Development and Clinical Evaluation of a Rapid Point of Care Test for Ebola Virus Infection in Humans
Zheng Wang,
Richard S. Bennett,
Michele Roehler,
Geraldine Guillon,
Mark J. Fischl,
Mary C. Donadi,
Jim Makovetz,
Natalie Holmes,
Toral Zaveri,
Eamon Toolan,
Heather L. Gontz,
Graham D. Yearwood,
James Logue,
J. Kyle Bohannon,
Lisa Mistretta,
Russell Byrum,
Dan Ragland,
Marisa St. Claire,
Lisa A. Kurtz,
Tiffany Miller,
Michael R. Reed,
Janean Young,
John Lee,
Lisa E. Hensley,
Keith Kardos,
Jody D. Berry
Affiliations
Zheng Wang
OraSure Technologies, Inc., Bethlehem, PA 18015, USA
Richard S. Bennett
Integrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick, MD 21702, USA
Michele Roehler
OraSure Technologies, Inc., Bethlehem, PA 18015, USA
Geraldine Guillon
OraSure Technologies, Inc., Bethlehem, PA 18015, USA
Mark J. Fischl
OraSure Technologies, Inc., Bethlehem, PA 18015, USA
Mary C. Donadi
OraSure Technologies, Inc., Bethlehem, PA 18015, USA
Jim Makovetz
OraSure Technologies, Inc., Bethlehem, PA 18015, USA
Natalie Holmes
OraSure Technologies, Inc., Bethlehem, PA 18015, USA
Toral Zaveri
OraSure Technologies, Inc., Bethlehem, PA 18015, USA
Eamon Toolan
OraSure Technologies, Inc., Bethlehem, PA 18015, USA
Heather L. Gontz
OraSure Technologies, Inc., Bethlehem, PA 18015, USA
Graham D. Yearwood
OraSure Technologies, Inc., Bethlehem, PA 18015, USA
James Logue
Integrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick, MD 21702, USA
J. Kyle Bohannon
Integrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick, MD 21702, USA
Lisa Mistretta
Integrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick, MD 21702, USA
Russell Byrum
Integrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick, MD 21702, USA
Dan Ragland
Integrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick, MD 21702, USA
Marisa St. Claire
Integrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick, MD 21702, USA
Lisa A. Kurtz
OraSure Technologies, Inc., Bethlehem, PA 18015, USA
Tiffany Miller
OraSure Technologies, Inc., Bethlehem, PA 18015, USA
Michael R. Reed
OraSure Technologies, Inc., Bethlehem, PA 18015, USA
Janean Young
OraSure Technologies, Inc., Bethlehem, PA 18015, USA
John Lee
Biomedical Advanced Research and Development Authority (BARDA), U.S. Department of Health & Human Services, Washington, DC 20201, USA
Lisa E. Hensley
Integrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick, MD 21702, USA
Keith Kardos
OraSure Technologies, Inc., Bethlehem, PA 18015, USA
Jody D. Berry
OraSure Technologies, Inc., Bethlehem, PA 18015, USA
The genus Ebolavirus contains multiple species of viruses that are highly contagious and lethal, often causing severe hemorrhagic fever. To minimize the global threat from Ebola virus disease (EVD), sustainable, field-appropriate tools are needed to quickly screen and triage symptomatic patients and conduct rapid screening of cadavers to ensure proper handling of human remains. The OraQuick® Ebola Rapid Antigen Test is an in vitro diagnostic single-use immunoassay for the qualitative detection of Ebola virus antigens that detects all known species within the genus Ebolavirus. Here, we report the performance of the OraQuick® Ebola Rapid Antigen Test and provide a comparison of its performance with other rapid diagnostic tests (RDTs) for EVD. OraQuick® Ebola demonstrated clinical sensitivity of 84.0% in archived EVD patient venous whole-blood (WB) samples, 90.9% in Ebola virus-infected monkey fingerstick samples, and 97.1% in EVD patient cadaver buccal swabs, as well as clinical specificity of 98.0–100% in venous WB samples and 99.1–100% in contrived saliva samples. It is the only 510(k)-cleared Ebola rapid test, has analytical sensitivity as good as or better than all RDT comparators for EVD, and can detect the Sudan virus. Our data demonstrate that the OraQuick® Ebola Rapid Antigen Test is a sensitive and specific assay that can be used for rapid detection of EBOV in humans and could support efforts for EVD-specific interventions and control over outbreaks.
