FilmArray BioThreat-E Test, kit/6

General description:
The FilmArray BioThreat-E test is a qualitative multiplexed nucleic acid-based in vitro diagnostic (IVD) test intended for the presumptive detection of Ebola Zaire virus in whole blood specimens or undiluted urine specimens. The FilmArray BioThreat-E test is performed on the FilmArray Instrument to detect RNA from the Ebola Zaire virus in specimens from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors. Testing with the FilmArray BioThreat-E test should not be performed unless the individual has signs and symptoms of infection with Ebola Zaire that meet clinical and epidemiologic criteria for testing suspect specimens.

The results should be confirmed by additional testing and confirmation procedures in consultation with public health or other authorities for whom reporting is required. For professional use only.

Technical specifications:
Sample type: Whole blood, urine (NOTE: Urine should not be the sole specimen tested from a patient. If a urine specimen from a patient is tested, it must be tested in conjunction with a whole blood specimen from the patient)
Sample volume: 200µl
Sensitivity on whole blood and urine: 96.00%
Specificity on whole blood and urine: 100%

Manufacturer product reference: BioFire Defense LLC., RFIT-ASY-0122

Items supplied with:
·6 × Individually packaged FilmArray BioThreat-E pouches
·7 × Single-use (1.0ml) Sample Buffer ampoules
·7 × Single-use freeze-dried protease vials
·7 × Single-use pre-filled (1.5ml) Hydration Injection Vials
·(blue)
·7 × Single-use Sample Injection Vials (red)
·7 × Individually packaged Transfer Pipettes
·1 × Instructions for use

Items required, but not supplied:
Gloves, FilmArray System with computer, FilmArray Pouch Loading Station compatible with the use of the FilmArray Injection Vials (included with FilmArray System), bleach, de-ionized water

Shelf life:
12 months from the date of manufacturing.

Weight & volume:
Estimated weight: 0.050kg

Storage & transportation condition:
At 15-25°C. Do not refrigerate. Avoid storage of any materials near heating or cooling vents or in direct sunlight.

Useful links:
Ebola EUAL Status after PHEIC Termination

WHO EUAL Public Report