NOW AVAILABLE
The BioFire® Respiratory 2.1 (RP2.1) Panel with SARS-CoV-2 is now authorized under an EUA for use on both the BioFire 2.0 and BioFire Torch Systems. In addition to the detection of SARS-CoV-2, the BioFire RP2.1 detects 21 additional respiratory pathogens to help clinicians quickly rule in and rule out other common causes of respiratory illness in about 45 minutes. BioFire also intends to submit the BioFire RP2.1 Panel to the FDA for de novo clearance on an accelerated timeline.
About Emergency Use Authorization:
- 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.
| Date of EUA Issuance | Letter of Authorization | Fact Sheets and Labeling | EUA Determination and Declaration | Technical Notes | Software |
|---|---|---|---|---|---|
| May 1, 2020 |
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THE BIOFIRE RESPIRATORY 2.1 (RP2.1) PANEL MENU with SARS-CoV-2
Overall 97.1% Sensitivity and 99.3% Specificity1
Sample Type: Nasopharyngeal swab in transport media
VIRUSES:
● Adenovirus
● Coronavirus HKU1
● Coronavirus NL63
● Coronavirus 229E
● Coronavirus OC43
● Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
● Human Metapneumovirus
● Human Rhinovirus/Enterovirus
● Influenza A
● Influenza A/H1
● Influenza A/H3
● Influenza A/H1-2009
● Influenza B
● Parainfluenza Virus 1
● Parainfluenza Virus 2
● Parainfluenza Virus 3
● Parainfluenza Virus 4
● Respiratory Syncytial Virus
BACTERIA:
● Bordetella parapertussis
● Bordetella pertussis
● Chlamydia pneumoniae
● Mycoplasma pneumoniae
Click the icons below for more information on the other respiratory solutions currently offered by BioFire Diagnostics to help clinicians quickly identify common respiratory pathogens.
The BioFire® FilmArray®
Respiratory EZ (RP EZ) Panel
The BioFire® FilmArray®
Pneumonia (PN) Panel
Reference:
- The stated performance is based on the aggregate data from the prospective portion of the clinical study for the BioFire® FilmArray® Respiratory Panel 2.