文章摘要
权娅茹,陈震,邱平,任晋楷,万文妍,李长贵,陈国庆.评价水痘-带状疱疹病毒抗体的新型酶联免疫吸附方法[J].中国药事,2024,38(8):899-905
评价水痘-带状疱疹病毒抗体的新型酶联免疫吸附方法
New Enzyme-linked Immunosorbent Assay for Detection of Antibody to Varicella-zoster Virus
投稿时间：2024-03-04  
DOI：10.16153/j.1002-7777.20240166
中文关键词: 水痘  糖蛋白  酶联免疫吸附方法  血清学评价
英文关键词: varicella  glycoproteins  ELISA method  serological evaluation
基金项目:国家科技重大专项-国家重大新药创制（编号 2018ZX09101001-002）
作者单位
权娅茹 中国食品药品检定研究院，北京 102629 
陈震 中国食品药品检定研究院，北京 102629 
邱平 中国食品药品检定研究院，北京 102629 
任晋楷 北京万泰生物药业股份有限公司，北京 102206 
万文妍 中国食品药品检定研究院，北京 102629 
李长贵 中国食品药品检定研究院，北京 102629 
陈国庆 中国食品药品检定研究院，北京 102629 
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中文摘要:
      目的：水痘-带状疱疹病毒（VZV）糖蛋白已被证明是高度准确的VZV特异性免疫指标。本研究以重组蛋白作为包被抗原建立了酶联免疫吸附方法（ELISA），用于评价水痘疫苗接种后的血清抗体水平。方法：筛选ELISA包被抗原，以重组蛋白gE和gB作为包被抗原，W1044国际参考品作为标准品，初步建立VZV抗体的ELISA法并对其进行验证。将建立的ELISA法与膜抗原荧光抗体（FAMA）法进行比对。结果：以gE和gB作为包被抗原，成功建立了ELISA方法，采用线性拟合，标准曲线在抗体浓度0.25~4 mIU·mL-1范围内具有良好的线性关系，R2＞0.990，回收率为85%~120%，定量限为0.25mIU·mL-1，精密度CV＜15%，特异性良好。与FAMA法相比，ELISA法的灵敏度为89%，特异性为93%，总符合率为90%。结论：本课题成功建立了VZV抗体ELISA检测方法，可作为一种灵敏、特异的水痘疫苗临床血清评价方法。
英文摘要:
      Objective: Varicella-zoster Virus (VZV) glycoproteins are the antigens that have been demonstratedto be a highly accurate indicator of VZV-specific immunity. This study established an enzyme-linkedimmunosorbent assay (ELISA) using recombinant glycoproteins as the coated antigens for evaluation of theserum antibody level after varicella vaccination. Methods: The ELISA coated antigen was screened, and thenthe recombinant proteins gE and gB were used as the coated antigens, and the W1044 international referencesubstance was used as the standard, and the ELISA method of VZV antibody was preliminarily establishedand verified. The established ELISA method was compared with the fluorescent antibody to membrane antigen(FAMA) method. Results: Using gE and gB as coated antigens, ELISA method was successfully established.Using linear fitting, the standard curve showed a good linear relationship within the antibody concentration rangeof 0.25-4 mIU·mL-1, R2＞0.990, with 85%-120% recovery rate, 0.25 mIU·mL-1 limit of quantification, and lessthan 15% of precision CV. Compared with the FAMA method, the ELISA showed a sensitivity of 89%, specificityof 93% and overall conformity rate of 90%. Conclusion: This study successfully established a VZV antibodyELISA detection method, which can be used as a sensitive and specific quantitative method to evaluate clinicalserum antibody level after varicella vaccination.
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