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Abstract <p>Foot-and-mouth disease (FMD) is a highly contagious viral disease affecting cloven-hoofed animals, posing significant threats to global livestock industries. Post-vaccination neutralizing antibody levels reflect vaccine efficacy, but traditional virus neutralization tests (VNT) for detecting neutralizing antibodies requires restrictive biocontainment facilities to handle live virus, is time-consuming and laborious. In this study, we successfully established a high-efficiency magnetic particle-based chemiluminescence immunoassay (MP-CLIA)&#xa0;using&#xa0;two&#xa0;previously characterized&#xa0;monoclonal antibodies (W125 and W145)&#xa0;generated through&#xa0;single B cell antibody technology. The MP-CLIA method exhibited a sensitivity of 95.93% and specificity of 100%, with a cut-off value of 41.395 activity units (U) by detecting the known 221 positive and 122 negative sera. The positive/negative coincidence rate between the MP-CLIA and VNT was 92.2% and the kappa coefficient was 78.19%, indicating a relatively high level of consistency. When integrated with a fully automated chemiluminescence immunoassay analyzer, this method only takes 20&#xa0;min for a single test. These results show that MP-CLIA is a promising tool for the safe, rapid, and fully automatic detection of neutralizing antibodies against FMD virus (FMDV) serotype A.</p> Key points <p><UnorderedList Mark="Bullet"> <ItemContent> <p>A MP-CLIA using two bovine single B cell antibodies was established.</p> </ItemContent> <ItemContent> <p>The MP-CLIA method exhibited a sensitivity of 95.93% and specificity of 100%.</p> </ItemContent> <ItemContent> <p>The MP-CLIA specifically detects neutralizing antibodies against FMDV serotype A.</p> </ItemContent> </UnorderedList></p>

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A chemiluminescence immunoassay for detecting neutralizing antibodies of foot-and-mouth disease virus serotype A

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年10月18日

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  • Mengyang Sun,
  • Yanfang Bao,
  • Kun Li,
  • Yili Zuo,
  • Huiyan Zhang,
  • Yuanfang Fu,
  • Pinghua Li,
  • Pu Sun,
  • Zhixun Zhao,
  • Tao Jiang,
  • Xingwen Bai,
  • Mi Lin,
  • Zengjun Lu,
  • Yimei Cao

摘要

Abstract

Foot-and-mouth disease (FMD) is a highly contagious viral disease affecting cloven-hoofed animals, posing significant threats to global livestock industries. Post-vaccination neutralizing antibody levels reflect vaccine efficacy, but traditional virus neutralization tests (VNT) for detecting neutralizing antibodies requires restrictive biocontainment facilities to handle live virus, is time-consuming and laborious. In this study, we successfully established a high-efficiency magnetic particle-based chemiluminescence immunoassay (MP-CLIA) using two previously characterized monoclonal antibodies (W125 and W145) generated through single B cell antibody technology. The MP-CLIA method exhibited a sensitivity of 95.93% and specificity of 100%, with a cut-off value of 41.395 activity units (U) by detecting the known 221 positive and 122 negative sera. The positive/negative coincidence rate between the MP-CLIA and VNT was 92.2% and the kappa coefficient was 78.19%, indicating a relatively high level of consistency. When integrated with a fully automated chemiluminescence immunoassay analyzer, this method only takes 20 min for a single test. These results show that MP-CLIA is a promising tool for the safe, rapid, and fully automatic detection of neutralizing antibodies against FMD virus (FMDV) serotype A.

Key points

A MP-CLIA using two bovine single B cell antibodies was established.

The MP-CLIA method exhibited a sensitivity of 95.93% and specificity of 100%.

The MP-CLIA specifically detects neutralizing antibodies against FMDV serotype A.