The Food and Drug Adminis-tration has cleared Luminex Corporation’s new Aries Bordetella assay for use in detecting and identifying Bordetella pertussis and Bordetella parapertussis in clinically symptomatic individuals. This automated test provides results in less than 2 hours and is performed on nasopharyngeal swab specimens from patients with respiratory tract infections that are potentially attributable to either of these bacteria. Using real-time polymerase chain reaction, the assay targets both the pertussis toxin promoter in the genome of B. pertussis and the IS1001 repeat sequence in the genome of B. parapertussis. It is not intended for testing asymptomatic individuals, however, due to a high likelihood of false-positive results.
Luminex also previously received the CE mark for the Bordetella assay and is developing further Aries-based testing for Clostridium difficile and Group A Streptococcus.