FDA approves combination Ebola fingerstick test with battery-operated reader

The U.S. Food and Drug Administration (FDA) recently announced an emergency use authorization (EUA) for the first single-use fingerstick tests for Ebola virus detection, complete with a portable reader system more easily used outside of labs.

While this is the second fingerstick test made available under EUA, the DPP Ebola Antigen System is a first for its portable addition reader, which uses blood specimens to identify those infected.

“Our FDA team of experts in drugs, vaccines, and diagnostics continue to collaborate with our Federal, international and industry partners to employ our collective expertise, experiences from previous incidents, and resources to assist in the global response to the Ebola outbreak in the Democratic Republic of Congo,” FDA Commissioner Scott Gottlieb said. “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 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.”

EUA allows the FDA to, in emergencies, approve the use of otherwise unapproved medical products when no alternatives are available. Based on current evidence, the FDA believes that the DPP Ebola Antigen System will be an effective, beneficial test, with concerns outweighed by those benefits.

The new test will allow healthcare professionals to test potential Ebola victims even in places without access to virus nucleic acid tests, which require lab settings. The FDA still asks that these tests be utilized only in facilities, however, such as treatment centers and public health centers.

The fingerstick tests could prove especially useful in the face of ongoing Ebola outbreaks in West Africa, which have struck the country in small outbreaks since 2014.