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A bioassay method validation framework for laboratory and semi-field tests used to evaluate vector control tools
Vector control interventions play a fundamental role in the control and elimination of vector-borne diseases. The evaluation of vector control products relies on bioassays, laboratory and semi-field tests using live insects to assess the product’s effectiveness. Bioassay method development requires...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10540336/ https://www.ncbi.nlm.nih.gov/pubmed/37770855 http://dx.doi.org/10.1186/s12936-023-04717-w |
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author | Matope, Agnes Lees, Rosemary S. Spiers, Angus Foster, Geraldine M. |
author_facet | Matope, Agnes Lees, Rosemary S. Spiers, Angus Foster, Geraldine M. |
author_sort | Matope, Agnes |
collection | PubMed |
description | Vector control interventions play a fundamental role in the control and elimination of vector-borne diseases. The evaluation of vector control products relies on bioassays, laboratory and semi-field tests using live insects to assess the product’s effectiveness. Bioassay method development requires a rigorous validation process to ensure that relevant methods are used to capture appropriate entomological endpoints which accurately and precisely describe likely efficacy against disease vectors as well as product characteristics within the manufacturing tolerance ranges for insecticide content specified by the World Health Organization. Currently, there are no standardized guidelines for bioassay method validation in vector control. This report presents a framework for bioassay validation that draws on accepted validation processes from the chemical and healthcare fields and which can be applied for evaluating bioassays and semi-field tests in vector control. The validation process has been categorized into four stages: preliminary development; feasibility experiments; internal validation, and external validation. A properly validated method combined with an appropriate experimental design and data analyses that account for both the variability of the method and the product is needed to generate reliable estimates of product efficacy to ensure that at-risk communities have timely access to safe and reliable vector control products. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12936-023-04717-w. |
format | Online Article Text |
id | pubmed-10540336 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-105403362023-09-30 A bioassay method validation framework for laboratory and semi-field tests used to evaluate vector control tools Matope, Agnes Lees, Rosemary S. Spiers, Angus Foster, Geraldine M. Malar J Case Study Vector control interventions play a fundamental role in the control and elimination of vector-borne diseases. The evaluation of vector control products relies on bioassays, laboratory and semi-field tests using live insects to assess the product’s effectiveness. Bioassay method development requires a rigorous validation process to ensure that relevant methods are used to capture appropriate entomological endpoints which accurately and precisely describe likely efficacy against disease vectors as well as product characteristics within the manufacturing tolerance ranges for insecticide content specified by the World Health Organization. Currently, there are no standardized guidelines for bioassay method validation in vector control. This report presents a framework for bioassay validation that draws on accepted validation processes from the chemical and healthcare fields and which can be applied for evaluating bioassays and semi-field tests in vector control. The validation process has been categorized into four stages: preliminary development; feasibility experiments; internal validation, and external validation. A properly validated method combined with an appropriate experimental design and data analyses that account for both the variability of the method and the product is needed to generate reliable estimates of product efficacy to ensure that at-risk communities have timely access to safe and reliable vector control products. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12936-023-04717-w. BioMed Central 2023-09-28 /pmc/articles/PMC10540336/ /pubmed/37770855 http://dx.doi.org/10.1186/s12936-023-04717-w Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Case Study Matope, Agnes Lees, Rosemary S. Spiers, Angus Foster, Geraldine M. A bioassay method validation framework for laboratory and semi-field tests used to evaluate vector control tools |
title | A bioassay method validation framework for laboratory and semi-field tests used to evaluate vector control tools |
title_full | A bioassay method validation framework for laboratory and semi-field tests used to evaluate vector control tools |
title_fullStr | A bioassay method validation framework for laboratory and semi-field tests used to evaluate vector control tools |
title_full_unstemmed | A bioassay method validation framework for laboratory and semi-field tests used to evaluate vector control tools |
title_short | A bioassay method validation framework for laboratory and semi-field tests used to evaluate vector control tools |
title_sort | bioassay method validation framework for laboratory and semi-field tests used to evaluate vector control tools |
topic | Case Study |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10540336/ https://www.ncbi.nlm.nih.gov/pubmed/37770855 http://dx.doi.org/10.1186/s12936-023-04717-w |
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