandem mass spectrometry，LC-MS/MS)与化学发光免疫分析法(chemiluminescence immunoassay，CLIA)测定人血浆伏立康唑浓度结果的差异性、相关性和一致性，为临床监测伏立康唑血药浓度及个体化用药提供参考。
      方法 收集伏立康唑血药浓度达稳态后的患者血液样本153例，离心后取血浆，分别用LC-MS/MS和CLIA 2种方法测定伏立康唑血药浓度，并对2种方法测定的结果进行统计学分析。
      结果 CLIA测得的伏立康唑浓度为4.61(2.95，6.67)μg·mL−1，低于LC-MS/MS测得的伏立康唑浓度4.85(3.44，6.66)μg·mL−1，且Wilcoxon配对检验结果显示差异有统计学意义(Z=−4.175，P<0.001)；Spearman相关分析结果显示，CLIA与LC-MS/MS所测伏立康唑血药浓度的相关系数为0.970(P<0.01)；Passing-Bablok回归分析结果显示，CLIA与LC-MS/MS检测伏立康唑血药浓度的回归方程为CCLIA=−0.436+1.035CLC-MS/MS；Bland-Altman散点图分析结果显示，CLIA与LC-MS/MS检测伏立康唑血药浓度的差值中，有5.23%(8/153)的差值散点在一致性界限(±1.96 SD)之外；山形图山顶对应的2种方法测得的差值也趋向于0；Kappa分析显示CLIA和LC-MS/MS检测伏立康唑血药浓度的临床符合率为94.12%(144/153)，一致性系数Kappa=0.884。
      结论 CLIA与LC-MS/MS测定的伏立康唑血药浓度具有良好的相关性和一致性，但CLIA测定的结果总体上低于LC-MS/MS，因此临床用不同方法测定伏立康唑血药浓度时，对不同测定方法的差异应予以关注并作相应调整。

       

      Abstract:
      OBJECTIVE  To evaluate the difference, correlation and consistency of the results of voriconazole concentration in human plasma determined by liquid chromatography-tandem mass spectrometry(LC-MS/MS) and chemiluminescence immunoassay(CLIA), so as to provide a reference for clinical monitoring of voriconazole blood concentration and individualized medication.
      METHODS  Blood samples of 153 patients were collected after voriconazole blood concentration reached steady state, and plasma was obtained after centrifugation. The voriconazole blood concentration was determined by LC-MS/MS and CLIA, respectively, and the results of the 2 methods were statistically analyzed.
      RESULTS  The voriconazole concentration measured by CLIA was 4.61(2.95, 6.67) μg·mL−1, which was lower than that by LC-MS/MS, which was 4.85(3.44, 6.66) μg·mL−1. And the Wilcoxon paired test showed that the difference was statistically significant(Z=–4.175, P<0.001). The Spearman correlation analysis showed that the correlation coefficient between the blood concentrations of voriconazole measured by CLIA and LC-MS/MS was 0.970(P<0.01). The Passing-Bablok regression analysis showed that the regression equation of CLIA and LC-MS/MS for detection of voriconazole blood concentration was CCLIA=–0.436+1.035CLC-MS/MS. The Bland-Altman scatter plot analysis showed that 5.23%(8/153) of the difference of voriconazole concentration measured by CLIA and LC-MS/MS was outside the consistency limit (±1.96 SD). The difference between the 2 methods corresponding to the top of the mountain plot also tended to 0. Kappa analysis showed that the clinical compliance rate of voriconazole blood concentration detected by CLIA and LC-MS/MS was 94.12%(144/153), and the consistency coefficient Kappa=0.884.
      CONCLUSION  The blood concentrations of voriconazole determined by CLIA and LC-MS/MS show good correlation and consistency, but the results of CLIA are generally lower than those of LC-MS/MS. Therefore, when different methods are used to determine the blood concentration of voriconazole in clinical practice, the differences between these methods should be paid attention to and corresponding adjustments should be made.

       

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