HCMV-IgM室内质控物的研制及其临床应用  

Development and Application of Indoor Quality Control Substance for HCMV-IgM

作　　者：丁华[1] 何维娜[1] 华建江[1] 陈望[1] 许瑞娜[1] 陈伟光[1] 熊远香[1] 

机构地区：[1]广州医科大学附属深圳沙井医院检验科,广东深圳518104

出　　处：《标记免疫分析与临床》2015年第3期226-229,共4页Labeled Immunoassays and Clinical Medicine

基　　金：深圳市宝安区科技计划项目(2013152)

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;HCMVIgM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。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-Ig M 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-Ig M 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.

关 键 词：HCMV-IgM抗体 优生优育 室内质控物 稳定性 

分 类 号：R392[医药卫生—免疫学] R446.6[医药卫生—基础医学]