Evidence map›Paper›PMID 35041672›Full record

ArticlePLoS neglected tropical diseases2022

Evaluation of the CL Detect Rapid Test in Ethiopian patients suspected for Cutaneous Leishmaniasis.

Saskia van Henten, Helina Fikre, Roma Melkamu, Dilargachew Dessie, Tigist Mekonnen, Mekibib Kassa, Tadfe Bogale, Rezika Mohammed, Lieselotte Cnops, Florian Vogt and 2 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in PLoS neglected tropical diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03837431 (Diagnosis of Cutaneous Leishmaniasis Using the CL-Detect Rapid Test in Ethiopia), which is not on this map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
6.2field-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.

NCT03837431 completednot on this map

Diagnosis of Cutaneous Leishmaniasis Using the CL-Detect Rapid Test in Ethiopia

TypeobservationalSponsorInstitute of Tropical Medicine, BelgiumRan2019 to 2023Enrolled351ConditionsCutaneous LeishmaniasesArmsSkin slit, Dental broach, Tape disc
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Review
  6. Leishmaniasis.Nature reviews. Disease primers · 2025
    Review
  7. Cutaneous leishmaniasis in Afghanistan.Transactions of the Royal Society of Tropical Medicine and Hygiene · 2025
    Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Diagnostic Tools for Cutaneous Leishmaniasis Caused byDiagnostics (Basel, Switzerland) · 2023
    Review
  15. Article
  16. Article
  17. How I Approach Leishmaniasis: Diagnosis and Treatment in the United States.Journal of the Pediatric Infectious Diseases Society · 2022
    Article
  18. Review
  19. ImagingMicroorganisms · 2022
    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

12 authors at 3 institutions in 3 countries.

Saskia van HentenDepartment of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.ORCID https://orcid.org/0000-0001-6627-0474
Helina FikreLeishmaniasis Research and Treatment Center, Gondar University Hospital, Gondar, Ethiopia.
Roma MelkamuLeishmaniasis Research and Treatment Center, Gondar University Hospital, Gondar, Ethiopia.
Dilargachew DessieLeishmaniasis Research and Treatment Center, Gondar University Hospital, Gondar, Ethiopia.
Tigist MekonnenLeishmaniasis Research and Treatment Center, Gondar University Hospital, Gondar, Ethiopia.
Mekibib KassaLeishmaniasis Research and Treatment Center, Gondar University Hospital, Gondar, Ethiopia.
Tadfe BogaleLeishmaniasis Research and Treatment Center, Gondar University Hospital, Gondar, Ethiopia.
Rezika MohammedLeishmaniasis Research and Treatment Center, Gondar University Hospital, Gondar, Ethiopia.
Lieselotte CnopsDepartment of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
Florian VogtDepartment of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
Myrthe PareynDepartment of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.ORCID https://orcid.org/0000-0002-8918-3901
Johan van GriensvenDepartment of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
University of Gondar · ETInstituut voor Tropische Geneeskunde · BEAustralian National University · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCutaneous leishmaniasis (CL) is common in Ethiopia, mainly affecting impoverished populations in rural areas with poor access to health care. CL is routinely diagnosed using skin slit smear microscopy, which requires skilled staff and appropriately equipped laboratories. We evaluated the CL Detect Rapid Test (InBios, Washington, USA), which is supplied with a dental broach sampling device, as a diagnostic alternative which could be used in field settings. METHODOLOGY/PRINCIPAL

findingsWe evaluated the diagnostic accuracy of the CL Detect Rapid Test on skin slit and dental broach samples from suspected CL patients at the Leishmaniasis Research and Treatment Center in Gondar, Ethiopia. A combined reference test of microscopy and PCR on the skin slit sample was used, which was considered positive if one of the two tests was positive. We recruited 165 patients consecutively, of which 128 (77.6%) were confirmed as CL. All microscopy-positive results (n = 71) were also PCR-positive, and 57 patients were only positive for PCR. Sensitivity of the CL Detect Rapid Test on the skin slit was 31.3% (95% confidence interval (CI) 23.9-39.7), which was significantly higher (p = 0.010) than for the dental broach (22.7%, 95% CI 16.3-30.6). Sensitivity for both methods was significantly lower than for the routinely used microscopy, which had a sensitivity of 55.5% (IQR 46.8-63.8) compared to PCR as a reference. CONCLUSIONS/SIGNIFICANCE: The diagnostic accuracy of the CL Detect Rapid Test was low for skin slit and dental broach samples. Therefore, we do not recommend its use neither in hospital nor field settings.

trial registrationThis study is registered at ClinicalTrials.gov as NCT03837431.

Indexed as

AdolescentAdultAntigens, ProtozoanCross-Sectional StudiesDNA, ProtozoanEthiopiaFemaleHumansImmunoassayLeishmaniaLeishmaniasis, CutaneousMalePeroxiredoxinsPolymerase Chain ReactionSensitivity and SpecificitySkinAntigens, ProtozoanDNA, ProtozoanPeroxiredoxins

Identifiers

PMID35041672
PMCPMC8797207
OpenAlexW4205417011

What OpenQuestion holds

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LicenceCC BY
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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.