The FDA announced it has granted an emergency use authorization for a rapid, single-use test for detecting the Ebola virus that uses a portable battery-operated reader.
The DPP Ebola Antigen System (Chembio Diagnostic Systems Inc.) is used with blood from individuals with signs and symptoms of Ebola virus disease (EVD) and other risk factors, including living in an area with large numbers of EVD cases or having contact with other individuals with signs and symptoms of EVD, according to the FDA.
It is the second Ebola rapid antigen finger-stick test available under emergency use authorization (EUA) but the first to use a portable reader, which can provide diagnostic results outside of laboratories where patients are likely to be treated, the agency said. In such locations, a health care provider does not have access to authorized Ebola virus nucleic acid tests, which are highly sensitive but can be performed in only equipped laboratory settings, according to the agency.
EUA authority allows the FDA 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.
The newly approved test detects Zaire Ebolavirus, the most lethal species of the virus and the one causing the current Ebola outbreak in the Democratic Republic of the Congo (DRC). FDA Commissioner Scott Gottlieb, MD, said the agency is committed to helping the DRC fight the outbreak, although it was unclear if the finger-stick test would be used by responders there.
“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 [diseases] available as quickly as possible,” Gottlieb said in a statement. “We’re committed to helping the people of the DRC effectively confront and end the current Ebola outbreak. By authorizing the first finger-stick 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.”
The FDA cautioned that a negative result using the finger-stick test “should not be used as the sole basis for patient management decisions. The diagnosis of EVD must be made based on multiple factors such as, history, signs, symptoms, exposure likelihood and other laboratory evidence in addition to the detection of Ebola virus.” – by Bruce Thiel
Disclosure: Gottlieb reports no relevant financial disclosures.