Evidence map›Paper›PMID 27058033›Full record

ArticlePLoS neglected tropical diseases2016

Sensitivity and Specificity of a Prototype Rapid Diagnostic Test for the Detection of Trypanosoma brucei gambiense Infection: A Multi-centric Prospective Study.

Sylvie Bisser, Crispin Lumbala, Etienne Nguertoum, Victor Kande, Laurence Flevaud, Gedeao Vatunga, Marleen Boelaert, Philippe Büscher, Theophile Josenando, Paul R Bessell and 2 more

Registry-linked trialOpen access · goldAbstract readComparative StudyEvaluation StudyMulticenter Study
In one paragraph

Article in PLoS neglected tropical diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03356665 (Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials), which is not on this map. Cited by 57 papers.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed
6.4field-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.

NCT03356665 nacompletednot on this mapstarted 2017, after this paper: background citation

Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP2 Passive Case Detection

TypeinterventionalSponsorInstitut de Recherche pour le DeveloppementRan2017 to 2021Enrolled10,700ConditionsAfrican Trypanosomiases, West African, Trypanosomiasis, Sleeping SicknessArmsRapid diagnostic test (RDT), Serological and molecular tests on DBS
3 · Its place in the literature

Who cites it

57 citing papers in PubMed, 85 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Observational
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Review
  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

12 authors at 6 institutions in 6 countries.

Sylvie BisserINSERM UMR1094, Institute of Neuroepidemiology and Tropical Neurology, Limoges, France.
Crispin LumbalaProgramme National de Lutte contre la Trypanosomiase Humaine Africaine (PNLTHA), Kinshasa, Democratic Republic of the Congo.
Etienne NguertoumInstitut Centrafricain de la Recherche Agronomique (ICRA), Bangui, Central African Republic.
Victor KandeProgramme National de Lutte contre la Trypanosomiase Humaine Africaine (PNLTHA), Kinshasa, Democratic Republic of the Congo.
Laurence FlevaudMédecins Sans Frontières (MSF) Operational Centre Barcelona-Athens (OCBA), Barcelona, Spain.
Gedeao VatungaInstituto de Combate e Controlo das Tripanossomiases, Luanda, Angola.
Marleen BoelaertInstitute of Tropical Medicine Antwerp, Antwerpen, Belgium.
Philippe BüscherInstitute of Tropical Medicine Antwerp, Antwerpen, Belgium.
Theophile JosenandoInstituto de Combate e Controlo das Tripanossomiases, Luanda, Angola.
Paul R BessellEpi Interventions Ltd., Edinburgh, United Kingdom.
Sylvain BiélerFoundation for Innovative New Diagnostics, Campus Biotech, Geneva, Switzerland.
Joseph M Ndung'uFoundation for Innovative New Diagnostics, Campus Biotech, Geneva, Switzerland.
Foundation for Innovative New Diagnostics · CHInstituut voor Tropische Geneeskunde · BEProgramme National Multisectoriel de Lutte contre le sida · CDUniversidade Lusíada de Angola · AOInstitut d’Epidémiologie Neurologique et de Neurologie Tropicale · FRMédecins Sans Frontières · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA major challenge in the control of human African trypanosomiasis (HAT) is lack of reliable diagnostic tests that are rapid and easy to use in remote areas where the disease occurs. In Trypanosoma brucei gambiense HAT, the Card Agglutination Test for Trypanosomiasis (CATT) has been the reference screening test since 1978, usually on whole blood, but also in a 1/8 dilution (CATT 1/8) to enhance specificity. However, the CATT is not available in a single format, requires a cold chain for storage, and uses equipment that requires electricity. A solution to these challenges has been provided by rapid diagnostic tests (RDT), which have recently become available. A prototype immunochromatographic test, the SD BIOLINE HAT, based on two native trypanosomal antigens (VSG LiTat 1.3 and VSG LiTat 1.5) has been developed. We carried out a non-inferiority study comparing this prototype to the CATT 1/8 in field settings. METHODOLOGY/PRINCIPAL

findingsThe prototype SD BIOLINE HAT, the CATT Whole Blood and CATT 1/8 were systematically applied on fresh blood samples obtained from 14,818 subjects, who were prospectively enrolled through active and passive screening in clinical studies in three endemic countries of central Africa: Angola, the Democratic Republic of the Congo and the Central African Republic. One hundred and forty nine HAT cases were confirmed by parasitology. The sensitivity and specificity of the prototype SD BIOLINE HAT was 89.26% (95% confidence interval (CI) = 83.27-93.28) and 94.58% (95% CI = 94.20-94.94) respectively. The sensitivity and specificity of the CATT on whole blood were 93.96% (95% CI = 88.92-96.79) and 95.91% (95% CI = 95.58-96.22), and of the CATT 1/8 were 89.26% (95% CI = 83.27-93.28) and 98.88% (95% CI = 98.70-99.04) respectively. CONCLUSION/SIGNIFICANCE: After further optimization, the prototype SD BIOLINE HAT could become an alternative to current screening methods in primary healthcare settings in remote, resource-limited regions where HAT typically occurs.

Indexed as

AngolaCentral African RepublicChromatography, AffinityDemocratic Republic of the CongoDiagnostic Tests, RoutineHumansProspective StudiesSensitivity and SpecificityTime FactorsTrypanosoma brucei gambienseTrypanosomiasis, African

Identifiers

PMID27058033
PMCPMC4825971
OpenAlexW2315678501

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.