FDA Clears First Ebola Fingerstick Test With Portable Reader

Megan Brooks

Disclosures

November 09, 2018

The US Food and Drug Administration (FDA) has granted emergency use of a new rapid antigen fingerstick test to detect Ebola virus.

The DPP Ebola Antigen System (Chembio Diagnostic Systems Inc) is the second Ebola rapid antigen fingerstick test granted emergency use authorization (EUA), but it is the first that employs a portable battery-operated reader, which can help provide clear diagnostic results outside of laboratories and in areas where patients are likely to be treated, the FDA 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, [diagnose] or treat available as quickly as possible," said FDA Commissioner Scott Gottlieb, MD, in a statement.

"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," said Gottlieb.

The DPP Ebola Antigen System provides fast results and can be performed in locations where a healthcare provider does not have access to authorized Ebola virus nucleic acid tests (polymerase chain reaction testing).

"The DPP Ebola Antigen System should only be run in facilities, including treatment centers and public health clinics where patients are likely to be treated, and laboratories that are adequately equipped, trained and capable of such testing," the FDA advised.

The FDA said a negative result from the DPP Ebola Antigen System, especially for patients who have signs and symptoms of Ebola virus disease, should not be used as the sole basis for patient management decisions. The diagnosis of Ebola virus disease must made on the basis of multiple factors, such as history, signs, symptoms, exposure likelihood, and other laboratory evidence in addition to the detection of Ebola virus, the agency said.

Since the end of the Ebola outbreak in West Africa in 2014, ongoing, smaller Ebola outbreaks have continued. "Recent outbreaks in remote areas with limited resources can benefit from rapid diagnostic tools, and the issuance of an EUA for the DPP Ebola Antigen System is an important step in addressing these outbreaks," the FDA said.

The FDA's EUA authority allows the agency to authorize the use of an unapproved medical product or the unapproved use of an approved medical product when, among other circumstances, there are no adequate, approved, and available alternatives, according to the FDA release.

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