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Target product profile: Trypanosoma brucei gambiense test for low-prevalence settings
Having caused devastating epidemics during the 20th century, the incidence of life-threatening human African trypanosomiasis has fallen to historically low levels as a result of sustained and coordinated efforts over the past 20 years. Humans are the main reservoir of one of the two pathogenic trypa...
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
World Health Organization
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10388146/ https://www.ncbi.nlm.nih.gov/pubmed/37529025 http://dx.doi.org/10.2471/BLT.23.290176 |
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author | Priotto, Gerardo Franco, Jose R Lejon, Veerle Büscher, Philippe Matovu, Enock Ndung'u, Joseph Biéler, Sylvain Mumba, Dieudonné Van Reet, Nick Verlé, Paul Jamonneau, Vincent Simarro, Pere P Ebeja, Augustin Kadima Sankara, Dieudonné Dagne, Daniel Argaw |
author_facet | Priotto, Gerardo Franco, Jose R Lejon, Veerle Büscher, Philippe Matovu, Enock Ndung'u, Joseph Biéler, Sylvain Mumba, Dieudonné Van Reet, Nick Verlé, Paul Jamonneau, Vincent Simarro, Pere P Ebeja, Augustin Kadima Sankara, Dieudonné Dagne, Daniel Argaw |
author_sort | Priotto, Gerardo |
collection | PubMed |
description | Having caused devastating epidemics during the 20th century, the incidence of life-threatening human African trypanosomiasis has fallen to historically low levels as a result of sustained and coordinated efforts over the past 20 years. Humans are the main reservoir of one of the two pathogenic trypanosome subspecies, Trypanosoma brucei gambiense, found in western and central Africa. The expected advent of a safe and easy-to-use treatment to be given to seropositive but microscopically unconfirmed individuals would lead to further depletion; in the meantime, the presence of T. b. gambiense infection in the community must be monitored to allow the control strategy to be adapted and the elimination status to be assessed. The World Health Organization has therefore developed a target product profile that describes the optimal and minimal characteristics of an individual laboratory-based test to assess T. b. gambiense infection in low-prevalence settings. Development of the target product profile involved the formation of a Neglected Tropical Diseases Diagnostics Technical Advisory Group and a subgroup on human African trypanosomiasis diagnostic innovation needs, and an analysis of the available products and development pipeline. According to the product profile, the test should ideally: (i) require a minimally invasive or non-invasive specimen, collectable at peripheral facilities by minimally trained health workers; (ii) demonstrate good sensitivity and high specificity; (iii) have a stability of samples allowing transfer to reference laboratories preferably without cold chain; (iv) be stable over a wide range of environmental conditions for more than 2 years; and (v) after marketing, be available at low cost for at least 7 years. |
format | Online Article Text |
id | pubmed-10388146 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | World Health Organization |
record_format | MEDLINE/PubMed |
spelling | pubmed-103881462023-08-01 Target product profile: Trypanosoma brucei gambiense test for low-prevalence settings Priotto, Gerardo Franco, Jose R Lejon, Veerle Büscher, Philippe Matovu, Enock Ndung'u, Joseph Biéler, Sylvain Mumba, Dieudonné Van Reet, Nick Verlé, Paul Jamonneau, Vincent Simarro, Pere P Ebeja, Augustin Kadima Sankara, Dieudonné Dagne, Daniel Argaw Bull World Health Organ Policy & Practice Having caused devastating epidemics during the 20th century, the incidence of life-threatening human African trypanosomiasis has fallen to historically low levels as a result of sustained and coordinated efforts over the past 20 years. Humans are the main reservoir of one of the two pathogenic trypanosome subspecies, Trypanosoma brucei gambiense, found in western and central Africa. The expected advent of a safe and easy-to-use treatment to be given to seropositive but microscopically unconfirmed individuals would lead to further depletion; in the meantime, the presence of T. b. gambiense infection in the community must be monitored to allow the control strategy to be adapted and the elimination status to be assessed. The World Health Organization has therefore developed a target product profile that describes the optimal and minimal characteristics of an individual laboratory-based test to assess T. b. gambiense infection in low-prevalence settings. Development of the target product profile involved the formation of a Neglected Tropical Diseases Diagnostics Technical Advisory Group and a subgroup on human African trypanosomiasis diagnostic innovation needs, and an analysis of the available products and development pipeline. According to the product profile, the test should ideally: (i) require a minimally invasive or non-invasive specimen, collectable at peripheral facilities by minimally trained health workers; (ii) demonstrate good sensitivity and high specificity; (iii) have a stability of samples allowing transfer to reference laboratories preferably without cold chain; (iv) be stable over a wide range of environmental conditions for more than 2 years; and (v) after marketing, be available at low cost for at least 7 years. World Health Organization 2023-08-01 2023-06-26 /pmc/articles/PMC10388146/ /pubmed/37529025 http://dx.doi.org/10.2471/BLT.23.290176 Text en (c) 2023 The authors; licensee World Health Organization. https://creativecommons.org/licenses/by/3.0/igo/This is an open access article distributed under the terms of the Creative Commons Attribution IGO License (http://creativecommons.org/licenses/by/3.0/igo/legalcode (https://creativecommons.org/licenses/by/3.0/igo/) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. In any reproduction of this article there should not be any suggestion that WHO or this article endorse any specific organization or products. The use of the WHO logo is not permitted. This notice should be preserved along with the article's original URL. |
spellingShingle | Policy & Practice Priotto, Gerardo Franco, Jose R Lejon, Veerle Büscher, Philippe Matovu, Enock Ndung'u, Joseph Biéler, Sylvain Mumba, Dieudonné Van Reet, Nick Verlé, Paul Jamonneau, Vincent Simarro, Pere P Ebeja, Augustin Kadima Sankara, Dieudonné Dagne, Daniel Argaw Target product profile: Trypanosoma brucei gambiense test for low-prevalence settings |
title | Target product profile: Trypanosoma brucei gambiense test for low-prevalence settings |
title_full | Target product profile: Trypanosoma brucei gambiense test for low-prevalence settings |
title_fullStr | Target product profile: Trypanosoma brucei gambiense test for low-prevalence settings |
title_full_unstemmed | Target product profile: Trypanosoma brucei gambiense test for low-prevalence settings |
title_short | Target product profile: Trypanosoma brucei gambiense test for low-prevalence settings |
title_sort | target product profile: trypanosoma brucei gambiense test for low-prevalence settings |
topic | Policy & Practice |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10388146/ https://www.ncbi.nlm.nih.gov/pubmed/37529025 http://dx.doi.org/10.2471/BLT.23.290176 |
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