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Scott Gottlieb
The FDA announced that it had granted an emergency use authorization for a single-use rapid test to detect Ebola with the help of a portable reader to Battery.
The Ebola DPP antigen system (Chembio Diagnostic Systems Inc.) is used with blood from subjects with signs and symptoms of Ebola Virus Disease (EVD) and other risk factors, particularly in an area where Many people living with disease show signs and symptoms of Ebola virus disease, according to the FDA.
This is the second Ebola Rapid Antigen finger 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 at risk. 'to be treated, said the agency. In such places, a health care provider does not have access to the authorized Ebola virus nucleic acid tests, which are very sensitive but can only be performed in equipped laboratories, according to the report. ;agency.
The EUA authority authorizes the FDA to authorize the use of an unapproved medical product or the unapproved use of an approved medical product in the absence of an approved medical product. adequate, approved and available alternatives.
Newly approved test detects Ebolavirus from Zaire, the deadliest species of the virus and the one that is causing the current Ebola outbreak in the Democratic Republic of Congo (DRC). Commissioner of the FDA Scott Gottlieb, MD, The agency is committed to helping the DRC fight the epidemic, although it is unclear if the finger test would be used by the people who respond to it.
"This EUA is part of the agency's ongoing efforts to help mitigate potential future threats by manufacturing medical products that can prevent, diagnose or treat [diseases] available as soon as possible, "Gottlieb said in a statement." We are committed to helping DRC residents effectively cope with and end the current Ebola outbreak by allowing the first manual test with a portable reader, we hope to better arm healthcare providers in the field to more quickly detect the virus in patients and improve outcomes for patients. "
The FDA warned that a negative result using the fingertip test "should not be used as the sole basis for patient management decisions. The diagnosis of Ebola virus disease should be based on multiple factors such as history, signs, symptoms, likelihood of exposure and other laboratory evidence, in addition to the detection of Ebola virus. " – by Bruce Thiel
Disclosure: Gottlieb does not report any relevant financial information.
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