均相酶免疫法与液质联用法测定人血清中卡马西平浓度的比较

Comparison of homogeneous enzyme immunoassay versus liquid chromatography-mass spectrometry for determination of carbamazepine in human serum

目的:比较均相酶免疫法(HEIA)与液质联用法(LC-MS)检测人血清中卡马西平浓度结果。方法:入组110份临床样本,分别用2种方法测定,检验2组检测数据的正态性和显著性差异,采用Spearman法进行相关性分析,绘制Bland-Altman偏差图考察检测方法的差异性,Passing-Bablok回归法考察2种方法等效性。结果:HEIA法和LC-MS法的测定平均值分别为(8.23±5.59)μg·mL^(-1)和(6.19±4.35)μg·mL^(-1)。2组数据不呈正态分布,差异有统计学意义(P<0.05),呈高度相关(r=0.982 0)。2种方法测定值的差值的平均值为(29.5±21.3)%,且不同浓度水平差异相当,一致性较好。Passing-Bablok回归方程为:Y_(HEIA)=0.012 9+1.318 7X_(LC-MS),2种方法不具有等效性。结论:HEIA法比LC-MS法的检测值高,采用2种方法开展卡马西平治疗药物监测工作时,应考虑不同方法的测定差异值,根据临床实际疗效和安全性调整参考范围。

OBJECTIVE To compare the results of carbazepine in human serum detected by homogeneous enzyme immunoassay(HEIA)versusliquid chromatography-mass spectrometry(LC-MS).METHODS A total of 110 clinical samples were harvested and measured by two methods.Normality and significance of two datasets were examined.Spearman’s method was employed for correlation analysis.Bland-Altman deviation chart was plotted for examining the difference of two tests.And Passing-Bablok regression was utilized for investigating their equivalence.RESULTS The mean values of HEIA and LC-MS were(8.23±5.59)μg·mL^(-1)and(6.19±4.35)μg·mL^(-1)respectively.Neither dataset presented a normal distribution.There were significant inter-group differences(P<0.05)with a high correlation(r=0.982 0).The mean inter-group difference was(29.5±21.3)%.The difference in different concentration levels was similar and there was a decent consistency.The Passing-Bablok regression equation was Y_(HEIA)=0.012 9+1.318 7X_(LC-MS),and two methods werenot equivalent.CONCLUSION The test result of HEIA method was higher than that of LC-MS method.When two methods are applied for therapeutic drug monitoring of carbamazepine, the differentialvalue should be considered.And reference range should be adjusted according to the clinical efficacy and safety.