Performance verification of the detection of serum copper in Roche Cobas 8000 automatic biochemical analyzer / 中国基层医药

ABSTRACT

Objective To evaluate the performance verification of serum copper detected by Roche Cobas 8000 automatic biochemical analyzer.Methods Referring to CLSI files and other documents,the precision,accuracy,analysis of measuring range and reference interval of serum copper from Roche Cobas 8000 automatic biochemical analyzer were verified.Results The coefficient of variations (CV) of within-run precision with high and low values were 2.96％,2.91％,respectively;CV of the between-run precision with high and low values were 3.07％,2.99％,respectively,which were all less than the CV provided by the manufacturer (10.00％).The bias between detection results and target value were 1.78％ and 1.56％,respectively,which were all within the measurement range of quality assessment.Analysis of measuring range of the detected items was in line with the linear range provided by the specification.The quotative biological reference range conformed to the group of this laboratory services.ConclusionThe main analytic characteristic of serum copper measurement by Roche Cobas 8000 automatic biochemical analyzer is consistent with acceptable quality standards,and the experimental evaluation project of CLSI shows maneuverability and practicability.