Evidence map›Paper›PMID 27115155›Full record

ArticlePLoS neglected tropical diseases2016

An Innovative Field-Applicable Molecular Test to Diagnose Cutaneous Leishmania Viannia spp. Infections.

Omar A Saldarriaga, Alejandro Castellanos-Gonzalez, Renato Porrozzi, Gerald C Baldeviano, Andrés G Lescano, Maxy B de Los Santos, Olga L Fernandez, Nancy G Saravia, Erika Costa, Peter C Melby and 1 more

Registry-linked trialOpen access · goldAbstract readEvaluation 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 NCT04500873 (Diagnostic Performance of a Recombinant Polymerase Amplification Test - Lateral Flow), which is not on this map. Cited by 27 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 2 pooled it
4.2field-weighted citation impact, top 6% 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.

NCT04500873 completednot on this mapstarted 2018, after this paper: background citation

Diagnostic Performance of a Recombinant Polymerase Amplification Test - Lateral Flow (RPA-LF) for Cutaneous Leishmaniasis in an Endemic Setting of Colombia

TypeobservationalSponsorCentro Internacional de Entrenamiento e Investigaciones MédicasRan2018 to 2019Enrolled128ConditionsCutaneous Leishmaniasis (Diagnosis)
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 2 syntheses or guidelines pooled it, 54 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Crusted, Chronic, and Confusing.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Article
  4. Review
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  15. Novel CRISPR-based detection ofFrontiers in microbiology · 2022
    Article
  16. Article
  17. Article
  18. Observational
  19. Article
  20. Rapid detection ofPeerJ · 2021
    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.

Omar A SaldarriagaDivision of Infectious Diseases, Department of Internal Medicine, University of Texas Medical Branch (UTMB), Galveston, Texas, United States of America.
Alejandro Castellanos-GonzalezDivision of Infectious Diseases, Department of Internal Medicine, University of Texas Medical Branch (UTMB), Galveston, Texas, United States of America.
Renato PorrozziLaboratório de Pesquisa em Leishmaniose, Instituto Oswaldo Cruz, Rio de Janeiro, Brazil.
Gerald C BaldevianoU.S. Naval Medical Research Unit No. 6 (NAMRU-6), Lima, Perú
Andrés G LescanoU.S. Naval Medical Research Unit No. 6 (NAMRU-6), Lima, Perú
Maxy B de Los SantosU.S. Naval Medical Research Unit No. 6 (NAMRU-6), Lima, Perú
Olga L FernandezCentro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia.
Nancy G SaraviaCentro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia.
Erika CostaLaboratório de Pesquisa em Leishmaniose, Instituto Oswaldo Cruz, Rio de Janeiro, Brazil.
Peter C MelbyDivision of Infectious Diseases, Department of Internal Medicine, University of Texas Medical Branch (UTMB), Galveston, Texas, United States of America.
Bruno L TraviDivision of Infectious Diseases, Department of Internal Medicine, University of Texas Medical Branch (UTMB), Galveston, Texas, United States of America.
The University of Texas Medical Branch at Galveston · USCentro Internacional de Entrenamiento e Investigaciones Medicas · COFundação Oswaldo Cruz · BRNaval Medical Research Unit Six · PEUniversidad Peruana Cayetano Heredia · PE

Funding

UTMB Clinical and Translational Science AwardUL1TR001439 · NCATS · UNIVERSITY OF TEXAS MED BR GALVESTON · PI URBAN, RANDALL J · 2015 to 2024
$40.0M
UTMB Clinical and Translational Science AwardUL1TR000071 · NCATS · UNIVERSITY OF TEXAS MED BR GALVESTON · PI BRASIER, ALLAN R. · 2012 to 2014
$14.4M
Peru Infectious Diseases Epidemiology Research Training ConsortiumD43TW007393 · FIC · UNIVERSIDAD PERUANA CAYETANO HEREDIA · PI Andres G Lescano · 2005 to 2026
$5.9M
Vector/Host-Parasite Interface of Leishmaniasis in ColombiaD43TW006589 · FIC · YALE UNIVERSITY · PI GORE SARAVIA, NANCY, TSCHUDI, CHRISTIAN · 2003 to 2024
$4.3M
Improved Treatment of American Cutaneous Leishmaniasis by ImmunomodulationR01AI093775 · NIAID · YALE UNIVERSITY · PI GORE SARAVIA, NANCY, MCMAHON PRATT, DIANE · 2011 to 2014
$2.6M
FIC NIH HHS D43 TW006589FIC NIH HHS D43 TW007393NCATS NIH HHS UL1 TR000071NCATS NIH HHS UL1 TR001439NIAID NIH HHS R01 AI093775
6 · The paper itself

Abstract

Cutaneous and mucosal leishmaniasis is widely distributed in Central and South America. Leishmania of the Viannia subgenus are the most frequent species infecting humans. L. (V.) braziliensis, L. (V.) panamensis are also responsible for metastatic mucosal leishmaniasis. Conventional or real time PCR is a more sensitive diagnostic test than microscopy, but the cost and requirement for infrastructure and trained personnel makes it impractical in most endemic regions. Primary health systems need a sensitive and specific point of care (POC) diagnostic tool. We developed a novel POC molecular diagnostic test for cutaneous leishmaniasis caused by Leishmania (Viannia) spp. Parasite DNA was amplified using isothermal Recombinase Polymerase Amplification (RPA) with primers and probes that targeted the kinetoplast DNA. The amplification product was detected by naked eye with a lateral flow (LF) immunochromatographic strip. The RPA-LF had an analytical sensitivity equivalent to 0.1 parasites per reaction. The test amplified the principal L. Viannia species from multiple countries: L. (V.) braziliensis (n = 33), L. (V.) guyanensis (n = 17), L. (V.) panamensis (n = 9). The less common L. (V.) lainsoni, L. (V.) shawi, and L. (V.) naiffi were also amplified. No amplification was observed in parasites of the L. (Leishmania) subgenus. In a small number of clinical samples (n = 13) we found 100% agreement between PCR and RPA-LF. The high analytical sensitivity and clinical validation indicate the test could improve the efficiency of diagnosis, especially in chronic lesions with submicroscopic parasite burdens. Field implementation of the RPA-LF test could contribute to management and control of cutaneous and mucosal leishmaniasis.

Indexed as

Point-of-Care SystemsChromatography, AffinityDNA, KinetoplastDNA PrimersDNA, ProtozoanHumansLeishmaniaLeishmaniasis, CutaneousMolecular Diagnostic TechniquesNucleic Acid Amplification TechniquesOligonucleotide ProbesSensitivity and SpecificityDNA, KinetoplastDNA PrimersDNA, ProtozoanOligonucleotide Probes

Identifiers

PMID27115155
PMCPMC4845993
OpenAlexW2343014459

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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.