TY - JOUR
T1 - Expert Guidance on Target Product Profile Development for AMR Diagnostic Tests
AU - Bachmann, Till T
AU - Mitsakakis, Konstantinos
AU - Hays, John P.
AU - van Belkum, Alex
AU - Russom, Aman
AU - Luedke, Gerd
AU - Simonsen, Gunnar Skov
AU - Abel, Gyorgy
AU - Peter, Harald
AU - Goossens, Herman
AU - Moran-Gilad, Jacob
AU - Vila, Jordi
AU - Becker, Karsten
AU - Moons, Pieter
AU - Sampath, Rangarajan
AU - Peeling, Rosanna
AU - Luz, Saturnino
AU - Van Staa, Tjeerd
AU - Di Gregori, Valentina
PY - 2023/12/18
Y1 - 2023/12/18
N2 - Diagnostics 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 (i.e., 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.
AB - Diagnostics 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 (i.e., 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.
KW - Antimicrobial resistance;
KW - Target Product Profile;
KW - Diagnostics;
KW - Microorganisms;
KW - Technological innovation
M3 - Article
SN - 2059-7908
VL - 8
SP - 1
EP - 7
JO - BMJ Global Health
JF - BMJ Global Health
M1 - e012319
ER -