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BIOFIRE® FILMARRAY® Pneumonia Panel plus

The BIOFIRE® FILMARRAY® Pneumonia Panel plus enables rapid and accurate automated testing for 27 bacteria and viruses that cause pneumonia and other lower respiratory tract infections (LRTI), as well as for 7 genetic markers of antibiotic resistance.

  • Simple: 2 minutes of hands-on time
  • Easy: No precise measuring or pipetting required
  • Fast: Turnaround time of about an hour
  • Comprehensive: Simultaneously tests for 34 targets
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Simple, comprehensive pneumonia and LRTI testing

The BIOFIRE® FILMARRAY® Pneumonia Panel plus tests for 18 bacteria (11 Gram negative, 4 Gram positive and 3 atypical), 7 antibiotic resistance markers, and 9 viruses that cause pneumonia and other lower respiratory tract infections. It offers an overall sensitivity and specificity for bronchoalveolar (BAL)-like samples of 96,2% and 98.3%, respectively, and for sputum samples a sensitivity and specificity of 96.3% and 97.2%, respectively. The BIOFIRE® Pneumonia panel plus is run  on the BIOFIRE® FILMARRAY® System, a US FDA, CE-IVD, and TGA certified multiplex PCR system. The system integrates sample preparation, nucleic acid extraction and purification, amplification, detection and analysis into one simple system that requires just 2 minutes of hands-on time, with a total run time of about one hour.

The new panel complements the existing BIOFIRE® FILMARRAY® Respiratory Panel 2 plus to provide a comprehensive diagnostic tool for pneumonia and other lower respiratory tract infections. For, A rapid and accurate identification of the causative agent of both community and health care associated  respiratory infections can help improve patient management by informing timely and effective antibiotic or antiviral therapy. A rapid 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 reduceoverall health care costs. 

  • Simple: 2 minutes of hands-on time
  • Easy: No precise measuring or pipetting required
  • Fast: Turnaround time of about an hour
  • Comprehensive: 34-target pneumonia panel

The BIOFIRE® FILMARRAY® Pneumonia Panel plus and the BIOFIRE FILMARRAY Pneumonia Panel are one of five FDA-cleared and CE-marked panels for use on the BIOFIRE® FILMARRAY® multiplex PCR system. Taken together, the five BIOFIRE® FILMARRAY® Panels comprise the largest infectious disease pathogen menu commercially available. The other available panels are:

34 targets at once

The BIOFIRE® FILMARRAY® Pneumonia Panel plus is incredibly comprehensive, with simultaneous testing for 27 of the most common pathogens involved in LRTI and 7 genetic markers of antibiotic resistance.

Bacteria (semi quantitative) Antibiotic Resistance Genes
Acinetobacter calcoaceticus-baumannii complex
Enterobacter cloacae
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
ESBL
CTX-M
 
Carbapenemases
KPC 
NDM 
Oxa48-like
VIM 
IMP
 
Methicilin Resistance
mecA/mecC and MREJ

 

Atypical Bacteria (Qualitative) Viruses
Legionella pneumophila
Mycoplasma pneumoniae
Chlamydia pneumoniae
Influenza B
Adenovirus
Coronavirus
Parainfluenza virus
Respiratory Syncytial virus
Human Rhinovirus/Enterovirus
Human Metapneumovirus
Middle East Respiratory Syndrome Coronavirus (MERS-CoV)*
 
* MERS-CoV will only be available on the Pneumonia Panel plus


Pneumonia: A leading cause of mortality globally

“Lower respiratory infections remained the most deadly communicable disease, causing 3.0 million deaths worldwide in 2016.” 1

Lower respiratory tract infections (LRTI) including pneumonia are considered the third leading cause of death worldwide, and the most deadly communicable disease.1 The severity of pneumonia can range from  mild to severe– and is particularly dangerous for people who are very young, elderly, have co-morbidities such as asthma or chronic obstructive pulmonary disease (COPD) or immunocompromised. A number of pathogens cause pneumonia, including viruses, bacteria and fungi. Streptococcus pneumoniae is the most common cause of bacterial pneumonia, followed by Haemophilus influenzae type b (Hib). Respiratory syncytial virus (RSV) and the influenza virus are the first and second most common causes of viral pneumonia. 1,2

Pneumonia can be difficult to diagnose because the typical symptoms – shortness of breath, weakness, high fever, coughing, and fatigue – can also signal other illnesses, and the symptoms may not be pathogen specific..2, Aside from the symptoms, x-rays, demographic information and identification of potential causative agents are important for making a diagnosis of pneumonia . Inappropriate antibiotic treatment for pneumonia is common,  in part because it is often treated empirically without determining the cause,.3,4 This contributes to longer hospital stays and higher costs, as well as to the development of antimicrobial resistance. 

 

References:

  1. WHO Top 10 causes of death 2016: http://www.who.int/en/news-room/fact-sheets/detail/the-top-10-causes-of-...
  2. WHO Pneumonia fact sheet 2016: http://www.who.int/news-room/fact-sheets/detail/pneumonia
  3. Fleming-Dutra, K.E. et. al. “Prevalence of Inappropriate Antibiotic Prescriptions Among US Ambulatory Care Visits, 2010-2011”. JAMA. 2016;315(17):1864-1873
  4. Biscevic-Tokic J., et. al. “Pneumonia as the Most Common Lower Respiratory Tract Infection”. Med Arch. 2013 Dec; 67(6): 442–445
 

Panel Specification

Sample Handling Performance 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: 200 μL collected with a flocked swab Run time: About an hour

  

 

 

 

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