Development and Clinical Evaluation of a Rapid Point of Care Test for Ebola Virus Infection in Humans

• Published in: Viruses Vol. 15; no. 2; p. 336
• Main Authors: Wang, Zheng, Bennett, Richard S, Roehler, Michele, Guillon, Geraldine, Fischl, Mark J, Donadi, Mary C, Makovetz, Jim, Holmes, Natalie, Zaveri, Toral, Toolan, Eamon, Gontz, Heather L, Yearwood, Graham D, Logue, James, Bohannon, J Kyle, Mistretta, Lisa, Byrum, Russell, Ragland, Dan, St Claire, Marisa, Kurtz, Lisa A, Miller, Tiffany, Reed, Michael R, Young, Janean, Lee, John, Hensley, Lisa E, Kardos, Keith, Berry, Jody D
• Format: Journal Article
• Language: English
• Published: Switzerland MDPI AG 25-01-2023; MDPI
• Subjects: Animals; Antigens; Antigens, Viral; Cadavers; Care and treatment; Diagnosis; Disease; Ebola virus; Ebolavirus; Epidemics; Evaluation; Fatalities; FDA approval; Hemorrhage; Hemorrhagic fever; Hemorrhagic Fever, Ebola - diagnosis; Humans; Medical tests; Monkeys & apes; Pathogens; Point-of-Care Testing; Public health; rapid antigen test; Rapid Diagnostic Tests; Saliva; Sensitivity analysis; Viruses; United States; Liberia; Sierra Leone; United States > US; Sudan; Ebola virus; diagnosis; rapid antigen test
• ISSN: 1999-4915; 1999-4915
• DOI: 10.3390/v15020336

The genus
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
. 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.