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Development of a sandwich ELISA for the quantification of enterovirus 71
Authors:Shujun Ma  Qunying Mao  Zhenglun Liang  Cuijuan Zhang  Wenxing Yang  Zhe Sun  Haijiang Zhang  Xinliang Shen  Shengli Bi  Le Sun
Institution:1. AbMax Biotechnology Co., LTD, 99 Kechuang 14th St,BDA, Beijing, 101111, China
2. National Institutes for Food and Drug Control, Beijing, 100050, China
3. Beijing Vigoo Biologicals Co., LTD, 4 South San Jian Fan, Beijing, 100024, China
4. Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, 100052, China
Abstract:Since 2008, enterovirus 71 (EV71) has been responsible for high-mortality seasonal epidemics of hand, foot and mouth disease in China. Currently many groups in the world are in the process of developing EV71 vaccines to combat this deadly disease. We have developed three EV71-specific monoclonal antibodies, and in this study we report the establishment of a fast and cost-effective sandwich ELISA kit for measurement of virus concentration in EV71 vaccines using a pair of mouse anti-EV71 monoclonal antibodies. The system is specific for EV71 virus, with no cross-reactivity to coxsackievirus A16, H1N1, rabies, and hepatitis A. Using a reference EV71 vaccine standard, the sensitivity of the assay kit was determined to be 0.82 U/ml, with a linear range between 3.75 and 120 U/ml.
Keywords:Enterovirus (EV) 71  Vaccine  Sandwich ELISA  Quantification
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