【摘要】 目的探讨实验室内不同自建生化检测系统间检测结果的可比性,为本实验室不同生化检测系统检验结果的互认提供依据。方法参考美国临床实验室标准化委员会(NCCLS)的EP92A2文件,以日立7600检测系统为目标系统,用患者新鲜血清对实验检测系统(东芝40检测系统Y1、日立7180检测系统Y2)的常规生化结果与目标检测系统进行比对,计算实验检测系统(Y1、Y2)和目标检测系统(X)之间的相对偏差,以美国临床医学检验部门修正法规(CLIA′88)允许总误差的1/2为标准,判断检验结果的可比性。结果自建实验检测系统(Y1)的总胆红素、直接胆红素、尿素、肌酐和三酰甘油等项目与目标检测系统不具可比性;实验检测系统Y1和实验检测系统Y2的丙氨酸氨基转移酶和天门冬氨酸转移酶在低值时与目标检测系统不具可比性,因该两种酶的降低在临床上缺乏实际意义,故认为与目标检测系统具有可比性;其余项目在各医学决定水平处的SE%均小于或等于1/2CLIA′88TEa,与目标检测系统具有可比性。结论实验检测系统与目标检测系统的常规生化结果依项目不同存在不同程度的偏差;当用两个以上的检测系统检测同一检验项目时,应进行方法比对和临床可接受性评价,以实现检验结果的可比性。更多还原

【Abstract】 Objective To investigate the comparability of detection results among different self-developed biochemical detection systems and to provide the evidence of the laboratory results inter-accreditation among different biochemical detection systems.Methods In accordance to the document EP9-A2 of NCCLS,we took the Hitachi 7600 detection system as the target system(X),and the TOSHIBA-40 and the Hitachi 7180 detection systems as the testing systems(Y1,Y2).The fresh serum samples of the patients were comparatively measured by the target system and the testing systems.The coefficient and linear equation were used to evaluate the system bias between the target system and the testing systems.And we judged the comparability of different investigating systems with the half of total error permitted by CLIA′88 as standard.Results The results of TBIL,DBil,urea,Cr and TG in the self-developed testing system(Y1) and the target system(X) showed no comparability.The lower level results of ALT and AST in the testing systems(Y1 and Y2) and the target system(X) also showed no comparability.Because the decrease of these two enzymes lacked the practical significance in clinic,therefore the testing systems was considered to possess the comparability with the target system.And SE% of the others biochemical items at their medical decision level for the testing systems(Y1,Y2) was ≤ 1/2 CLIA′88 TEa,showing the comparability with the target system.Conclusion The routine biochemistry results have different degrees of bias between the testing systems and the target system according to different items.When a same item is tested by more than two systems,it is necessary to perform the method comparison and evaluate the clinical acceptability for realizing the comparability of detection results.更多还原