Evidence map›Paper›PMID 27587634›Full record

ArticleThe Journal of infectious diseases2016

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

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 and 24 more

Open access · bronzeAbstract read
In one paragraph

Article in The Journal of infectious diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
6.7field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 51 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Recent Advances in Therapeutic Approaches Against Ebola Virus Infection.Recent advances in anti-infective drug discovery · 2024
    Review
  7. 50 Years of Lassa Fever Research.Current topics in microbiology and immunology · 2023
    Article
  8. 50 Years of Lassa Fever Research.Current topics in microbiology and immunology · 2023
    Article
  9. Technologies for Frugal and Sensitive Point-of-Care Immunoassays.Annual review of analytical chemistry (Palo Alto, Calif.) · 2022
    Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Analysis of CD8Proceedings of the National Academy of Sciences of the United States of America · 2018
    Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

34 authors at 8 institutions in 2 countries.

Robert W CrossGalveston National Laboratory, University of Texas Medical Branch.
Matthew L BoisenCorgenix, Broomfield, Colorado Department of Microbiology and Immunology Zalgen Labs, Germantown, Maryland.
Molly M MillettCorgenix, Broomfield, Colorado.
Diana S NelsonCorgenix, Broomfield, Colorado Zalgen Labs, Germantown, Maryland.
Darin OottamasathienCorgenix, Broomfield, Colorado.
Jessica N HartnettDepartment of Microbiology and Immunology.
Abigal B JonesCorgenix, Broomfield, Colorado.
Augustine GobaLassa Fever Program, Kenema Government Hospital Ministry of Health and Sanitation.
Mambu MomohLassa Fever Program, Kenema Government Hospital Ministry of Health and Sanitation Eastern Polytechnic Institute, Kenema, Sierra Leone.
Mohamed FullahLassa Fever Program, Kenema Government Hospital Ministry of Health and Sanitation Eastern Polytechnic Institute, Kenema, Sierra Leone.
Zachary A BornholdtThe Scripps Research Institute, La Jolla, California.
Marnie L FuscoThe Scripps Research Institute, La Jolla, California.
Dafna M AbelsonThe Scripps Research Institute, La Jolla, California.
Shunichiro OdaThe Scripps Research Institute, La Jolla, California.
Bethany L BrownCorgenix, Broomfield, Colorado.
Ha PhamCorgenix, Broomfield, Colorado.
Megan M RowlandZalgen Labs, Germantown, Maryland.
Krystle N AgansGalveston National Laboratory, University of Texas Medical Branch.
Joan B GeisbertGalveston National Laboratory, University of Texas Medical Branch.
Megan L HeinrichZalgen Labs, Germantown, Maryland.
Peter C KulakoskyAutoimmune Technologies, New Orleans, Louisiana.
Jeffrey G ShafferSchool of Public Health and Tropical Medicine, Tulane University.
John S SchieffelinSection of Infectious Diseases, Department of Pediatrics, School of Medicine.
Brima KargboMinistry of Health and Sanitation.
Momoh GbetuwaLassa Fever Program, Kenema Government Hospital Ministry of Health and Sanitation.
Sahr M GevaoLassa Fever Program, Kenema Government Hospital University of Sierra Leone, Freetown.
Russell B WilsonAutoimmune Technologies, New Orleans, Louisiana.
Erica Ollmann SaphireThe Scripps Research Institute, La Jolla, California.
Kelly R PittsCorgenix, Broomfield, Colorado.
Sheik Humarr KhanLassa Fever Program, Kenema Government Hospital Ministry of Health and Sanitation.
Donald S GrantLassa Fever Program, Kenema Government Hospital Ministry of Health and Sanitation.
Thomas W GeisbertGalveston National Laboratory, University of Texas Medical Branch.
Luis M BrancoZalgen Labs, Germantown, Maryland.
Robert F GarryDepartment of Microbiology and Immunology Zalgen Labs, Germantown, Maryland.
Corgenix (United States) · USZalgen (United States) · USScripps Research Institute · USThe University of Texas Medical Branch at Galveston · USAutoimmune Technologies (United States) · USSierra Leone Agricultural Research Institute · SLTulane University · USUniversity of Sierra Leone · SL

Funding

Mechanistic Virology CoreU19AI109762 · NIAID · SCRIPPS RESEARCH INSTITUTE, THE · PI LAI, JONATHAN R. · 2014 to 2018
$29.6M
Tulane Building Interdisciplinary Research Careers in Women's Health (BIRCWH)K12HD043451 · NICHD · TULANE UNIVERSITY OF LOUISIANA · PI KROUSEL-WOOD, MARIE · 2002 to 2023
$9.9M
Preclinical development of recombinant antigen diagnostics for Lassa feverU01AI082119 · NIAID · TULANE UNIVERSITY OF LOUISIANA · PI GARRY, ROBERT F · 2009 to 2013
$6.7M
Recombinant antigen assays for Lassa and other arenaviruUC1AI067188 · NIAID · TULANE UNIVERSITY OF LOUISIANA · PI GARRY, ROBERT F · 2005 to 2005
$3.9M
Recombinant antigen diagnostics for filovirusesR44AI088843 · NIAID · ZALGEN LABS, LLC · PI BOISEN, MATTHEW L · 2014 to 2016
$3.0M
Recombinant antigen diagnostics for filovirusesR43AI088843 · NIAID · CORGENIX MEDICAL CORPORATION · PI LOPEZ, LUIS R. · 2010 to 2011
$590k
NIAID NIH HHS R43 AI088843NIAID NIH HHS R44 AI088843NIAID NIH HHS U01 AI082119NIAID NIH HHS U19 AI109762NIAID NIH HHS UC1 AI067188NICHD NIH HHS K12 HD043451
6 · The paper itself

Abstract

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 × 10

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.

Indexed as

Disease OutbreaksPoint-of-Care SystemsAfrica, WesternAnimalsAntigens, ViralEbolavirusEnzyme-Linked Immunosorbent AssayHemorrhagic Fever, EbolaHumansImmunoassayLimit of DetectionReagent Kits, DiagnosticSensitivity and SpecificityViral Matrix ProteinsAntigens, ViralReagent Kits, DiagnosticViral Matrix ProteinsVP40 protein, virusdiagnosticEbola, point of carelateral flow immunoassay

Identifiers

PMID27587634
PMCPMC5050482
OpenAlexW2510400413

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.