BioFire® SARS-COV-2 Assay
The BioFire® COVID-19 Assay is a nested multiplexed real-time RT-PCR test intended for the qualitative detection of SARS-CoV-2 RNA in nasopharyngeal swabs in transport media from individuals suspected of COVID-19 by their healthcare provider. This assay is designed to run on both the BioFire® FilmArray® 2.0 and BioFire® FilmArray® Torch Systems and has been authorized by FDA under an EUA for use by authorized laboratories.
Availability: Commercially Available
| Manufacturer |
| BioFire Defense, LLC |
| Product Name |
| BioFire® SARS-COV-2 Assay |
| Detection Category |
| Biological |
| Detection Principle |
| Molecular; |
| Detection Method |
| Assays;Polymerase Chain Reaction; |
| Application |
| Diagnostics; |
| Product Model Number |
| 423745 (6 pack kit). 423744 (30 pack kit) |
| Equipment Type |
| Diagnostic |
| Product Synopsis |
| The BioFire® COVID-19 Assay is a nested multiplexed real-time RT-PCR test intended for the qualitative detection of SARS-CoV-2 RNA in nasopharyngeal swabs in transport media from individuals suspected of COVID-19 by their healthcare provider. This assay is designed to run on both the BioFire® FilmArray® 2.0 and BioFire® FilmArray® Torch Systems and has been authorized by FDA under an EUA for use by authorized laboratories. |
| Availability |
| Commercially Available |
| Technology Readiness Level (TRL) |
| 9 |
| Market Entry Date |
| April 2020 |
| User Feedback Sources |
| Indifferent/No user feedback |
| Supporting Documentation |
| Docs: BioFire-COVID-19-Test-Info-Sheet.pdf; |
| Transportability |
| Handheld |
| Solvents/Reagents |
| Hydration solution |
| Calibration Schedule |
| BioFire Defense makes available an external positive assayed quality control kit to monitor the performance of the BioFire COVID-19 Test performed on FilmArray® 2.0 and FilmArray Torch® systems. Evaluation of external controls is recommended prior to using a new shipment or new lot of BioFire COVID-19 Test Kits. This kit may also be used for laboratory verification |
| Expected Operational Life |
| Single use item |
| Shelf Life |
| <5 years; Store at room temperature in original packaging for 2 years |
| Other Biological Targets |
| SARS-CoV-2 |
| Adaptability |
| No; cannot detect or add new targets |
| Sample Introduction |
| Liquid; |
| Response Time (Sample Application To Output) |
| >15 minutes; <45 minutes |
| Other Operational Parameters |
| The FilmArray test contains all the required reagents for sample preparation, reverse transcription-PCR, PCR, and detection in a freeze-dried, room temperature stable format. Prior to a run, the operator injects hydration solution and the unknown sample into the pouch. The FilmArray instrument does the rest. |
| Training Required |
| <1 day training |
| Training Available |
| Yes |
| Manuals Available |
| Yes |
