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FDA Approves Ebola Test for Emergency Use
The FDA has authorized emergency use of the ReEBOV antigen rapid test (Corgenix Medical Corp.) for the presumptive detection of Ebola Zaire virus –– detected in the West Africa outbreak in 2014 –– in individuals with signs and symptoms of Ebola virus infection (EVI) in conjunction with epidemiological risk factors, including geographic locations with a high prevalence of EVI.
ReEBOV is the first rapid diagnostic test and the first immunoassay authorized for emergency use by the FDA for the presumptive detection of EVI. The test is not intended for use for general EVI screening, such as airport screening or contact tracing.
Unlike molecular testing, which in West Africa can still take days to return results from central testing laboratories, the ReEBOV test is a point-of-care assay that can be used in any clinical facility adequately equipped for and capable of such testing, or in any field laboratory with trained personnel. The test can diagnose suspected Ebola cases in 15 to 25 minutes.
The FDA’s authorization follows last week’s World Health Organization listing of the ReEBOV test for procurement, which made the test available to the health care community worldwide.
EVI and other viral hemorrhagic fevers are difficult to identify because many of the early signs and symptoms are nonspecific and common to other infectious diseases, such as Dengue fever, Lassa fever, typhoid, and malaria.
Source: Corginex Medical Corp.; February 26, 2015.