狂犬疫苗糖蛋白ELISA定量分析方法的建立及验证Establishment and Verification of ELISA Quantitative Analysis Method for Rabies Vaccine Glycoprotein
叶珂;张志高;何春辉;方浩霖;林冠峰;卞论;许四宏;吴英松;
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)
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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