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FDA Grants Emergency Use Authorization for Ebola Diagnostic Test
The FDA has granted emergency use authorization (EUA) for Xpert Ebola (Cepheid), a molecular diagnostic test for Ebola Zaire virus that delivers results in less than 2 hours.
The test runs in a self-contained cartridge to minimize potential contamination.
Ebola was first discovered in 1976 near the Ebola River in what is now the Democratic Republic of the Congo. Since then, outbreaks have appeared sporadically in Africa. The 2014 Ebola epidemic is the largest in history, affecting several countries in West Africa. Four cases have been reported in the U.S.: two imported cases that included one death, and two locally acquired cases in health care workers.
In August 2014, the Secretary of Health and Human Services declared that circumstances justified authorization of the emergency use of in vitro diagnostics for the detection of Ebola virus infection. The Xpert Ebola test has not been cleared or approved by the FDA, but it will remain available in the U.S. as an EUA product as long as the declared emergency remains in effect or until the test ceases to be authorized by the FDA.
The Xpert Ebola test can be used by Clinical Laboratory Improvement Amendments (CLIA) moderate- and high-complexity laboratories in the U.S. or by similarly qualified non-U.S. laboratories.
Shipments of the test will begin in April 2015.
Source: Cepheid; March 24, 2015.