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BIOFIRE® FILMARRAY® SYSTEMS 

BIOFIRE FILMARRAY Multiplex Real-Time PCR Systems

The BIOFIRE® FILMARRAY® system is an FDA, CE-IVD, and TGA certified multiplex PCR system that integrates sample preparation, amplification, detection and analysis.

  • Simple: 2 minutes of hands-on time
  • Easy: No precise measuring or pipetting required
  • Fast: Turnaround time of about an hour
  • Comprehensive: Tests for a variety of pathogens that cause viral respiratory, pneumonia, bloodstream, gastrointestinal infections and meningitis-encephalitis as well antimicrobial resistance genes. 
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Comprehensive panels for key healthcare challenges

The BIOFIRE® FILMARRAY® system is an FDA, CE-IVD, and TGA certified multiplex PCR system that integrates sample preparation, amplification, detection and analysis. This simple system requires just 2 minutes of hands-on time, with a total run time of about an hour – you get fast results to assist in better patient care.

The BIOFIRE® FILMARRAY® system enables simultaneous testing for bacteria, viruses, yeast, parasites and/or antimicrobial resistant genes. It is designed to be used with comprehensive panels that each offer testing for sets of pathogens associated with some of today’s most pressing healthcare challenges.

  • BIOFIRE® FILMARRAY® Respiratory Panels [3]: tests for a comprehensive panel of 20 respiratory viruses and bacteria.

     
  • BIOFIRE® FILMARRAY® Blood Culture Identification Panel [4]: tests for a comprehensive list of 24 pathogens and 3 antibiotic resistance genes associated with bloodstream infections. With just one test you can identify pathogens in 9 out of 10 positive blood cultures.

     
  • BIOFIRE® FILMARRAY® Gastrointestinal Panel [5]: tests for 22 common gastrointestinal pathogens including viruses, bacteria and protozoa that cause infectious diarrhea.  

     
  • BIOFIRE® FILMARRAY® Meningitis Encephalitis Panel [6]: tests directly in Cerebral Spinal Fluidfor the 14 most relevant ME-associated pathogens, including bacteria, viruses and a parasite.

     
  • BIOFIRE® FILMARRAY® Pneumonia plus Panel [7]: 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. 

Fast, accurate molecular diagnostics testing for syndromic diagnosis

BIOFIRE® FILMARRAY® performs the extraction, amplification and detection in a closed system, minimizing contamination. It is a syndromic testing system for a variety of pathogens associated with key healthcare concerns. The rapid results offer the information needed to help primary care providers and emergency room [8] physicians to better triage patients and make timely, confident medical decisions. 

  • Simple: 2 minutes of hands-on time
  • Easy: No precise measuring or pipetting required
  • Fast: Turnaround time of about an hour
  • Comprehensive: Tests for a variety of pathogens that cause viral respiratory [3], pneumonia, bloodstream [4], gastrointestinal infections [5] and meningitis-encephalitis [6] as well antimicrobial resistance genes. 

Easy, intuitive operation

The BIOFIRE® FILMARRAY® multiplex PCR system makes it easy to provide fast, comprehensive and accurate diagnostic results.

  1. Insert the BIOFIRE® FILMARRAY® pouch into the loading station, and inject the hydration solution along with a sample
  2. The vacuum in the pouch ensures that the correct volume of hydration solution and sample is drawn into the pouch, so you don’t have to worry about pipetting
  3. Insert the pouch into the BIOFIRE® FILMARRAY® system and start your run
  4. Run time is approximately 1 hour
  5. Obtain results in easy-to-read reports

     

[9]

Click to enlarge » [9]

 

The BIOFIRE® FILMARRAY® self-contained pouch



Click to enlarge » [10]

The BIOFIRE® FILMARRAY® pouch stores all the necessary reagents for cell lysis, DNA/RNA extraction and purification, amplification, and detection in one closed pouch.

  • BIOFIRE® FILMARRAY® extracts and purifies all nucleic acids from the unprocessed sample and performs a nested multiplex PCR
  • During PCR I, the system performs a single, large volume, multiplexed reaction
  • Individual, singleplex PCR II reactions detect the products from the first-stage PCR.

     

 

The BIOFIRE® FILMARRAY® software

The BIOFIRE® FILMARRAY® software [11] walks you through the entire process - from sample to result. When the run is complete, the software analyzes and reports results in a simple, easy-to-read format.

BIOFIRE® FILMARRAY® Multiplex PCR System Specifications

System Specifications
Reagents
  • Freeze-dried in durable plastic pouches
  • Room temperature storage
(BIOFIRE® FILMARRAY® 2.0.) Instrument Specifications
  • Weight: 9 kg (20 lbs)
  • Size: 25.4 x 39.3 x 16.5 cm (10 x 15.5 x 6.5 in.)
Performance Parameters
  • Hands on time: Approx. 2 minutes
  • Run turn-around time : Approx. 1 hours
Environmental Specification
  • Operating: 15°C to 30°C at 20 to 80% humidity
  • Storage: -30°C to 65°C
(BIOFIRE® FILMARRAY® 2.0.) Desktop Software (Pre-loaded on supplied laptop)
  • Windows-based instrument control and data analysis software
  • Barcode reader for data input
  • Automated qualitative and reporting
  • Separate advanced analysis software

 

  • Healthcare Information​
    • Gastrointestinal infections healthcare information page [12]
    • Healthcare-associated infections healthcare information page [13]

       
  • Our Solutions
    • Sepsis Management Solutions page [14]
    • Emergency Department patient management Solutions page [8]
    • Antimicrobial Resistance Management Solutions page [15]

       
  • Your Challenges...
    • Time to result [16]
    • Improving patient care [17]
    • Clinical decision making [18]
    • Managing Antibiotic Resistance [19]

 

Technical Notes:

Guidelines for Laboratories Establishing Daily Quality Control Equivalence for BIOFIRE® FILMARRAY® Systems [20]

Instructions for Use and Manuals:

  • BIOFIRE® FILMARRAY® 1.5. Operator’s Manual [21]
  • BIOFIRE® FILMARRAY® 2.0. Operator’s Manual [22]
  • BIOFIRE® FILMARRAY®  Torch Operator's Manual [23]

EC Declarations of conformity:

BIOFIRE® FILMARRAY® 1.5 – EC Declaration of Conformity [24]

BIOFIRE® FILMARRAY® 2.0 – EC Declaration of Conformity [25]

BIOFIRE® FILMARRAY® Torch – EC Declaration of Conformity [26]

Advisory Notice:

Contamination Prevention and Decontamination [27]

Product Support Documents

BIOFIRE® FILMARRAY® 2.0. System MSD2  [28]

BIOFIRE® FILMARRAY® Torch MSD2 [29]

BIOFIRE® FILMARRAY® Torch Quick Guide [30]

[31]
FILMARRAY® Demo [32]

Discover how it works in video

[32]

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

COMPLETE YOUR SOLUTION

  • [6]

    BIOFIRE® FILMARRAY® ME Panel [6]

    BIOFIRE FILMARRAY Meningitis/Encephalitis Panel [6]

  • [5]

    BIOFIRE® FILMARRAY® GI Panel [5]

    BIOFIRE® FILMARRAY® Gastrointestinal Panel [5]

  • [4]

    BIOFIRE® BCID2 Panel [4]

    BIOFIRE Blood Culture Identification 2 Panel (BCID2) [4]

  • [3]

    BIOFIRE® Respiratory 2.1 plus Panel [3]

    BIOFIRE FILMARRAY Respiratory Panel [3]

  • [8]

    Emergency Department patient management [8]

    In the Emergency Department, accurate diagnosis in a minimum o... [8]

  • [14]

    Sepsis Management [14]

    Sepsis is now defined as a life-threatening organ dysfunction ... [14]


Source URL: https://www.biomerieux-diagnostics.com/filmarrayr-multiplex-pcr-system

Links
[1] https://www.biomerieux-diagnostics.com/contact?pdt=898
[2] http://go.biomerieux.com/filmarray-torch?utm_source=push-clinical-product
[3] https://www.biomerieux-diagnostics.com/filmarrayr-respiratory-panel
[4] https://www.biomerieux-diagnostics.com/biofire-bcid2-panel
[5] https://www.biomerieux-diagnostics.com/filmarrayr-gi-panel
[6] https://www.biomerieux-diagnostics.com/filmarray-meningitis-encephalitis-me-panel
[7] https://www.biomerieux-diagnostics.com/biofire-filmarray-pneumonia-plus-panel
[8] https://www.biomerieux-diagnostics.com/emergency-department-patient-management
[9] http://www.biomerieux-diagnostics.com/sites/clinic/files/filmarray-steps.jpg
[10] http://www.biomerieux-diagnostics.com/sites/clinic/files/self-contained-pouch.png
[11] http://www.biomerieux-diagnostics.com/video/1622/player
[12] https://www.biomerieux-diagnostics.com/gastrointestinal-infections
[13] https://www.biomerieux-diagnostics.com/healthcare-associated-infections
[14] https://www.biomerieux-diagnostics.com/sepsis-solution
[15] https://www.biomerieux-diagnostics.com/antimicrobial-resistance-management
[16] https://www.biomerieux-diagnostics.com/time-result
[17] https://www.biomerieux-diagnostics.com/improving-patient-care
[18] https://www.biomerieux-diagnostics.com/clinical-decision-making
[19] https://www.biomerieux-diagnostics.com/managing-antibiotic-resistance
[20] https://www.biomerieux-diagnostics.com/sites/clinic/files/tn-flm1-prt-0215-guidelines-for-laboratories-establishing-daily-quality-control-equivalence-for-filmarray-systems.pdf
[21] https://www.e-labeling.eu/ITI0001
[22] https://www.e-labeling.eu/ITI0025
[23] https://www.online-ifu.com/ITI0066
[24] https://www.biomerieux-diagnostics.com/sites/clinic/files/filmarray_1.5._instrument_ivd_ec_declaration.pdf
[25] https://www.biomerieux-diagnostics.com/sites/clinic/files/filmarray_2.0._instrument_ivd_ec_declaration.pdf
[26] https://www.biomerieux-diagnostics.com/sites/clinic/files/filmarray_torch_ec_declaration_htfa-prt-0010-02.pdf
[27] https://www.biomerieux-diagnostics.com/sites/clinic/files/an-flm1-prt-0113-01-contamination-prevention-and-decontamination.pdf
[28] https://www.biomerieux-diagnostics.com/sites/clinic/files/filmarray-2.0-system-mds2.pdf
[29] https://www.biomerieux-diagnostics.com/sites/clinic/files/filmarraytorch_system_mds2.pdf
[30] https://www.online-ifu.com/ITI0077
[31] http://go.biomerieux.com/l/149271/2017-05-02/2x1z8h
[32] https://www.biomerieux-diagnostics.com/video/2585/player