Evidence map›Paper›PMID 39407317›Full record

ArticleParasites & vectors2024

Evaluation of Loopamp Leishmania detection kit for the diagnosis of cutaneous leishmaniasis in Ethiopia.

Behailu Taye, Roma Melkamu, Fitsumbrhan Tajebe, Ana Victoria Ibarra-Meneses, Desalegn Adane, Saba Atnafu, Mohammed Adem, Gashaw Adane, Mekibib Kassa, Mezgebu Silamsaw Asres and 3 more

Abstract readEvaluation Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Parasites & vectors, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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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

13 authors.

Behailu TayeDepartment of Immunology and Molecular Biology, University of Gondar, Gondar, Ethiopia. behailutaye096@gmail.com.
Roma MelkamuLeishmaniasis Research and Treatment Center, University of Gondar, Gondar, Ethiopia.
Fitsumbrhan TajebeDepartment of Immunology and Molecular Biology, University of Gondar, Gondar, Ethiopia.
Ana Victoria Ibarra-MenesesDépartement de Pathologie et Microbiologie, Faculté de Médecine Vétérinaire, Université de Montréal, Saint-Hyacinthe, QC, Canada.
Desalegn AdaneLeishmaniasis Research and Treatment Center, University of Gondar, Gondar, Ethiopia.
Saba AtnafuLeishmaniasis Research and Treatment Center, University of Gondar, Gondar, Ethiopia.
Mohammed AdemDepartment of Immunology and Molecular Biology, University of Gondar, Gondar, Ethiopia.
Gashaw AdaneDepartment of Immunology and Molecular Biology, University of Gondar, Gondar, Ethiopia.
Mekibib KassaLeishmaniasis Research and Treatment Center, University of Gondar, Gondar, Ethiopia.
Mezgebu Silamsaw AsresLeishmaniasis Research and Treatment Center, University of Gondar, Gondar, Ethiopia.
Johan van GriensvenDepartment of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
Saskia van HentenDepartment of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
Myrthe PareynDepartment of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCutaneous leishmaniasis (CL) in Ethiopia and some parts of Kenya is predominantly caused by Leishmania aethiopica. While skin-slit (SS) microscopy is routinely used for CL diagnosis, more sensitive molecular tests are available. The Loopamp™ Leishmania detection kit (Loopamp) is a robust loop-mediated isothermal amplification (LAMP) assay with the potential for implementation in primary healthcare facilities. In this study, we comparatively assessed the diagnostic accuracy of four methods currently used to diagnose CL: Loopamp, kinetoplast DNA (kDNA) PCR, spliced leader RNA (SL-RNA) PCR and SS microscopy.

methodsA study on 122 stored tape disc samples of suspected CL patients was conducted in Gondar, northwestern Ethiopia. Routine SS microscopy results were obtained from all patients. Total nucleic acids were extracted from the tapes and subjected to PCR testing targeting kDNA and SL-RNA, and Loopamp. Diagnostic accuracy was calculated with SS microscopy as a reference test. The limit of detection (LoD) of Loopamp and kDNA PCR were determined for cultured L. aethiopica and Leishmania donovani.

resultsOf the 122 patients, 64 (52.5%) were identified as CL cases based on SS microscopy. Although the PCR tests showed a sensitivity of 95.3% (95% confidence interval [CI] 91.6-99.1), Loopamp only had 48.4% (95% CI 39.6-57.3) sensitivity and 87.9% (95% CI 82.1-93.7) specificity. The LoD of Loopamp for L. donovani was 100-fold lower (20 fg/µl) than that for L. aethiopica (2 pg/µl).

conclusionsThe Loopamp™ Leishmania detection kit is not suitable for the diagnosis of CL in Ethiopia, presumably due to a primer mismatch with the L. aethiopica 18S rRNA target. Further research is needed to develop a simple and sensitive point-of-care test that allows the decentralization of CL diagnosis in Ethiopia.

Indexed as

LeishmaniaLeishmaniasis, CutaneousMolecular Diagnostic TechniquesNucleic Acid Amplification TechniquesSensitivity and SpecificityAdolescentAdultChildChild, PreschoolDNA, KinetoplastDNA, ProtozoanEthiopiaFemaleHumansLeishmania donovaniLimit of DetectionDNA, KinetoplastDNA, ProtozoanReagent Kits, DiagnosticCutaneous leishmaniasisLAMPLeishmania aethiopicaMolecular diagnosis

Identifiers

PMID39407317
PMCPMC11481786

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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.