中文摘要：

目的：研制优生优育项目TORCH-IgM特异性抗体（即CMV-IgM，TOX-IgM，RV-IgM，HSV-IgM）室内质量控制物的制备方法及在临床免疫实验室室内质量控制中的应用。方法收集孕妇CMV-IgM，TOX-IgM，RV-IgM和HSV-IgM抗体检测全部阴性的混合血清，一部分作为阴性质量控制物，另一部分加入适量以上4种抗体均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TORCH-IgM弱阳性室内质量控制物，分别保存于室温、4℃、-20℃、-80℃，每天各监测1次，连续监测1年，以评价其稳定性和应用效果。结果自制的TORCH-IgM室内质量控制物浓度处于试验方法的弱阳性水平，其稳定性较好，可验证检测试剂的灵敏度；阴性质量控制物不含TORCH-IgM 抗体，可验证该检测试剂的特异性；TORCH-IgM 定性试验质量控制物在室温条件下，至少可稳定30 d，4℃条件下，至少可稳定60 d，-20℃和-80℃条件下，均可稳定365 d以上。结论自制TORCH-IgM定性试验室内质量控制物，经济、便捷、稳定，可以满足临床免疫实验室室内质量控制的要求，具有较好的临床应用价值。

英文摘要：

Objective To research a method to make a piece of control substance for the critical value of TORCH-IgM（CMV-IgM, TOX-IgM, RV-IgM, HSV-IgM） antibodies,which related to bearing and rearing better children, and the application of control substance in the indoor quality control of clinical immunology laboratory. Methods To collect the pregnant women mixed serum, the CMV-IgM, TOX-IgM, RV-IgM and HSV-IgM antibodies of which were negative. One part were used as negative qulity control, another part added to above four postive pooled serum to prepare the required concentration, the protein stabilization reagents and sodium azide were added in the solution. Then the indoor quality control substance of the critical value of TORCH-IgM came into being, respectively saved at the room temperature, 4 ℃, -20 ℃ and -80 ℃, tested every day, to evaluate the stable and efficacy by one year′s continuous monitoring. Results The concentration of the homemade indoor quality control of TORCH-IgM was clinical critical level, quality control had good instability, could validate the sensitivity for the detection reagents; The negative quality control substance had no TORCH-IgM antibodies, could validate the specificity for the detection reagents. The negative quality control substance had a service life of 30 d at least when the ambient temperature was the room temprature , 60 d at least in 4℃, 365 d at least in-20 ℃and-80 ℃. Conclusion To prepare the homemade qualitative indoor quality control of TORCH-IgM was economic, convenient, stable, it can meet the requirement of the indoor quality control of the clinical immunology laboratory,and had significant value in clinical application.