USFDA clears Roche 15-minute Bordetella PCR Test
Basel: Roche has announced that its first point-of-care test for the diagnosis of whooping cough (pertussis) and other Bordetella infections, has been granted U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver, in addition to CE IVDR certification.
The groundbreaking PCR test uses the cobas liat system to deliver results in just 15 minutes in GP practices and Emergency Rooms. This speed enables physicians to diagnose patients during their consultation and take immediate action to provide appropriate antibiotics that can prevent severe complications and onward transmission.
Pertussis affects people of all ages but can be more severe in children, causing an estimated 24.1 million cases and 170,000 deaths annually. A major diagnostic challenge is that early symptoms are often indistinguishable from other respiratory illnesses. This lack of rapid, accessible diagnostics causes clinicians to treat based on symptoms, a delay that allows the disease to progress and leads to severe outcomes, especially for vulnerable groups.
"Faster and more accurate clinical decisions are critical for reducing the risk of severe complications and ultimately stopping the transmission of Bordetella infections.” said Matt Sause, CEO of Roche Diagnostics. “This new test allows clinicians to quickly make a definitive and precise diagnosis to ensure patients get the right treatment earlier."
The test not only detects Bordetella infections but also differentiates between three key species: B. pertussis, the cause of classic whooping cough; B. parapertussis, which causes a milder pertussis-like illness that may not respond to standard treatments; and B. holmesii, an emerging pathogen increasingly associated with pertussis-like symptoms and potential diagnostic challenges.
Whooping cough is a cyclical disease that typically peaks in severity every three to five years. With a surge underway, the increase in cases has been further amplified by interruptions in routine vaccinations during the pandemic, along with waning immunity and vaccine hesitancy. These factors have driven infections across all age groups, including older children and adults, where symptoms can be less typical and harder to recognise.
Bordetella infections, including whooping cough, are a significant challenge for clinicians due to the similarity of early symptoms to other respiratory infections. Accurately identifying Bordetella among these conditions is essential to delivering the right treatment and ensuring timely intervention.
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