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.

  • 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.

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

Date of EUA Issuance
Letter of Authorization
Fact Sheets and Labeling
EUA Determination and Declaration
Software
March 23, 2020 Authorization Letter (PDF,  257 KB) Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Coronavirus (COVID-19) 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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