| 人用狂犬病疫苗ELISA快速鉴别试验的建立及验证 |
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| 引用本文： | 曹守春,唐建蓉,胡巧玲,徐葛林,李加,吴小红,刘景华,曲小肃,石磊泰,董关木. 人用狂犬病疫苗ELISA快速鉴别试验的建立及验证[J]. 药物分析杂志, 2011, 0(9) |
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| 作者姓名： | 曹守春 唐建蓉 胡巧玲 徐葛林 李加 吴小红 刘景华 曲小肃 石磊泰 董关木 |
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| 作者单位： | 中国药品生物制品检定所;武汉生物制品研究所; |
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| 基金项目： | “艾滋病和病毒性肝炎等重大传染病防治”科技重大专项(项目批准号:2009ZX10004-804) |
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| 摘 要： | 目的:建立人用狂犬病疫苗快速鉴别试验并进行验证。方法:采用双抗体夹心ELISA,以4株抗狂犬病毒核蛋白单抗包被微孔板,通过捕捉检品中狂犬病病毒核蛋白进行快速鉴别试验,对该方法进行特异性、灵敏度、重复性和适用性验证。结果:采用双抗体夹心ELISA进行鉴别试验,验证结果显示该方法具有较高的特异性和灵敏性,RSD<15%,对于不同疫苗生产毒株均可有效鉴别。结论:双抗体夹心ELISA可以替代传统效力试验对人用狂犬病疫苗进行快速鉴别。
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| 关 键 词： | 生物制品 疫苗 狂犬病 鉴别 酶联免疫吸附试验 验证 |
Establishment and validation of the rapid identification test on rabies vaccine by ELISA methods |
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| CAO Shou-chun,TANG Jian-rong,HU Qiao-ling,XU Ge-lin,LI Jia,WU Xaio-hong,LIU Jing-hua,QU Xiao-su,SHI Lei-tai,DONG Guan-mu. Establishment and validation of the rapid identification test on rabies vaccine by ELISA methods[J]. Chinese Journal of Pharmaceutical Analysis, 2011, 0(9) |
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| Authors: | CAO Shou-chun TANG Jian-rong HU Qiao-ling XU Ge-lin LI Jia WU Xaio-hong LIU Jing-hua QU Xiao-su SHI Lei-tai DONG Guan-mu |
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| Affiliation: | CAO Shou-chun1,TANG Jian-rong1,HU Qiao-ling2,XU Ge-lin2,LI Jia1,WU Xaio-hong1,LIU Jing-hua1,QU Xiao-su1,SHI Lei-tai1,DONG Guan-mu1(1.National Institute for the Control of Pharmaceutical and Biological Products,Beijing 100050,China,2.Wuhan Institute of Biological Products,Wuhan 430060,China) |
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| Abstract: | Objective:To establish and validate a method of rapid identification testing of rabies vaccine for human use which in order to replace the previously methods.Method:To set up the double-antibody sandwich ELISA methods that coated microplates by four strain monoclonal antibodies against rabies virus nucleoprotein.Then validate the method by specificity,sensitivity,repeatability and applicability.Results:The results of validiation show that the ELISA method had high specificity,and sensitivity.The RSD was les... |
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| Keywords: | biological vaccine rabies identification test ELISA validation |
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