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Multicentric evaluation of a point of care test for the diagnosis of whooping cough
Background
The magnitude of the epidemic wave that struck France and Europe in 2024 clearly highlighted the need for a simple and fast molecular tool for the diagnosis of whooping cough. The main cause of whooping cough is Bordetella pertussis although other Bordetella species can also cause infection We evaluated the performance of the automated qPCR Vivalytic Bordetella test (Bosch Healthcare Solutions GmbH, Germany) for the detection of Bordetella species outside its intended use, using additional sample types. The Vivalytic platform, with its intuitive cartridge system, is designed for application in laboratories and point of care settings.
Results
The nasopharyngeal swabs in UTM medium showed a sensitivity of 77.78% (95% Confidence Interval [CI]: 57.74%-91.38% while the nasopharyngeal aspirates exhibited a higher sensitivity of 92% (95% CI: 73.97%-99.02%).
More nasopharyngeal aspirates will be included in the ongoing evaluation at Institut Pasteur National Reference Center for Whooping Cough and other Bordetella infections.
Conclusions
The Vivalytic Bordetella test is an easy to use assay for the rapid detection of Bordetella species in <1h. Our results showed a suboptimal sensitivity for nasopharyngeal samples in UTM. Therefore, it is more suitable for this sample type to use the recommended eNAT transport medium. However, we could show for the first time that aspirates from infants and young children with a sensitivity of more than 90 are a suitable sample type for the Vivalytic assay. Additionally, the ease to use and the rapid time to result make Vivalytic a valuable tool for the diagnosis of whooping cough and eventually disease management.