15-minute POC diagnostic for Bordetella species approved by FDA with CLIA waiver
Roche's innovative PCR-based point-of-care test for Bordetella infections has received FDA 510(k) clearance and CLIA waiver, enabling rapid diagnosis during patient visits with results in just 15 minutes.
Roche announced that its first point-of-care test for the detection of Bordetella infections, including whooping cough (pertussis), has been granted U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver.
The groundbreaking PCR test uses the cobasliat system to deliver results in just 15 minutes at the point of care. 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.
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.
B. holmesii, an emerging pathogen increasingly associated with pertussis-like symptoms and potential diagnostic challenges.
