叶珂;张志高;何春辉;方浩霖;林冠峰;卞论;许四宏;吴英松;

• 1:南方医科大学检验与生物技术学院广东省高等学校抗体工程重点实验室
• 2:中国食品药品检定研究院
• 3:广州诺诚生物制品有限公司

摘要(Abstract)：

为狂犬疫苗生产质量控制建立简便、高效、精准的糖蛋白体外效力分析方法,研制适用于狂犬疫苗生产质量控制的狂犬病毒糖蛋白酶联免疫吸附(ELISA)定量分析试剂。采用双抗体夹心法建立狂犬病毒糖蛋白ELISA定量分析体系,优化反应各项参数后考核试剂性能。线性范围为1～180 mIU/mL,灵敏度为0.4497 mIU/mL,分析内变异系数为5.8%～8.2%,分析间变异系数为7.2%～14.4%。用自制试剂与National Institutes of Health(NIH)动物法平行检测10份疫苗相关样品,两种方法测定结果的相对系数r2为0.8943,相关性良好。自制ELISA试剂各项性能指标良好,且与NIH动物法检测结果相关性良好,有望推广用于狂犬疫苗生产质量控制。

关键词(KeyWords)： 狂犬疫苗;糖蛋白;质量控制;双抗体夹心酶联免疫吸附试验(ELISA)

Abstract:

Keywords:

基金项目(Foundation): 广州市协同创新重大专项（项目号：201400000004-1），题目：重大传染病创新检测试剂的研制和应用研究~~

作者(Authors): 叶珂;张志高;何春辉;方浩霖;林冠峰;卞论;许四宏;吴英松;

DOI: 10.13242/j.cnki.bingduxuebao.003940

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