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

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.