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US FDA allows sales of rapid Ebola test

Diagnostic is intended for use on people with symptoms or suspected of having died from the virus

by Britt E. Erickson
October 18, 2019 | A version of this story appeared in Volume 97, Issue 41


The US Food and Drug Administration has given the green light to OraSure Technologies to sell a rapid diagnostic for Ebola in the US. The OraQuick Ebola Rapid Antigen Test detects the VP40 antigen produced in response to Ebola viruses. It can be used to test blood from people with symptoms of Ebola and oral fluid from people suspected of having died from the virus.

The test, which can take up to 30 min, is the first rapid diagnostic for Ebola authorized by the FDA for marketing in the US. The World Health Organization (WHO) concluded in 2016 that the test is acceptable for use in emergencies to aid in diagnosing Ebola as the cause of death and to test people with symptoms of the virus to help prevent transmission. Both the WHO and the FDA note that results from the quick test should be confirmed with an approved nucleic acid test for Ebola.

The Democratic Republic of Congo (DRC) is in the midst of an Ebola outbreak that has killed thousands of people. An Ebola outbreak in West Africa in 2014 killed more than 11,000 people; during that outbreak, people who traveled to the US from affected countries were screened and monitored for the disease.

“One of the most important tools in stopping these outbreaks is quickly diagnosing patients and supporting safe and dignified burials,” FDA acting commissioner Norman “Ned” Sharpless says in a statement. “The ability to use this test to promptly make a presumptive Ebola diagnosis could help providers to more quickly isolate patients and begin treatments that can be potentially life-saving,” he says. The US government is working with the WHO and others to help DRC contain the current outbreak.



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