Study on comparability of measured values of serum enzymes by Copas500 and Olympus640 detection systems

Objective To conduct the bias evaluation and methodological comparison on detection results of serum enzymes by different detection systems in different laboratories and to study the comparability of serum enzymes detection results between different detection systems to provide the basis for the mutual recognition of measured results in different laboratories.Methods According to the stipulation of EP9-A2 on the United States Committee for Clinical Laboratory Standards(NCCLS),the different detection systems were compared. The Roche Cobas500 biochemical analyzer,Roche original reagents,c.f.a.s calibrators and quality controlling products were taken as the target system (comparative method),and the Olympus640 biochemical analyzer as the evaluating system (experimental method).The physiological value(PNU) and pathological value(PPU) in the Roche quality controlling serum and serum enzymes in 45 fresh serum samples were detected by the two different detection systems. The precision of the two systems was evaluated,the relative deviation between the experimental method and comparative method was calculated and the comparability of enzyme detection results between different systems was judged with the permissible error range of 1/2 stipulated by CLIA'88 External Quality Assessment as the standard.Results The difference of enzyme detection results between the two different detection systems had no statistical significance by the paired t test. The systematic error of 5 serum enzymes detection results was clinically acceptable.Conclusion The detection results of 5 serum enzymes by two different detection systems possess the comparability except the high value of ALT. The clinical acceptability is acceptable.