Quick New Ebola Test Approved by FDA
Administration authorizes emergency use of first Ebola fingerstick test with portable reader
FRIDAY, Nov. 9, 2018 (HealthDay News) -- A fast, single-use fingerstick test for infection with the Ebola virus has been approved by the U.S. Food and Drug Administration.
The emergency use authorization (EUA) is for the DPP Ebola Antigen System. It analyzes blood samples from people who have signs and symptoms of Ebola in addition to other risk factors, such as living in an area with large numbers of Ebola cases or having contact with other people who have signs and symptoms of Ebola infection.
This is the second rapid antigen fingerstick test approved under EUA but the first that uses a portable battery-operated reader, which can offer clear results outside of laboratories and in areas where patients are likely to be treated, according to the FDA.
The EUA enables the FDA to authorize the use of an unapproved medical product or the unapproved use of an approved medical product when there are no adequate, approved, and available alternatives. The FDA has so far issued EUAs for nine nucleic acid tests and two rapid diagnostic tests for detecting the Ebola virus in people.