Strengthen Your Clinic
The BioFire® Respiratory 2.1-EZ (RP2.1-EZ) Panel (EUA)* with SARS-CoV-2 is now available for use in the point-of-care space.
Several respiratory pathogens cause similar, overlapping symptoms. In fact, less than 10% of tests for SARS-CoV-2 in the United States have been positive.1 Get answers fast with the FDA Emergency Use Authorized BioFire RP2.1-EZ Panel, which identifies 4 bacterial and 15 viral targets—including SARS-CoV-2—in one fast and easy test.
Faster testing. Relieved patients.
Your clinic can provide more timely and accurate diagnosis with on-site testing using the BioFire® FilmArray® Panels. Each test takes just two minutes of hands-on time and one small sample, helping to streamline your workflow and provide results to your patients in about an hour.
77%
of patients
prefer onsite
lab services.1
67%
of patients will drive up
to 20 minutes to a clinic
with onsite lab services.1
Syndromic testing from BioFire can help:
- Improve operational efficiency
- Reduce unnecessary testing
- Put confidence in treatment plans
- Prescribe the right treatment sooner
The BioFire® Respiratory 2.1-EZ Panel
Sample Type: Nasopharyngeal swab
Overall 97.1% sensitivity | 99.3% specificity (prospective specimens)3
SARS-CoV-2 98.0% sensitivity and 100% specificity (archived specimens)4
SARS-CoV-2 100% PPA and 100% NPA (contrived specimens)5
19 Targets in One Test
The BioFire RP2.1-EZ Panel is designed to run on the CLIA-waived BioFire® FilmArray® 2.0 EZ Configuration System. The comprehensive panel offers the ability to detect 15 viral and 4 bacterial targets, including SARS-CoV-2, with results available in about an hour.
Product not available outside U.S.
The BioFire® FilmArray® Respiratory EZ (RP EZ) Panel
Sample Type: Nasopharyngeal swab
Overall 96.8% Sensitivity | 99.5% Specificity2
14 Targets in One Test
The BioFire RP EZ Panel tests for a comprehensive set of 14 respiratory viral and bacterial pathogens. It is a CLIA-waived version of the FDA-cleared BioFire® FilmArray® Respiratory (RP) Panel, and is designed to run on the BioFire 2.0 EZ Configuration System.
Product not available outside U.S.
The BioFire® FilmArray® Gastrointestinal (GI) Panel**
Sample Type: Stool in Cary Blair
Overall 98.5% Sensitivity | 99.2% Specificity2
22 Targets in One Test
The BioFire GI Panel tests for a comprehensive set of 22 gastrointestinal pathogens. The BioFire GI Panel tests stool specimens for common pathogens associated with gastroenteritis. Quickly identifying the correct pathogen can ensure appropriate treatment, improve patient management, and help detect infectious gastroenteritis which can lead to severe illness or death.
References:
- The COVID Tracking Project. The Atlantic. Available from: https://covidtracking.com/data.
- The Advisory Board Company. (2014) Primary Care Consumer Choice Survey. Washington, DC.
- Based on the prospective portion of the clinical study for the BioFire® FilmArray® Respiratory 2 (RP2) Panel
- Based on the archived specimen study in the BioFire Respiratory 2.1 (RP2.1) Panel EUA submission
- Based on the contrived specimen study in the BioFire Respiratory 2.1 (RP2.1) Panel EUA submission
- The stated performance is the overall aggregate performance of the prospective clinical study data presented in the IFU.
*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.
**CLIA moderately complex license required to run the BioFire GI Panel