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To assist doctors in diagnosing Ebola virus disease quickly, the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) will pursue development of an Ebola virus diagnostic test for use in a doctor’s office, hospital, clinic, or field setting that will provide results within 20 minutes.
“Fast and inexpensive point-of-care diagnostics will improve our ability to control Ebola virus disease outbreaks,” says Robin Robinson, PhD, director of ASPR’s Biomedical Advanced Research and Development Authority (BARDA), which will oversee this development program for HHS. “Faster diagnosis of Ebola virus infections allows for more immediate treatment and an earlier response to protect public health worldwide.”
Diagnosing Ebola virus infections quickly in resource-poor areas would enable health care providers to isolate and provide necessary treatment and supportive care to patients suffering from Ebola. Quickly isolating patients helps limit the spread of the disease. Emerging evidence has shown that early initiation of supportive care improves outcomes for patients suffering from Ebola virus disease.
The development of this simple, low-cost, lateral-flow test, called the OraQuick rapid Ebola antigen test, will take place under a $1.8 million contract with OraSure Technologies Inc., headquartered in Bethlehem, Pa. Lateral flow tests detect the presence of a virus with a drop of the patient’s blood or saliva on a test strip, similar to the tests used in doctors’ offices to diagnose strep throat.
The agreement supports clinical and non-clinical work necessary to apply for approval of the test by the Food and Drug Administration (FDA). The contract could be extended for up to a total of 39 months and $10.4 million.
In addition, OraSure will evaluate whether the test can be used in the post-mortem analysis of oral fluids. During the current epidemic, people died before Ebola virus infections could be confirmed, yet the bodies of people infected with Ebola virus would have remained highly infectious. A simple, rapid test that could determine disease status quickly from the body’s oral fluids would facilitate infection control efforts and support the appropriate handling of remains infected with the Ebola virus.
The OraQuick rapid Ebola antigen test is the first point-of-care Ebola virus testing device to receive BARDA support. To help the United States prepare for and control Ebola virus disease outbreaks, BARDA also is supporting development of vaccines to prevent Ebola virus infections and therapeutic drugs to treat the disease.
The new test is part of BARDA’s comprehensive integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear (CBRN) agents, pandemic influenza, and emerging infectious diseases.