FDA Allows Marketing of First Rapid Diagnostic Test for Detecting Ebola Virus Antigens

fda.gov - October 10, 2019

Today, the U.S. Food and Drug Administration allowed marketing of a rapid diagnostic test (RDT) to detect Ebola virus antigens (proteins) in human blood from certain living individuals and samples from certain recently deceased individuals suspected to have died from Ebola (cadaveric oral fluid). The OraQuick Ebola Rapid Antigen Test is the first rapid diagnostic test the FDA has allowed to be marketed in the U.S. for the Ebola Virus Disease (EVD). The test provides a rapid, presumptive diagnosis that must be confirmed.

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ALSO SEE ADDITIONAL INFORMATION WITHIN THE LINKS BELOW . . .

OraQuick Ebola Rapid Antigen Test (8 page .PDF document)
https://www.accessdata.fda.gov/cdrh_docs/pdf19/DEN190025.pdf

OraSure - OraQuick Ebola Rapid Antigen Test
http://www.orasure.com/products-infectious/products-infectious-oraquick-ebola.asp