改良人巨细胞病毒抗体ELISA试剂盒的研制及质量鉴定

Study of rapid IgG/IgM-based ELISA methed for detecting HCMV

目的建立一种快速、稳定、特异、实用的检测抗人巨细胞病毒(HCMV)IgG、IgM抗体的方法。方法对传统间接酶联免疫吸附试验(ELISA法)进行改良,使用自制的抗原并在试剂液中添加吸附剂、保护剂、稳定剂。结果改良的ELISA试剂具有稳定、敏感、特异性强、重复性好等优点,实验温育时间只需40min;对819例婚前查体妇女进行检测,HCMV-IgM阳性率为2.32%,HCMV-IgG阳性率为95.11%。结论本试剂可用于HCMV抗体的检测。

Objective： To establish a rapid IgG/IgM-based ELISA method to detect HCMV. Methods：Traditional ELISA method was modified using domestic antigen, adsorbent, protective agent and stabilizer to improve the stability and specificity in HCMV diagnosis. Results ：The modified ELISA method was sensitive and specific,repeatable and stable. When used in the premarrial health check of 819 women, the positive rates of HCMV-IgM and HCMV-IgG were 2. 320/00 and 95. 11% respectively. Conclusion：The modified ELISA method may be a good tool in HCMV detection.