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