摘要
目的:通过对雅培I2000型化学发光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:雅培ARCHITECT 12000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 Abbott I2000 chemiluminescence analyzer for determining carcinoembryonic antigen,and to verify the evaluation program and the experimental method by the performance of methodolgy of clinical immunological quantitative detection emthods.Methods：According to a method by CLSI ercommended,the precision,accuracy,linear range,reportoble range and analytical sensitivity（lowest detectable limit） of carcinoembryonic antigen were determined .Biological reference interval and carryover indicators were verifide.Results：The results of the performance of methodology were consistent with accuracy claimed by manufacturers.Biological reference interval was not affected by the environment and population.Conclusions：The abbott I2000 chemiluminescence analyzer can meet the requirements of clinical testing.The evaluation program is scientific and reliable;data provided by the manufacturers should be verificated first before using.
出处
《内蒙古医学杂志》
2011年第4期416-418,共3页
Inner Mongolia Medical Journal
关键词
肿瘤标记物
方法学性能
评价
Tumor Markers
Performance Methodology
Evcluation
