Methodological Evaluation of Abbott I2000 Chemiluminescence Analyzer for Determining Carcinoembryonice Antigen

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.