Quidel Receives FDA Clearance for Solana® Bordetella Complete® Molecular Diagnostic Assay for the Detection of Pertussis (Whooping Cough), Parapertussis Infections

Quidel Receives FDA Clearance for Solana® Bordetella Complete® Molecular Diagnostic Assay for the Detection of Pertussis (Whooping Cough), Parapertussis Infections

5 years ago
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https://www.businesswire.com/news/home/20180716005542/en/

SAN DIEGO--(BUSINESS WIRE)--Jul 16, 2018--Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market its Solana Bordetella Complete Assay, a molecular diagnostic assay to be used with the Solana molecular diagnostic instrument for the qualitative detection and differentiation of Bordetella pertussis and Bordetella parapertussis nucleic acids isolated from nasopharyngeal swab specimens obtained from patients suspected of having a respiratory tract infection attributable to Bordetella pertussis and Bordetella parapertussis.

Pertussis, or whooping cough, is a very contagious disease caused by the Bordetella pertussis bacteria, which attach to the cilia that line part of the upper respiratory tract, causing inflammation through the release of toxins, which cause airways to swell. 1 Pertussis is spread from person to person through the inhalation of bacteria from an infected person’s cough or sneeze. Symptoms, such as a runny nose, low-grade fever, or mild cough usually develop within 5–10 days after exposure, but sometimes appear as long as 3 weeks later. Although whooping cough can cause serious illness in children and adults, it is most dangerous for infants and babies. According to the Centers for Disease Control and Prevention (CDC), about half of infants younger than 1 year of age who get this disease require hospitalization. 2