Performance verification on ROCHE cobas 8000 automatic biochemical analyzer / 国际检验医学杂志

ABSTRACT

Objective To verify the analytical performance of the Roche cobas 8000 automatic biochemical analyzer.Methods The intra-batch and inter-batch precisions,accuracy,linearity and reference interval were validated according to the Clinical and La-boratory Standards Institute (CLSI)documents (EP5-A2,EP15-A2,EP6-A;C28-A2 ).Results The intra-batch precision was 0.5%-2.3% and the inter-batch precision was 0.8%-3.11%,which were all less than 1/4 Tea(CLIA'88).The detection results of various items had better correlation with the target values(r2 >0.99);the linear range of various detected items were in line with the linear range provided by the specification;the quotative biological reference range conformed to the group of this laboratory services.Conclusion The various performance indexes of the Roche cobas 8000 automatic biochemical analyzer conform to the qual-ity requirements and this analyzer can be used in clinical biochemical detection work..