Evidence map›Paper›PMID 29246478›Full record

Trial reportEBioMedicine2018

A Phase III Diagnostic Accuracy Study of a Rapid Diagnostic Test for Diagnosis of Second-Stage Human African Trypanosomiasis in the Democratic Republic of the Congo.

Marleen Boelaert, Deby Mukendi, Emmanuel Bottieau, Jean Roger Kalo Lilo, Kristien Verdonck, Luigi Minikulu, Barbara Barbé, Philippe Gillet, Cédric P Yansouni, François Chappuis and 1 more

Open access · goldAbstract readClinical Trial, Phase III
In one paragraph

Trial report in EBioMedicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
2.8field-weighted citation impact, top 9% 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

17 citing papers in PubMed, 32 citations in OpenAlex.

  1. Trial
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  5. Review
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  12. NTD Diagnostics for Disease Elimination: A Review.Diagnostics (Basel, Switzerland) · 2020
    Review
  13. Article
  14. Article
  15. Article
  16. Case Report:The American journal of tropical medicine and hygiene · 2019
    Article
  17. A One Health systematic review of diagnostic tools forFood and waterborne parasitology · 2019
    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

11 authors at 5 institutions in 4 countries.

Marleen BoelaertInstitute of Tropical Medicine, Nationalestraat 155, Antwerp B-2000, Belgium. Electronic address: mboelaert@itg.be.
Deby MukendiInstitut National de Recherche Biomédicale, Kinshasa, Democratic Republic of the Congo. Electronic address: debymukendi@yahoo.fr.
Emmanuel BottieauInstitute of Tropical Medicine, Nationalestraat 155, Antwerp B-2000, Belgium. Electronic address: ebottieau@itg.be.
Jean Roger Kalo LiloProgramme National de Lutte contre la Trypanosomiase Humaine Africaine, Kinshasa, Democratic Republic of the Congo. Electronic address: lilo.kalo@yahoo.fr.
Kristien VerdonckInstitute of Tropical Medicine, Nationalestraat 155, Antwerp B-2000, Belgium. Electronic address: tverdonck@itg.be.
Luigi MinikuluHôpital Général de Mosango, Ministry of Health, Democratic Republic of the Congo. Electronic address: luigiminikulu@yahoo.fr.
Barbara BarbéInstitute of Tropical Medicine, Nationalestraat 155, Antwerp B-2000, Belgium. Electronic address: bbarbe@itg.be.
Philippe GilletInstitute of Tropical Medicine, Nationalestraat 155, Antwerp B-2000, Belgium. Electronic address: philippegillet@proximus.be.
Cédric P YansouniMcGill University Health Centre, Montreal, QC H4A 3J1, Canada. Electronic address: cedric.yansouni@mail.mcgill.ca.
François ChappuisGeneva University Hospitals, Geneva 1205, Switzerland. Electronic address: Francois.Chappuis@hcuge.ch.
Pascal LutumbaInstitut National de Recherche Biomédicale, Kinshasa, Democratic Republic of the Congo. Electronic address: plutumba@taskforce.org.
Instituut voor Tropische Geneeskunde · BENational Institute of Biomedical Research · CDMcGill University Health Centre · CAProgramme National Multisectoriel de Lutte contre le sida · CDUniversity Hospital of Geneva · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo estimate the diagnostic accuracy of HAT Sero K-SeT for the field diagnosis of second-stage human African trypanosomiasis (HAT).

designA phase III diagnostic accuracy design. Consecutive patients with symptoms clinically suggestive of HAT were prospectively enrolled. We compared results of the index test HAT Sero K-SeT with those of a composite reference standard: demonstration of trypanosomes in cerebrospinal fluid (CSF), or trypanosomes detected in any other body fluid AND white blood cell count in CSF >5/μl.

settingRural hospital in the Democratic Republic of the Congo.

participantsAll patients above five years old presenting at Mosango hospital with a neurological problem of recent onset at the exclusion of trauma.

interventionsn.a.

main outcome measuresSensitivity and specificity of HAT Sero K-SeT test.

resultsThe sensitivity of the HAT Sero K-SeT was 8/8 or 100.0% (95% confidence interval: 67.6 to 100.0%) and the specificity was 258/266 or 97.0% (94.2% to 98.5%).

conclusionThe high sensitivity of the HAT Sero K-SeT is in line with previously published estimates, though the sample of HAT cases in this study was small. The specificity estimate was very high and precise. This test, when negative, allows the clinician to rule out HAT in a clinical suspect in a hospital setting in this endemic region.

Indexed as

Diagnostic Tests, RoutineAdolescentAdultAgedAgglutination TestsChildDemocratic Republic of the CongoDemographyFemaleHumansMaleMiddle AgedReference StandardsTrypanosomiasis, AfricanYoung AdultDiagnostic accuracyHuman African trypanosomiasisRapid diagnostic testSensitivity& specificityTrypanosoma brucei gambiense

Identifiers

PMID29246478
PMCPMC5828295
OpenAlexW2772396595

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.