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<p><i>Bordetella pertussis</i>, the causative agent of <i>pertussis</i>, is a highly contagious respiratory pathogen. Rapid and reliable diagnostics are essential for early detection and disease control. Here, we developed an enzymatic recombinase amplification–lateral flow dipstick (ERA-LFD) assay targeting the IS1663 gene of <i>B. pertussis</i>. The assay achieves high sensitivity with detection limit of 10 copies/µL, and analytical specificity reached 100%. It was performed at 32 ℃ for 15&#xa0;min, with visual results obtainable within 20&#xa0;min. Clinical evaluation of 50 nasopharyngeal swab samples demonstrated a sensitivity of 96.6%, specificity of 100%, negative predictive value of 95.2%, and positive predictive value of 100%, showing excellent agreement with quantitative PCR (Kappa = 0.96). These results indicate that the ERA-LFD assay is a rapid, reliable, and field-deployable tool for <i>B. pertussis</i> on-site detection, particularly suitable for point-of-care testing in resource-limited settings.</p>

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An Enzymatic Recombinase Amplification Coupled Lateral Flow Assay for Rapid, Visual, and Cost-Effective Detection of Bordetella pertussis

  • 期刊论文

  • 发表日期：

    2026年3月25日

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  • Piaoting Wen,
  • Jian Liu,
  • Mingqi Jiao,
  • Hangxi Liu,
  • Mei Lin,
  • Sheping Zhang,
  • Jun He,
  • Ziyi Li,
  • Changhui Xiao,
  • Zhongliang Deng

摘要

Bordetella pertussis, the causative agent of pertussis, is a highly contagious respiratory pathogen. Rapid and reliable diagnostics are essential for early detection and disease control. Here, we developed an enzymatic recombinase amplification–lateral flow dipstick (ERA-LFD) assay targeting the IS1663 gene of B. pertussis. The assay achieves high sensitivity with detection limit of 10 copies/µL, and analytical specificity reached 100%. It was performed at 32 ℃ for 15 min, with visual results obtainable within 20 min. Clinical evaluation of 50 nasopharyngeal swab samples demonstrated a sensitivity of 96.6%, specificity of 100%, negative predictive value of 95.2%, and positive predictive value of 100%, showing excellent agreement with quantitative PCR (Kappa = 0.96). These results indicate that the ERA-LFD assay is a rapid, reliable, and field-deployable tool for B. pertussis on-site detection, particularly suitable for point-of-care testing in resource-limited settings.