罗氏e601环孢霉素试剂的性能验证与方法学比较
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摘要
目的评价罗氏公司Cobas e601型全自动电化学发光免疫分析仪(e601)环孢霉素试剂的分析性能。探讨化学发光微粒子免疫分析(chemiluminescencemicroparticle immune assay,CMIA)、酶放大免疫分析(enzyme multiplied immunoassay technique,EMIT)与电化学发光免疫分析(electrochemoluminescence immunoassay,ECLIA)三种免疫分析系统环孢霉素血药物浓度检测结果的相关性和一致性。方法依照美国临床和实验室标准化协会(Clinical and Laboratory Standards Institute,CLSI)文件对e601环孢霉素试剂盒进行精密度、正确度、批号间稳定性、方法学比较的性能验证。结果 e601环孢霉素分析系统检测全血样本的批内精密度和实验室内精密度与厂家说明书声明的精密度一致;偏倚小于RCPA对于Cs A评价标准;不同批号试剂间的Pearson相关系数r=0. 988,回归方程Y=1. 0619X+6. 7916。三种检测方法的相关性好,ECLIA与EMIT、CMIA方法的相关系数分别为0. 974,0. 930。ECLIA的检测结果稍高于CMIA、EMIT(差值均数分别为5. 0ng/m L,5. 1ng/m L)。结论 e601环孢霉素试剂盒符合厂家声明的性能参数,三种方法检测环孢霉素血药浓度相关性良好。
Objective To evaluate the analytical performance of Roche' s Cobas e601 automatic electrochemiluminescence immunoassay analyzer(e601) cyclosporine reagent,and to explore the correlation and consistency of cyclosporine concentrations among three immunoassays including CMIA,EMIT and ECLIA. Methods According to CLSI documents,we verified the performance of cyclosporine reagent including the accuracy,precision,lot-to-lot stability,and conducted methodological comparison. Results The lot intra-assay and lab intra-assay precisions were consistent with the statement of manufacturer' s instructions;The bias was less than the criteria of RCPA for CsA evaluation; The correlation coefficient between different reagent lots was 0. 988,and the regression equation was Y = 1. 0619 X + 6. 7916. There were good correlations among three methods. The correlation coefficient between ECLIA and EMIT was 0. 974,and that between ECLIA and CMIA was 0. 930. The results of ECLIA were slightly higher than those of CMIA and EMIT(the mean difference was 5. 0 ng/mL,5. 1 ng/mL). Conclusion The e601 elecsys cyclosporine is consistent with the performance parameters declared by the manufacturer. CMIA,EMIT and ECLIA have good correlations in the measurement of cyclosporine.
Objective To evaluate the analytical performance of Roche' s Cobas e601 automatic electrochemiluminescence immunoassay analyzer(e601) cyclosporine reagent,and to explore the correlation and consistency of cyclosporine concentrations among three immunoassays including CMIA,EMIT and ECLIA. Methods According to CLSI documents,we verified the performance of cyclosporine reagent including the accuracy,precision,lot-to-lot stability,and conducted methodological comparison. Results The lot intra-assay and lab intra-assay precisions were consistent with the statement of manufacturer' s instructions;The bias was less than the criteria of RCPA for CsA evaluation; The correlation coefficient between different reagent lots was 0. 988,and the regression equation was Y = 1. 0619 X + 6. 7916. There were good correlations among three methods. The correlation coefficient between ECLIA and EMIT was 0. 974,and that between ECLIA and CMIA was 0. 930. The results of ECLIA were slightly higher than those of CMIA and EMIT(the mean difference was 5. 0 ng/mL,5. 1 ng/mL). Conclusion The e601 elecsys cyclosporine is consistent with the performance parameters declared by the manufacturer. CMIA,EMIT and ECLIA have good correlations in the measurement of cyclosporine.
引文
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[6]刘晓,张相林,张镭,等.单克隆荧光偏振免疫法、多克隆荧光偏振免疫法和高效液相色谱法分别测定环孢素A血药浓度结果的相关性探讨[J].中国药学杂志,2009,44(10):790-793.
[7]缪海均,邓渝林,恽芸蕾,等.不同免疫分析仪在环孢素A血药浓度监测中的差异[J].中国医院药学杂志,2004(4):222-224.
[8]梁晓丽,刘蕾,陈頔,等. HPLC-MS/MS和FPIA法测定全血中环孢素浓度的比较方法学[J].中国药学杂志,2009,44(24):1904-1908.
[9]CLSI. Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures[S]. Approved Guideline EP10-A3. 2014.
[10]CLSI. User Verification of Precision and Estimation of Bias[S].Approved Guideline EP15-A3. 2014.
[11]徐建华,刘冬冬,徐宁,等. CLSI EP15-A3在临床生化精密度验证中的应用[J].临床检验杂志,2016,34(3):215-218.
[12]蒋红君,蒋杰,王凡.全自动生化分析仪的检测精密度、正确度评价及参考区间的验证[J].国际检验医学杂志,2013,34(9):1147-1148.
[13]CLSI. Measurement Procedure Comparison and Bias Estimation Using Patient Samples[S]. Approved Guideline EP09-A3. 2013.
[14]徐建华,刘冬冬,黄宪章,等.新指南CLSI EP9-A3在方法学比对及偏移评估中的应用[J].中华医学杂志,2015,95(12):894-897.
[15]王佑春.体外生物诊断试剂的质量评价[J].临床输血与检验,2006,8(4):309-314.
[16]QIN X,RUI J,XIA Y,et al. Multi-center Performance Evaluations of Tacrolimus and Cyclosporine Electrochemiluminescence Immunoassays in the Asia-Pacific Region[J]. Ann Lab Med,2018,38(2):85-94.
[17]卓海通.环孢素的药物动力学[J].中国医院药学杂志,1991(7):319-322.
[18]BERESINI M H,DAVALIAN D,ALEXANDER S,et al. Evaluation of EMIT Cyclosporine Assay for use with whole blood[J]. Clin Chem,1993,39(11 Pt 1):2235-2241.
[19]BRATE E M,FINLEY D M,GROTE J,et al. Development of an Abbott ARCHITECT cyclosporine immunoassay without metabolite cross-reactivity[J]. Clin Biochem,2010,43(13-14):1152-1157.
[20]WALLEMACQ P,MAINE G K,ROSIERE T,et al. Multisite analytical evaluation of the Abbott ARCHITECT cyclosporine assay[J]. Clin Biochem,2010,32(2):145-151.
[2]吴笑春,李罄.肾移植患者应用环孢素的有效血药浓度范围[J].中国医院药学杂志,2000,20(3):173-175.
[3]FAYNOR S M,MOYER T P,STERIOFF S,et al. Therapeutic drug monitoring of cyclosporine[J]. Mayo Clinic Proceedings,1984,59(8):571-572.
[4]高洁,刘金奎.环孢素毒副作用的防治研究进展[J].中国综合临床,2003,19(2):101-102.
[5]王磊,孙文利,李培余,等.环孢素A血药浓度检测方法比较分析[J].中华临床医师杂志(电子版),2017,11(3):417-421.
[6]刘晓,张相林,张镭,等.单克隆荧光偏振免疫法、多克隆荧光偏振免疫法和高效液相色谱法分别测定环孢素A血药浓度结果的相关性探讨[J].中国药学杂志,2009,44(10):790-793.
[7]缪海均,邓渝林,恽芸蕾,等.不同免疫分析仪在环孢素A血药浓度监测中的差异[J].中国医院药学杂志,2004(4):222-224.
[8]梁晓丽,刘蕾,陈頔,等. HPLC-MS/MS和FPIA法测定全血中环孢素浓度的比较方法学[J].中国药学杂志,2009,44(24):1904-1908.
[9]CLSI. Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures[S]. Approved Guideline EP10-A3. 2014.
[10]CLSI. User Verification of Precision and Estimation of Bias[S].Approved Guideline EP15-A3. 2014.
[11]徐建华,刘冬冬,徐宁,等. CLSI EP15-A3在临床生化精密度验证中的应用[J].临床检验杂志,2016,34(3):215-218.
[12]蒋红君,蒋杰,王凡.全自动生化分析仪的检测精密度、正确度评价及参考区间的验证[J].国际检验医学杂志,2013,34(9):1147-1148.
[13]CLSI. Measurement Procedure Comparison and Bias Estimation Using Patient Samples[S]. Approved Guideline EP09-A3. 2013.
[14]徐建华,刘冬冬,黄宪章,等.新指南CLSI EP9-A3在方法学比对及偏移评估中的应用[J].中华医学杂志,2015,95(12):894-897.
[15]王佑春.体外生物诊断试剂的质量评价[J].临床输血与检验,2006,8(4):309-314.
[16]QIN X,RUI J,XIA Y,et al. Multi-center Performance Evaluations of Tacrolimus and Cyclosporine Electrochemiluminescence Immunoassays in the Asia-Pacific Region[J]. Ann Lab Med,2018,38(2):85-94.
[17]卓海通.环孢素的药物动力学[J].中国医院药学杂志,1991(7):319-322.
[18]BERESINI M H,DAVALIAN D,ALEXANDER S,et al. Evaluation of EMIT Cyclosporine Assay for use with whole blood[J]. Clin Chem,1993,39(11 Pt 1):2235-2241.
[19]BRATE E M,FINLEY D M,GROTE J,et al. Development of an Abbott ARCHITECT cyclosporine immunoassay without metabolite cross-reactivity[J]. Clin Biochem,2010,43(13-14):1152-1157.
[20]WALLEMACQ P,MAINE G K,ROSIERE T,et al. Multisite analytical evaluation of the Abbott ARCHITECT cyclosporine assay[J]. Clin Biochem,2010,32(2):145-151.