The Food and Drug Administration (FDA) has granted marketing authorization for the OraQuick Ebola Rapid Antigen Test (OraSure Technologies) for the detection of Ebola virus antigens.
The OraQuick Ebola Rapid Antigen Test was previously available during the 2014 Ebola outbreak through Emergency Use Authorization. The test is intended for the presumptive detection of the Ebola Zaire virus in patients suspected of, or presenting with signs and symptoms of the infection in conjunction with epidemiological risk factors (eg, geographical location). It is also used to detect Ebola Zaire virus in cadaveric oral fluid specimens to help in diagnosing the virus to prevent further transmission within a community.
The in vitro diagnostic single-use immunoassay utilizes venipuncture whole blood and fingerstick whole blood for the qualitative detection of antigens from Ebola viruses. The test consists of a single-use device and a developer solution vial. The whole blood specimen is collected via a plastic micropipette and transferred to the device that contains a results window. Positive results have been observed as early as 4 minutes and negative results have to be read 30 minutes after inserting the device into the developer vial. Additional testing and confirmation procedures are required for negative results.
“Today’s marketing authorization provides another important tool in the effort to fight Ebola, which continues to be a priority of the US Government, especially as we work with our partners, including the World Health Organization, to help address the current Ebola outbreak in the Democratic Republic of Congo (DRC),” said Acting FDA Commissioner Ned Sharpless, MD “The current outbreak in the DRC has already killed thousands and the outbreaks in West Africa that began in 2014 tragically killed more than 11,000.”
For more information visit fda.gov.