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检测抗水痘-带状疱疹病毒抗体的糖蛋白ELISA的建立和初步验证

  • 董金蓉 易应磊 刘芬 陈则
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  • 200051 上海生物制品研究所有限责任公司第四研究室

网络出版日期: 2025-08-16

基金资助

国家重大新药创制专项(2013ZX09402-302-007);上海市科委科技支撑项目(16431904500)

Establishment and preliminary validation of glycoprotein ELISA for detection of anti-varicella zoster virus antibody 

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  • No4 Research Laboratory, Shanghai Institute of Biological Products Co., Ltd., Shanghai 200051, China

Online published: 2025-08-16

Supported by

National Science and Technology Major Project of China for “Major New Drugs Innovation and Development” (2013ZX09402-302-007);  The Shanghai Municipal Science and Technology Support Project(16431904500)

摘要

目的   建立抗水痘-带状疱疹病毒(varicella zoster virus;VZV)抗体的VZV糖蛋白(glycoprotein,gp)ELISA(VZVgp ELISA),提高抗VZV抗体的检测灵敏度。 方法   将收获的VZV进行超声破碎和亲和层析,得到纯化的VZVgp。以VZVgp作为包被抗原,用筛选的高滴度抗VZV抗体阳性血清摸索ELISA的相关条件来建立VZVgp ELISA,并验证该法的特异性、精密度和灵敏度。同时将建立的VZVgp ELISA与同类进口试剂盒进行比较。结果  成功建立了检测VZV抗体的VZVgp ELISA,该法特异性强、精密度好(变异系数<10%)、灵敏度高,与国外同类试剂盒检测结果间的差异无统计学意义(χ2=1.310,P=0.252)。结论  建立的VZVgp ELISA特异、灵敏,可用于人群血清抗VZV抗体的筛查和VZV感染的流行病学调查。

本文引用格式

董金蓉 易应磊 刘芬 陈则 . 检测抗水痘-带状疱疹病毒抗体的糖蛋白ELISA的建立和初步验证[J]. 国际生物制品学杂志, 2016 , 39(6) : 269 -274 . DOI: 10.3760/cma.j.issn.1673-4211.2016.06.003

Abstract

Objective   To establish glycoprotein ELISA assay for detection of anti-varicella zoster virus (VZV) antibody, in order to improve sensitivity of anti-VZV antibody detection. Methods   VZV glycoprotein (VZVgp) was prepared form harvested VZV by ultrasonication and affinity chromatography. With VZVgp was as coated antigen, and ELISA conditions were found out by using high titer anti-VZV antibody positive serum. The specificity, precision and sensitivity of VZVgp ELISA were validated. Meanwhile, VZVgp ELISA was compared with similar imported kit.  Results  VZVgp ELISA was successfully established and had high specificity, good precision (coefficient of variation<10%) and high sensitivity. The difference of detection results between VZVgp ELISA and imported kit had no statistical significance (χ2=1.310, P=0.252). Conclusion  The established VZVgp ELISA has good specificity and sensitivity, and can be used for screening serum anti-VZV antibody in population and carrying on epidemiological investigation of VZV infection.   
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