Today, the U.S. Food and Drug Administration allowed marketing of a rapid diagnostic test (RDT) to detect Ebola virus antigens (proteins) in human blood from certain living individuals and samples from certain recently deceased individuals suspected to have died from Ebola (cadaveric oral fluid). The Ora Quick Ebola Rapid Antigen Test is the first rapid diagnostic test the FDA has allowed to be marketed in the U.S. for the Ebola Virus Disease (EVD). The test provides a rapid, presumptive diagnosis that must be confirmed.
“Today’s marketing authorization provides another important tool in the effort to fight Ebola, which continues to be a priority of the U.S. 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, M.D. “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. Investigational vaccines and therapeutics have shown promising results, but one of the most important tools in stopping these outbreaks is quickly diagnosing patients and supporting safe and dignified burials. This marketing authorization may provide additional assurances to health care professionals seeking to use these types of rapid diagnostics. The ability to use this test to promptly make a presumptive Ebola diagnosis could help providers to more quickly isolate patients and begin treatments that can be potentially life-saving. Additionally, this device could be used to support safe and dignified burials while helping to reduce the risk of transmission during those burials.”
EVD, which is caused by the Ebola virus, is a severe, often fatal disease in humans that can spread through direct contact with blood or body fluids or objects contaminated with body fluids, as well as from the bodies of those who have died from the virus. EVD has led to several large outbreaks in Africa, including the West African Ebola epidemic that began in 2014 and was the largest outbreak of EVD in recorded history, and the ongoing outbreak in the DRC, which is currently the second largest outbreak.
Extensive efforts are underway by the Ministry of Health in the DRC to contain the current outbreak with support from the World Health Organization, the U.S. government, and other partners. These measures include campaigns to promote good hygiene, large-scale vaccination campaigns, specialized Ebola treatment centers where those infected or exposed to the virus can receive investigational therapeutics, and comprehensive efforts to trace and prevent the spread of EVD through vaccination campaigns, monitoring for symptoms, diagnostic testing, and implementation of infection prevention and control measures, such as safe and dignified burial procedures.