摘要
目的:验证并评价化学发光免疫分析法(CLIA)用于伏立康唑血药浓度的测定。方法:(1)验证CLIA法,进行检测限、重复性、线性、准确度及精密度5个方面的验证;(2)评价CLIA法,收集2023年1—2月该院进行伏立康唑血药浓度监测的113例患者的血浆样本,分别用超高效液相色谱-串联质谱法(UPLC-MS/MS)和CLIA法进行检测,采用配对t检验、组内相关系数(ICC)、Passing-Bablok回归和Bland-Altman分析比较两种方法的相关性及一致性。结果:经验证,CLIA法用于测定伏立康唑血药浓度符合分析技术要求,方法稳定可靠。CLIA法检测的血浆伏立康唑平均浓度为(3.843±2.056)μg/mL,高于UPLC-MS/MS法测得的(3.399±1.959)μg/mL,差异有统计学意义(P<0.01)。两种方法测定结果的ICC为0.932(P<0.001);Passing-Bablok回归方程为Y=0.0834+1.099 X(R=0.956,n=113),方程斜率为1.099(95%CI=1.030~1.161),截距为0.0834(95%CI=-0.062~0.251),两种方法测定值之间存在良好的线性相关关系。Bland-Altman分析显示,两种方法的平均偏差为0.442μg/mL(95%CI=0.331~0.558μg/mL),平均偏差百分比为14.49%(95%CI=11.47%~17.51%),一致性尚可接受。结论:CLIA法稳定可靠、操作简便、检测效率高,更适用于临床样本检测。CLIA法与UPLC-MS/MS法测定的结果相关性良好,一致性尚可,CLIA法可作为UPLC-MS/MS法的潜在替代方法用于临床检测伏立康唑血药浓度。
OBJECTIVE:To validate and evaluate the chemiluminescence immunoassay(CLIA)for the determination of voriconazole blood concentration.METHODS:(1)The CLIA method was verified in five aspects:detection limit,repeatability,linearity,accuracy and precision.(2)The CLIA method was evaluated.Plasma samples of 113 patients who were monitored for voriconazole blood concentration in the hospital from Jan.to Feb.2023 were collected and detected by ultra-high performance liquid chromatography-tandem mass spectrometry(UPLC-MS/MS)and CLIA method respectively.The correlation and consistency of the two methods were compared by using paired t-test,intragroup correlation coefficient(ICC),Passing-Bablok regression,and Bland-Altman analysis.RESULTS:It was validated that the CLIA method for the determination of voriconazole blood concentration met the requirements of analytical techniques,and the method was stable and reliable.The mean concentration of voriconazole in plasma was(3.843±2.056)μg/mL determined by CLIA method,higher than(3.399±1.959)μg/mL by UPLC-MS/MS method,with statistically significant differences(P<0.01).ICC of the two methods was 0.932(P<0.001).The Passing-Bablok regression equation was Y=0.0834+1.099 X(R=0.956,n=113),the slope of the equation was 1.099(95%CI=1.030-1.161),and the intercept was 0.0834(95%CI=-0.062-0.251),there was a good linear correlation between the two methods.According to the Bland-Altman analysis,the mean absolute bias between CLIA and UPLC-MS/MS was 0.442μg/mL(95%CI=0.331-0.558μg/mL),the average bias in percentage between CLIA and UPLC-MS/MS was 14.49%(95%CI=11.47%-17.51%),which was an acceptable consistency between the two methods.CONCLUSIONS:The CLIA method is stable,reliable,easy to operate,and has high detection efficiency,making it more suitable for clinical sample testing.The correlation between the results determined by CLIA method and UPLC-MS/MS method is good and in acceptable consistency,and the CLIA method can be used for the clinical detection of voriconazole as a potential alternative to the UPLC-MS/MS method.
作者
张倩
李沭
李博
秦伟
王晓雪
张丹
杜雯雯
王晓星
李朋梅
张相林
陈文倩
ZHANG Qian;LI Shu;LI Bo;QIN Wei;WANG Xiaoxue;ZHANG Dan;DU Wenwen;WANG Xiaoxing;LI Pengmei;ZHANG Xianglin;CHEN Wenqian(Dept.of Pharmacy,China-Japan Friendship Hospital,Beijing 100029,China)
出处
《中国医院用药评价与分析》
2024年第10期1221-1224,1229,共5页
Evaluation and Analysis of Drug-use in Hospitals of China
基金
中日友好医院临床研究与转化跃升项目(No.2023-NHLHCRF-YYPP-TS-03)。
关键词
伏立康唑
化学发光免疫分析法
质谱法
治疗药物监测
Voriconazole
Chemiluminescence immunoassay
Mass spectrometry
Therapeutic drug monitoring
