The US Food and Drug Administration (FDA) has allowed marketing of the first rapid diagnostic test (RDT) to identify Ebola virus antigens, or proteins, in certain body fluids from living and deceased individuals, according to an agency news release.
The OraQuick Ebola Rapid Antigen Test (OraSure Technologies) detects Ebola virus antigens in “human blood from certain living individuals and samples from certain recently deceased individuals suspected to have died from Ebola (cadaveric oral fluid).”
“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),” Acting FDA Commissioner Ned Sharpless, MD, said in the release.
“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,” Sharpless continued. “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 healthcare 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,” Sharpless explained.
The recommendation for marketing approval follows consideration of data from many clinical studies of blood and cadaveric oral fluid samples obtained during the 2014 West African Outbreak and from various analytic studies. The FDA determined that it is necessary to test patients after they have developed symptoms that are severe enough for the Ebola virus to be detectable by the test; therefore, they caution against its use for screening, such as at an airport.
The test may be used to test cadaveric oral fluid from individuals who have recently died and who had epidemiologic risk factors that suggest they expired from Ebola virus disease (EVD) to direct safe handling of cadavers and prevent the spread of infection.
The FDA cautions that negative test results do not mean a patient does not have Ebola virus infection and that definitive identification of the virus necessitates “additional testing and confirmation procedures (such as by a more sensitive but less rapid polymerase chain reaction test) and in consultation with public health and/or other authorities to whom reporting is required.”
During the 2014 Ebola outbreak, the secretary of the Department of Health and Human Services declared public health circumstances justified the approval of emergency use of in vitro diagnostics for the diagnosis of Ebola virus and worked to make them available through the Emergency Use Authorization pathway.
The FDA reviewed the test under the De Novo premarket review pathway, a regulatory pathway for new types of devices considered low-to-moderate risk. The FDA will develop special controls in addition to general controls that will help ensure the safety and effectiveness of tests for identifying Ebola virus antigens.
The FDA also granted Breakthrough Device designation to the OraQuick Ebola Test and worked closely with OraSure Technologies to improve device development and facilitate the generation of evidence and the FDA’s review of the device.