OraQuick® Ebola Rapid Antigen Test (OraSure Technologies, Inc.) – For Use with whole Blood – July 31, 2015
On July 31, 2015, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the OraQuick® Ebola Rapid Antigen Test for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in venipuncture whole blood or fingerstick whole blood specimens from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors (including geographic locations with high prevalence of Ebola infection), by laboratories and facilities adequately equipped, trained, and capable of testing for Ebola infection (including treatment centers and public health clinics). The test may also detect antigens from Sudan Ebola virus and Bundibugyo Ebola virus; however, it does not distinguish between these different Ebola virus species. The OraQuick® Ebola Rapid Antigen Test is intended for circumstances when the use of a rapid Ebola virus test is determined to be more appropriate than the use of an authorized Ebola virus nucleic acid test, which has been demonstrated to be more sensitive in detecting the Ebola Zaire virus. The OraQuick® Ebola Rapid Antigen Test is not intended for use for general Ebola virus infection screening, such as airport screening or contact tracing of individuals without signs and symptoms of Ebola infection.
- Letter of Authorization
- Fact Sheet for Healthcare Providers
- Fact Sheet for Patients
- Labeling
OraQuick® Ebola Rapid Antigen Test (OraSure Technologies, Inc.) – For Use with Cadaveric Oral Fluid – March 4, 2016
On March 4, 2016, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the OraQuick® Ebola Rapid Antigen Test for the detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in cadaveric oral fluid swab specimens from individuals with epidemiological risk factors for Ebola virus infection and suspected to have died of Ebola. The test is intended to aid in diagnosing Ebola Zaire virus infection as the cause of death in order to inform decisions on safe and dignified burial procedures to prevent transmission of Ebola virus in the community. The OraQuick® Ebola Rapid Antigen Test for use with cadaveric oral fluid is not intended for use with oral fluid specimens from living individuals.
- Letter of Authorization
- Fact Sheet for the Response Team
- Fact Sheet for Relatives and Caregivers
- Instructions for Use