Evaluation on the performance of the Olympus AU5400 automatic biochemistry analyzer

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 by the CLSI EP5-A2 document and CLSI EP9-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(r20.95)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(r20.95);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.