FDA Clears OraSure’s Ebola Test

FDA has granted a de novo clearance for OraSure Technologies’s OraQuick Ebola Rapid Antigen Test 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. “The test provides a rapid, presumptive diagnosis that must be confirmed,” an agency release says.

Marketing authorization was granted based on data from multiple clinical studies of blood samples and cadaveric oral fluid from the 2014 West African outbreak and from several analytical studies, the agency says. “The studies demonstrated the importance of testing only symptomatic individuals so that the amount of virus is high enough to be detectable by this test,” it says. “Therefore, the OraQuick Ebola Test is intended for use in patients suspected of and with signs or symptoms consistent with [ebola virus disease], and when the patient meets the CDC’s Ebola virus epidemiological criteria, such as history of residence in or travel to a geographic region with active [ebola virus disease] transmission at the time of travel.”