罗氏e601环孢霉素试剂的性能验证与方法学比较

The Performance Verification and Methodology Comparison of Roche e601 Cyclosporine Reagents

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 5.0ng/mL,5.1 ng/mL）. Conclusion The e601elecsys cyclosporine is consistent with the performance parameters declared by the manufacturer.CMIA,EMIT and ECLIA have good correlations in the measurement of cyclosporine.