Objective:To evaluate the precision

accuracy

and lower limit of detection of the qualitative test of HBV markers to provide a basis for the selection of acceptable method and reagents.Methods:ELISA was used in our laboratary for HBV markers.The within-run precision of 40 samples were evaluated.The between-run precision of 120 samples of IQC were evaluated.The concordance rates of positive and negative of 120 samples of IQC were counted.The coincidence rate of positive and negative of 165 samples of EQC in three years were counted.The experiment to evaluate the lower limit of detection of reagent used gradient dilution method to dilute valued serum.And the lower limit of detection is the lowest concentration at which maker could be examined qualitatively.Results:The within-run precision

the between-run precision

and the coincidence rates of positive ≥ 95%

and negative of 160 cases were all ≥ 95%;The coincidence rates of positive and negative of 165 cases were both 95%

and Kappa was≥ 0.75.The lower limit of detection of HBSAg

HBSAb

HBeAg

HBeAb

HBcAb were 0.6 IU/ml

20 MIU/ml

2 NCU/ml

3 NCU/ml and 0.5 NCU/ml respectively.Conclusion:The precision

accuracy and lower limit of detection of the test of HBV markers in our lab all can meet the requirements of the detection performance and the need of clinical purpose.