罗氏Cobas E601检测癌胚抗原的方法学性能评价  

Evaluation of Roche Cobas E601 for Determining CEA

作　　者：苏维[1] 王淑仙[1] 陈占良[1] 冯惠清[1] 段琳[1] 李逸阳 

机构地区：[1]河北大学附属医院检验科,河北保定071000

出　　处：《医学研究与教育》2013年第6期30-34,共5页Medical Research and Education

摘　　要：目的对罗氏CobasE601全自动电化学发光免疫分析仪检测癌胚抗原（CEA）的分析性能进行验证。方法对CEA的精密度、准确度、测量线性范围、参考区间和交叉污染率进行验证实验。结果批内精密度高低两种浓度的（CV）分别为4．96％和4．38％，日间精密度高低两种浓度的cV分别为4．99％和4．81％；5份室间质控品的检测结果与靶值的偏倚在1．49％。3．57％；测量线性范围与厂家提供的范围相近；CEA的测量数值有96．3％在提供的参考区间内；交叉污染率为0．12％。结论罗氏CobasE601检测CEA的方法学性能良好，检验结果准确可靠，能够满足临床检测的要求。Objective To evaluate the effects of Roche Cobas E601 automatic electrochemiluminescence immunoassay analyzer for determining CEA. Methods To analyze E601＇s measurement precision, accuracy, measurement range, reference interval and carryover rate of CEA, verification experiments were taken to measure. Results The high and low values of CV of inter-assay were 4.96% and 4.38%, and between-day CV were 4.99% and 4.81%; 5 quality-control serum＇s relative bias were between 1.49%-3.57%; there was good linear relationship between measured values and expected values; there was 96.3% of the measurement data in the recommended reference interval; carryover rate range was 0.12%. Conclusion Roche Cobas E601 analyzer is stable, precise and accurate.

关 键 词：电化学发光免疫分析仪 性能评价 癌胚抗原 

分 类 号：R73[医药卫生—肿瘤]