Corgenix Medical Corporation announced that it has received emergency use authorization (EUA) from the Food and Drug Administration (FDA) for its ReEBOV Antigen Rapid Test for use in patients with signs and symptoms of Ebola Zaire virus infection in conjunction with epidemiological risk factors, including geographic locations with high prevalence of Ebola infection.

The ReEBOV Antigen Rapid Test is the first rapid diagnostic test (RDT) and the first immunoassay authorized for emergency use by the FDA for the presumptive detection of Ebola virus. It is a point-of-care test that 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 as little as 15–25 minutes from a single drop of blood from a finger prick. It is not intended for use for general Ebola virus infection screening, such as airport screening or contact tracing.

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The ReEBOV Antigen Rapid Test was developed by Corgenix in cooperation with the Viral Hemorrhagic Fever Consortium (VHFC) and supported by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), The Bill & Melinda Gates Foundation, and the Paul G. Allen Family Foundation.

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