BD Diagnostics, a segment of global medical technology company BD (Becton, Dickinson and Company), and Diagenode, an international biotech company based in Belgium, have announced the European-only launch of the Diagenode Bordetella pertussis/parapertussis real-time polymerase chain reaction (PCR) kit for use on the BD MAX™ System.
The Diagenode Bordetella pertussis/parapertussis real-time PCR kit has been CE-marked and validated to run on the BD MAX™ System using the BD MAX™ ExK™ DNA-1 Extraction Kit, an open system reagent. The BD MAX™ System is a fully automated system that standardizes the extraction process and offers ease-of-use and improved laboratory workflow for customers.
Bordetella pertussis is responsible for 30-50 million cases yearly of the highly contagious respiratory disease commonly referred to as pertussis or "whooping cough".
Timely detection through PCR is essential in preventing the spread of disease and reducing the risk of widespread outbreaks. PCR testing is ideal in enabling the prompt differential diagnosis of pertussis from other respiratory diseases such as atypical pneumonia, bronchitis or respiratory viruses.
"There is a need to rapidly address the outbreak issues associated with whooping cough in both pediatric and adult cases," said Gregory Meehan, vice president, product planning, BD Diagnostics – Diagnostic Systems. "The Bordetella pertussis/parapertussis real-time PCR kit expands the syndrome-specific menu offering through our partner assays with a test that is timely and highly relevant in meeting the market need."
The disease most commonly affects infants and young children and can be fatal, especially in infants less than one year of age; adults may also be affected. Older children and adults with waning natural or vaccine-induced immunity, in contrast, present with a more diverse spectrum of symptoms that necessitate testing to establish a definitive diagnosis.
Bordetella parapertussis infection is similar to, but milder and of shorter duration than, infection associated with B. pertussis. Approximately 40% of persons with B. parapertussis infection are asymptomatic. Persons in all age groups can be infected by B. parapertussis and experience illness; however, parapertussis occurs most frequently among children under ten years of age.
Through collaborations with leading in vitro diagnostic (IVD) developers such as Diagenode, BD is rapidly expanding the molecular testing menu by offering syndrome specific and clinically relevant IVD assays across a number of disease syndromes.
"The Diagenode Bordetella pertussis/parapertussis real-time PCR kit adds a significant assay to the BD MAX™ System that truly builds on the flexibility and versatility of the platform, which when coupled with the open system reagents, facilitates the rapid development of molecular testing assays," stated Didier Allaer, CEO of Diagenode.
The expanding BD MAX™ System menu and open capability, full automation and standardized workflow, will enable laboratories to consolidate and standardize a broad range of molecular tests to build programs that meet both their current and future clinical needs.