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BIOFIRE® FILMARRAY® Pneumonia (PN) & Pneumonia plus (PNplus) Panels

1 Test. Up to 34 Targets. ~1 Hour. 

The BIOFIRE PN and PNplus Panels target a comprehensive menu of bacteria and viruses associated with pneumonia and other lower respiratory tract infections, as well as seven antimicrobial resistance markers.

 

Disclaimer: Product availability varies by country. Please consult your local bioMérieux representative for product availability in your country.

Overview

Syndromic Infectious Disease Testing for Pneumonia

The overlapping symptoms of pneumonia patients make it hard to pinpoint the causative pathogen. As such, patients are often prescribed antimicrobials that may not be appropriate or necessary. The BIOFIRE® FILMARRAY® Pneumonia (PN) and Pneumonia plus (PNplus) Panels deliver fast, accurate pathogen identification in about one hour, which may allow physicians to initiate appropriate therapy more promptly for patients, reducing unnecessary antibiotic use and improving overall care.1,2,3

The BIOFIRE PN and PNplus Panels 
identify over 30 clinically relevant targets from sputum-like (sputum or endotracheal aspirate) or bronchoalveolar lavage (BAL)-like (BAL or mini-BAL) specimens. For 15 bacteria, the panels provide semi-quantitative results, which may help determine whether an organism is a colonizer or a pathogen. The fast and comprehensive panels are run on the BIOFIRE®FILMARRAY® TORCH System, which integrates sample preparation, amplification, detection, and analysis.

  • Simple: 2 minutes hands-on time
  • Fast: Turnaround time of about 1 hour
  • Comprehensive:
    • BIOFIRE PN Panel: 33 targets (18 bacteria, 8 viruses, 7 antimicrobial resistance genes)
    • BIOFIRE PNplus Panel: 34 targets (18 bacteria, 9 viruses, 7 antimicrobial resistance genes)
  • Accurate: 
    • BAL-like: 96.2% sensitivity and 98.3% specificity (PNplus: 98.4%)1
    • Sputum-like: 96.3% sensitivity and 97.2% specificity (PNplus: 97.3%)1

Semi-quantitative Results for 15 Common Colonizers

The BIOFIRE PN and PNplus Panels report levels of organism concentration in genome copies/mL. Values are calculated based on an internal quantified standard material (QSM) that is present in the pouch at a known concentration. The difference between real-time amplification of the QSM and the amplification of a target is used to extrapolate a copies/mL concentration for the target. Values calculated below 103.5 copies/mL are reported as “not detected.”

Values Reported by the BIOFIRE PN and PNplus Panels

Superior Clinical Outcomes

Fast and accurate identification of the causative agent of both community- and healthcare-associated respiratory infections can help improve patient management by informing timely and effective antibiotic or antiviral therapy. A quick diagnosis can assist with directing appropriate infection control practices thereby aiding in the prevention of secondary spread of infection, shorten hospital stays, reduce ancillary testing, and reduce overall health care costs.

References

1. Data on File at BioFire Diagnostics.

2. Buchan BW, Windham S, Balada-Llasat JM, Leber A, Harrington A, Relich R, et al. Practical Comparison of the BioFire FilmArray Pneumonia Panel to Routine Diagnostic Methods and Potential Impact on Antimicrobial Stewardship in Adult Hospitalized Patients with Lower Respiratory Tract Infections. J Clin Microbiol. 2020;58(7).

3. Poole S, Tanner AR, Naidu VV, Borca F, Phan H, Saeed K, et al. Molecular point-of-care testing for lower respiratory tract pathogens improves safe antibiotic de-escalation in patients with pneumonia in the ICU: results of a randomised controlled trial. The Journal of infection. 2022.

Panels Menu

The BIOFIRE® FILMARRAY® Pneumonia (PN) Panel Menu

Bacteria (Semi-Quantitative)

  • Acinetobacter calcoaceticus-baumannii complex
  • Enterobacter cloacae complex
  • Escherichia coli
  • Haemophilus influenzae
  • Klebsiella aerogenes
  • Klebsiella oxytoca
  • Klebsiella pneumoniae group
  • Moraxella catarrhalis
  • Proteus spp.
  • Pseudomonas aeruginosa
  • Serratia marcescens
  • Staphylococcus aureus
  • Streptococcus agalactiae
  • Streptococcus pneumoniae
  • Streptococcus pyogenes

Atypical Bacteria (Qualitative)

  • Chlamydia pneumoniae
  • Legionella pneumophila
  • Mycoplasma pneumoniae

 

Viruses

  • Adenovirus
  • Coronavirus
  • Human metapneumovirus
  • Human rhinovirus/enterovirus
  • Influenza A virus
  • Influenza B virus
  • Parainfluenza virus
  • Respiratory syncytial virus

Antimicrobial Resistance Genes

  • Carbapenemases
    • IMP
    • KPC
    • NDM
    • OXA-48-like
    • VIM
  • ESBL
    • CTX-M
  • Methicillin Resistance
    • mecA/C and MREJ (MRSA)

FDA Cleared


The BIOFIRE® FILMARRAY® Pneumonia plus (PNplus) Panel Menu

Bacteria (Semi-Quantitative)

  • Acinetobacter calcoaceticus-baumannii complex 
  • Enterobacter cloacae complex 
  • Escherichia coli 
  • Haemophilus influenzae 
  • Klebsiella aerogenes 
  • Klebsiella oxytoca 
  • Klebsiella pneumoniae group 
  • Moraxella catarrhalis 
  • Proteus spp. 
  • Pseudomonas aeruginosa 
  • Serratia marcescens 
  • Staphylococcus aureus 
  • Streptococcus agalactiae 
  • Streptococcus pneumoniae 
  • Streptococcus pyogenes

Atypical Bacteria (Qualitative)

  • Chlamydia pneumoniae
  • Legionella pneumophila
  • Mycoplasma pneumoniae


Viruses

  • Adenovirus
  • Coronavirus
  • Human metapneumovirus
  • Human rhinovirus/enterovirus
  • Influenza A virus
  • Influenza B virus
  • Middle East respiratory syndrome coronavirus (MERS-CoV)
  • Parainfluenza virus
  • Respiratory syncytial virus

Antimicrobial Resistance Genes

  • Carbapenemases
    • IMP
    • KPC
    • NDM
    • OXA-48-like
    • VIM
  • ESBL
    • CTX-M
  • Methicillin Resistance
    • mecA/C and MREJ (MRSA)

Services & Support

Customer Support: bioMérieux offers the best possible support with dedicated BIOFIRE® technical experts.

Application Specialists: bioMérieux offers dedicated support teams who are available to help set up equipment and troubleshoot any issues.

For assistance: please contact our customer technical support team at biofiresupport@biomerieux.com

Specs & Resources

Technical Panel Specifications

Sample HandlingPerformance Parameters

Sample Type: 

Sputum-like: Induced and expectorated Sputum; Endotracheal aspirates.

BAL-like: BAL and mini-BAL

Hands-on time: Approx. 2 minutes

Sample Volume: 0.2 mL collected with a flocked swab

Run time: ~1 Hour
Product NamePart NumberQuantity
BIOFIRE® PN Panel Reagent KitRFIT-ASY-014430-Pouches
BIOFIRE® PNplus Panel Reagent KitRFIT-ASY-0143
30-Pouches

Resources