Abstract：Objective To develop a method to make a piece of control substance for HCMV-IgM antibodies and the application of control substance in the indoor quality control of clinical immunology laboratory. Methods The HCMV-IgM antibodies in pregnant women were detected by ELISA and the HCMV-IgM antibodies negative serum were collected and mixed. One part of mixed serum was used as negative quality control, the other part serum were added with HCMV-IgM antibodies postive serum to prepare the required concentration samples. The protein stabilization reagents and sodium azide were added into the solution to make indoor quality control substance of HCMV-IgM antibodies. The samples were saved at room temperature, 2-8℃ and -70℃ and tested every day to evaluate the stability and efficacy with one year continuous monitoring. Results The homemade indoor quality control of HCMV-IgM had good stability. It was used to validate the sensitivity for the detection reagents. The negative quality control substance had no HCMV-IgM antibodies. The negative quality control substance were stable for 35, 80 and 365 days at room temperature, 2-8℃ and -70℃ respectively. Conclusion The homemade indoor quality control of HCMV-IgM is stable for one year stored at -70℃ and could meet the requirement for clinical immunology laboratory, and have significant value in clinical application.