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.

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Availability: Commercially Available

Christina Flowers
U.S. Sales Account Manager
Christina.flowers@biofiredefense.com
+1 800 735 6544
390 Wakara Way
Salt Lake City, UT 84108
USA
www.biofiredx.com/covid-19/
Manufacturer
bioMérieux, Inc.
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;
Power Requirements
None
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
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
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