Olympus AU5400生化分析仪性能的评价

Evaluation on the performance of the Olympus AU5400 automatic biochemistry analyzer

目的对Olympus AU5400生化分析仪主要性能进行评价,判断其是否能够满足本实验室需求。方法依照实验室管理办法及国家实验室认可的要求,分别采用美国临床和实验室标准协会(CLSI)的EP5-A2、EP9-A2、和EP6-A文件评价方法分析丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、梅毒螺旋体(TP)、空腹血糖(Glu)、钾(K+)、钠(Na+)的精密度、准确度和线性;并对各检测项目引用的参考区间进行验证。结果Olym-pus AU5400生化分析仪ALT、AST、TP、Glu、K+、Na+高、低两水平批内精密度变异系数(CV)均小于或等于1/4CLIA′88,总精密度CV均小于或等于1/3CLIA′88;在比对试验中,Olympus AU5400两个单元ALT、AST、TP、Glu及K+、Na+与Olympus AU640检测系统呈明显相关,相关系数r2>0.95,各检测项目在其医学决定水平上的相对偏倚均小于或等于1/2CLIA′88;Olympus AU5400两个单元ALT、AST、TP、Glu线性良好(r2>0.95);各检测项目引用的参考区间合适。结论Olympus AU5400生化分析仪性能满足本实验室需求。

Objective To analyze the performance characteristics of Olympus AU5400 biochemistry analyzer, and to identify whether the performance is acceptable for the goals of laboratory performance. Methods In accordance with the clinical laboratory principle and the requirement of accreditation of national laboratory, the precision and accuracy of the 6 test methods （ALT, AST, TP, Glu, K＋ , Na＋ ） were identified hy the CLSI EP5-A2 document and CLSI EPg-A2 document;According to CLSI EP6-P document, the linear range of ALT,AST,TP and Glu in the two unites were analyzed,validating the reference range of the 6 test methods. Results The within-batch precision of ALT,AST,TP,Glu,K^＋ ,Na＋ are lower than that of the quarter of CLIA＇88 and the total precision are lower than one-third of CLIA＇88;the correlation of the 6 test methods between the two unites of the Olympus AU5400 systems and the Olympus AU640 systems was fairly good（r2〉0.95） in the method comparison test,and the relative biases of all items could be accepted at different medical determinate level according to the half of CLIA＇88 standard;The linearity of ALT, AST,TP, Glu in two unites of the Olympus AU5400 systems was also good in the linear range （r2 〉0. 95） ;The reference range of the 6 test methods cited in our laboratory were satisfied. Conclusion The Olympus AU5400 automatic biochemistry analyzer satisfy the needs of the laboratory performance.