• Robert W Cross, Matthew L Boisen, Molly M Millett, Diana S Nelson, Darin Oottamasathien, Jessica N Hartnett, Abigal B Jones, Augustine Goba, Mambu Momoh, Mohamed Fullah, Zachary A Bornholdt, Marnie L Fusco, Dafna M Abelson, Shunichiro Oda, Bethany L Brown, Ha Pham, Megan M Rowland, Krystle N Agans, Joan B Geisbert, Megan L Heinrich, Peter C Kulakosky, Jeffrey G Shaffer, John S Schieffelin, Brima Kargbo, Momoh Gbetuwa, Sahr M Gevao, Russell B Wilson, Erica Ollmann Saphire, Kelly R Pitts, Sheik Humarr Khan, Donald S Grant, Thomas W Geisbert, Luis M Branco, and Robert F Garry.
• Galveston National Laboratory, University of Texas Medical Branch.
• J. Infect. Dis. 2016 Oct 15; 214 (suppl 3): S210-S217.

BackgroundEbola virus disease (EVD) is a severe viral illness caused by Ebola virus (EBOV). The 2013-2016 EVD outbreak in West Africa is the largest recorded, with >11 000 deaths. Development of the ReEBOV Antigen Rapid Test (ReEBOV RDT) was expedited to provide a point-of-care test for suspected EVD cases.MethodsRecombinant EBOV viral protein 40 antigen was used to derive polyclonal antibodies for RDT and enzyme-linked immunosorbent assay development. ReEBOV RDT limits of detection (LOD), specificity, and interference were analytically validated on the basis of Food and Drug Administration (FDA) guidance.ResultsThe ReEBOV RDT specificity estimate was 95% for donor serum panels and 97% for donor whole-blood specimens. The RDT demonstrated sensitivity to 3 species of Ebolavirus (Zaire ebolavirus, Sudan ebolavirus, and Bundibugyo ebolavirus) associated with human disease, with no cross-reactivity by pathogens associated with non-EBOV febrile illness, including malaria parasites. Interference testing exhibited no reactivity by medications in common use. The LOD for antigen was 4.7 ng/test in serum and 9.4 ng/test in whole blood. Quantitative reverse transcription-polymerase chain reaction testing of nonhuman primate samples determined the range to be equivalent to 3.0 × 105-9.0 × 108 genomes/mL.ConclusionsThe analytical validation presented here contributed to the ReEBOV RDT being the first antigen-based assay to receive FDA and World Health Organization emergency use authorization for this EVD outbreak, in February 2015.© The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

27 keywords...

hide…