BioFire® FilmArray® BioSurveillance System

Fully Automated BioDetection

The BioFire FilmArray System is able to identify, in a closed system, dozens of the most lethal viruses and bacteria, including emerging infectious diseases. The easy-to-use, syringe-loaded system represents the next generation in automated detection systems.

The BioFire FilmArray System uses a plastic pouch with automated capabilities, including sample preparation, reverse transcription for RNA viruses, and a two-stage nested multiplex PCR process. The results are a revolutionary detection system in a lightweight, small-footprint format.

 

Bench Top System

This all-in-one system integrates sample preparation, amplification, detection and analysis into one instrument that processes sample to results in about one hour.

Efficient

With just two minutes of hands on time, this closed system does all the work so you can start the run and return for the results.

Comprehensive Test Panels

Identifies dozens of the most lethal viruses, bacteria and parasites including emerging infectious diseases. This results in a revolutionary detection system with a lightweight, small-footprint format.

*Image shown with optional hard case

Download the BioFire FilmArray 2.0 System Information Sheet

Benefits from a Complete Product Solution

  • Multi-Use: Used for BioThreat Detection and Pandemic BioSurveillance.
  • Fully Automated: Sample prep, amplification, identification, and reporting.
  • Single Instrument Integration: Reduce the amount of equipment and consumables.
  • Freeze-dried Reagents: Room temperature stable.
  • Easy-to-Use: Automated protocol requires limited hands-on time and training.
  • Network: Interoperable with global information grid.
  • Quick Test Times: Results in 1 hour.

BioFire FilmArray Test Kits

1 Streamlined System. Many BioThreat Targets.

A BioFire FilmArray reagents pouch contains all the required reagents for sample preparation, PCR and detection in a freeze-dried, room temperature stable format making it the ideal system for any mobile lab. Prior to a run, the operator injects hydration solution and the unknown sample into the pouch. The FilmArray instrument does the rest.

Setting up BioFire FilmArray is Simple

  • Simple: 2 minutes of hands-on time
  • Easy: No precise measuring or pipetting required
  • Fast: Turnaround time of about 1 hour

Download the BioFire Defense BioFire FilmArray Panels Information Sheet

Steps 1 & 2: Insert Pouch into Loading Station and Inject Hydration Solution into Pouch

Steps 1 & 2: Insert Pouch into Loading Station and Inject Hydration Solution into Pouch

Steps 3 & 4: Add Sample Buffer to Sample Vial and Add Raw Sample to Sample Vial

Steps 5 & 6: Inject Sample into Pouch and then Insert Pouch into FilmArray and Start Run

BioFire FilmArray Panels

For In Vitro Diagnostic Use Panels

BioFire Global Fever Panel
Emergency Use Authorization Panels

FilmArray BioThreat-E Test BioFire COVID-19 Test
Not for Diagnostic Use Panels

FilmArray BioThreat Panel FilmArray Global Fever Panel – RUO FilmArray Food & Water Panel
DoD Controlled Panels

FilmArray Sentinel Panel FilmArray NGDS Warrior Panel (IVD)
Additional BioFire FilmArray panels available for purchase through BioFire Defense are below. Click for details.

  • BioFire Respiratory Panels – RP, RP2, and RP2.1
  • BioFire Blood Culture Identification 2 (BCID) Panel
  • BioFire FilmArray Gastrointestinal (GI) Panel
  • BioFire FilmArray Meningitis/Encephalitis (ME) Panel
  • BioFire FilmArray Pneumonia (PN) Panel
 Additional Panel is Available through bioMérieux, click for details

    • BioFire Mycoplasma Panel

FilmArray® BioThreat Panel

1 Test. 16 BioThreat Pathogens/26 Targets. All in about an hour.

The FilmArray BioThreat Panel tests for a comprehensive list of 16 BioThreat pathogens. With just one test, you can identify pathogens in environmental samples in about an hour with only 2 minutes of hands-on time.

Not For Diagnostic Use.

Targets

  • Bacillus anthracis, 3 Targets
  • Brucella melitensis, 2 Targets
  • Burkholderia, 2 Targets
  • Clostridium botulinum
  • Coxiella burnetii, 2 Targets
  • Ebola virus (Zaire)
  • EEE virus
  • F. tularensis, 2 Targets
  • Marburg virus, 2 Targets
  • Ricinus communis
  • Rickettsia prowazekii, 2 Targets
  • Variola virus
  • VEE virus, 2 Targets
  • WEE virus
  • Yersinia pestis, 2 Targets
  • Orthopox virus, 2 Targets

Specifications

  • Sample Types: Swab, powder, liquid, culture, soil.
  • Sample Volume: 250 µL
  • Storage Conditions: Freeze-dried in durable plastic pouches. Room temperature storage.
  • Kit Contents: Includes 6 test pouches and supplies for 6 tests.

Kit Part No.: RFIT-ASY-0094

Download the FilmArray BioThreat Panel Information Sheet Download FilmArray BioThreat Panel – Support Documents

 

Featured Video

Thanks to the Pacific Northwest National Laboratory (PNNL) for using the FilmArray system, a Polymerase Chain Reaction (PCR) instrument to demonstrate how to screen for suspicious powders.

Featured Research Paper

Evaluation of the FilmArray® system for detection of Bacillus anthracis, Francisella tularensis and Yersinia pestis

DR Seiner, HA Colburn, C Baird, RA Bartholomew, T Straub, K Victry, JR Hutchison, N Valentine, and CJ Bruckner-Lea

Pacific Northwest National Laboratory, Chemical and Biological Signature Science Group, National Security Directorate, Richland, WA, USA; Cynthia J. Bruckner-Lea, Chemical and Biological Signature Science Group, National Security Directorate, Pacific Northwest National Laboratory;

J Appl Microbiol. 2013 Apr;114(4):992-1000. doi: 10.1111/jam.12107. Epub 2013 Jan 31.

The anthrax attacks of 2001 and the uncovering of recent bioterror plots highlight the importance of  biodetection systems that can rapidly and accurately identify a wide range of potential biothreats in environmental samples (Schmitt and Shanker 2011; Kman and Bachmann 2012). An ideal system consistently detects the target organism(s) of interest at low levels without significant false-positive or false-negative results, interrogates a single sample for multiple targets (e.g. multiplexed detection), requires limited training and is cost-effective. One of the promising approaches to meet these needs is a detection system that identifies genetic signatures of biothreat pathogens using polymerase chain reaction (PCR). In this study, we evaluated a PCR-based detection system for the analysis of Bacillus anthracis (Ba), Yersinia pestis (Yp) and Francisella tularensis (Ft).

FilmArray® Global Fever Panel – RUO

1 Test. 19 Targets. All in about an hour.

The RUO FilmArray Global Fever Panel tests for a comprehensive list of 6 bacterial, 9 viral and 4 protozan targets directly from whole blood. With just one test and only 2 minutes of hands-on time you can identify these targets in about an hour.

Not For Diagnostic Use

Targets

Viruses

  • Chikungunya virus
  • Crimean-Congo hemorrhagic fever virus
  • Dengue virus
  • Ebola virus
  • Lassa virus
  • Marburg virus
  • West Nile virus
  • Yellow fever virus
  • Zika virus
 Bacteria

  • Bacillus anthracis
  • Francisella tularensis
  • Leptospira spp.
  • Salmonella enterica serovar Typhi
  • Salmonella enterica serovar Paratyphi A
  • Yersinia pestis
 Protozoa

  • Leishmania spp.
  • Plasmodium spp.
  • P. falciparum
  • P. vivax/ovale  

Specifications

  • Sample Types: Whole Blood.
  • Sample Volume: ~0.2 mL (200 μL)
  • Storage Conditions: Freeze-dried in durable plastic pouches. Room temperature storage.
  • Kit Contents: Includes 6 test pouches and supplies for 6 tests.

Kit Part No.: DFA2-ASY-0003

Download the Global Fever Panel – RUO Information Sheet Download Global Fever Panel – RUO Support Documents

 

Analytical Performance of the FilmArray Global Fever Panel

Jared R. Helm, Corike Toxopeus, Pascal Belgique, Lex Border, Olivia Davidson, Alex Kelley, Micah Mortenson, Cynthia Phillips

ABSTRACT: Acute Febrile Illness (AFI) can be caused by a large number of pathogens that include bacteria, viruses and parasites. BioFire Defense is developing the Global Fever (GF) Panel to be used on the FilmArray System in collaboration with the Department of Defensea and NIAIDb. The FilmArray System is an in vitro diagnostic test platform that combines nucleic acid purification and nested multiplex PCR for the simultaneous identification of many infectious agents in under an hour using a closed, sample-to-answer system. The FilmArray GF Panel detects and identifies nucleic acid from Chikungunya virus, CCHF virus, dengue virus (serotypes 1-4), Ebolavirus, Lassa virus, Marburgvirus, West Nile virus, Yellow fever virus, Zika virus, Bacillus anthracis, Francisella tularensis, Leptospira spp., Salmonella enterica serovar Typhi and Paratyphi A, Yersinia pestis, Leishmania donovani complex, and Plasmodium spp. in venous blood specimens from individuals with signs and/or symptoms of AFI or recent AFI and with known or suspected exposure to target pathogens. Estimated LoD studies demonstrate clinically relevant detection levels and exclusivity testing shows high specificity. For example, estimated LoD levels for the following organisms: dengue virus New Guinea C at 360 copies/mL, Marburgvirus Musoke at 50 copies/mL, Zika virus at 130 copies/mL, Leishmania donovani at 10 copies/mL, Plasmodium at 10 copies/mL, Bacillus anthracis at 64 copies/mL, and Yersinia pestis at 15 copies/mL.c Preliminary off-panel exclusivity studies assessing specificity with closely related organisms or organisms that may be found in whole blood show no significant cross-reactivity. A multiplex FilmArray panel could aid in rapid and actionable AFI diagnosis.

Learn More

FilmArray® BioThreat-E Test

1 Test for Ebola Zaire virus (detected in the West Africa outbreak in 2014)

The FilmArray BioThreat-E test is for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) on the FilmArray Instrument using whole blood and urine specimens in individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors.

For In Vitro Diagnostic Use

  • This test has not been FDA cleared or approved;
  • This test has been authorized by FDA under an Emergency Use Authorization for use by CLIA Moderate and High Complexity Laboratories;
  • This test has been authorized only for the detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) and not for any other viruses or pathogens; and
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of Ebola Zaire virus under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

The EUA for the FilmArray BioThreat-E Test enables CLIA moderate and high complexity laboratories to conduct a PCR test for Ebola in-house, providing results in approximately one hour.

Date of EUA Issuance
Letter of Authorization
Fact Sheets and Labeling
EUA Determination and Declaration
October 25, 2014 Authorization (PDF,  73 KB) Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 12, 2014)

Kit Part No: RFIT-ASY-0122

Download BioThreat-E Kit – Information Sheet Download BioThreat-E Kit –  Support Documents

 

External Controls
Reporting
Customers seeking external control materials for the BioThreat-E Test may find sources here: BioTheat-E Test External Controls Please report adverse events associated with the use of the BioThreat-E Test here: BioThreat-E Test Report Form

BioFire® COVID-19 Test

1 Test for Coronavirus (COVID-19) with results in about 45 minutes.

The BioFire® COVID-19 Test is a nested multiplexed real-time RT-PCR test intended for the qualitative detection of SARS-CoV-2 RNA in nasopharyngeal swabs in transport media from individuals suspected of COVID-19 by their healthcare provider.

For In Vitro Diagnostic Use

Click Here for Details

BioFire® Global Fever Panel

1 Clinical Test. 6 Targets.  All in under an Hour. 

With just one test, bacterial, viral and protozoan targets can be identified in whole blood in under an hour with only 2 minutes of hands-on time using the BioFire FilmArray 2.0 System.

For In Vitro Diagnostic Use 

Targets

Viruses

  • Chikungunya virus
  • Dengue virus
 Bacteria

  • Leptospira spp.
 Protozoa

  • Plasmodium spp.
  • P. falciparum
  • P. vivax/ovale

Specifications

  • Sample Types: EDTA Whole Blood
  • Sample Volume: ~0.2 mL (200 μL)
  • Storage Conditions: Freeze-dried in durable plastic pouches. Room temperature storage.
  • Kit Contents: Includes 6 test pouches and supplies for 6 tests.

Kit Part No: DFA2-ASY-0004

Download Global Fever Panel – IVD Information Sheet Download Global Fever Panel – IVD Support Documents

 

The BIOFIRE SHIELD assayed quality controls reduce the risk of false positive results due to contamination by producing a distinct melting temperature and minimizing manipulation of positive control material. These controls are available for use with the BioFire Global Fever Panel and may be used to monitor test performance and perform test verifications according to laboratory procedures.

Kit Part No: DFA2-ASY-0006

FilmArray® Sentinel Panel

1 Test. 19 Targets. All in about an hour.

This FilmArray Panel is manufactured solely for use by the US Department of Defense laboratories, and laboratories designated by the Department of Defense.

For Environmental Surveillance Only

Targets

Viruses

  • Ebolavirus spp.
  • Marburg Marburgvirus
  • Orthopox viruses
  • Variola virus
  • EEE virus
  • VEE virus
  • WEE virus
 Bacteria

  • Bacillus anthracis
  • Brucella melitensis
  • Brucella spp.
  • Burkholderia spp.
  • Burkholderia pseudomallei
  • Coxiella burnetii
  • Francisella tularensis
  • Rickettsia prowazekii
  • Yersinia pestis
 Toxin Gene

  • Clostridium botulinum
  • Ricin communis

Training Targets

  • Bacillus globigii
  • Bacillus thuringiensis
  • Saccharomyces cerevisiae

Specifications

  • Sample Types: Powder; Surface Swab; Soil; Sand; Mammalian Blood; Food; Liquids: Culture Medium, Aerosol Collection Buffer, Surface Water; Vectors: Flea, Tick, Louse, Mosquito
  • Sample Volume: Varies.
  • Storage Conditions: Freeze-dried in durable plastic pouches. Room temperature storage.
  • Kit Contents: Includes 30 test pouches and supplies for 30 tests.

FilmArray® NGDS Warrior Panel

1 Test. 6 Targets. All in about an hour.

This FilmArray Panel is manufactured solely for use by the US Department of Defense laboratories, and laboratories designated by the Department of Defense.

For In Vitro Diagnostic Use

Targets

Viruses

  • Ebolavirus spp.
  • Marburg Marburgvirus
 Bacteria

    • Bacillus anthracis
    • Coxiella burnetii
    • Francisella tularensis
    • Yersinia pestis

Specifications

  • Sample Types: Whole Blood, Positive Blood Culture and Sputum
  • Sample Volume: Varies.
  • Storage Conditions: Freeze-dried in durable plastic pouches. Room temperature storage.
  • Kit Contents: Includes 30 test pouches and supplies for 30 tests.

FilmArray® Food & Water Panel

1 Test for 15 Targets. All in about an hour.

The FilmArray Food & Water Panel is a qualitative multiplexed DNA based test intended for use in the screening of food and beverage samples on the FilmArray platform.

This FilmArray Panel is manufactured solely for use by the US Department of Defense laboratories, and laboratories designated by the Department of Defense.

For Environmental Surveillance Only

Targets

Bacteria

  • Campylobacter (C. jejuni / C. coli / C. upsaliensis)

  • Salmonella spp.

  • Vibrio (V. parahaemolyticus / V. vulnificus / V. cholerae)

  • V. cholerae

  • Yersinia enterocolitica

Diarrheagenic E. coli / Shigella

  • Enteroaggregative E. coli (EAEC)

  • Enteropathogenic E. coli (EPEC)

  • Enterotoxigenic E. coli (ETEC) lt/st

  • Shiga-like toxin-producing E. coli (STEC) stx1/stx2

  • E. coli O157

  • Shigella / Enteroinvasive E. coli (EIEC)

Viruses

  • Norovirus GI/GII

Parasites

  • Cryptosporidium parvum
  • Cyclospora cayetanensis
  • Giardia lamblia

Specifications

  • Sample Types: Tap Water, Chicken, Beef, Bagged Spinach, Sliced Ham, Weiner, Smoked Salmon Spread, Bagged Shredded Cheddar, Orange & Apple Juice, Oatmeal
  • Sample Volume: Varies.
  • Storage Conditions: Freeze-dried in durable plastic pouches. Room temperature storage.
  • Kit Contents: Includes 30 test pouches and supplies for 30 tests.