Roche’s Point-of-Care PCR Test Gains FDA’s 510(k) Clearance with CLIA Waiver and European CE Mark to Diagnose Bordetella infections
Shots:
- Roche has received 510(k) clearance with CLIA waiver & CE-IVDR certification for its point-of-care test to diagnose whooping cough (pertussis) & other Bordetella infections
- The PCR test on the cobas liat system delivers results in 15min. in GP clinics & emergency rooms, allowing real-time diagnosis during consultation & supporting immediate antibiotic decisions to help prevent complications & transmission
- The test detects & distinguishes between 3 Bordetella species: B. pertussis (whooping cough), B. parapertussis (a milder pertussis-like illness with variable treatment response), & B. holmesii (an emerging pathogen linked with pertussis-like symptoms), supporting more accurate diagnosis & management
Ref: Roche | Image: Roche | Press Release
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