BioFire’s Respiratory Solutions
with SARS-CoV-2
BioFire has brought its syndromic approach to COVID-19 testing. BioFire’s comprehensive panels provide fast, accurate results, helping to inform faster treatment decisions and relieve anxious patients.
Now Available for the Lab
BioFire® Respiratory 2.1 (RP2.1) Panel
Now the first FDA De Novo authorized test for COVID-19, the BioFire RP2.1 Panel detects 22 respiratory pathogens, including SARS-CoV-2, to help clinicians quickly rule in and rule out common causes of respiratory illness in about 45 minutes. The BioFire RP2.1 Panel runs on the BioFire® FilmArray® Torch and the BioFire® FilmArray® 2.0 Systems in laboratories certified to perform CLIA high complexity or moderate complexity tests.
Sample type: nasopharyngeal swab (NPS) in transport media or saline
Now Available for the Clinic
BioFire® Respiratory 2.1-EZ (RP2.1-EZ) Panel (EUA)*
Authorized by the FDA for the point-of-care space under an Emergency Use Authorization, the BioFire RP2.1-EZ Panel (EUA) identifies a menu of 19 respiratory targets, including SARS-CoV-2, in one multiplex PCR test, with results in about 45 minutes. The BioFire RP2.1-EZ Panel (EUA) is designed to run on the CLIA-waived BioFire® FilmArray® 2.0 EZ Configuration System.
Sample type: nasopharyngeal swab (NPS) in transport media
SARS-CoV-2 Reactivity with BioFire Respiratory Panels
Bioinformatics for the SARS-CoV-2 virus is expanding at a rapid rate since the emergence of the virus in human infection in late 2019. Thousands of viral whole genome sequences are being evaluated and submitted to public and private databases on a weekly basis.
BioFire continues to monitor these new sequences and is performing regular in silico analyses of the SARS-CoV-2 assays in the BioFire RP2.1 Panel family of products (the BioFire RP2.1 Panel, the BioFire® Respiratory 2.1 plus Panel**, and the BioFire RP2.1-EZ Panel [EUA]) in accordance with the FDA’s policy for evaluating the impact of viral mutations on COVID-19 tests.
Please consult the BioFire Respiratory Panels SARS-CoV-2 Reactivity Technical Note for the latest reactivity updates with emerging variants.
Don’t guess. Know.
SARS-CoV-2 is a top concern for patients and clinicians, but several respiratory pathogens can cause nearly indistinguishable symptoms. BioFire’s syndromic panels combine the ability to detect several of these possible pathogens into one, rapid test, taking the guesswork out of choosing which pathogens to test for. BioFire’s multiplex PCR technology is more sensitive than culture and can help inform timely optimal therapy.
*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 and differentiation of nucleic acid of SARS-CoV-2 from multiple respiratory viral and bacterial organisms; and this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics 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.
**BioFire Respiratory 2.1 plus Panel not cleared for sale in the US. Product availability may vary by country.