WASHINGTON, Nov. 9 (Xinhua) -- The United States Food and Drug Administration (FDA) authorized Friday the first antigen finger-stick test for Ebola virus detection using a portable battery-operated reader.
The rapid, single-use test called the DPP Ebola Antigen System can help provide clear diagnostic results outside of laboratories and in areas where patients are likely to be treated, according to FDA.
The test came under "Emergency Use Authorization" (EUA) which allows the agency 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.
It uses blood specimens, including capillary "finger-stick" whole blood, from individuals with signs and symptoms of Ebola virus disease and with other risk factors like living in an area with large numbers of potential Ebola cases and/or having contact with those individuals exhibiting signs and symptoms.
"By authorizing the first fingerstick test with a portable reader, we hope to better arm health care providers in the field to more quickly detect the virus in patients and improve patient outcomes," said FDA Commissioner Scott Gottlieb.
