CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
November 2019—The FDA granted in October marketing authorization of the OraQuick Ebola Rapid Antigen Test to OraSure Technologies. The 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 EVD transmission at the time of travel. It may also be used in recently deceased individuals suspected to have died from Ebola (cadaveric oral fluid). The test is not intended to be used for general Ebola infection screening or testing of individuals at risk of exposure without observable signs of infection.
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