雌二醇试剂盒换代升级的偏倚评估和可比性分析

摘要

Objective To evaluate the consistency of estradiol kits between E2-Ⅲ and the upgraded Enhanced Estradiol(eE2)kit with chemiluminescence immunoassay analyzer Siemens ADVIA Centaur.Methods Used duplicate samples and removed outliers to test the two reagents′stability;document EP9-A2 were used as reference to do the methodological comparison and bias estimation. Results There was good correlation between the two reagents with different concentrations,the correlation coefficients were grea-ter than 0.975;the percentage of bias was varied among different groups.Conclusion It is effective to reduce the interference of up-dated estradiol kits on the assisted reproduction treatment cycles by assessing the bias through comparison tests of the two kits in advance.%目的：评价西门子化学发光免疫分析仪 ADVIA Centaur 试剂盒由第三代雌二醇（E2-Ⅲ）换代升级为 Enhanced Es-tradiol（eE2）后，二者检测结果的一致性。方法使用双份样本试验并去除离群值以检测2种试剂的稳定性；参照 EP9-A2文件用患者样本对2种试剂进行方法学比对及偏倚评估。结果此2种试剂的检测结果在不同的浓度组中具有良好的相关性，相关系数均大于0．975；而二者在不同的浓度组中百分比偏倚有所不同。结论通过比对试验对2种试剂预先进行偏倚评估，可有效地降低雌二醇试剂换代升级对助孕周期诊疗上的干扰。