• Technology: Multiplex PCR-based molecular diagnostics (multiplexed test)
• Format: Single, self-contained, freeze-dried reagent pouch
• Sample Type: Upper Respiratory Swab Specimens, Lower Respiratory Specimens, Saliva Specimens Collected without Preservatives, Pooled Samples for up to 8 Upper Respiratory Specimens (DOD use only)
• Result Time: About 45 minutes
• Ease of Use: Automated workflow from sample to result, requiring minimal hands-on time

The BioFire COVID-19 Test is a powerful tool for detecting SARS-CoV-2 with seven unique assays to increase confidence in results across all variants of the SARS-CoV-2 virus.

US FDA – BioFire COVID-19 Test v1.1

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

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.

Date of Issuance

Issued: March 23, 2020
Updated: May 24, 2022
EUA No: EUA200044

Letter of Authorization

Authorization Letter (Link to FDA.gov)

Fact Sheets and Labeling

• Healthcare Provider Fact Sheet
• Patient Fact Sheet

Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Coronavirus (COVID-19) (Link to FDA.gov)

Reporting

Please report adverse events associated with the use of the BioFire COVID-19 Test here: BioFire COVID-19 Test Report Form

BioFire COVID-19 Test – Version 1.1

BioFire COVID-19 Software Pouch Module for v1.1 (Updated May 2022)

• BioFire COVID-19 Test Pouch Module Installation Instructions

BioFire COVID-19 Test v1.1 ERM Software Download Form (Released September 2022)

• BioFire COVID-19 Test v1.1 Electronic Report Module Technical Note

The BIOFIRE^® SHIELD^™ Control Kit for the BioFire^® COVID-19 Test v1.1 is an external quality control panel used to routinely evaluate and monitor test performance to follow good laboratory practice and meet accreditation requirements.