CL-2000i全自动化学发光免疫分析法CEA参考区间适应性验证

Adaptive verification on CEA reference interval of CL-2000i automated chemiluminescence immunoassay

目的:验证深圳迈瑞CL-2000i全自动化学发光检测系统CEA项目参考范围。方法:按不同年龄及性别比例选取合格的健康参考个体3 904名,采用迈瑞全自动发光仪及原装配套CEA试剂进行检测,对结果进行分析。结果:本实验室CL2000i全自动化学发光免疫技术CEA参考区间为0.55~5.17 ng/m L;男女在年龄段资料比较,差异有统计学意义(P<0.01)。结论:厂家提供CEA的参考区间不适用于本地区本实验室,建议使用以上结果建立本实验室的参考值区间。

Objective:To verify the reference range of CEA project of Shenzhen MINDRAY CL-2000i automaticchemiluminescence detection system.Methods:3904healthy reference individuals were selected according to different age andsex ratio.They were tested by MINDRAY automatic luminescence instrument and CEA reagent,then we analyzed their results.Results:The CEA reference interval of CL2000i automatic chemiluminescence immunoassay was0.55～5.17ng/mL,and the dataof male and female in age group was statistically significant(P<0.01).Conclusion:The reference interval provided bymanufacturers is not suitable for the laboratory in this area.We suggested that the reference range of our laboratory should beestablished by using the above results of CEA.