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Expert guidance on target product profile development for AMR diagnostic tests

Bachmann, Till T. (författare)
Center for Inflammation Research, University of Edinburgh, Edinburgh, UK
Mitsakakis, Konstantinos (författare)
Laboratory for MEMS Applications, IMTEK-Department of Microsystems Engineering, University of Freiburg, Freiburg, Germany; Hahn-Schickard, Freiburg, Germany
Hays, John P. (författare)
Department of Medical Microbiology & Infectious Diseases, Erasmus University Medical Centre (Erasmus MC), Rotterdam, Netherlands
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van Belkum, Alex (författare)
BioMérieux Open Innovation & Partnerships, La Balme Les Grottes, France
Russom, Aman, Prof. 1976- (författare)
KTH,Nanobioteknologi,Division of Nanobiotechnology, KTH Royal Institute of Technology, Stockholm, Sweden
Luedke, Gerd (författare)
Curetis GmbH, Holzgerlingen, Germany
Simonsen, Gunnar Skov (författare)
Department of Microbiology and Infection Control, University Hospital of North Norway, Tromsø, Norway; Faculty of Health Sciences, UiT - The Arctic University of Norway, Tromsø, Norway
Abel, Gyorgy (författare)
Division of Pathology and Laboratory Medicine, Lahey Hospital & Medical Center, Burlington, Massachusetts, USA; Department of Pathology, Harvard Medical School, Boston, Massachusetts, USA
Peter, Harald (författare)
Branch Bioanalytics and Bioprocesses, Fraunhofer Institute for Cell Therapy and Immunology, Potsdam, Germany, Branch Bioanalytics and Bioprocesses
Goossens, Herman (författare)
Vaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp, Antwerp, Belgium; Department of Medical Microbiology, Antwerp University Hospital, Antwerp, Belgium
Moran-Gilad, Jacob (författare)
Department of Health Policy and Management, School of Public Health, Ben-Gurion University of the Negev, Beer-Sheva, Israel
Vila, Jordi (författare)
Department of Clinical Microbiology, Biomedical Diagnostic Centre (CDB), Hospital Clínic, School of Medicine, University of Barcelona, Barcelona, Spain
Becker, Karsten (författare)
University Hospital Münster, Münster, Germany
Moons, Pieter (författare)
Vaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp, Antwerp, Belgium; Department of Medical Microbiology, Antwerp University Hospital, Antwerp, Belgium
Sampath, Rangarajan (författare)
Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland
Peeling, Rosanna W. (författare)
Department of Clinical Research, London School of Hygiene and Tropical Medicine Faculty of Infectious and Tropical Diseases, London, UK
Luz, Saturnino (författare)
Usher Institute, University of Edinburgh, Edinburgh, UK
van Staa, Tjeerd (författare)
Health eResearch Centre, Farr Institute for Health Informatics Research, University of Manchester, Manchester, UK
Di Gregori, Valentina (författare)
San Pier Damiano Hospital GVM Care and Research, Ravenna, Italy
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 (creator_code:org_t)
BMJ Publishing Group, 2023
2023
Engelska.
Ingår i: BMJ Global Health. - : BMJ Publishing Group. - 2059-7908. ; 8:12
Relaterad länk:
https://doi.org/10.1...
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https://urn.kb.se/re...
https://doi.org/10.1...
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  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
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  • 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 (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.

Ämnesord

TEKNIK OCH TEKNOLOGIER  -- Maskinteknik -- Energiteknik (hsv//swe)
ENGINEERING AND TECHNOLOGY  -- Mechanical Engineering -- Energy Engineering (hsv//eng)

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