摘要:目的 探讨人巨细胞病毒IgM特异性抗体（HCMV-IgM）室内质控物的制备方法及其临床应用。方法 用酶联免疫法检测孕妇HCMV-IgM抗体，收集检测结果全部阴性的混合血清，一部分作为阴性质控物，另一部分按比例加入适量HCMV-IgM抗体阳性的混合血清配制成所需浓度，加入蛋白稳定剂和叠氮钠，制备出HCMV-IgM室内质控物，分别保存于室温、2～8℃、-70℃，每天各监测一次，连续监测一年，以评价其稳定性和临床应用效果。 结果 自制的HCMV-IgM室内质控物稳定性很好，可验证检测试剂的灵敏度；阴性质控物不含HCMV-IgM抗体，可验证该检测试剂的特异性；HCMV-IgM室内质控物在室温、2～8℃和-70℃条件下，分别可稳定35天、80天和365天。结论 自制HCMV-IgM室内质控物，-70℃条件下保存稳定性最佳，能满足实验室室内质量控制的要求，使检测结果准确可靠，对优生优育具有重要临床应用价值。

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.