摘要
目的评价化学发光微粒子免疫分析法(CMIA)和电化学发光免疫分析法(ECLIA)测定他克莫司血药浓度结果的一致性和相关性。方法收集服用他克莫司的患者标本200例,分别用CMIA法和ECLIA法检测他克莫司的血药浓度,并比较这2种方法分别检测低、中、高3个水平质控的结果,用GraphPad Prism 8.02软件进行统计学分析。结果 CMIA法和ECLIA法在各质控水平的日内及日间精密度均相当(RSD<5%)。2种方法测定结果的整体样本分析(P<0.001)及分层分析(P0.5~2.0 ng·mL-1<0.001和P>2.0 ng·mL-1<0.001)显示,差异均有统计学意义,但是Spearman相关分析显示,2种方法测定结果呈显著相关(P<0.05),相关系数分别为0.995 6,0.938 1和0.993 5。Bland-Altman分析显示,2种方法产生的偏倚分别为0.185 9,0.313 9和0.165 9,均有95%以上的差值落在95%置信区间范围内。结论虽然CMIA法和ECLIA法检测他克莫司的血药浓度结果间差异有统计学意义,但是二者相关性,一致性较好,均适用于该项目的临床检测,但是从检测成本考虑,ECLIA法优于CMIA法。
Objective To evaluate the consistency and relevance of chemiluminescent particle immunoassay(CMIA) and electrochemical luminescence immunoassay(ECLIA) in the determination of tacrolimus blood concentration.Methods The concentration of tacrolimus was measured by CMIA and ECLIA methods respectively in 200 samples of patients received tacrolimus.Results of clinical samples and quality control products(low, middle, high, three different levels) obtained from the two methods were analyzed by GraphPad Prism 8.02.Results The intra-day and inter-day precision was similar in ECLIA compared to CMIA(RSD<5%).Overall sample analysis(P<0.001) and stratification analysis(P0.5-2.0 ng·mL-1<0.001 and P>2.0 ng·mL-1<0.001)showed that there was statistical difference between tacrolimus concentrations measured by these two methods, but Spearman correlation analysis showed that the results were significantly correlated(P<0.05) with correlation coefficients of 0.995 6, 0.938 1 and 0.993 5 respectively.Bland-Altman analysis showed that the bias generated by the two methods was 0.185 9,0.313 9 and 0.165 9 respectively,more than 95% difference value was within the 95%confidence interval.Conclusion Although there was statistical difference between tacrolimus concentrations measured by CMIA method and ECLIA method,the correlation and consistency between the two methods were good,and they were applicable to the clinical testing of this project.However,considering the test cost,ECLIA method was superior to CMIA method.
作者
赵海艳
刘博宇
封宇飞
ZHAO Hai-yan;LIU Bo-yu;FENG Yu-fei(Department of Pharmacy,Peking University People,s Hospital,Beijing 100044,China)
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2020年第7期838-841,共4页
The Chinese Journal of Clinical Pharmacology
