BioFire® FilmArray® 2.0
With single database management of up to 8 instruments per computer, the BioFire® FilmArray® 2.0 can test up to 175 samples a day. Its LIS-interfacing capabilities enable simplified test ordering and send outs, quicker turnaround times, and increased accuracy by minimizing manual data entry. Detection of SARS-CoV-2 RNA in nasopharyngeal swabs in transport media from individuals suspected of COVID-19 by their healthcare provider. For use under the Emergency Use Authorization (EUA) by CLIA Moderate and High Complexity Laboratories. (Approved Mar. 23, 2020)
Availability: Commercially Available
| Manufacturer |
| BioFire Defense, LLC |
| Product Name |
| BioFire® FilmArray® 2.0 |
| Detection Category |
| Biological |
| Detection Principle |
| Molecular; |
| Detection Method |
| Polymerase Chain Reaction; |
| Application |
| Emergency Response;Detection;Laboratory Analysis; |
| Equipment Type |
| Instrument |
| Product Synopsis |
| With single database management of up to 8 instruments per computer, the BioFire® FilmArray® 2.0 can test up to 175 samples a day. Its LIS-interfacing capabilities enable simplified test ordering and send outs, quicker turnaround times, and increased accuracy by minimizing manual data entry. Detection of SARS-CoV-2 RNA in nasopharyngeal swabs in transport media from individuals suspected of COVID-19 by their healthcare provider. For use under the Emergency Use Authorization (EUA) by CLIA Moderate and High Complexity Laboratories. (Approved Mar. 23, 2020) |
| Availability |
| Commercially Available |
| Technology Readiness Level (TRL) |
| 9 |
| User Feedback Sources |
| Indifferent/No user feedback |
| Transportability |
| Person-Portable |
| Operating Conditions |
| 15 to 30°C (59 to 86°F) |
| Solvents/Reagents |
| Sample Hydration solution, reagent pouches |
| Available Accessories |
| Hard sided rolling case |
| Data Analysis Support Equipment |
| Laptop. Windows based instrument control and data analysis software |
| Communications Interface |
| BioFire® FilmArray® System LIS Connectivity |
| Maintenance Cost |
| $180 per test |
| Tested For Biological Agents |
| Biological threat pathogens (18 viral, 3 bacterial): B. anthracis (Anthrax), Brucella melitensis, Burkholderia, Clostridium botulinum, Coxiella burnetii, Ebola virus (Zaire), EEE virus, F. tularensis (Tularemia), Marburg virus, Ricinus communis, Rickettsia prowazekii, Variola virus, VEE virus, WEE virus, Y. pestis (Plague), Orthopox virus, Botulinum toxin, Staph Enterotoxin B (SEB), Smallpox |
| Other Biological Targets |
| Influenza A/B, Parainfluenza 1-4, human rhinovirus, human metapneumovirus, Coronavirus, Adenovirus, pertussis, pneumoniae, candida, meningitidis, E. coli, proteus, baumannii, mecA, van A/B, KPC, streptococcus, listeria, enterococcus, herpes, SARS-CoV-2 |
| Adaptability |
| Yes |
| Sample Introduction |
| Liquid; |
| Start Up Time (From Cold Start To Sample Ready) |
| < 5 minutes |
| Response Time (Sample Application To Output) |
| >15 minutes; < 55 minutes |
| Alarm Capability |
| Audible |
| Software Control |
| BioFire® FilmArray® System LIS Connectivity |
| Training Required |
| <1 week training |
| Training Available |
| Yes |
| Manuals Available |
| Yes |
