The U.S. Food and Drug Administration (FDA) recently granted emergency use authorization to a new rapid test kit for the diagnosis of Ebola infection — the ReEBOVTM Antigen Rapid Test.
The Ebola virus is one of the deadliest viruses in the world, causing an acute, severe illness in humans. The virus is transmitted to humans by wild animals (such as fruit bats and chimpanzees) and spreads within the human population via human-to-human contact. The average case fatality is around 50%, although in past outbreaks it has ranged from 25 to 90%. The most recent outbreak in 2014 in West Africa is the largest and most complex Ebola outbreak since the virus was discovered in 1976, and the countries affected most severely were Sierra Leone, Guinea and Liberia.
Researchers from the University of Texas Medical Branch (UTMB) have been involved in assessing the efficacy of this new Ebola test. “The kit was tested using the live Ebola virus under high containment conditions at the Galveston National Laboratory [GNL] to determine its effectiveness prior to field trials,” said Dr. Robert Cross at UTMB in a news release. Dr. Cross was part of a small team who went to Sierra Leone during the peak of the recent Ebola outbreak to validate this new diagnosis test also in the field. In just over six months, the test’s entire development process was completed.
This new rapid Ebola test is important since the virus can take hold within five to seven days after infection, and in some extreme cases, this can be the timeframe required to make a diagnosis. It is a test very similar to a pregnancy test, where a test strip able to determine infection status is exposed to potentially viral-infected bodily fluids. The results are available after just a few minutes.
“The central mission of the GNL is to provide support to research entities, including private partners and other universities, on extremely dangerous pathogens,” said Dr. Cross. “This was an exciting project because we were involved from the start with the goal of developing a test that could provide a quick answer to clinicians about someone’s condition. Instead of taking several days to find out if someone has Ebola, this new test provides an answer within about 15 minutes. Follow-up testing with conventional testing will be necessary to confirm the illness, but the rapid test allows medical providers to get a jump start on treating suspected patients.”
This FDA-approved diagnostic test is the result of a collaboration established at the beginning of the Ebola epidemic between Corgenix Medical Corporation (a worldwide developer and marketer of diagnostic test kits) along with UTMB, Tulane University, and other partners with the Viral Hemorrhagic Fever Consortium.
“This has the potential to be a game-changer in stopping the spread of the epidemic,” said Dr. Robert Garry at Tulane University. Dr. Garry is the program manager of the Viral Hemorrhagic Fever Consortium, founded by Tulane University, which has a field site for medical research on Lassa fever in Sierra Leone.
“Completing this product development in less than a year demonstrates how governmental agencies, regulatory bodies, industry, non-profits and others can work together to find solutions to catastrophic events such as the Ebola virus outbreak,” noted Corgenix President and CEO, Douglass Simpson. “The collaboration has enabled us to quickly deliver this critically important point-of-care test and potential breakthrough in the fight against Ebola in the current outbreak in West Africa.”
This is the first Ebola rapid diagnostic test for emergency use approved by the FDA and is expected to accelerate Ebola diagnosis and help in patient management and to improve the safety of healthcare workers.