BioFire® Respiratory 2.1plus Panel
Manufactured by bioMerieux, France - https://www.biomerieux-diagnostics.com/
Device identification number
1804
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated
Physical Support
Cartridge
Target type
Nucleic acid
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The BioFire® Respiratory 2.1 plus Panel (CE-IVD) uses a syndromic approach (detects 23 pathogens, including SARS-CoV-2 simultaneously) to accurately detect and identify the pathogens most commonly associated with respiratory infections. Fast and comprehensive, the BioFire RP2.1 plus Panel offers a run time of about 45 minutes, enabling high efficiency and throughput on the BioFire® FilmArray® 2.0 and the BioFire® FilmArray® Torch Systems. Rapid respiratory PCR test results may enable better-informed diagnosis and treatment of patients. Quick turnaround on a broad menu of pathogens may also help clinicians make vital decisions regarding admission, isolation, cohorting, and additional diagnostic testing.
Assay Type
Nucleic acid-PCR
Reader Required
Yes
Method
RT-PCR
Measurement
Qualitative
Time
45 minutes
LOD
160 cpm
Positive control
ZeptoMetrix NATtrol™ SARS-Related Coronavirus 2 (SARS-CoV-2) External Run Control; NATSARS(COV2)-ERC
Analytical Sensitivity
98 %
Analytical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
100 %
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements