BioFire® COVID-19 Test

 

1 Test for Coronavirus (COVID-19) with results in about 45 minutes.

The BioFire® COVID-19 Test is a nested multiplexed 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.

US FDA

  • This test has not been FDA cleared or approved;
  • This test has been authorized by FDA under an EUA for use by authorized laboratories;
  • This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Health Canada

  • Authorized for use in Canada in accordance with the Interim Order Respecting the Importation and Sale of Medical Devices in relation to COVID-19.

 

Date of Issuance
Letter of Authorization
Fact Sheets and Labeling
Determination and Declarations
US FDA Documentation – EUA

The EUA (Emergency Use Authorization) for the BioFire COVID-19 Test enables CLIA moderate and high complexity laboratories to conduct a PCR test for SARS-CoV-2 in-house, providing results in approximately one hour.

March 23, 2020

EUA No: EUA200044

Authorization Letter (PDF,  257 KB) Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Coronavirus (COVID-19)
Health Canada Documentation
May 4, 2020

Interim Order No. 314097

Interim order respecting the importation and sale of medical devices for use in relation to COVID-19

 

Software
BioFire COVID-19 Software Pouch Module

 

Kits Available
Part No. Kit Description
423745 BioFire COVID-19 Test kit (6-pack)
423744 BioFire COVID-19 Test kit (30-pack)
Part No. Kit Description
423748 BioFire COVID-19 Test External Control kit
(6 positive control vials)
Quick Guide for BioFire COVID-19 Test (PDF, 1.2 MB) Quick Guide for BioFire COVID-19 External Control Kit (PDF, 1.1 MB)
Download the BioFire COVID-19 Test Kit Information Sheet

 

Technical Notes
SDS
BioFire® COVID-19 Test SDS Sheet

BioFire COVID-19 Test
External Control Kit NHPS

 

External Controls
Reporting
BioFire Defense also developed an External Control Kit for the BioFire COVID-19 Test. Information for the External Control Kit is combined in the BioFire COVID-19 Test Instructions for Use and in this Quick Guide for BioFire COVID-19 External Control Kit (+). Please report adverse events associated with the use of the BioFire COVID-19 Test here: COVID-19 Test Report Form

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