Development and Clinical Evaluation of a Rapid Point of Care Test for Ebola Virus Infection in Humans
Author:
Wang Zheng12, Bennett Richard S.3ORCID, Roehler Michele1, Guillon Geraldine1, Fischl Mark J.1, Donadi Mary C.1, Makovetz Jim1, Holmes Natalie1, Zaveri Toral1, Toolan Eamon1, Gontz Heather L.1, Yearwood Graham D.12, Logue James3ORCID, Bohannon J. Kyle3, Mistretta Lisa3, Byrum Russell3, Ragland Dan3, St. Claire Marisa3, Kurtz Lisa A.1, Miller Tiffany1, Reed Michael R.1ORCID, Young Janean1, Lee John4, Hensley Lisa E.3, Kardos Keith1, Berry Jody D.1
Affiliation:
1. OraSure Technologies, Inc., Bethlehem, PA 18015, USA 2. Bristol Myers Squibb, Princeton, NJ 08540, USA 3. Integrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick, MD 21702, USA 4. Biomedical Advanced Research and Development Authority (BARDA), U.S. Department of Health & Human Services, Washington, DC 20201, USA
Abstract
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.
Funder
US Department of Health and Human Services National Institute of Allergy and Infectious Diseases NIAID Division of Intramural Research and NIAID Division of Clinical Research
Subject
Virology,Infectious Diseases
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