Meridian Bioscience announced that the FDA clearance for its new Bordetella pertussis (B. pertussis) molecular diagnostic test, the fifth assay on the illumigene platform. This test is the first FDA-cleared molecular stand-alone assay for B. pertussis.
Healthcare providers often send away bacterial cultures to reference laboratories which may take more than a week for a result. An earlier diagnosis can reduce the delay in necessary antibiotic treatment for the patient. The illumigene platform utilizes nasopharyngeal swab samples and the procedure takes less than an hour to report a result. The platform amplifies the specific DNA target for B. pertussis detection which allows for a more definitive result.
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The illumigene Pertussis assay will be commercially available within 30 days.
For more information call (800) 543-1980 or visit MeridianBioscience.com.