News from the FDA/CDC

FDA authorizes emergency use of rapid fingerstick test for Ebola


 

The Food and Drug Administration has issued an emergency use authorization (EUA) for the DPP Ebola Antigen System, a rapid, single-use test for the detection of Ebola virus.

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The DPP Ebola Antigen System can provide rapid results in locations where health care providers lack access to authorized Ebola virus nucleic acid tests, which are highly sensitive but require an adequately equipped laboratory setting. The new system is authorized to use blood specimens from capillary whole blood, ethylenediaminetetraacetic acid (EDTA) venous whole blood, and EDTA plasma. It is to be used in individuals with signs and symptoms of Ebola virus disease, in addition to other risk factors, such as living in an area with high Ebola virus prevalence or having had contact with people showing signs or symptoms of the disease.

The system is the second Ebola rapid antigen fingerstick test made available through the EUA, but it is the first to use a portable, battery-operated reader, allowing for easier use in remote areas where patients are likely to be treated.

The FDA noted that a negative result from the DPP Ebola Antigen system does not necessarily indicate a negative diagnosis and should not be taken authoritatively, especially in individuals displaying signs and systems of Ebola virus disease.

“This EUA is part of the agency’s ongoing efforts to help mitigate potential, future threats by making medical products that have the potential to prevent, diagnosis, or treat available as quickly as possible. We’re committed to helping the people of the DRC [Democratic Republic of the Congo] effectively confront and end the current Ebola outbreak. 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,” FDA Commissioner Scott Gottlieb, MD, said in the press release.

Find the full press release on the FDA website.

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