摘要
目的探讨不同生化分析仪检测结果的可比性和临床可接受性。方法以罗氏试剂、罗氏cfas校准液、罗氏7600全自动生化分析仪为标准检测系统,标佳试剂及自带校准液、雅培AEROSET全自动生化分析仪为待检测系统(以下简称雅培A),德赛试剂及自带校准液、另一台雅培AEROSET全自动生化分析仪为另一待检测系统(以下简称雅培M)。用罗氏7600、雅培A和雅培M 3个检测系统同时测定40份新鲜人血清的总蛋白(TP)、肌酐(Cr)两项生化指标,并将所得结果根据NCCLS提供的标准化文件EP9-A中的对比方法进行线性回归分析。结果同一新鲜混合血清在3台仪器上检测CV均小于2.5%,精密度良好,结果稳定;两个项目的相关系数R2>0.95,说明各检测系统有良好的线性和相关性;A系统TP在各医学决定水平处和Cr在医学决定水平中值处SE%<1/2CLIA′88允许误差(Ea%),M系统Cr在医学决定水平高值处的SE%<1/2CLIA′88 Ea%,偏倚可接受;其余值则均大于1/2CLIA′88 Ea%。结论实验室内对比试验能有效对实验室检测能力进行质量监控,实验室其他项目对比工作需不断完善。
Objective To study the comparability and clinical acceptability of the results detected by different biochemistry analytical systems .Methods Detection reagents ,cfas calibration solution and 7600 automatic biochemi-cal analyzer of Roche company were taken as standard detection system （Roche 7600 system） .One experiment system （Abbott A system） included detection reagents and calibration solution of Biaojia company ,and AEROSET automatic biochemical analyzer of Abbott company .The other experiment system（Abbott M system） included detection rea-gents and calibration solution of Desai company ,and another AEROSET automatic chemical analyzer .Levels of total protein（TP） and creatinine（Cr） in 40 fresh serum samples were detected by the three systems ,and the results were analyzed by linear regression analysis ,according to EP9-A document of Clinical and Laboratory Standard Institute （CLSI） .Results Coefficient of variability of the results detected by the three systems was less than 2 .5% ,with fine precision and stability .Correlation coefficients （R2 ） of TP and Cr were both more than 0 .95 ,indicating that there were fine linearity and correlation between the three systems .System error（SE% ） of TP detected by Abbott A sys-tem at various medical decision levels （MDL） and SE% of Cr detected at mid-value of MDL ,and SE% of Cr detected by Abbott M system at high-value of MDL were all less than the half value of allowed error （Ea% ） ruled in Clinical Laboratory Improvement Amendments of 1988（CLIA′88） ,indicating that the bias were acceptable .Other SE% val-ues were more than the half value of Ea% ruled in CLIA′88 .Conclusion Internal comparative tests in laboratory might be helpful for the quality monitoring of the performance of detection .
出处
《检验医学与临床》
CAS
2014年第9期1213-1214,1216,共3页
Laboratory Medicine and Clinic
关键词
比对试验
医学决定水平
生化分析仪
Comparison method
M edical decision level
Biochemical analyzer
