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Background <p>Porcine epidemic diarrhoea virus (PEDV) causes substantial financial losses on pig farming worldwide. Monitoring PEDV-specific IgA antibodies is essential for assessing vaccine efficacy. In this study, we developed a fully automated chemiluminescence immunoassay (CLIA) for the detection of PEDV IgA antibodies in both serum and milk.</p> Results <p>This S1-CLIA utilizes recombinant S1 protein-coated magnetic particles (S1-MPs) for antibody capture and an acridinium ester-labeled mouse anti-pig IgA monoclonal antibody (mpIgA-AE) to generate chemiluminescence signals. Under optimized conditions, S1-CLIA achieved a diagnostic sensitivity of 96.30% and specificity of 98.48%, with a cut-off index of 1.0. S1-CLIA exhibited excellent repeatability (coefficient of variation &lt; 10%) and no cross-reactivity with sera positive for other common swine pathogens. Compared to a commercial enzyme-linked immunosorbent assay (ELISA), S1-CLIA achieved 93.93% agreement rate, but offered a significantly broader dynamic range (35.48-fold). Notably, S1-CLIA results correlated well with virus neutralization titers (VNT), yielding R² values of 0.6660 (serum) and 0.7639 (milk).</p> Conclusions <p>With capability of fully automated testing, this novel S1-CLIA presents a robust platform for large-scale evaluation of PEDV immunity.</p>

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Development of an automated chemiluminescence immunoassay for detection of IgA antibodies against porcine epidemic diarrhea virus spike

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月7日

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  • Duan Li,
  • Daoping Zeng,
  • Qi Wang,
  • Leyi Zhang,
  • Yanling Liu,
  • Cuiqin Huang,
  • Changxu Song,
  • Lei Wang

摘要

Background

Porcine epidemic diarrhoea virus (PEDV) causes substantial financial losses on pig farming worldwide. Monitoring PEDV-specific IgA antibodies is essential for assessing vaccine efficacy. In this study, we developed a fully automated chemiluminescence immunoassay (CLIA) for the detection of PEDV IgA antibodies in both serum and milk.

Results

This S1-CLIA utilizes recombinant S1 protein-coated magnetic particles (S1-MPs) for antibody capture and an acridinium ester-labeled mouse anti-pig IgA monoclonal antibody (mpIgA-AE) to generate chemiluminescence signals. Under optimized conditions, S1-CLIA achieved a diagnostic sensitivity of 96.30% and specificity of 98.48%, with a cut-off index of 1.0. S1-CLIA exhibited excellent repeatability (coefficient of variation < 10%) and no cross-reactivity with sera positive for other common swine pathogens. Compared to a commercial enzyme-linked immunosorbent assay (ELISA), S1-CLIA achieved 93.93% agreement rate, but offered a significantly broader dynamic range (35.48-fold). Notably, S1-CLIA results correlated well with virus neutralization titers (VNT), yielding R² values of 0.6660 (serum) and 0.7639 (milk).

Conclusions

With capability of fully automated testing, this novel S1-CLIA presents a robust platform for large-scale evaluation of PEDV immunity.