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
Because 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...
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| Published in | PLoS neglected tropical diseases Vol. 13; no. 8; p. e0007446 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Public Library of Science
01.08.2019
Public Library of Science (PLoS) |
| Subjects | |
| Online Access | Get full text |
| ISSN | 1935-2735 1935-2727 1935-2735 |
| DOI | 10.1371/journal.pntd.0007446 |
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| Abstract | Because 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).
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.
All 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.
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.
ClinicalTrials.gov NCT03465488. |
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| AbstractList | Background
Because 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 findings
All 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 registration
ClinicalTrials.gov NCT03465488 Background Because 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 findings All 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 registration ClinicalTrials.gov NCT03465488 To control the burden caused by intestinal worms, the World Health Organization recommends large-scale deworming programs where anti-worm drugs are administered to at-risk populations. The decision to scale down drug distribution is based on the periodically assessment of prevalence and intensity of infections using a standard diagnostic method. Today, the scientific community strongly doubts whether this method can be used throughout the program. This is in particular when it fails to detect infections of low intensity, and hence may result in prematurely stopping the distribution of drugs. We compared the diagnostic performance of alternative diagnostic methods in three drug efficacy trials in two African and one Asian country. The diagnostic methods were based on demonstration of worm eggs or worm DNA in stool. We also checked the results with minimal diagnostic criteria which have been recently been proposed by the scientific community. Our results indicate that of all diagnostic methods based on demonstration of worm eggs, only the current standard method fulfills the diagnostic criteria for planning, monitoring and evaluation phases of deworming program. Furthermore, we showed that DNA-based methods could be considered in the phase that aims to seek confirmation for cessation of the deworming program. Because 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).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).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.METHODOLOGYWe 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.All 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.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.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.CONCLUSIONS/SIGNIFICANCEOur 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.ClinicalTrials.gov NCT03465488.TRIAL REGISTRATIONClinicalTrials.gov NCT03465488. 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).MethodologyWe 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/significanceOur 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. Because 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). 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. All 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. 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. ClinicalTrials.gov NCT03465488. |
| Author | Dana, Daniel Matoso, Leonardo F. Ame, Shaali Maya, Catalina Pinto, Simone A. Thomas, Eurion Corrêa-Oliveira, Rodrigo Cools, Piet Vlaminck, Johnny Verweij, Jaco J. Vercruysse, Jozef Maurelli, Maria P. Rinaldi, Laura Keiser, Jennifer Montresor, Antonio Sayasone, Somphou Mekonnen, Zeleke Mirams, Greg José Antonio, Barrios Perez Albonico, Marco Ayana, Mio Cringoli, Giuseppe Levecke, Bruno |
| AuthorAffiliation | 1 Department of Virology, Parasitology and Immunology, Ghent University, Merelbeke, Belgium 5 Jimma University Institute of Health, Jimma University, Jimma, Ethiopia 13 Lao Tropical and Public Health Institute, Ministry of Health, Vientiane, Lao People’s Democratic Republic Emory University, UNITED STATES 9 University of Basel, Basel, Switzerland 3 Department of Life Sciences and Systems Biology, University of Turin, Italy 7 Department of Veterinary Medicine and Animal Production, University of Naples Federico II, Naples, Italy 11 Department of Control of Neglected Tropical Diseases, World Health Organization, Geneva, Switzerland 8 Department of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, Basel, Switzerland 6 Engineering Institute of National Autonomous University of Mexico, Mexico City, Mexico 14 Techion Group Ltd, Aberystwyth, United Kingdom 10 Laboratory of Molecular and Cellular Immunology, Research Center René Rachou—FIOCRUZ, Belo Horizonte, Brazil |
| AuthorAffiliation_xml | – name: 5 Jimma University Institute of Health, Jimma University, Jimma, Ethiopia – name: 11 Department of Control of Neglected Tropical Diseases, World Health Organization, Geneva, Switzerland – name: 8 Department of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, Basel, Switzerland – name: 13 Lao Tropical and Public Health Institute, Ministry of Health, Vientiane, Lao People’s Democratic Republic – name: 9 University of Basel, Basel, Switzerland – name: 2 Center for Tropical Diseases, Sacro Cuore Don Calabria Hospital, Negrar, Italy – name: 12 Techion Group Ltd, Dunedin, New Zealand – name: 4 Public Health Laboratory-Ivo de Carneri, Chake Chake, United Republic of Tanzania – name: 7 Department of Veterinary Medicine and Animal Production, University of Naples Federico II, Naples, Italy – name: Emory University, UNITED STATES – name: 3 Department of Life Sciences and Systems Biology, University of Turin, Italy – name: 14 Techion Group Ltd, Aberystwyth, United Kingdom – name: 6 Engineering Institute of National Autonomous University of Mexico, Mexico City, Mexico – name: 10 Laboratory of Molecular and Cellular Immunology, Research Center René Rachou—FIOCRUZ, Belo Horizonte, Brazil – name: 1 Department of Virology, Parasitology and Immunology, Ghent University, Merelbeke, Belgium – name: 15 Laboratory for Medical Microbiology and Immunology, Elisabeth-Tweesteden Hospital, Tilburg, The Netherlands |
| Author_xml | – sequence: 1 givenname: Piet orcidid: 0000-0003-2980-5307 surname: Cools fullname: Cools, Piet – sequence: 2 givenname: Johnny orcidid: 0000-0002-3601-9825 surname: Vlaminck fullname: Vlaminck, Johnny – sequence: 3 givenname: Marco surname: Albonico fullname: Albonico, Marco – sequence: 4 givenname: Shaali surname: Ame fullname: Ame, Shaali – sequence: 5 givenname: Mio surname: Ayana fullname: Ayana, Mio – sequence: 6 givenname: Barrios Perez orcidid: 0000-0002-6328-7497 surname: José Antonio fullname: José Antonio, Barrios Perez – sequence: 7 givenname: Giuseppe surname: Cringoli fullname: Cringoli, Giuseppe – sequence: 8 givenname: Daniel surname: Dana fullname: Dana, Daniel – sequence: 9 givenname: Jennifer surname: Keiser fullname: Keiser, Jennifer – sequence: 10 givenname: Maria P. surname: Maurelli fullname: Maurelli, Maria P. – sequence: 11 givenname: Catalina surname: Maya fullname: Maya, Catalina – sequence: 12 givenname: Leonardo F. surname: Matoso fullname: Matoso, Leonardo F. – sequence: 13 givenname: Antonio surname: Montresor fullname: Montresor, Antonio – sequence: 14 givenname: Zeleke surname: Mekonnen fullname: Mekonnen, Zeleke – sequence: 15 givenname: Greg surname: Mirams fullname: Mirams, Greg – sequence: 16 givenname: Rodrigo surname: Corrêa-Oliveira fullname: Corrêa-Oliveira, Rodrigo – sequence: 17 givenname: Simone A. surname: Pinto fullname: Pinto, Simone A. – sequence: 18 givenname: Laura surname: Rinaldi fullname: Rinaldi, Laura – sequence: 19 givenname: Somphou surname: Sayasone fullname: Sayasone, Somphou – sequence: 20 givenname: Eurion surname: Thomas fullname: Thomas, Eurion – sequence: 21 givenname: Jaco J. surname: Verweij fullname: Verweij, Jaco J. – sequence: 22 givenname: Jozef surname: Vercruysse fullname: Vercruysse, Jozef – sequence: 23 givenname: Bruno surname: Levecke fullname: Levecke, Bruno |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/31369558$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Copyright | 2019 Cools et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. 2019 Cools et al 2019 Cools et al |
| Copyright_xml | – notice: 2019 Cools et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. – notice: 2019 Cools et al 2019 Cools et al |
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| DOI | 10.1371/journal.pntd.0007446 |
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| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 ObjectType-Article-2 ObjectType-Feature-1 content type line 23 The FECPAKG2 technology was produced and distributed by Techion Group Ltd, of which ET is an employee and GM is managing director. Both hold stocks in Techion Group Ltd. The Mini-FLOTAC device is a commercial product distributed by GC, LR and MPM through the University of Napoli Federico II. However, the affiliations of ET, GM, GC, LR and MPM did not play any role in the preparation and submission of this manuscript. All other authors declared that they have no competing interests. |
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| Snippet | Because the success of deworming programs targeting soil-transmitted helminths (STHs) is evaluated through the periodically assessment of prevalence and... Background Because the success of deworming programs targeting soil-transmitted helminths (STHs) is evaluated through the periodically assessment of prevalence... To control the burden caused by intestinal worms, the World Health Organization recommends large-scale deworming programs where anti-worm drugs are... BackgroundBecause the success of deworming programs targeting soil-transmitted helminths (STHs) is evaluated through the periodically assessment of prevalence... Background Because the success of deworming programs targeting soil-transmitted helminths (STHs) is evaluated through the periodically assessment of prevalence... |
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| SubjectTerms | Adolescent Animals Biology and Life Sciences Brazil Child Clinical trials Communities Criteria Deoxyribonucleic acid Detection Diagnostic software Diagnostic systems Diagnostic Tests, Routine - instrumentation Diagnostic Tests, Routine - methods DNA Drug efficacy Eggs Ethiopia - epidemiology Feces - parasitology Female Funding Helminthiasis - diagnosis Helminthiasis - epidemiology Helminthiasis - parasitology Helminthiasis - transmission Helminths - genetics Helminths - isolation & purification Humans Immunology Infections Laboratories Laos - epidemiology Male Medicine and Health Sciences Methods Microscopy Molecular Diagnostic Techniques - instrumentation Molecular Diagnostic Techniques - methods Parasite Egg Count - methods Parasitology Prevalence Profiles Public health Real-Time Polymerase Chain Reaction - methods Reproduction (copying) Research and analysis methods Sensitivity Sensitivity and Specificity Software Soil Soil - parasitology Soils Supervision Tanzania - epidemiology Tropical diseases Veterinary medicine Virology World Health Organization |
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| Title | 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 |
| URI | https://www.ncbi.nlm.nih.gov/pubmed/31369558 https://www.proquest.com/docview/2291479791 https://www.proquest.com/docview/2268313691 https://pubmed.ncbi.nlm.nih.gov/PMC6675048 https://doaj.org/article/3e919f760a36453d968ed82d58ecfb49 http://dx.doi.org/10.1371/journal.pntd.0007446 |
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