Evaluation of detection performance of DXI800 chemiluminescence analyzer according to EP10-A2 document of CLSI

Objective To evaluate the detection performance of DXI800chemiluminescence analyzer(DXI800 analyzer)according to EP10-A2document of Clinic and Laboraroty Standard Institute(CLSI).Methods According to EP10-A2document,human growth hormone(hGH)in quality control serum were continuously detected for five days with a certain order,then the deviation,total imprecision,intercept,slope rate,non-linearity,cross-contamination and drift were analyzed by using Microsoft Excel software.Results The linearity between measured value and target value was relatively well(Y=0.992 X+0.083,r2=0.978)when the concentrations of hGH were 2.15,5.47 and 10.80mmol/L,with bias of 0.066,0.265and 0.055 mmol/L,and total imprecision of 6.57%,8.53% and 4.56%,respectively.Simple sample t test indicated that the difference of intercept,slope rate,non-linearity,crosscontamination and drift was no statistically significant(P0.05).Conclusion The deviation,total imprecision,intercept,slope rate,non-linearity,cross-contamination and drift of DXI800analyzer might be within permission limit,and could satisfy the request of clinical application and scientific research of hGH.