Point-of-Care Diagnostic Testing

Bring the Power of PCR to Your Clinic

Strengthen your clinic with the syndromic BIOFIRE suite of systems and PCR panels. Our point-of-care solutions give your clinic flexibility, with options that range from our groundbreaking CLIA-waived BIOFIRE^® SPOTFIRE^® Respiratory Solution to comprehensive syndromic panels for infectious gastroenteritis and joint infections.

Onsite infectious disease diagnostics enable outpatient clinics to provide patients with fast answers, while giving clinicians the information they need to make timely, targeted treatment decisions.

Benefits of Syndromic Testing in the Clinic

Our 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 bioMérieux can help inform timely treatment decisions and may reduce the use of unnecessary antibiotics.

Syndromic testing 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.^1,2 And comprehensive onsite testing may also enable family practice physicians, urgent care providers, and other point-of-care clinics to see improved patient satisfaction.

Improve Patient Satisfaction

77% of patients prefer onsite lab services³

Reduce Unnecessary Testing

Fast, comprehensive answers may reduce additional testing, including expensive send-out tests.

Reduce Appointment Times

Pediatric patients tested with the BIOFIRE Respiratory Panels experience shorter appointment times than those tested with rapid antigen tests.⁴

Streamline Workflow

The BIOFIRE^® SPOTFIRE^® System and the BIOFIRE^® FILMARRAY^® System are easy to use and require minimal hands-on time.

Watch Patient & Customer Testimonials

“Luckily the BioFire [respiratory] panel came back and it showed that his symptoms were caused by a virus so we were able to avoid using antibiotics and be able to treat…the symptoms, until the virus passed.”

– Katie HurstMother of pediatric patient

“I think it’s better to have [the BioFire FilmArray] and not need it than need it and not have it. There’s a lot of clinical settings where it can be really helpful. It really makes you sleep a lot easier at night when you have kids you’re worried about. I recommend that everyone have [the BioFire FilmArray] in their office.”

– Daniel Bruckner, MD, PediatricianBalboa Pediatrics, Providence Health & Services Encino CA, USA

Dr. Bruckner is a paid consultant for bioMérieux.

Point-of-Care Diagnostic Panels

BIOFIRE^® SPOTFIRE^® Respiratory (R) Panel Mini

Sample type: Nasopharyngeal swab collected in 1 to 3 mL of viral transport media
Overall Performance:⁵ PPA: 98.7%, NPA: 98.4%
SARS-CoV-2 Performance:⁵ PPA: 97.3%, NPA: 99.4%

TARGETED SYNDROMIC TESTING. The FDA-cleared and CLIA waived SPOTFIRE R Panel Mini enhances respiratory testing capabilities with lab-quality, PCR-based diagnostics designed for the point of care. The SPOTFIRE R Panel Mini provides results on 5 of the most common respiratory targets, including influenza, human rhinovirus, respiratory syncytial virus, and SARS-CoV-2, with results in about 15 min. The SPOTFIRE R Panel is designed to run on the revolutionary BIOFIRE^® SPOTFIRE^® System.

MORE INFO HERE

BIOFIRE^® SPOTFIRE^® Respiratory (R) Panel

Sample type: Nasopharyngeal swab collected in 1 to 3 mL of viral transport media
Overall Peformance:⁵ PPA: 98.5%, NPA: 99.1%
SARS-CoV-2 Performance:⁵ PPA: 97.3%, NPA: 99.4%

EXPANDED SYNDROMIC TESTING. The FDA-cleared and CLIA waived SPOTFIRE R Panel brings diagnostic power to outpatient clinicians via a lab-quality, PCR-based expanded syndromic approach. The SPOTFIRE R Panel tests for the 15 most probable viruses and bacteria that cause respiratory tract infections, with results in about 15 minutes, enabling clinicians to quickly diagnose and provide informed treatment. This panel is designed to run on the revolutionary, easy-to-use BIOFIRE^® SPOTFIRE^® System.

MORE INFO HERE

BIOFIRE^® Respiratory 2.1 (RP2.1) Panel

Sample type: Nasopharyngeal swab in transport media or saline
Overall Performance: 97.1% sensitivity and 99.3% specificity (prospective specimens)⁶
SARS-CoV-2 Performance: 98.4% PPA and 98.9% NPA⁷

Get comprehensive 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 is intended to be run on the BIOFIRE^® FILMARRAY^® 2.0 and the BIOFIRE^® FILMARRAY^® TORCH Systems in CLIA-moderate settings.

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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.

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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.

MORE INFO HERE

Point-of-Care PCR Testing Systems

BIOFIRE^® SPOTFIRE^® System

The SPOTFIRE System is the latest advancement in PCR infectious disease diagnostics. Designed especially for outpatient settings, the SPOTFIRE System requires minimal benchtop space and can be scaled vertically for customizable throughput. Intuitive and easy to use, the SPOTFIRE System can be used by any healthcare professional in any healthcare setting. The SPOTFIRE System is designed to run the SPOTFIRE R Panels.

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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.

MORE INFO HERE

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.

MORE INFO HERE

Take the Lead on Antimicrobial Stewardship

At least 30% of antibiotics prescribed in the outpatient setting are unnecessary.¹⁰Fast, comprehensive, and accurate—syndromic BIOFIRE Panels give clinicians the information they need to make timely, informed treatment decisions and avoid unnecessary antibiotics.

Accurate results on a comprehensive panel may also help clinicians have productive conversations with patients about whether or not antibiotics are appropriate.

AMR SOLUTIONS HERE

Listen to On Point Episodes Exploring Outpatient Diagnostic Testing

Listen in as clinicians discuss how the syndromic approach to infectious disease diagnostics enhances their point-of-care practice, helping get patients on the right treatment sooner and impacting patient satisfaction.

FIND EPISODES HERE

Request a BIOFIRE System Demo

Are you ready to order the BIOFIRE 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.

REQUEST A DEMO

Product availability varies by country. Consult your bioMérieux representative.

References:

Axelrad JE, et al. J of Clin. Microbiology. 2019; 27;57(3). e01775-18.
Cybulski R, et al. 2018. Clinical Infectious Diseases, ciy357, https://pubmed.ncbi.nlm.nih.gov/29697761/.
The Advisory Board Company. (2014) Primary Care Consumer Choice Survey. Washington, DC.
Beal S, et al. Pedatr Infect Dis. 2020;39(3):188-191.
Overall performance and SARS-CoV-2 performance based on the prospective clinical study for the BIOFIRE SPOTFIRE Respiratory (R) Panel; data on file, BioFire Diagnostics.
Based on the prospective portion of the clinical study for the BioFire® FilmArray® Respiratory 2 Panel.
Overall performance based on prospective SARS-COV-2 clinical study for the BioFire® Respiratory 2.1 Panel in comparison to 3 EUA tests, Data on file, BioFire Diagnostics.
The stated performance is the overall aggregate of the prospective data from the clinical study presented in the BIOFIRE GI Panel Instructions for Use.
Stated sensitivity and specificity is the aggregate performance from the prospective clinical study data as presented in the BIOFIRE JI Panel Instructions for Use.
Fleming-Dutra K, et al. JAMA. 2016 May 3;315(17):1864-73.