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dc.contributor.authorBachmann, Till T.
dc.contributor.authorMitsakakis, Konstantinos
dc.contributor.authorHays, John P.
dc.contributor.authorvan Belkum, Alex
dc.contributor.authorRussom, Aman
dc.contributor.authorLuedke, Gerd
dc.contributor.authorSimonsen, Gunnar Skov
dc.contributor.authorAbel, Gyorgy
dc.contributor.authorPeter, Harald
dc.contributor.authorGoossens, Herman
dc.contributor.authorMoran-Gilad, Jacob
dc.contributor.authorVila, Jordi
dc.contributor.authorBecker, Karsten
dc.contributor.authorMoons, Pieter
dc.contributor.authorSampath, Rangarajan
dc.contributor.authorPeeling, Rosanna W.
dc.contributor.authorLuz, Saturnino
dc.contributor.authorvan Staa, Tjeerd
dc.contributor.authorDi Gregori, Valentina
dc.date.accessioned2024-01-25T09:19:14Z
dc.date.available2024-01-25T09:19:14Z
dc.date.issued2023-12-18
dc.description.abstractDiagnostics are widely considered crucial in the fight against antimicrobial resistance (AMR), which is expected to kill 10 million people annually by 2030. Nevertheless, there remains a substantial gap between the need for AMR diagnostics versus their development and implementation. To help address this problem, target product profiles (TPP) have been developed to focus developers’ attention on the key aspects of AMR diagnostic tests. However, during discussion between a multisectoral working group of 51 international experts from industry, academia and healthcare, it was noted that specific AMR-related TPPs could be extended by incorporating the interdependencies between the key characteristics associated with the development of such TPPs. Subsequently, the working group identified 46 characteristics associated with six main categories (ie, Intended Use, Diagnostic Question, Test Description, Assay Protocol, Performance and Commercial). The interdependencies of these characteristics were then identified and mapped against each other to generate new insights for use by stakeholders. Specifically, it may not be possible for diagnostics developers to achieve all of the recommendations in every category of a TPP and this publication indicates how prioritising specific TPP characteristics during diagnostics development may influence (or not) a range of other TPP characteristics associated with the diagnostic. The use of such guidance, in conjunction with specific TPPs, could lead to more efficient AMR diagnostics development.en_US
dc.identifier.citationBachmann, Mitsakakis, Hays, van Belkum, Russom, Luedke, Simonsen, Abel, Peter, Goossens, Moran-Gilad, Vila, Becker, Moons, Sampath, Peeling, Luz, van Staa, Di Gregori. Expert guidance on target product profile development for AMR diagnostic tests. BMJ Global Health. 2023;8(12)en_US
dc.identifier.cristinIDFRIDAID 2230322
dc.identifier.doi10.1136/bmjgh-2023-012319
dc.identifier.issn2059-7908
dc.identifier.urihttps://hdl.handle.net/10037/32729
dc.language.isoengen_US
dc.publisherBMJ Publishing Groupen_US
dc.relation.journalBMJ Global Health
dc.rights.accessRightsopenAccessen_US
dc.rights.holderCopyright 2023 The Author(s)en_US
dc.rights.urihttps://creativecommons.org/licenses/by-nc/4.0en_US
dc.rightsAttribution-NonCommercial 4.0 International (CC BY-NC 4.0)en_US
dc.titleExpert guidance on target product profile development for AMR diagnostic testsen_US
dc.type.versionpublishedVersionen_US
dc.typeJournal articleen_US
dc.typeTidsskriftartikkelen_US
dc.typePeer revieweden_US


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Attribution-NonCommercial 4.0 International (CC BY-NC 4.0)
Except where otherwise noted, this item's license is described as Attribution-NonCommercial 4.0 International (CC BY-NC 4.0)