FDA approves marketing of rapid diagnostic test for detecting Ebola antigens

The Food and Drug Administration last week authorized marketing of a rapid diagnostic test to detect Ebola virus antigens in human blood from certain living individuals as well as samples from those recently deceased who are suspected to have died from Ebola. The OraQuick Ebola Rapid Antigen Test is the first rapid diagnostic test that the FDA has allowed to be marketed in the U.S. for the Ebola Virus Disease. “Today’s marketing authorization provides another important tool in the effort to fight Ebola,” said FDA Acting Commissioner Ned Sharpless, M.D. “…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.”