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Introduction <p>Whooping cough, caused by <i>Bordetella pertussis</i>, is a re-emerging vaccine-preventable respiratory disease with serious complications, especially in infants, making early and accurate diagnosis essential. This study aimed to compare the clinical performance of three PCR methods for <i>Bordetella</i> detection, highlighting the importance of CE-IVDR-certified tests and the potential of point of care testing (POCT) for effective disease management.</p> Materials and methods <p>From October 2023 to March 2024, nasopharyngeal swabs from suspected pertussis cases were collected and tested with the Bordetella ELITe MGB Kit, FlexStar<sup>®</sup> Bordetella PCR Detection Mix, and Vivalytic POCT PCR. A composite reference standard was used for statistical analysis, with positive samples defined by agreement between at least two methods.</p> Results <p>A total of 94 nasopharyngeal samples were tested, of which 57 were positive and 22 negatives across all three PCR assays. The concordance rate between the Altona and ELITe MGB assays was 91.75%. Concordance between Altona and Vivalytic reached 87.63%, while the agreement between the Vivalytic assay and the ELITe MGB Kit was 89.69%. Based on the composite reference standard, both the Altona and ELITe MGB Kit assays demonstrated a positive percent agreement (PPA) of 98.4% for the detection of <i>Bordetella</i> species. For <i>B. pertussis</i> specifically, high PPA values (&gt; 98% and &gt; 92%) and negative percent agreement (NPA) values (&gt; 96% and &gt; 92%) were observed, indicating strong diagnostic performance across platforms.</p> Conclusion <p>This study compared three PCR methods (Altona, ELITe MGB Kit, and Vivalytic) for <i>Bordetella</i> detection. Practical considerations such as sample throughput, operational costs, and reimbursement policies in Belgium suggest that POCT is particularly beneficial in pediatric emergency settings, while larger labs might prefer batch processing.</p>

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Evaluation of three real-time PCR methods for the detection and the differentiation of Bordetella pertussis, Bordetella parapertussis and Bordetella holmesii

  • 期刊论文

  • 发表日期：

    2025年4月16日

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  • Sara Cherkaoui,
  • Magali Wautier,
  • Helena Martini,
  • Hafid Dahma,
  • Sigi van den Wijngaert,
  • Delphine Martiny,
  • Nicolas Yin

摘要

Introduction

Whooping cough, caused by Bordetella pertussis, is a re-emerging vaccine-preventable respiratory disease with serious complications, especially in infants, making early and accurate diagnosis essential. This study aimed to compare the clinical performance of three PCR methods for Bordetella detection, highlighting the importance of CE-IVDR-certified tests and the potential of point of care testing (POCT) for effective disease management.

Materials and methods

From October 2023 to March 2024, nasopharyngeal swabs from suspected pertussis cases were collected and tested with the Bordetella ELITe MGB Kit, FlexStar® Bordetella PCR Detection Mix, and Vivalytic POCT PCR. A composite reference standard was used for statistical analysis, with positive samples defined by agreement between at least two methods.

Results

A total of 94 nasopharyngeal samples were tested, of which 57 were positive and 22 negatives across all three PCR assays. The concordance rate between the Altona and ELITe MGB assays was 91.75%. Concordance between Altona and Vivalytic reached 87.63%, while the agreement between the Vivalytic assay and the ELITe MGB Kit was 89.69%. Based on the composite reference standard, both the Altona and ELITe MGB Kit assays demonstrated a positive percent agreement (PPA) of 98.4% for the detection of Bordetella species. For B. pertussis specifically, high PPA values (> 98% and > 92%) and negative percent agreement (NPA) values (> 96% and > 92%) were observed, indicating strong diagnostic performance across platforms.

Conclusion

This study compared three PCR methods (Altona, ELITe MGB Kit, and Vivalytic) for Bordetella detection. Practical considerations such as sample throughput, operational costs, and reimbursement policies in Belgium suggest that POCT is particularly beneficial in pediatric emergency settings, while larger labs might prefer batch processing.