The US Food and Drug Administration on Wednesday in Washington said a diagnostic test developed by the Department of Defence to detect Ebola has been authorised for use.
FDA said the DoD EZ1 Real-time RT-PCR Assay, an invitro diagnostic that has not yet been approved, would help to contain the world’s worst outbreak of the deadly virus.
The agency said it has been authorised for use in laboratories designated by the Department of Defence to help respond to the ongoing Ebola outbreak in West Africa,
“It was intended for use by US Defence personnel with signs and symptoms of Ebola or who are at risk for exposure to the virus, or who may have been exposed to it,” it said.
The FDA also said the test “may also be used to test aid workers and responders as needed”.
More than 900 people have died in an ongoing Ebola outbreak in West Africa.
The hemorrhagic fever’s outbreak has overwhelmed rudimentary healthcare systems and prompted troops’ deployment to quarantine the worst-hit areas in the remote border region of Guinea, Liberia and Sierra Leone.
The FDA can issue an “emergency use authorisation” for an unapproved medical product or the unapproved use of an approved medical product during emergencies.
This is when there are no adequate, approved and available alternatives.
The agency may invoke the authorisation in emergency situations or to prepare for an emergency situation.