Simplexa^® Bordetella Direct Kit

Pertussis, commonly called whooping cough, is a highly contagious disease of the respiratory system caused by small gram negative bacteria; Bordetella pertussis and Bordetella parapertussis. Clinically, it presents with a prolonged cough and patients with classic disease often have episodes of violent cough that may be followed by an inspiratory whoop and vomiting. There were 48,227 cases reported in the United States in 2012, making it the year with the highest number of reported cases since 1955.¹ The World Health Organization estimates that there are 50 million whooping cough cases worldwide each year, resulting in 350,000 deaths.^2,3 Pertussis can be detected among all age groups (e.g., neonates, children, adolescents and adults). A great majority of these cases are caused by Bordetella pertussis; however, up to 20% of cases are caused by Bordetella parapertussis, which can present clinically as a milder pertussis-like disease.⁴

1. Centers for Disease Control Data. Available at: https://www.cdc.gov/pertussis/outbreaks/trends.html
2. Kerr et al. Eur J Clin Microbiol Infect Dis. 2000. 19:77-88. 
3. Loeffelholz, M.J. J. Clin Microbiol. 2012. 50:2186-2190. 
4. Leber, A.L. Clin Lab Med. 2014. 34:237-255.

A CLIA moderate complexity assay for the direct detection and differentiation of the B. pertussis IS481 and B. parapertussis IS1001 repeat elements. The assay improves efficiency with a true sample-to-answer workflow without DNA extraction.