罗氏e601型电化学发光分析仪测定癌胚抗原的方法学性能评价

Methodology performance of Roche e601 electrochemical illuminescent analyzer for determining carcinoembryonic antigen

目的通过对罗氏e601型电化学发光分析仪测定癌胚抗原的方法学性能评价，探讨临床免疫学定量检测的方法学性能验证评价方案和实验方法。方法按照CLSI推荐的方法测定癌胚抗原的精密度、正确度、线性范围和可报告范围、分析灵敏度（最低检测限）、生物参考区间的验证、携带污染率指标进行验证。结果癌胚抗原的方法学评价结果在厂家提供的范围之内，癌胚抗原的生物参考区间范围不受地区和人群等因素的影响。结论罗氏e601型电化学发光分析仪检测系统性能能满足临床要求，评价方案科学可靠，厂家提供的数据必须经验证后才能引用。

Objective To evaluate the performance methodology of Roche e601 electrochemical illumineseent analyzer for determining eareinoembryonie antigen , and to verify the evaluation program and the experimental method by the performance of methodology of elinleal immunological quantitative detection emthods. Methods According to a method by CLSI ereommended, the precision , aeeuraey,linear range , reportoble range and analytieal ~nsifivity（lowest detectable limit） of eareinocmbryonie antigen were determined. Biological reference interval and carryover indicators were verified. Results The results of the performance of methodology were consistent with accuracy claimed by manufacturers. Biologieal reference interval was not -fleeted by the environment and population. Conclusions The Roche e601 eleetroehemieal illuminescent analyzer can meet the requirements of clinical testing. The evaluation program is seientifie and reliable ; data provided by the manufacturers should be verlfleated first before using.