BECKMAN LX-20系统与ROCHEP800系统比对分析及校准  

Comparative analysis and calibration of BECKMAN LX-20 system and ROCHE P800 system

作　　者：葛玲[1] 程训民[1] 张琪[1] 

机构地区：[1]安徽省淮北市人民医院检验科,235000

出　　处：《检验医学与临床》2014年第A01期65-67,共3页Laboratory Medicine and Clinic

摘　　要：目的对罗氏MoudularP800和BeckmanLx-20两种全自动生化系统酶学测定结果一致性的比对，探讨不同溯源的生化检测系统间酶类项目检测结果可比性，其误差是否能被11盏床所接收。方法参照美国临床实验室标准化委员会（CLSI）的EP5-A及EP9-A文件要求，以MoudularP800为参比系统，BeckmanLx-20为实验系统，用患者的新鲜血清和质控物分别在两台仪器上测定丙氨酸氨基转移酶（ALT）、天门冬氨酸氨基转移酶（AST）、γ-谷胺酰转肽酶（GGT）、碱性磷酸酶（ALP）、磷酸肌酸激酶（cK）、乳酸脱氢酶（LDH）6个酶类项目，计算相关系数、直线回归方程及两系统之间的相对偏差（SE％），分析比对两生化系统测定结果，以允许误差范围在1／2CLIA’88内为标准，判断两系统6个酶类项目的偏差能否被临床接受。结果Moudular P800和BeckmanLx-20两生化系统精密度均达到质量要求，6个比对项目，仪器校正前ALP、GGT偏差超出临床可接受范围（SE％分别是28．81％、23．53％），仪器校正后两系统测定结果的偏差均被临床接受。结论MoudularP800和BeckmanLx-20可以通过比对分析与校准，实现两系统酶测定结果的一致性，能满足临床的需要。Objective Two kinds of automatic biochemical systems（Roche Moudular PS00 and Beckman Lx- 20） measure enzymatic assay, Compare the consistency of result. Explore different biochemical detection systems traceable enzymes project test results comparable,whether the error could be received by clinical. Methods Accord- ing to the United States of America Committee for clinical laboratory standards（CLSI） EP5-A and EPg-A documents,using Moudular P800 as the reference system,Beckman Lx-20 as experimental system,the determination of ALT, AST, ALP, GGT,CK, LDH in the two instruments were used in patients with fresh serum and quality control, calculation of correlation coefficient, linear regression equation, the relative deviation （SE%）, With Moudular P800 and Beckman Lx-20 two kinds of automatic biochemical systems measure alanine aminotransferase（ALT）, aspartate aminotransferase（ AST）, gamma- glutamyltranspeptidase （GGT）, alkaline phosphatase （ ALP）, creatine phosphokinase （CK） ,lactic dehydrogenase（LDH） ,compare the consistency of result. Compared different biochemical detection systems traceable enzymes project test results. In the allowable error range in 1/2 CLIA t88 as the standard, determine two biochemical system deviation detection results could be clinically accepted. Results Moudular PS00 and Beckman Lx-20 all meeted the quality requirements of precision, before the instrument calibration,ALP, GGT deviation exceeds clinically accepted range（SE respectively 28.81 %, 23.53 %）, when the instrument was calibrated, the measurement result of two systems could be accepted by clinical. Conclusion Moudular P800 and Beckman Lx-20 through comparison analysis and calibration, to achieve consistent results,meet the clinical needs.

关 键 词：检测系统 比对 酶 一致性 偏差 

分 类 号：R446.112[医药卫生—诊断学]