FRIDAY, Nov. 9, 2018 — The U.S. Food and Drug Administration has approved emergency use of a new Ebola fingerstick test, which includes a reader that makes it possible to obtain results outside a laboratory.
The DPP Ebola Antigen System makes obtaining test results possible in remote areas with limited lab resources, such as those in African nations affected by Ebola outbreaks, the agency said Friday in a news release.
“The scourge of Ebola tragically demonstrates that we’re a global community when it comes to public health protection. Infectious disease doesn’t recognize nation states,” said FDA Commissioner Dr. Scott Gottlieb.
The emergency declaration permitting the test’s use was made in response to an Ebola outbreak in the central-African nation of the Congo, the FDA said.
The agency cautioned that test results shouldn’t be the only criterion used to determine a patient’s course of treatment. Medical professionals also should consider a patient’s history, vital signs, symptoms and likelihood of exposure, the FDA said.
The test is produced by Chembio Diagnostic Systems, based in Medford, N.Y.
The FDA has more about this action.
Posted: November 2018
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