Quidel’s Bordetella Assay Receives FDA Clearance

The FDA granted 510(k) clearance to Quidel’s Solana Bordetella assay, a molecular diagnostic assay used with its Solana molecular diagnostic instrument for detection of pertussis bacteria.

Together, the assay and diagnostic instrument can differentiate between Bordetella pertussis and Bordetella parapertussis nucleic acids obtained from patients suspected of having a respiratory tract infection caused by the bacteria.

Pertussis, also known as whooping cough, is a highly contagious disease that has become more common in recent years.