The Savvygen™ B. pertussis test allows the qualitative detection and differentiation of Bordetella pertussis, Bordetella parapertussis and/or Bordetella holmesii by real time PCR in respiratory samples. The product is intended for use in the diagnosis of Bordetella alongside clinical data of the patient and other laboratory tests outcomes.

The genus Bordetella bacteria are gram negative bacilli which are isolated from the upper respiratory tract. Bordetella pertussis is the main causative agent of whooping cough, although Bordetella parapertussis, can also produce the disease, but with a milder symptomatology. Additionally, Bordetella bronchiseptica and Bordetella holmesii have been identified as causing respiratory tract diseases with clinical manifestations similar to that of the pertussis syndrome but mainly in immunocompromised individuals The estimated incidence of these disease worldwide ranges from 30 to 50 million cases causing about 195,000 deaths a year. Most cases occur in developing countries where vaccination programs do not exist. In developed countries, despite the dramatic decrease in the incidence of this disease since the introduction of vaccination in the 1950s, a global resurgence of the disease has been observed in the last two decades, despite having Vaccination and high vaccine coverage. Isolation of B. pertussis in culture is definitive for diagnosis, and although the low sensitivity (50%) remains the diagnostic reference method. PCR allows rapid diagnosis and enhances culture sensitivity.

The Savvygen™ B .pertussis test is a ready-to used test which contains in each well all the necessary reagents for real time PCR assay in a stabilized format. In addition, an internal control allows the detection of a possible reaction inhibition. The amplification of the target sequence is detected through the FAM channel whereas the internal control (IC) in HEX channel.