Evidence map›Paper›PMID 27521365›Full record

ArticleThe Journal of infectious diseases2016

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

Matthew L Boisen, Robert W Cross, Jessica N Hartnett, Augustine Goba, Mambu Momoh, Mohamed Fullah, Michael Gbakie, Sidiki Safa, Mbalu Fonnie, Francis Baimba and 21 more

Open access · bronzeAbstract readValidation Study
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 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
4.2field-weighted citation impact, top 6% 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

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Technologies for Frugal and Sensitive Point-of-Care Immunoassays.Annual review of analytical chemistry (Palo Alto, Calif.) · 2022
    Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Analysis of CD8Proceedings of the National Academy of Sciences of the United States of America · 2018
    Article
  15. Status, quality and specific needs of Ebola virus diagnostic capacity and capability in laboratories of the two European preparedness laboratory networks EMERGE and EVD-LabNet.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2018
    Article
  16. Article
  17. Article
  18. Review
  19. 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

31 authors at 6 institutions in 2 countries.

Matthew L BoisenCorgenix, Broomfield, Colorado Department of Microbiology and Immunology.
Robert W CrossGalveston National Laboratory, University of Texas Medical Branch.
Jessica N HartnettDepartment of Microbiology and Immunology.
Augustine GobaLassa Fever Program, Kenema Government Hospital Ministry of Health and Sanitation, Freetown, Sierra Leone.
Mambu MomohLassa Fever Program, Kenema Government Hospital Eastern Polytechnic Institute, Kenema Ministry of Health and Sanitation, Freetown, Sierra Leone.
Mohamed FullahLassa Fever Program, Kenema Government Hospital Ministry of Health and Sanitation, Freetown, Sierra Leone.
Michael GbakieLassa Fever Program, Kenema Government Hospital Ministry of Health and Sanitation, Freetown, Sierra Leone.
Sidiki SafaLassa Fever Program, Kenema Government Hospital Ministry of Health and Sanitation, Freetown, Sierra Leone.
Mbalu FonnieLassa Fever Program, Kenema Government Hospital Ministry of Health and Sanitation, Freetown, Sierra Leone.
Francis BaimbaLassa Fever Program, Kenema Government Hospital Ministry of Health and Sanitation, Freetown, Sierra Leone.
Veronica J KoromaLassa Fever Program, Kenema Government Hospital Ministry of Health and Sanitation, Freetown, Sierra Leone.
Joan B GeisbertGalveston National Laboratory, University of Texas Medical Branch.
Stephanie McCormickAutoimmune Technologies.
Diana K S NelsonCorgenix, Broomfield, Colorado.
Molly M MillettCorgenix, Broomfield, Colorado.
Darin OottamasathienCorgenix, Broomfield, Colorado.
Abby B JonesCorgenix, Broomfield, Colorado.
Ha PhamCorgenix, Broomfield, Colorado.
Bethany L BrownCorgenix, Broomfield, Colorado.
Jeffrey G ShafferTulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.
John S SchieffelinDepartment of Pediatrics, Section of Infectious Diseases, Tulane University.
Brima KargboMinistry of Health and Sanitation, Freetown, Sierra Leone.
Momoh GbetuwaLassa Fever Program, Kenema Government Hospital.
Sahr M GevaoLassa Fever Program, Kenema Government Hospital Eastern Polytechnic Institute, Kenema Ministry of Health and Sanitation, Freetown, Sierra Leone.
Russell B WilsonAutoimmune Technologies.
Kelly R PittsCorgenix, Broomfield, Colorado.
Thomas W GeisbertGalveston National Laboratory, University of Texas Medical Branch.
Luis M BrancoZalgen Labs, Germantown, Maryland.
Sheik H KhanLassa Fever Program, Kenema Government Hospital Ministry of Health and Sanitation, Freetown, Sierra Leone.
Donald S GrantLassa Fever Program, Kenema Government Hospital Ministry of Health and Sanitation, Freetown, Sierra Leone.
Robert F GarryDepartment of Microbiology and Immunology Zalgen Labs, Germantown, Maryland.
Ministry of Health and Sanitation · SLCorgenix (United States) · USThe University of Texas Medical Branch at Galveston · USAutoimmune Technologies (United States) · USTulane University · USZalgen (United States) · US

Funding

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 UC1 AI067188NICHD NIH HHS K12 HD043451
6 · The paper itself

Abstract

backgroundThe 2013-2016 West African Ebola virus disease (EVD) epidemic is the largest recorded. Triage on the basis of clinical signs had limited success, and the time to diagnosis by quantitative reverse transcription-polymerase chain reaction (qRT-PCR) could exceed 5 days. Here we describe the development and field validation of the ReEBOV Antigen Rapid Test (ReEBOV RDT) to aid triage of individuals with suspected EVD.

methodsSamples from patients with suspected EVD were submitted to Kenema Government Hospital, Sierra Leone, for Lassa fever and EVD screening throughout 2014. Banked residual clinical samples were tested in November 2014 and January 2015 in a blinded field trial to estimate the clinical effectiveness of the ReEBOV RDT, compared with EBOV-specific qRT-PCR.

resultsPreliminary ReEBOV RDT performance demonstrated a positive percentage agreement (PPA) of 91.1% (195 of 214 results; 95% confidence interval [CI], 86.5%-94.6%) and a negative percentage agreement (NPA) of 90.2% (175 of 194; 95% CI, 85.1%-94.0%). The final estimates used by the Food and Drug Administration to determine whether to grant emergency use authorization for the test, which excluded a qRT-PCR reference method threshold cutoff, were a PPA of 62.1% (72 of 116 results; 95% CI, 52.6%-70.9%) and a NPA of 96.7% (58 of 60; 95% CI, 88.5%-99.6%), with a diagnostic likelihood of 18.6. A subsequent, independent evaluation by the World Health Organization generated results consistent with the preliminary performance estimates.

conclusionsThe ReEBOV RDT demonstrated the potential to provide clinically effective rapid and accurate point-of-care test results and, thus, to be a powerful tool for increasing triage efficiency.

Indexed as

Point-of-Care SystemsAntigens, ViralEbolavirusHemorrhagic Fever, EbolaHospitalsHumansImmunoassayReagent Kits, DiagnosticReal-Time Polymerase Chain ReactionReproducibility of ResultsRNA, ViralSensitivity and SpecificitySierra LeoneAntigens, ViralReagent Kits, DiagnosticRNA, ViralclinicalEbolalateral flow immunoassaypoint of carevalidation

Identifiers

PMID27521365
PMCPMC5050478
OpenAlexW4232964714

What OpenQuestion holds

Textmetadata
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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.