同室2台全自动生化分析仪常规项目检测结果比对和偏差评估

Routine item test results comparison and deviation assessment between the two automatic biochemical analyzers in the same room

目的通过对本实验室OLYMPUS AU640和BECKMAN AU5821全自动生化分析仪部分项目检测结果进行比对和偏差评估,探讨2台生化分析仪检测结果是否具有可比性。方法参考美国临床实验室标准化委员(NCCLS)的EP9-A2文件要求,分别在2台仪器上测定新鲜临床混合血清和质控血清,以OLYMPUS AU640为参考仪器,BECKMAN AU5821作为比对仪器,利用相关回归分析和配对t检验对相同项目的检测结果进行比对和偏差评估,以美国临床实验室改进修正案能力验证(CLIA′88)允许总误差的1/2为标准,评价检测结果是否具有可比性。结果 2台生化分析仪的大部分检测结果具有较好的一致性。结论通过对不同生化分析仪测定结果进行比对和偏差分析,可以验证相同项目检测结果间的相关性,有助于对仪器评价、校正,以满足临床需求。

Objective According to the comparison and deviation assessment of the part item test results between the OLYMPUS AU640 and BECKMAN AU5821 automatic biochemical analyzer in the laboratory,explore whether the test results between the 2 biochemical analyzers is comparable or not.Methods Reference EP9-A2 file requirements of the American Clinical Laboratory Standardization Committee（NCCLS）,test the fresh clinical mixed serum and quality control serum in the 2 equipments respectively,the OLYMPUS AU640 is the reference equipment,the BECKMAN AU5821 is alignment equipment,using regression analysis and paired t test to compare the test results and deviation assessment of the same item,the standard is 1/2 of the total error which the American clinical laboratory improvement amendment（CLIA′88）allowed,evaluate test results whether is comparable or not.Results Most test results showed good consistency between the 2 biochemical analyzers.Conclusion Through the comparison and deviation assessment in the different biochemical analyzers,the correlation of the same test results can be validated,it is useful to evaluate and correct the equipment,and meet the needs of the clinical.