Feb. 12, 2019
- FDA uses emergency powers to allow device for Ebola detection
- Chembio Diagnostics proposed device for this use in November
The FDA is allowing emergency use of an in vitro diagnostic device to detect the Ebola virus, which recently has caused deaths of over 500 people in the Democratic Republic of the Congo.
The Food and Drug Administration issued a Feb. 12 Emergency Use Authorization (EUA), permitting use of Chembio Diagnostics Systems Inc.’s fingerstick test, sometimes used for fertility testing, to identify Ebola. The company asked the FDA to use its product for Ebola in November. The test can provide results in as little as 15 minutes, according to its web site.
The FDA’s move comes shortly after Ebola vaccines were given to South Sudanese workers, which neighbors the Congo, to prevent potential spread of the virus, according to the the World Health Organization.
An FDA emergency authorization such as this allows the use of any drug or device to be used “to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by biological, chemical, nuclear, or radiological agent,” when there isn’t another alternative approved or available. The FDA said in a fact sheet that the test should only be performed on people with signs and symptoms of Ebola.
Ebola can be diagnosed after a person shows a combination of symptoms such as fever, severe headaches, muscle pain, vomiting, and diarrhea, according to the Centers for Disease Control and Prevention.