Evidence map›Paper›PMID 31369558›Full record

Trial reportPLoS neglected tropical diseases2019

Diagnostic performance of a single and duplicate Kato-Katz, Mini-FLOTAC, FECPAKG2 and qPCR for the detection and quantification of soil-transmitted helminths in three endemic countries.

Piet Cools, Johnny Vlaminck, Marco Albonico, Shaali Ame, Mio Ayana, Barrios Perez José Antonio, Giuseppe Cringoli, Daniel Dana, Jennifer Keiser, Maria P Maurelli and 13 more

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in PLoS neglected tropical diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03465488 (Validation of Both Automated Quality Assured Egg Counting System and Molecular Markers for Monitoring the Spread of Anthelmintic Resistance.), which is not on this map. Cited by 69 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
69citing papers in PubMed, 2 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.

NCT03465488 nacompletednot on this map

Validation of Both Automated Quality Assured Egg Counting System and Molecular Markers for Monitoring the Spread of Anthelmintic Resistance.

TypeinterventionalSponsorUniversity GhentRan2016 to 2019Enrolled1,000ConditionsSoil-transmitted Helminth InfectionsArmsAlbendazole Pill 400mg (GSK)
3 · Its place in the literature

Who cites it

69 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Anthelmintic drugs for treating ascariasis.The Cochrane database of systematic reviews · 2020
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  16. Assessing the diagnostic value of qPCR forFrontiers in parasitology · 2025
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9 more citing papers are in PubMed but not listed here.

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

23 authors.

Piet CoolsDepartment of Virology, Parasitology and Immunology, Ghent University, Merelbeke, Belgium.ORCID 0000-0003-2980-5307
Johnny VlaminckDepartment of Virology, Parasitology and Immunology, Ghent University, Merelbeke, Belgium.ORCID 0000-0002-3601-9825
Marco AlbonicoCenter for Tropical Diseases, Sacro Cuore Don Calabria Hospital, Negrar, Italy.
Shaali AmePublic Health Laboratory-Ivo de Carneri, Chake Chake, United Republic of Tanzania.
Mio AyanaJimma University Institute of Health, Jimma University, Jimma, Ethiopia.
Barrios Perez José AntonioEngineering Institute of National Autonomous University of Mexico, Mexico City, Mexico.ORCID 0000-0002-6328-7497
Giuseppe CringoliDepartment of Veterinary Medicine and Animal Production, University of Naples Federico II, Naples, Italy.
Daniel DanaJimma University Institute of Health, Jimma University, Jimma, Ethiopia.
Jennifer KeiserDepartment of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, Basel, Switzerland.
Maria P MaurelliDepartment of Veterinary Medicine and Animal Production, University of Naples Federico II, Naples, Italy.
Catalina MayaEngineering Institute of National Autonomous University of Mexico, Mexico City, Mexico.
Leonardo F MatosoLaboratory of Molecular and Cellular Immunology, Research Center René Rachou-FIOCRUZ, Belo Horizonte, Brazil.
Antonio MontresorDepartment of Control of Neglected Tropical Diseases, World Health Organization, Geneva, Switzerland.
Zeleke MekonnenJimma University Institute of Health, Jimma University, Jimma, Ethiopia.
Greg MiramsTechion Group Ltd, Dunedin, New Zealand.
Rodrigo Corrêa-OliveiraLaboratory of Molecular and Cellular Immunology, Research Center René Rachou-FIOCRUZ, Belo Horizonte, Brazil.
Simone A PintoLaboratory of Molecular and Cellular Immunology, Research Center René Rachou-FIOCRUZ, Belo Horizonte, Brazil.
Laura RinaldiDepartment of Veterinary Medicine and Animal Production, University of Naples Federico II, Naples, Italy.
Somphou SayasoneLao Tropical and Public Health Institute, Ministry of Health, Vientiane, Lao People's Democratic Republic.
Eurion ThomasTechion Group Ltd, Aberystwyth, United Kingdom.
Jaco J VerweijLaboratory for Medical Microbiology and Immunology, Elisabeth-Tweesteden Hospital, Tilburg, The Netherlands.
Jozef VercruysseDepartment of Virology, Parasitology and Immunology, Ghent University, Merelbeke, Belgium.
Bruno LeveckeDepartment of Virology, Parasitology and Immunology, Ghent University, Merelbeke, Belgium.

Funding

World Health Organization 001
6 · The paper itself

Abstract

backgroundBecause the success of deworming programs targeting soil-transmitted helminths (STHs) is evaluated through the periodically assessment of prevalence and infection intensities, the use of the correct diagnostic method is of utmost importance. The STH community has recently published for each phase of a deworming program the minimal criteria that a potential diagnostic method needs to meet, the so-called target product profiles (TPPs). METHODOLOGY: We compared the diagnostic performance of a single Kato-Katz (reference method) with that of other microscopy-based methods (duplicate Kato-Katz, Mini-FLOTAC and FECPAKG2) and one DNA-based method (qPCR) for the detection and quantification of STH infections in three drug efficacy trials in Ethiopia, Lao PDR, and Tanzania. Furthermore, we evaluated a selection of minimal diagnostic criteria of the TPPs. PRINCIPAL

findingsAll diagnostic methods showed a clinical sensitivity of ≥90% for all STH infections of moderate-to-heavy intensities. For infections of very low intensity, only qPCR resulted in a sensitivity that was superior to a single Kato-Katz for all STHs. Compared to the reference method, both Mini-FLOTAC and FECPAKG2 resulted in significantly lower fecal egg counts for some STHs, leading to a substantial underestimation of the infection intensity. For qPCR, there was a positive significant correlation between the egg counts of a single Kato-Katz and the DNA concentration. CONCLUSIONS/SIGNIFICANCE: Our results indicate that the diagnostic performance of a single Kato-Katz is underestimated by the community and that diagnostic specific thresholds to classify intensity of infection are warranted for Mini-FLOTAC, FECPAKG2 and qPCR. When we strictly apply the TPPs, Kato-Katz is the only microscopy-based method that meets the minimal diagnostic criteria for application in the planning, monitoring and evaluation phase of an STH program. qPCR is the only method that could be considered in the phase that aims to seek confirmation for cessation of program.

trial registrationClinicalTrials.gov NCT03465488.

Indexed as

AdolescentAnimalsBrazilChildDiagnostic Tests, RoutineEthiopiaFecesFemaleHelminthiasisHelminthsHumansLaosMaleMicroscopyMolecular Diagnostic TechniquesParasite Egg CountSoil

Identifiers

PMID31369558
PMCPMC6675048

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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.