BIOFIRE® Respiratory 2.1 plus Panel

BIOFIRE FILMARRAY Respiratory Panel

The new BIOFIRE® FILMARRAY® Respiratory 2.1 plus Panel enables rapid and accurate automated detection of pathogens behind respiratory infections. It tests for 19 viruses including SARS-CoV-2, and 4 bacteria that cause respiratory tract infections in 45 min.

  • Simple: 2 minutes of hands-on time
  • Easy: No precise measuring or pipetting required
  • Fast: Turnaround time of 45 minutes for RP2 plus Comprehensive: 23 targets including viruses and bacteria

 

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Simple, comprehensive respiratory testing

The BIOFIRE®  Respiratory 2.1 plus Panel tests for 19 viruses and 4 bacteria which cause  respiratory tract infections with an overall sensitivity and specificity of 97,4% and 99,4% respectively. It works on the BIOFIRE® FILMARRAY® 2.0 and Torch systems, an FDA, CE-IVD, and TGA certified multiplex PCR system. BIOFIRE® FILMARRAY® integrates sample preparation, amplification, detection and analysis into one simple system that requires just 2 minutes of hands-on time, with a total run time of about an hour. Rapid and accurate identification of the causative agent of upper respiratory tract infections may improve patient management by informing timely and effective antibiotic or antiviral therapy, preventing secondary spread of infection, shortening hospital stays and reducing costs of unnecessary ancillary tests.

  • Simple: 2 minutes of hands-on time
  • Easy: No precise measuring or pipetting required
  • Fast: Turnaround time of about an hour
  • Comprehensive: 20 target respiratory panel
     

BIOFIRE® FILMARRAY® Respiratory 2.1 plus Panel is one of five FDA-cleared and/or 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:

23 targets at once

The BIOFIRE® FILMARRAY® Respiratory 2.1 plus Panel is incredibly comprehensive, with simultaneous testing for 23 of the most common pathogens, including SARS-CoV-2, involved in RTI.

Viruses Bacteria

Adenovirus

Coronavirus 229E

Coronavirus HKU1

Coronavirus OC43

Coronavirus NL63

Middle East Respiratory Syndrome CoronaVirus (Mers-CoV)

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Human Metapneumovirus

Human Rhinovirus/Enterovirus

Influenza A

Influenza A/H1

Influenza A/H1-2009

Influenza A/H3

Influenza B

Parainfluenza 1

Parainfluenza 2

Parainfluenza 3

Parainfluenza 4

RSV

Bordetella pertussis

Bordetella parapertussis

Chlamydophila pneumoniae

Mycoplasma pneumoniae

 

Panel Specification

Sample Handling Performance Parameters
Sample Type: Nasopharyngeal Swab Hands-on time: Approx. 2 minutes
Sample Volume: 300 μL Run turnaround time: About an hour

Clinical Sensitivity and Specificity of the BIOFIRE® FILMARRAY® Respiratory Pouch

Pathogen SENSITIVITY
Prospective
SENSITIVITY
Retrospective
SPECIFICITY
Prospective
Adenovirus
88.9% 100% 98.3%
Coronavirus HKU1 95.8% n/a 99.8%
Coronavirus NL63 95.8% n/a 100%
Coronavirus 229E 100% n/a 99.80%
Coronavirus OC43  100% n/a 99.60%
Middle East Respiratory Syndrome Coronavirus (MERS-CoV
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
n/a 100%
98%
99,48%
100%
Human Metapneumovirus 94.6% n/a 99.2%
Human Rhinovirus/Enterovirus 92.7% 95.7% 94.6%
Influenza A 90.0% n/a 99.8%
Influenza A/H1 n/a 100% 100%
Influenza A/H3 n/a 100% 100%
Influenza A/H1-2009 88.9%* 100% 99.6%
Influenza B n/a 100% 100%
Parainfluenza Virus 1 100%* 97.1% 99.9%
Parainfluenza Virus 2 87.4%* 100% 99.8%
Parainfluenza Virus 3 95.8%* 100% 99.8%
Parainfluenza Virus 4 100%* 100% 99.9%
Respiratory Syncytial Virus 100% n/a 89.1%
Bordetella pertussis 100%* 100% 99.90%
Chlamydophila pneumoniae 100%* n/a 100%
Mycoplasma pneumoniae 100%* 90.0% 100%

 

 

Our Solutions

 

Publications

Comparison of Turnaround Time (TAT) and Time to Oseltamivir Discontinuation between Two Respiratory Viral Panel Testing (RVP) Methodologies.
Pettit N., Matushek S., Charnot-Katsikas A., Tesic V., Boonlayangoor S., Brielmaier B., Pisano J.
JOURNAL OF MEDICAL MICROBIOLOGY 2015;64:312-313

Impact of a Rapid Respiratory Panel Test on Patient Outcomes.
Rogers B.B., Shankar P., Jerris R.C., Kotzbauer D., Anderson E.J., Watson JR., O'Brien L.A., Uwindatwa F, McNamara K, Bost J.E.
ARCHIVES OF PATHOLOGY & LABORATORY MEDICINE 2015;139(5):636-41

Seasonality and Prevalence of Respiratory Pathogens detected by multiplex PCR at a Tertiary Care Medical Center.
Litwin C.M., Bosley J.G.
ARCHIVES OF VIROLOGY 2014;159(1):65-72

Implementation of FILMARRAY® Respiratory Viral Panel in a Core Laboratory Improves Testing Turnaround Time and Patient Care.
Xu M., Qin X., Astion M.L., Rutledge JC., Simpson J., Jerome KR., Englund J.A., Zerr D.M., Migita R.T., Rich S., Childs J.C., Cent A., Del Beccaro M.A.
AMERICAN JOURNAL OF CLINICAL PATHOLOGY 2013;139(1):118-23

 
 

Fast facts on Respiratory Pathogens

What are Respiratory Pathogens?

The vast majority of respiratory illnesses are caused by viruses and bacteria. In both children and adults, acute respiratory infections  (ARI) are most frequently due to infections with Influenza A and B viruses, Parainfluenza viruses 1, 2 and 3, Respiratory Syncytial Virus (RSV A and B), Adenoviruses and Rhinoviruses. Others pathogens such as Coronaviruses, Bocaviruses, Enteroviruses, Parainfluenza 4, Human Metapneumovirus, Mycoplasma pneumonia and Chlamydophila pneumoniae also infect  the respiratory tract and can cause various diseases from mild self-limiting upper respiratory infections to potentially threatening pneumonia.

Who is most at risk?

Anyone can become infected and ill with these respiratory pathogens. However, young children, the elderly, immunocompromised or weakened individuals (including those with chronic disease, cancer, or in intensive care) are most likely to suffer serious and potentially life-threatening pneumopathies.

What are the benefits of Respiratory pathogens molecular testing?

Clinical symptoms for different respiratory illnesses are similar so in vitro diagnostic molecular methods are necessary to determine the causative agents. Early, rapid and specific detection of the virus or bacteria involved using real-time PCR methods is essential to provide patient-tailored therapy for better outcomes. An accurate diagnosis may also help to control outbreaks, reduce potential antibiotic resistance and facilitate a more rapid patient recovery.

 

Technical Notes and Advisory Notes:

Instructions for Use and Manuals:

Product Support Documents:

EC Declarations of conformity:

Secondary Bacterial Infections in COVID-19 Patients:
Is widespread antibiotic use really necessary?

Please consult your local bioMérieux representative for product availability in your country

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