Evidence map›Paper›PMID 29135995›Full record

ArticlePloS one2017

Efficacy of a new rapid diagnostic test kit to diagnose Sri Lankan cutaneous leishmaniasis caused by Leishmania donovani.

Gayani De Silva, Vijani Somaratne, Sujai Senaratne, Manuja Vipuladasa, Rajitha Wickremasinghe, Renu Wickremasinghe, Shalindra Ranasinghe

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03435419 (Point of Care Tests for Cutaneous Leishmaniasis), which is not on this map. Cited by 24 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 4 pooled it
2.7field-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.

NCT03435419 completednot on this map

Point of Care Tests for Cutaneous Leishmaniasis: Prospective Evaluation of LoopampTM and CL DetectTM Rapid Test for Cutaneous Leishmaniasis Diagnosis in Afghanistan

TypeobservationalSponsorFoundation for Innovative New Diagnostics, SwitzerlandRan2016 to 2016Enrolled274ConditionsCutaneous LeishmaniasesArmsLoopampTM Leishmania Detection Kit, CL DetectTM Rapid Test
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 4 syntheses or guidelines pooled it, 38 citations in OpenAlex.

  1. Pooled it
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  12. Diagnostic Tools for Cutaneous Leishmaniasis Caused byDiagnostics (Basel, Switzerland) · 2023
    Review
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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

7 authors at 2 institutions in 1 country.

Gayani De SilvaDepartment of Parasitology, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.
Vijani SomaratneDistrict General Hospital Hambantota, Hambantota, Sri Lanka.
Sujai SenaratneDepartment of Parasitology, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.
Manuja VipuladasaDistrict General Hospital Hambantota, Hambantota, Sri Lanka.
Rajitha WickremasingheDepartment of Public Health, University of Kelaniya, Sri Lanka.
Renu WickremasingheDepartment of Parasitology, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.
Shalindra RanasingheDepartment of Parasitology, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.ORCID http://orcid.org/0000-0002-8173-334X
University of Sri Jayewardenepura · LKUniversity of Kelaniya · LK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCutaneous leishmaniasis (CL) in Sri Lanka is caused by Leishmania donovani. This study assessed the diagnostic value of a new rapid diagnostic immunochromatographic strip (CL-Detect™ IC-RDT), that captures the peroxidoxin antigen of Leishmania amastigotes. METHODOLOGY/PRINCIPAL

findingsWe sampled 74 clinically suspected CL lesions, of which 59 (79.7%) were positive by PCR, 43 (58.1%) by Giemsa stained slit skin smear (SSS) and 21 (28.4%) by the new IC-RDT. All samples which were positive either by SSS or IC-RDT or both were positive by PCR. The sensitivities of the IC-RDT and SSS compared to PCR were 36% and 73%, respectively. Fifteen patients from this endemic region were negative by all three tests. Twenty two clinically non-CL skin lesions from a CL non-endemic region were also negative by all three methods. Specificity and PPV of both IC-RDT and SSS compared to PCR were 100%; the NPVs of IC-RDT and SSS were 37% and 58%, respectively. The median parasite grading of the 59 PCR positive samples was 2+ (1-10 parasites/100 HPFs) and IC-RDT positive lesions was 3+ (1-10 parasites /10HPFs). The duration of the lesion was not associated with IC-RDT positivity. CONCLUSIONS/SIGNIFICANCE: The median parasite grade of Sri Lankan CL lesions is low. The low sensitivities of SSS and CL Detect™ IC-RDT may be due to low parasite counts or low expression of peroxidoxin antigen in amastigotes of the Sri Lankan L. donovani strain. Our results indicate that negative SSS has to be combined with PCR for confirmation of CL in Sri Lanka. The current commercially available IC-RDT is not suitable to diagnose CL in Sri Lanka; an IC-RDT with improved sensitivity to detect L. donovani would be a valuable addition in the diagnostic tool kit for Sri Lanka.

Indexed as

Reagent Kits, DiagnosticAdolescentChildChild, PreschoolChromatography, AffinityFemaleHumansInfantInfant, NewbornLeishmania donovaniLeishmaniasis, CutaneousMalePolymerase Chain ReactionSensitivity and SpecificitySri LankaReagent Kits, Diagnostic

Identifiers

PMID29135995
PMCPMC5685575
OpenAlexW2769018984

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.