Abstract: Objective:To investigate feasibility of the self-made quality control serum as an internal quality control for quantitating HBV DNA. Method:Normal serum and abnormally high levels HBV DNA serum were collected and mixed thoroughly to make HBV DNA quality control serum, then the serum were disinfected and transferred into EP tubes.All the control serum were kept at －20℃ until analyzed.Every one tube of control serum was thawed at room temperature for half hour, then treated and detected like daily clinical samples.The remaining serum were stored at 4℃ and detected within two weeks.Result:The tube-to-tube variation was 1.23%.There was no significant difference among 12 monthly means of control serum(F=1.48,P=0.14). If the recapped control serum was used and stored at 4℃ for two weeks, no significant difference in measurement results was found(4.83±0.20 VS 4.83±0.23,P=0.91). In addition, combining with Levery-Jennings control rules, the self-made control serum could discriminate the events out of control resulted from sample degradation, standard degradation and abnormal amplification efficiency.Conclusion:The self-made HBV DNA control serum was homogeneous and stable, which was stable for 1 year and two weeks at least at -20℃ and 4℃, respectively, therefore, the self-made serum conformed to the requirement as an internal quality control.