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Implementing OECD GLP principles for the evaluation of novel vector control tools: a case study with two novel LLINs, SafeNet(®) and SafeNet NF(®)

BACKGROUND: To sustain high universal Long-Lasting Insecticidal Nets (LLINs) coverage, affordable nets that provide equivalent or better protection than standard LLINs, are required. Test facilities evaluating new LLINs require compliance to Good Laboratory Practice (GLP) standards to ensure the qua...

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Autores principales: Azizi, Salum, Snetselaar, Janneke, Kaaya, Robert, Matowo, Johnson, Onen, Hudson, Shayo, Magreth, Kisengwa, Ezekia, Tilya, Evod, Manunda, Baltazari, Mawa, Benson, Mosha, Franklin, Kirby, Matthew
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9188019/
https://www.ncbi.nlm.nih.gov/pubmed/35690824
http://dx.doi.org/10.1186/s12936-022-04208-4
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author Azizi, Salum
Snetselaar, Janneke
Kaaya, Robert
Matowo, Johnson
Onen, Hudson
Shayo, Magreth
Kisengwa, Ezekia
Tilya, Evod
Manunda, Baltazari
Mawa, Benson
Mosha, Franklin
Kirby, Matthew
author_facet Azizi, Salum
Snetselaar, Janneke
Kaaya, Robert
Matowo, Johnson
Onen, Hudson
Shayo, Magreth
Kisengwa, Ezekia
Tilya, Evod
Manunda, Baltazari
Mawa, Benson
Mosha, Franklin
Kirby, Matthew
author_sort Azizi, Salum
collection PubMed
description BACKGROUND: To sustain high universal Long-Lasting Insecticidal Nets (LLINs) coverage, affordable nets that provide equivalent or better protection than standard LLINs, are required. Test facilities evaluating new LLINs require compliance to Good Laboratory Practice (GLP) standards to ensure the quality and integrity of test data. Following GLP principles allows for the reconstruction of activities during the conduct of a study and minimizes duplication of efficacy testing. This case study evaluated the efficacy of two LLINs: SafeNet NF(®) and SafeNet(®) LLIN. METHODS: The study was conducted according to GLP principles and followed World Health Organization guidelines for evaluating LLINs. The LLINs were assessed in experimental huts against wild, pyrethroid-resistant Anopheles arabiensis mosquitoes. Nets were either unwashed or washed 20 times and artificially holed to simulate a used torn net. Blood-feeding inhibition and mortality were compared with a positive control (Interceptor(®) LLIN) and an untreated net. RESULTS: Mosquito entry in the huts was reduced compared to negative control for the unwashed SafeNet NF, washed Safenet LLIN and the positive control arms. Similar exiting rates were found for all the treatment arms. Significant blood-feeding inhibition was only found for the positive control, both when washed and unwashed. All insecticide treatments induced significantly higher mortality compared to an untreated net. Compared to the positive control, the washed and unwashed SafeNet NF(®) resulted in similar mortality. For the SafeNet(®) LLINs the unwashed net had an equivalent performance, but the mortality for the washed net was significantly lower than the positive control. Internal audits of the study confirmed that all critical phases complied with Standard Operating Procedures (SOPs) and the study plan. The external audit confirmed that the study complied with GLP standards. CONCLUSIONS: SafeNet NF(®) and SafeNet(®) LLIN offered equivalent protection to the positive control (Interceptor(®) LLIN). However, further research is needed to investigate the durability, acceptability, and residual efficacy of these nets in the community. This study demonstrated that GLP-compliant evaluation of LLINs can be successfully conducted by African research institutions. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12936-022-04208-4.
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spelling pubmed-91880192022-06-12 Implementing OECD GLP principles for the evaluation of novel vector control tools: a case study with two novel LLINs, SafeNet(®) and SafeNet NF(®) Azizi, Salum Snetselaar, Janneke Kaaya, Robert Matowo, Johnson Onen, Hudson Shayo, Magreth Kisengwa, Ezekia Tilya, Evod Manunda, Baltazari Mawa, Benson Mosha, Franklin Kirby, Matthew Malar J Research BACKGROUND: To sustain high universal Long-Lasting Insecticidal Nets (LLINs) coverage, affordable nets that provide equivalent or better protection than standard LLINs, are required. Test facilities evaluating new LLINs require compliance to Good Laboratory Practice (GLP) standards to ensure the quality and integrity of test data. Following GLP principles allows for the reconstruction of activities during the conduct of a study and minimizes duplication of efficacy testing. This case study evaluated the efficacy of two LLINs: SafeNet NF(®) and SafeNet(®) LLIN. METHODS: The study was conducted according to GLP principles and followed World Health Organization guidelines for evaluating LLINs. The LLINs were assessed in experimental huts against wild, pyrethroid-resistant Anopheles arabiensis mosquitoes. Nets were either unwashed or washed 20 times and artificially holed to simulate a used torn net. Blood-feeding inhibition and mortality were compared with a positive control (Interceptor(®) LLIN) and an untreated net. RESULTS: Mosquito entry in the huts was reduced compared to negative control for the unwashed SafeNet NF, washed Safenet LLIN and the positive control arms. Similar exiting rates were found for all the treatment arms. Significant blood-feeding inhibition was only found for the positive control, both when washed and unwashed. All insecticide treatments induced significantly higher mortality compared to an untreated net. Compared to the positive control, the washed and unwashed SafeNet NF(®) resulted in similar mortality. For the SafeNet(®) LLINs the unwashed net had an equivalent performance, but the mortality for the washed net was significantly lower than the positive control. Internal audits of the study confirmed that all critical phases complied with Standard Operating Procedures (SOPs) and the study plan. The external audit confirmed that the study complied with GLP standards. CONCLUSIONS: SafeNet NF(®) and SafeNet(®) LLIN offered equivalent protection to the positive control (Interceptor(®) LLIN). However, further research is needed to investigate the durability, acceptability, and residual efficacy of these nets in the community. This study demonstrated that GLP-compliant evaluation of LLINs can be successfully conducted by African research institutions. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12936-022-04208-4. BioMed Central 2022-06-11 /pmc/articles/PMC9188019/ /pubmed/35690824 http://dx.doi.org/10.1186/s12936-022-04208-4 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis 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 Research
Azizi, Salum
Snetselaar, Janneke
Kaaya, Robert
Matowo, Johnson
Onen, Hudson
Shayo, Magreth
Kisengwa, Ezekia
Tilya, Evod
Manunda, Baltazari
Mawa, Benson
Mosha, Franklin
Kirby, Matthew
Implementing OECD GLP principles for the evaluation of novel vector control tools: a case study with two novel LLINs, SafeNet(®) and SafeNet NF(®)
title Implementing OECD GLP principles for the evaluation of novel vector control tools: a case study with two novel LLINs, SafeNet(®) and SafeNet NF(®)
title_full Implementing OECD GLP principles for the evaluation of novel vector control tools: a case study with two novel LLINs, SafeNet(®) and SafeNet NF(®)
title_fullStr Implementing OECD GLP principles for the evaluation of novel vector control tools: a case study with two novel LLINs, SafeNet(®) and SafeNet NF(®)
title_full_unstemmed Implementing OECD GLP principles for the evaluation of novel vector control tools: a case study with two novel LLINs, SafeNet(®) and SafeNet NF(®)
title_short Implementing OECD GLP principles for the evaluation of novel vector control tools: a case study with two novel LLINs, SafeNet(®) and SafeNet NF(®)
title_sort implementing oecd glp principles for the evaluation of novel vector control tools: a case study with two novel llins, safenet(®) and safenet nf(®)
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9188019/
https://www.ncbi.nlm.nih.gov/pubmed/35690824
http://dx.doi.org/10.1186/s12936-022-04208-4
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