CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
September 2018—Quidel received 510(k) clearance from the FDA to market its Solana Bordetella Complete Assay, a molecular diagnostic assay for use with the Solana instrument for the qualitative detection and differentiation of Bordetella pertussis and Bordetella parapertussis nucleic acids isolated from nasopharyngeal swab specimens.
The assay utilizes helicase-dependent amplification technology and targets the IS481 and IS1001 sequence of the B. pertussis and B. pertussis genomes, respectively.
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