基于液相色谱串联质谱技术的喹硫平试剂盒临床一致性评价

Clinical consistency evaluation of quetiapine kit based on liquid chromatography tandem mass spectrometry technology

关键词:  液相色谱串联质谱  喹硫平  试剂盒  一致性  治疗药物监测

Key words:  LC-MS/MS  quetiapine  kits  consistency  therapeutic drug monitoring

摘要:

目的 评价喹硫平液相色谱串联质谱试剂盒与实验室自建方法(参比方法)在喹硫平治疗药物监测平台中检测结果的一致性。方法 收集2021年3月至10月在浙江大学医学院附属第一医院进行喹硫平治疗药物监测的120例患者的临床检测剩余血浆标本,分别用试剂盒方法与参比方法检测其喹硫平血药浓度。对检测结果进行离群值分析,线性回归评价其相关性,Bland-Altman法评价其一致性。结果 检测结果无离群值；线性回归方程为Y = 1.018X + 4.400,r = 0.998,相关性良好；Bland-Altman图显示一致性良好。结论 喹硫平液相色谱串联质谱试剂盒与参比方法检测结果一致性良好,可用于临床喹硫平治疗药物监测。

Abstract:

ABSTRACT：OBJECTIVE To evaluate the consistency between the quetiapine LC-MS/MS kit and the laboratory-built method (reference method) in the detection results of quetiapine therapeutic drug monitoring. METHODS A total of 120 plasma samples were collected from patients receiving quetiapine therapeutic drug monitoring from March to October in 2021. The concentration of quetiapine was detected by kit and reference method respectively. The analysis of correlations and consistency was performed by outlier analysis, linear regression and Bland-Altman method. RESULTS No outliers were detected. The linear regression equation was Y = 1.018X + 4.400 (r = 0.998), indicating a good correlation. The Bland Altman plot analysis showed good agreement between the two measurements. CONCLUSION The detection results of quetiapine LC-MS/MS kit and reference method are in good agreement. The kit can be used for clinical quetiapine treatment drug monitoring.