不同全自动生化分析仪血脂检测实验比对和偏倚评估

目的探讨AU5400和AU2700全自动生化分析仪血脂指标检测结果是否具有可比性。方法依据美国临床和实验室标准化协会(CLSI)EP9-A2文件,以美国临床实验室修正法规(CLIA′88)对室间评估允许误差的1/2为临床可接受依据,评价2台生化分析仪血脂指标检测结果的可比性。结果 2台分析仪血脂指标检测结果具有较好相关性(r>0.975),相对偏差均符合CLIA′88要求。结论应对不同分析系统相同指标检测结果进行比对分析及偏倚评估,判断其一致性,以保证检测结果的可比性。

Results comparison and bias estimation between two different biochemical detection systems for serum lipid level

Objective To investigate the results comparability of AU5400 and AU2700 biochemical analysis system for the detection of serum lipids.Methods According to document EP9-A2 of Clinic and Laboratory Standard Institute（CLSI） and taking the half of the allowed total error of Clinical Laboratory Improvement Amendment 88（CLIA′88） as clinically acceptable criterion,the comparability of these two systems for the detection of serum lipids was evaluated.Results There was fine correlation between the detection results of these two systems（r0.975） and the bias was consistent with requirements of CLIA′88.Conclusion Comparative test and bias evaluation of the detected results of the same tests should be performed between different analytical systems,thus to ensure the comparability among test results.