中国免疫学杂志2012，Vol.28Issue(4)：351-354,4.DOI:10.3969/j.issn.1000-484X.2012.04.015
柯萨奇病毒A组16型抗原的ELISA定量检测方法建立
Development of a quantitative ELISA detection method for Coxsackievirus A group 16 strain (CA16) antigen
贾继宗 1韩金乐 1杨亮 1李川 2何德磊 2张娜 1陈芹芹 1叶祥忠 1李益民1
作者信息
- 1. 泰生物药业股份有限公司,北京,102206
- 2. 厦门大学生命科学学院国家传染病诊断试剂与疫苗工程技术研究中心,厦门,361005
- 折叠
摘要
Abstract
Objective:To develop an a quantitative enzyme linked immunosorbent assay (Q-ELISA) to determine the concentration of Coxsackievirus A Group 16 Strain ( CA16) antigen. This method was used to determine CA16 antigen content at each stage of CA16 vaccine developing and manufacturing process. Methods:A double antibody sandwich Q-ELISA was developed to determine concentration of CA16 antigen,which was based on the high-affinity neutralizing monoclonal antibodies T26H12 as capture antibodies ,and NA14B9 as HRP-labeled antibody. The performance of reagent were evaluated. ResultS;The Q-ELISA for CA16 antigen content was successfully developed. The reagent had good performance. The quantitation scope was 8-128 ng/ml, the coefficient correlation was 0. 998, the limit of detection was 8 ng/ml,the recovery was between 87% and 113. 8% . The stability was up to 80% after reagent was heated for 6 days at 37℃ . The variation coefficient was lower than 15% ,and thereagent was no reaction with other sample except CA16 antigen. Conclusion;The Q-ELISA for CA16 antigen was developed with good specificity, accuracy, precision and stability. The method can be used to determine CA16 antigen content during development and production of CA16 vaccine.关键词
柯萨奇病毒A组16型/抗原/双抗体夹心ELISAKey words
Coxsackievirus A Group 16 Strain (CA16) / Antigen/ Double antibody sandwich ELISA分类
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贾继宗,韩金乐,杨亮,李川,何德磊,张娜,陈芹芹,叶祥忠,李益民..柯萨奇病毒A组16型抗原的ELISA定量检测方法建立[J].中国免疫学杂志,2012,28(4):351-354,4.
