FilmArray BioSurveillance System

Fully Automated BioDetection

The 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 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.

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.

 

FilmArray Test Kits

1 Streamlined System. Many BioThreat Targets.

A 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 FilmArray is Simple

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

FilmArray Panels

Not for Diagnostic Use Panels Emergency Use Authorization Panel
BioThreat Panel Global Fever Panel – RUO
  • Detection of 16 Pathogens / 26 Targets
  • Not For Diagnostic Use
  • Detection of 19 Targets from Whole Blood:
    6 Bacterial, 9 Viral and 4 Protozan
  • For Research Use Only
  • Not For Diagnostic Use
BioThreat-E Kit
  • Detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in whole blood and urine specimens.
  • For Use Under the Emergency Use Authorization (EUA) by CLIA Moderate and High Complexity Laboratories. (Approved Oct. 25, 2014)

Additional Panels are Available through BioFire Diagnostics, click for details

  • BioFire FilmArray Respiratory (RP) Panel
  • BioFire FilmArray Blood Culture (BCID) Panel
  • BioFire FilmArray Gastrointestinal (GI) Panel
  • BioFire FilmArray Meningitis/Encephalitis (ME) Panel
  • BioFire FilmArray Pneumonia 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.

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; Not For Diagnostic Use.
  • 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 Information Sheet

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.

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); Not For Diagnostic Use.
  • 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 Information Sheet

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.

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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.

  • 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 Information Sheet

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