1 Streamlined System. Many BioThreat Targets.

FilmArray PouchThe 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.

  1. First, the FilmArray extracts and purifies all nucleic acids from the unknown sample.
  2. Next, the FilmArray performs a nested multiplex PCR. During the first-stage PCR, the FilmArray performs a single, large volume, massively multiplexed reaction.
  3. Last, individual single-plex second-stage PCR reactions detect the products from the first stage PCR. Using endpoint melting curve data, the FilmArray software automatically generates a result for each target.

Setting up the 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 BioThreat Kits

BioThreat Panel

Global Fever Panel – RUO

BioThreat-E Kit

  • Detection of 16 Threat 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
  • 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)
FDA Cleared IVD Panels Available through BioFire Diagnostics > Click for Details
  • FilmArray Respiratory (RP) Panel
  • FilmArray Blood Culture (BCID) Panel
  • FilmArray Gastrointestinal (GI) Panel
  • FilmArray Meningitis/Encephalitis (ME) 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 threat 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

 

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 (Available Soon)

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 you can identify these targets in about an hour with only 2 minutes of hands-on time.

 

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 Type  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

 

Featured Scientific Poster

Analytical Performance of the FilmArray Global Fever Panel

Jared R. Helm1, Corike Toxopeus1, Natalie Batty1, Lex Border1, Olivia Davidson1, Alex Kelley1, Brandon Marble1, Bryan T. Gnade2, Stefan Fernandez2, Cynthia Phillips1
1BioFire Defense, LLC, Salt Lake City, UT; 2U.S. Army Medical Materiel Development Activity (USAMMDA), Fort Detrick, MD

 

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 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), Ebola virus, Lassa virus, Marburg virus, 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 36 copies/mL, Marburg virus Ravn at 26 copies/mL, Zika virus at 130 copies/mL, Leishmania donovani at 10 copies/mL, Plasmodium at 7 copies/mL, Bacillus anthracis at 640 copies/mL, and Yersinia pestis at 150 copies/mL. 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.

 

 

 

 

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