不同化学发光分析系统在皮质醇检测中的性能评价与比较

目的比较贝克曼Access 2Immunoassay System化学发光免疫分析系统及罗氏COBAS E 411电化学发光免疫分析系统对皮质醇的分析性能与检测结果相关性。方法按照ISO15189中方法评估贝克曼及罗氏分析系统对皮质醇检测的精密度、功能灵敏度、参考范围、方法学、阳性符合率、阴性符合率。结果贝克曼与罗氏分析系统在皮质醇检测中精密度良好,功能灵敏度符合各自厂商设定的临床检测的下限,实验室自建参考范围后,将两分析系统对皮质醇的测定值进行线性回归分析,二者间相关性良好,线性回归系数r~2=0.977,阳性符合率、阴性符合率均为100%。结论两分析系统对于皮质醇的分析性能优异,均可满足临床检验需求。经过方法学比对,二者相关性良好,能够通过回归方程对二者间测定值进行引证。

Performance evaluation and comparison of different chemiluminescence immunoassay systems in detection of cortisol

Objective To compare the analytical performance and results correlation of cortisol detection by the Beckman Access 2 Immunoassay System chemiluminescence system and the Roche COBAS E 411 electrochemical luminescence system .Methods The precision ,functional sensitivity ,reference range ,positive coincidence rate and negative coincidence rate of both Beckman Access 2 Immunoassay System and Roche COBAS E 411 systems for detecting cortisol were evaluated according to the method of ISO15198 .Results Both Beckman Access 2 Immunoassay System and Roche COBAS E 411 system exhibited better precision ,the functional sensitivity conformed to the lower limit of clinical detection set by the manufacturers ,after establishing the reference range of cortisol by the laboratory ,the cortisol values detected by these two systems were performed the linear regression analysis , the results indicated that the correlation between them was good ,the linear regression coefficient r2 =0 .977 ,and the positive and negative coincidence rates were 100% .Conclusion The two analytical systems have excellent performance for cortisol ,which all meet the clinical detection requirements .The methodological comparison shows good correlation between them ,and the detection re‐sults could be cited between these two systems by the regression equation .