Cherkaoui Sara, Wautier Magali, Martini Helena, Dahma Hafid, van den Wijngaert Sigi, Martiny Delphine, Yin Nicolas
Department of Microbiology, Laboratoire Hospitalier Universitaire de Bruxelles- Universitair Laboratorium Brussel (LHUB-ULB), Université libre de Bruxelles, Brussels, Belgium.
Department of Microbiology, National Reference Centre for Bordetella pertussis, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel (VUB), Brussels, Belgium.
Eur J Clin Microbiol Infect Dis. 2025 Apr 16. doi: 10.1007/s10096-025-05129-1.
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.
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.
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.
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.
由百日咳博德特氏菌引起的百日咳是一种再度出现的可通过疫苗预防的呼吸道疾病，会引发严重并发症，尤其是在婴儿中，因此早期准确诊断至关重要。本研究旨在比较三种用于检测博德特氏菌的聚合酶链反应（PCR）方法的临床性能，强调获得欧盟体外诊断医疗器械法规（CE-IVDR）认证的检测的重要性以及即时检测（POCT）在有效疾病管理中的潜力。
2023年10月至2024年3月，收集疑似百日咳病例的鼻咽拭子，并用博德特氏菌ELITe MGB试剂盒、FlexStar博德特氏菌PCR检测混合试剂和Vivalytic POCT PCR进行检测。采用综合参考标准进行统计分析，阳性样本由至少两种方法一致判定。
共检测了94份鼻咽样本，在所有三种PCR检测中，57份为阳性，22份为阴性。阿尔托纳（Altona）检测法与ELITe MGB检测法之间的一致性率为91.75%。阿尔托纳检测法与Vivalytic检测法之间的一致性达到87.63%，而Vivalytic检测法与ELITe MGB试剂盒之间的一致性为89.69%。基于综合参考标准，阿尔托纳检测法和ELITe MGB试剂盒检测法在检测博德特氏菌属时的阳性一致率（PPA）均为98.4%。对于百日咳博德特氏菌，观察到较高的PPA值（>98%和>92%）和阴性一致率（NPA）值（>96%和>92%），表明各平台的诊断性能强劲。
本研究比较了三种用于检测博德特氏菌的PCR方法（阿尔托纳检测法、ELITe MGB试剂盒和Vivalytic检测法）。比利时在样本通量、运营成本和报销政策等实际考量表明，POCT在儿科急诊环境中特别有益，而较大的实验室可能更喜欢批量处理。
