Bopei Cui: Divison of Hepatitis Virus and Enterovirus Vaccine, National Institutes for Food and Drug Control, Institute for Biological Product Control , Beijing, China.
Fang Cai: Research and Development Center, Sinovac Biotech Co., Ltd , Beijing, China. ORCID
Fan Gao: Divison of Hepatitis Virus and Enterovirus Vaccine, National Institutes for Food and Drug Control, Institute for Biological Product Control , Beijing, China.
Lianlian Bian: Divison of Hepatitis Virus and Enterovirus Vaccine, National Institutes for Food and Drug Control, Institute for Biological Product Control , Beijing, China.
Ruixia Wu: Research and Development Center, Sinovac Biotech Co., Ltd , Beijing, China.
Ruixiao Du: Divison of Bacterial Vaccine, National Vaccine and Serum Institute , Beijing, PR China.
Xing Wu: Divison of Hepatitis Virus and Enterovirus Vaccine, National Institutes for Food and Drug Control, Institute for Biological Product Control , Beijing, China.
Pei Liu: Divison of Hepatitis Virus and Enterovirus Vaccine, National Institutes for Food and Drug Control, Institute for Biological Product Control , Beijing, China.
Lifang Song: Divison of Hepatitis Virus and Enterovirus Vaccine, National Institutes for Food and Drug Control, Institute for Biological Product Control , Beijing, China.
Lisha Cui: Divison of Hepatitis Virus and Enterovirus Vaccine, National Institutes for Food and Drug Control, Institute for Biological Product Control , Beijing, China.
Yadi Yuan: Divison of Hepatitis Virus and Enterovirus Vaccine, National Institutes for Food and Drug Control, Institute for Biological Product Control , Beijing, China.
Siyuan Liu: Divison of Hepatitis Virus and Enterovirus Vaccine, National Institutes for Food and Drug Control, Institute for Biological Product Control , Beijing, China.
Xiangzhong Ye: Research and Development Center, Beijing Wantai Biological Pharmacy Enterprise , Beijing, China.
Tong Cheng: National Institute of Diagnostics and Vaccine Development in Infectious Diseases, School of Life Sciences, Xiamen University , Beijing, China. ORCID
Qunying Mao: Divison of Hepatitis Virus and Enterovirus Vaccine, National Institutes for Food and Drug Control, Institute for Biological Product Control , Beijing, China. ORCID
Qiang Gao: Research and Development Center, Sinovac Biotech Co., Ltd , Beijing, China.
Zhenglun Liang: Divison of Hepatitis Virus and Enterovirus Vaccine, National Institutes for Food and Drug Control, Institute for Biological Product Control , Beijing, China.
Coxsackievirus A16 (CV-A16), one of major etiological agents of hand, foot and mouth disease (HFMD), causes outbreaks of the disease in young children all over the world. In order to promote the prevention and control of HFMD, the research and development of CV-A16 vaccine have been carried out in China. However, due to lacking of a recognized CV-A16 antigen detection method, the evaluation and quality control (QC) of vaccine effectiveness are greatly limited. In this study, we established a quantitative enzyme-linked immunosorbent assay (Q-ELISA) to determine the antigen concentration in CV-A16 vaccines that can be applied in manufacturing in China. A neutralizing antibody 16E1 was used as a capture antibody that can bind to various CV-A16 antigens of different subgenotypes, and an antiserum from CV-A16-immunized rabbit conjugated by HRP was suitable for detecting and quantifying CV-A16 antigens. The Q-ELISA was validated for specificity, linearity, accuracy, precision and robustness by using the CV-A16 antigen national standard (NS). Furthermore, we utilized the Q-ELISA to quantify antigen contents of vaccine bulks from six manufacturers and other intermediate products from one manufacturer. The results indicated that the Q-ELISA can satisfy the requirements of QC for all manufacturers involved.
