DiaSorin Molecular has received FDA clearance for its new Simplexa Bordetella Direct test. This CLIA moderate-complexity assay is designed for use on the LIAISON MDX to quickly provide qualitative detection and differentiation of both Bordetella pertussis and Bordetella parapertussis in nasopharyngeal swabs. The assay is performed directly from NPS samples without extraction and provides results in approximately one hour. Pertussis can lead to more severe symptoms such as hypoxia, permanent brain damage, or death, particularly in infants.
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