检验医学与临床Issue(9)：1213-1214,1216,3.DOI:10.3969/j.issn.1672-9455.2014.09.027
生化分析系统的可比性研究
Comparability of different automated biochemistry analytical systems
暴旭广 1吕亚梅1
作者信息
- 1. 广东省广州市珠江医院检验医学部 510282
- 折叠
摘要
Abstract
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 .关键词
比对试验/医学决定水平/生化分析仪Key words
Comparison method/M edical decision level/Biochemical analyzer引用本文复制引用
暴旭广,吕亚梅..生化分析系统的可比性研究[J].检验医学与临床,2014,(9):1213-1214,1216,3.
