OraQuick Ebola test receives emergency use authorization

The U.S. Food and Drug Administration granted an Emergency Use Authorization (EUA) for OraSure Technologies, Inc.'s OraQuick Ebola Rapid Antigen Test on Monday.  

The test utilizes the same technological platform that OraSure's rapid HIV and HCV antibody test kits use. With the EUA, the test may be used in laboratory and medical facilities that are equipped to test for the Ebola virus. The OraQuick Ebola Rapid Antigen Test has not been granted full approval.

"The OraQuick Rapid Ebola Antigen Test is an easy-to-use, rapid test that we believe will be a critical tool in containing and controlling current outbreaks of the Ebola virus," Douglas A. Michels, president and CEO of OraSure Technologies, said. "We are grateful to the FDA for working closely with us throughout the EUA process to expedite deployment of our test."

The test utilizes blood samples and analyzes them for antigens of the virus. Positive results have come in as quickly as four minutes. For negative results, the waiting time is 30 minutes.

Funding for the OraQuick Ebola test's development was provided by the Biological Defense Research Directorate at the U.S. Navy Medical Research Center and the Viral Hemorrhagic Fever Consortium.

Organizations in this story

OraSure Technologies Inc 220 E 1st St Bethlehem, PA 18015

U.S. Navy 2 N Rotary Rd Arlington, VA 22202

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