1. Development of a sandwich ELISA to detect virus-like-particles in enterovirus A71 vaccines.
- Author
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Lim, Pei-Yin and Cardosa, Mary Jane
- Subjects
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VACCINES , *VIRUS-like particles , *ENTEROVIRUSES - Abstract
• A sandwich ELISA that recognized intact EV-A71 VLP was developed. • This ELISA recognized EV-A71 from different subgenogroups as well as VLP. • A reference standard was included in the ELISA to develop a quantitative ELISA (Q-ELISA). • Q-ELISA could be used to examine the yield, purity, stability and performance of VLP. The goal of this paper was to develop a sandwich ELISA that can detect intact human enterovirus A71 (EV-A71) virus-like particles (VLPs) in vaccines. This assay specifically detected EV-A71 viruses from different sub-genogroups as well as EV-A71 VLPs, and treatment of VLPs with high heat and low pH reduced or completely abolished detection of the VLPs suggesting that the ELISA detected assembled particles. Using a purified VLP as a reference standard, a quantitative sandwich ELISA (Q-ELISA) was established which was used to monitor the yield and purity of the VLPs during manufacturing. Coupled with immunogenicity studies, the Q-ELISA was used to evaluate the performance of the VLPs and formalin-inactivated EV-A71 vaccine. This assay has the potential to play an important role in the development of an efficient process to produce and purify the VLPs and in examining the quality of EV-A71 vaccines. [ABSTRACT FROM AUTHOR]
- Published
- 2019
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