Preliminary functional evaluation on self-built and matching biochemistry detection system by NCCLS EP10-A2

Objective To evaluate the preliminary function on self-built and matching biochemistry detection systems respectively.Methods The self-built detection system(OLYMPUS AU 400 biochemistry analyzer,Roche cfas calibrator and homemade reagents) and the matching detection system(OLYMPUS AU 400 biochemistry analyzer,OLYMPUS calibrator and OLYMPUS reagents) were applied into the determination of aspartate aminotransferase(AST),glucose(Glu),gamma-glutamyltransferase(GGT) and alanine aminotransferase(ALT) according to the Protocol EP10-A2 provided by National Committee for Clinical Laboratory Standards(NCCLS).The deviations,total imprecision,intercepts,slope rates,nonlinearities,carryovers and drifts were calculated and compared with the range of set value.Results For the data of self-built system,the low value of ALT,middle and high values of Glu in deviations and low value of ALT in total imprecision exceeded permissive ranges,and the other deviations and total imprecision were all in the permissive ranges,among which the nonlinearities,intercepts and slope rates of GGT and ALT showed significant difference,as well as the slope rate of Glu.No significant difference was showed in other intercepts,slope rates,nonlinearities,carryovers and drifts.For the data of matching system,the low value of ALT in total imprecision was out of the permissive range with the other deviations and total imprecision were all in the permissive ranges.The intercept and slope rate of GGT had significant difference with the other intercepts,slope rates,nonlinearities,carryovers and drifts showing no significant difference.Conclusions The self-built system,which is applied to detect AST,GGT and ALT,and matching biochemistry system,which is applied to detect AST,Glu,GGT and ALT,have shown the deviations in permissive ranges.The total imprecisions are all less than 1/3 the Clinical Laboratory Imptovement Amendments 88(CLIA′88) with low carryovers and good stabilities.Furthermore,the accuracy of self-built system used to detect Glu should be improved further.