BioFire’s PCR-based point-of-care diagnostic testing provides clinics with the power of molecular diagnostics in a rapid, easy-to-use system. Onsite infectious disease diagnostics enables clinics and urgent care centers to provide patients with fast answers, while giving clinicians the information they need to make targeted treatment decisions.
BioFire’s syndromic infectious disease testing is a symptom-driven broad grouping of probable pathogens into one, rapid test that maximizes the chance of getting the right answer in a clinically relevant timeframe. BioFire’s syndromic infectious disease testing offers operational, clinical, and cost savings benefits to point-of-care facilities such as urgent care clinics, pediatric offices, family practice clinics, gastroenterologists, and many others. For example, fast results may enable clinicians to provide answers to patients before the end of their visit. Rapid and comprehensive results may eliminate the need for follow-up testing or for sending tests out to a reference lab. Additionally, syndromic testing from BioFire can help inform timely treatment decisions and may reduce the use of unnecessary antibiotics.
Syndromic testing from BioFire may help pediatricians relieve anxious parents. Point-of-care gastrointestinal testing can help gastroenterologists—and their patients—avoid costly downstream testing, such as endoscopies and abdominal imaging.2,7 And comprehensive onsite testing may also enable family practice physicians and urgent care providers to see improved patient satisfaction.
The BioFire® FilmArray® System is easy to use, with only two minutes of hands-on time, making it simple to integrate into a clinic’s workflow. Learn more about the benefits of in-clinic testing and how syndromic testing impacts issues such as antimicrobial resistance and the ongoing COVID-19 pandemic.
Dr. Bruckner is a paid consultant for bioMérieux.
BioFire® Respiratory 2.1 (RP2.1) Panel
Sample type: Nasopharyngeal swab in transport media or saline
Overall 97.1% sensitivity and 99.3% specificity (prospective specimens)3
SARS-CoV-2 98.4% PPA and 98.9% NPA4
Several respiratory pathogens cause similar, overlapping symptoms. Get answers fast with the FDA De Novo authorized BioFire RP2.1 Panel. This frontline test identifies 22 of the most common respiratory targets, including SARS-CoV-2, enabling clinicians to quickly diagnose respiratory infections and offer timely, targeted treatment. With results in about 45 minutes, the BioFire RP2.1 Panel enables high efficiency and throughput on the BioFire® FilmArray® 2.0 and the BioFire® FilmArray® Torch Systems in CLIA-moderate settings.
BioFire® Respiratory 2.1-EZ (RP2.1-EZ) Panel (EUA)*
Sample type: Nasopharyngeal swab in transport media or saline
Overall 97.1% sensitivity and 99.3% specificity (prospective specimens)3
SARS-CoV-2 98.4% PPA and 98.9% NPA4
The BioFire RP2.1-EZ Panel (EUA) enables in-clinic testing of those suspected of COVID-19. This syndromic panel identifies 19 respiratory targets—including SARS-CoV-2—in one fast and easy test. The BioFire RP2.1-EZ Panel (EUA) is designed to run on the BioFire® FilmArray® 2.0 EZ configuration system, and is authorized for use at the Point of Care (POC) in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Product not available outside the U.S.
BioFire® FilmArray® Gastrointestinal (GI) Panel
Sample type: Stool in Cary Blair
Overall 98.5% Sensitivity and 99.2% Specificity5
Quickly distinguishing possible causes of gastroenteritis can be challenging, as symptoms are often overlapping. Waiting on traditional testing methods can take days and may not even provide results. Fortunately, the BioFire GI Panel can help—simultaneously testing for 22 of the most common GI pathogens, all in about an hour, directly on-site. The BioFire GI Panel is intended to be run in a CLIA-moderate setting on the BioFire Torch and BioFire 2.0 Systems.
BioFire® Joint Infection (JI) Panel
Sample type: 0.2 mL of synovial fluid
Overall 91.7% Sensitivity and 99.8% Specificity
The BioFire JI Panel tests for a comprehensive grouping of Gram-positive and Gram-negative bacteria, yeast, and antimicrobial resistance genes commonly associated with joint infections. It takes just one syndromic test, one small sample of synovial fluid, and about an hour to get results on 39 clinically relevant targets. The BioFire JI Panel is intended to be used in CLIA-moderate settings with the BioFire Torch or the BioFire 2.0 Systems.
BioFire® FilmArray® Torch System
The high-throughput BioFire Torch is a fully integrated, random-access system intended for use in CLIA-moderate settings. It can run 5 FDA-cleared BioFire Panels, including the BioFire RP2.1 Panel and the BioFire GI Panel. The BioFire Torch is scalable and provides the quick, comprehensive, and accurate results expected from the most advanced testing solution.
BioFire® FilmArray® 2.0 System
The BioFire 2.0 System offers a scalable configuration that allows clinics to customize their throughput needs and efficiently use laboratory space. It is intended for use in CLIA-moderate settings and can run the BioFire RP2.1 Panel and the BioFire GI Panel, along with the other FDA-cleared BioFire® FilmArray® Panels.
BioFire® FilmArray® 2.0 System EZ Configuration
The BioFire 2.0 System EZ Configuration facilitates rapid, near-patient molecular diagnostic testing. It is designed to be used with the BioFire® RP2.1-EZ Panel (EUA) in CLIA-waived testing sites, including clinics and physician offices. The BioFire 2.0 System EZ Configuration accurately provides results in about 45 minutes with only two minutes of hands-on time.
Are you ready to order the BioFire FilmArray System or want to request a free demo? Click below to take the next step towards faster results. Our team is ready to answer all of your questions.
Product availability varies by country. Consult your bioMérieux representative.
References:
*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 and differentiation of nucleic acid of SARS-CoV-2 from multiple respiratory viral and bacterial organisms; 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.