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Analytical Validation of the ReEBOV Antigen Rapid Test for Point-of-Care Diagnosis of Ebola Virus Infection.
- Source :
-
The Journal of infectious diseases [J Infect Dis] 2016 Oct 15; Vol. 214 (suppl 3), pp. S210-S217. Date of Electronic Publication: 2016 Aug 31. - Publication Year :
- 2016
-
Abstract
- 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.<br />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.<br />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 × 10 <superscript>5</superscript> -9.0 × 10 <superscript>8</superscript> genomes/mL.<br />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.<br /> (© 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.)
- Subjects :
- Africa, Western epidemiology
Animals
Ebolavirus isolation & purification
Enzyme-Linked Immunosorbent Assay
Hemorrhagic Fever, Ebola virology
Humans
Immunoassay
Limit of Detection
Reagent Kits, Diagnostic
Sensitivity and Specificity
Antigens, Viral blood
Disease Outbreaks
Ebolavirus immunology
Hemorrhagic Fever, Ebola diagnosis
Point-of-Care Systems
Viral Matrix Proteins blood
Subjects
Details
- Language :
- English
- ISSN :
- 1537-6613
- Volume :
- 214
- Issue :
- suppl 3
- Database :
- MEDLINE
- Journal :
- The Journal of infectious diseases
- Publication Type :
- Academic Journal
- Accession number :
- 27587634
- Full Text :
- https://doi.org/10.1093/infdis/jiw293