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

Download the BioFire Defense FilmArray Panels Information Sheet

FilmArray Panels

Not for Diagnostic Use Panels BioThreat Panel Global Fever Panel – RUO

Emergency Use Authorization Panels BioThreat-E Kit COVID-19

DoD Controlled Panels Sentinel Panel Warrior Panel Food & Water Panel

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

Targets

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

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 Defense^a and NIAID^b. 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

• 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.

Kit Part No: RFIT-ASY-0122

Download BioThreat-E Kit Information Sheet

Targets

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.

Targets

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.

Targets

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.