两种方法测定他克莫司血药浓度的对比分析  

Comparative analysis of two detection methods of tacrolimus blood concentration

作　　者：尚丽红 梁娇霞 石韶华 李宁 朱琳茹 Shang Lihong;Liang Jiaoxia;Shi Shaohua;Li Ning;Zhu Linru(Department of Kidney Transplant and Dialysis Center,Shanxi Second Provincial People′s Hospital,Taiyuan,Shanxi 030012,China)

机构地区：[1]山西省第二人民医院肾移植中心,山西太原030012

出　　处：《中国药物与临床》2023年第6期396-399,共4页Chinese Remedies & Clinics

摘　　要：目的评估乳胶增强免疫抑制法(PETIA)检测全血他克莫司浓度结果的重复性和准确性。评估电化学发光法(ECLIA)和PETIA法检测全血他克莫司浓度结果的一致性和相关性。方法用PETIA法对4份人全血混合样本分别测定80次,对结果进行精密度分析。用PETIA法对卫生部室间质评(EQA)3个水平样本分别检测3次,进行偏倚分析。分别用ECLIA和PETIA法对山西省第二人民医院230例肾移植患者全血样本分别进行他克莫司药物浓度检测,对检测结果进行相关性和偏差分析。结果PETIA法测定他克莫司在2.37 ng/ml、6.50 ng/ml、9.55 ng/ml和21.79 ng/ml浓度处的重复性变异系数分别为6.1%、3.6%、3.0%和2.5%,室间质评低、中、高3个水平的质控品偏倚分别为-3.13%、-4.82%和-0.75%。PETIA法和ECLIA法的测定结果之间的差异具有统计学意义(P<0.05),Spearman相关分析显示,2种方法测定结果显著相关(r=0.983,P<0.05)。2种方法间的偏倚为0.24,95%CI(-1.00,1.24)ng/ml。结论PETIA法检测他克莫司浓度结果重复性良好,用室间质评样本评估偏倚小,PETIA法和ECLIA法方法间的差异具有统计学意义,方法间具有很高的相关性,一致性较好,都可以满足临床检测的需求,但是从检测成本和测试速度角度出发,PETIA法优于ECLIA法。Objective To evaluate the repeatability and trueness of particle-enhanced turbidimetric im-munoassay(PETIA)for determination of tacrolimus(Tac)concentra-tion in human whole blood,and evaluate the consistency and correlation between the results of electrochemilumi-nescence Immunoassay(ECLIA)and PETIA methods.Methods The concentration of tacrolimus was measured by PETIA method in four mixed human samples and three levels of EQA(external quali-ty assessment)samples respectively.The ECLIA and PETIA methods were used to detect the concentration of tacrolimus in the whole blood samples of 230 kidney transplant patients,results were analyzed by SPSS 26.Results The intra-day and inter-day precision at the concentrations of 2.37 ng/ml,6.50 ng/ml,9.55 ng/ml and 21.79 ng/ml determined by the PETIA method were 6.1%,3.6%,3.0%and 2.5%re-spectively.The bias at the low,medium and high levels using EQA samples were-3.13%,-4.82%and-0.75%respectively.The Wilcoxon rank sum test analysis showed a statistically significant difference between the results of the PETIA method and the ECLIA method(P<0.05),Spearman correlation analysis showed that the results of the two methods were signif-icantly correlated(P<0.05),with a correlation coefficient of 0.983.The Bland Altman analysis showed a bias of 0.24 between the two methods,with a 95%confidence interval of-1.00 to 1.24 ng/ml.Conclusion The PETIA method has good repeatability and trueness for in vitro quantitative determination of tacrolimus(Tac)concentration in human whole blood.The difference between the PETIA and ECLIA method is statistically significant.The methods have high correlation and good consistency,and both of them can meet the needs of clinical testing.How-ever,the PETIA method is superior to the ECLIA method from the perspective of cost and testing speed.

关 键 词：血药浓度 他罗利姆 检测方法 

分 类 号：R969.1[医药卫生—药理学]