A uniform quantitative enzyme-linked immunosorbent assay for Coxsackievirus A16 antigen in vaccine

Cui, Bopei; Cai, Fang; Gao, Fan; Bian, Lianlian; Wu, Ruixia; Du, Ruixiao; Wu, Xing; Liu, Pei; Song, Ling; Cui, Lisha; Yuan, Yadi; Liu, Siyuan; Ye, Xiangzhong; Cheng, Tong; Mao, Qunying; Gao, Qiang; Liang, Zhenglun

doi:10.1080/21645515.2020.1776547

Cited by 2 publications

(1 citation statement)

References 20 publications

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“…It is crucial to accurately quantify the RBD in a vaccine to evaluate its immunogenicity, safety, and efficacy. However, differences in vaccine sequence, design, and expression system pose significant challenges for regulatory authorities worldwide [ 7 , 8 , 9 ]. Our aim was to establish a standardized universal RBD quantification method for SARS-CoV-2 protein subunit vaccines, which is essential to accelerate vaccine development and application.…”

Section: Introductionmentioning

confidence: 99%

Development of an ELISA Assay for the Determination of SARS-CoV-2 Protein Subunit Vaccine Antigen Content

Han

An²,

Liu³

et al. 2022

Viruses

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The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) protein subunit vaccine is one of the mainstream technology platforms for the development of COVID-19 vaccines, and most R&D units use the receptor-binding domain (RBD) or spike (S) protein as the main target antigen. The complexity of vaccine design, sequence, and expression systems makes it urgent to establish common antigen assays to facilitate vaccine development. In this study, we report the development of a double-antibody sandwich enzyme-linked immunosorbent assay (ELISA) to determine the antigen content of SARS-CoV-2 protein subunit vaccines based on the United States Pharmacopeia <1220> and ICH (international conference on harmonization) Q14 and Q2 (R2) requirements. A monoclonal antibody (mAb), 20D8, was identified as the detection antibody based on its high RBD binding activity (EC50 = 8.4 ng/mL), broad-spectrum anti-variant neutralizing activity (EC50: 2.7–9.8 ng/mL for pseudovirus and EC50: 9.6–127 ng/mL for authentic virus), good in vivo protection, and a recognized linear RBD epitope (369–379 aa). A porcine anti-RBD polyclonal antibody was selected as the coating antibody. Assay performance met the requirements of the analytical target profile with an accuracy and precision of ≥90% and adequate specificity. Within the specification range of 70–143%, the method capability index was >0.96; the misjudgment probability was <0.39%. The method successfully detected SARS-CoV-2 protein subunit vaccine antigens (RBD or S protein sequences in Alpha, Beta, Gamma, or Delta variants) obtained from five different manufacturers. Thus, we present a new robust, reliable, and general method for measuring the antigenic content of SARS-CoV-2 protein subunit vaccines. In addition to currently marketed and emergency vaccines, it is suitable for vaccines in development containing antigens derived from pre-Omicron mutant strains.

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Section: Introductionmentioning

confidence: 99%

Development of an ELISA Assay for the Determination of SARS-CoV-2 Protein Subunit Vaccine Antigen Content

Han

An²,

Liu³

et al. 2022

Viruses

Self Cite

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Recent Advances in Anti-Coxsackievirus A16 Viral Drug Research

et al. 2022

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Hand, foot and mouth disease, a childhood disorder caused by enteroviruses, is intermittently endemic in the Asia-Pacific region and endangers the lives of many infants and young children. Coxsackievirus A16 (CV-A16) is one of the major pathogens causing hand, foot, and mouth disease on occasion, resulting in catastrophic neurological sequelae and patient death. Currently, no clinical interventions are available that completely block the CV-A16 infection. Therefore, research on anti-CV-A16 treatment continues to be a significant focus of interest. This report provides a detailed background on and an introduction to CV-A16; a description of the viral gene and protein structures and a summary of the current advances in pharmaceutical targets, drug research and other related areas.

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A uniform quantitative enzyme-linked immunosorbent assay for Coxsackievirus A16 antigen in vaccine

Cited by 2 publications

References 20 publications

Development of an ELISA Assay for the Determination of SARS-CoV-2 Protein Subunit Vaccine Antigen Content

Development of an ELISA Assay for the Determination of SARS-CoV-2 Protein Subunit Vaccine Antigen Content

Recent Advances in Anti-Coxsackievirus A16 Viral Drug Research

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