Analytical Validation of the ReEBOV Antigen Rapid Test for Point-of-Care Diagnosis of Ebola Virus Infection

Background. Ebola 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 suspec...

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Bibliographic Details
Published in:The Journal of infectious diseases 2016-10, Vol.214 (suppl 3), p.S210-S217
Main Authors: Cross, Robert W., Boisen, Matthew L., Millett, Molly M., Nelson, Diana S., Oottamasathien, Darin, Hartnett, Jessica N., Jones, Abigal B., Goba, Augustine, Momoh, Mambu, Fullah, Mohamed, Bornholdt, Zachary A., Fusco, Marnie L., Abelson, Dafna M., Oda, Shunichiro, Brown, Bethany L., Pham, Ha, Rowland, Megan M., Agans, Krystle N., Geisbert, Joan B., Heinrich, Megan L., Kulakosky, Peter C., Shaffer, Jeffrey G., Schieffelin, John S., Kargbo, Brima, Gbetuwa, Momoh, Gevao, Sahr M., Wilson, Russell B., Saphire, Erica Ollmann, Pitts, Kelly R., Khan, Sheik Humarr, Grant, Donald S., Geisbert, Thomas W., Branco, Luis M., Garry, Robert F.
Format: Article
Language:English
Subjects:
Africa, Western - epidemiology
Animals
Antigens, Viral - blood
DIAGNOSIS
Disease Outbreaks
Ebola Outbreak in West Africa
Ebolavirus - immunology
Ebolavirus - isolation & purification
Enzyme-Linked Immunosorbent Assay
Hemorrhagic Fever, Ebola - diagnosis
Hemorrhagic Fever, Ebola - virology
Humans
Immunoassay
Limit of Detection
Point-of-Care Systems
Reagent Kits, Diagnostic
Sensitivity and Specificity
Viral Matrix Proteins - blood
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Summary:Background. Ebola 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. Methods. Recombinant 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. Results. The 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. Conclusions. The 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.
ISSN:0022-1899
1537-6613
DOI:10.1093/infdis/jiw293