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Emergency use Ebola diagnostic test, 7/15

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July 2015—Corgenix Medical has received U.S. FDA emergency use authorization for its Re­EBOV Antigen Rapid Test. The test is to be used for the presumptive detection of Ebola Zaire virus in individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors, including geographic locations with high prevalence of Ebola infection.

The point-of-care test can be used in any clinical facility adequately equipped, trained, and capable of such testing, or in any field laboratory with trained personnel capable of such testing, to diagnose suspected Ebola cases in 15 to 25 minutes. It is not intended for use for general Ebola virus infection screening, such as airport screening or contact tracing. The U.S. regulatory authorization follows the World Health Organization’s listing for procurement for the Corgenix Ebola RDT, making this test available to the health care community worldwide.

Corgenix, 303-453-8903

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