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. 2016 Oct 15;214(suppl 3):S210-S217.
doi: 10.1093/infdis/jiw293. Epub 2016 Aug 31.

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

Robert W Cross  1 , Matthew L Boisen  2 , Molly M Millett  3 , Diana S Nelson  4 , Darin Oottamasathien  3 , Jessica N Hartnett  5 , Abigal B Jones  3 , Augustine Goba  6 , Mambu Momoh  7 , Mohamed Fullah  7 , Zachary A Bornholdt  8 , Marnie L Fusco  8 , Dafna M Abelson  8 , Shunichiro Oda  8 , Bethany L Brown  3 , Ha Pham  3 , Megan M Rowland  9 , Krystle N Agans  1 , Joan B Geisbert  1 , Megan L Heinrich  9 , Peter C Kulakosky  10 , Jeffrey G Shaffer  11 , John S Schieffelin  12 , Brima Kargbo  13 , Momoh Gbetuwa  6 , Sahr M Gevao  14 , Russell B Wilson  10 , Erica Ollmann Saphire  8 , Kelly R Pitts  3 , Sheik Humarr Khan  6 , Donald S Grant  6 , Thomas W Geisbert  1 , Luis M Branco  9 , Robert F Garry  15
Affiliations

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

Robert W Cross et al. J Infect Dis. .

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.

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.

Keywords: Ebola, point of care; diagnostic; lateral flow immunoassay.

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Figures

Figure 1.
Figure 1.
ReEBOV Antigen Rapid Test visual aid. The package insert visual aid provides the operator with a reproduction of valid positive and negative control results and a panel of invalid test results to aid in correct interpretation of the rapid test. A scale of test line signal intensity is also provided, to help guide results interpretation.
See this image and copyright information in PMC

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