不同检测系统间生化检测结果的可比性分析

Comparability analysis on biochemical test results among different kinds of detection systems

目的:通过对不同检测系统进行方法对比分析,探讨各系统检测生化常规结果是否具有可比性。方法:参照美国临床实验室标准化委员会EP9-A文件要求,以可溯源的AU5400全自动生化仪作为目标检测系统,用日立7170A全自动生化分析仪作为自建检测系统,用病人新鲜血清对自建检测系统的10项生化结果与目标系统进行比对,计算自建检测系统(Y)与目标检测系统(X)之间的相对偏差(SE%),以美国临床实验室改进修正方案(CLIA'88)对室间质评的允许误差(Errorallowable,Ea)为判断依据,判断检验结果的可比性。结果:两系统的常规10项生化结果误差临床均可接受。结论:在同一实验室同一检测项目在2个以上的检测系统检测时,应该进行偏倚评估及方法比对试验,从而判断其在临床的可接受性能,用以保证检验结果的可比性。

Objective： To analyze and compare biomedical parameters test results oi dliferent anal- ysis system. Methods： Requirements of the United States Clinical Laboratory Standardization Committee （National Committee for Clinical Laboratory Standards. NCCLS） EP9-A document were used as refer- ence, 10 biomedical parameters of fresh blood samples were detected with AU5400 automatic biochemical analyzer （Y） and Hitachi 7170 A-type automatic Biochemical analyzer （X）, respectively. Relative partial investigation （SE%） between Y and the targeted X were calculated, External Quality Assessment of toler- ances （Errorallowable, Ea） were evaluated with Clinical Laboratory Improvement Amendments to judge the comparability of the test results. Results. Errors in 10 parameters results revealed by the two systems were acceptable. Conclusion. When the same parameters are detected with two different analyzers in the same laboratory, impartial assessment should be conducted to judge its comparability.