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Respiratory tract infection (RTI) - July 19, 2022

New Pneumocystis and Bordetella assays for the BD MAX™ System

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New Pneumocystis and Bordetella assays for the BD MAX™ System

CerTest Biotec and BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, have recently launched two new molecular respiratory assays for BD MAX™ System – VIASURE Pneumocystis jirovecii Real Time PCR Detection Kit for the BD MAX™ System and VIASURE Bordetella Real Time PCR Detection Kit for the BD MAX™ System – expanding the respiratory menu portfolio available on the BD MAX™ System.

These two new molecular assays have been CE marked to the IVD Directives (98/79/CE).

VIASURE Pneumocystis jirovecii Real Time PCR Detection Kit for the BD MAX™ System has been designed for the qualitative detection of P. jirovecii DNA in respiratory samples (bronchoalveolar lavage) contributing to the timely detection of this opportunistic fungus pathogen. P. jirovecii can cause potentially fatal pneumonia (PcP) in immunocompromised patients if not treated timely and effectively. About 30-40% of people who get PcP have HIV/AIDS 1 but mortality rate in this population is decreasing2. However mortality rate remains significantly high with an average of 30.6% in non-HIV patient with PcP.3

Because P. jirovecii cannot be propagated in culture, microscopic visualization of cysts or trophic forms in pulmonary specimens with cytochemical or immunofluorescent staining with monoclonal antibodies and/or DNA amplification are the standard procedures to detect this microorganism.4

A particular challenge is that symptoms induced by this disease are not specific, making clinical diagnosis very difficult. With VIASURE Pneumocystis jirovecci Real Time PCR Detection Kit for the BD MAX™ there is the possibility to test for other respiratory pathogen from the VIASURE line in the same rack or even on the same unitized reagent strip.

VIASURE Bordetella Real Time PCR Detection Kit for the BD MAX™ System is detecting and differentiating  B. pertussis, B. parapertussis and B. holmesii in respiratory samples (nasopharyngeal swabs and nasopharyngeal aspirates). The most important cause for whooping cough (pertussis) is B. pertussis infection, followed by B. parapertussis.5

Whooping cough is a very contagious disease which spreads from person to person usually by coughing or sneezing, or by close contact with an infected person in a common breathing space. Despite vaccination, pertussis remains endemic in most areas of the world. Nucleic acid amplification tests, including PCR and more recently real-time PCR, are key to help ensure a reliable and rapid diagnosis and overcome some of the limitations of culture and serological methods for the diagnosis of Bordetella infections5. Rapid diagnosis is required to start appropriate treatment and prophylaxis of contacts if needed, particularly for unvaccinated infants in whom pertussis might present as a life-threatening disease.5

The BD MAX™ System, a fully automated molecular diagnostic platform, is widely used in hundreds of laboratories across the EMEA. Each unit can return results in two to three hours and is capable of analyzing hundreds of samples over a 24-hour period with hands on time limited to less than 1.5 min per sample.

Both assays are sold through BD’s distribution network. The test snaps into the test-specific position on the BD MAX™ ExK™ TNA Extraction Strip, supplied by BD.

To locate a BD representative or request information, visit www.bd.com or www.certest.es.                           

VIASURE Kits are not available for sale in the U.S. Product availability may vary in different countries; please contact your local BD representative.

  1. CDC, Pneumocystis Available at: https://www.cdc.gov/fungal/diseases/pneumocystis-pneumonia/index.html. Accessed on May 2022.
  2. Schmidt et al., Clinical course, treatment and outcome of Pneumocystis pneumonia in immunocompromised adults: a retrospective analysis over 17 years. Critical Care. 2018. 22:307
  3. Liu et al., Risk factors for mortality from pneumocystis carinii pneumonia (PCP) in non-HIV patients: a meta-analysis. Oncotarget. Aufust 2017; 8(35): 59729-59739
  4. VIASURE Pneumocystis jirovecii Real Time PCR Detection Kit for the BD MAX™ System – IFU 444207
  5. VIASURE Bordetella Real Time PCR Detection Kit for the BD MAX™ System – IFU 444204
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