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Sökning: id:"swepub:oai:DiVA.org:kth-342375" > Expert guidance on ...

  • Bachmann, Till T.Center for Inflammation Research, University of Edinburgh, Edinburgh, UK (författare)

Expert guidance on target product profile development for AMR diagnostic tests

  • Artikel/kapitelEngelska2023

Förlag, utgivningsår, omfång ...

  • BMJ Publishing Group,2023
  • printrdacarrier

Nummerbeteckningar

  • LIBRIS-ID:oai:DiVA.org:kth-342375
  • https://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-342375URI
  • https://doi.org/10.1136/bmjgh-2023-012319DOI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

Ingår i deldatabas

Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • QC 20240118
  • 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 och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Mitsakakis, KonstantinosLaboratory for MEMS Applications, IMTEK-Department of Microsystems Engineering, University of Freiburg, Freiburg, Germany; Hahn-Schickard, Freiburg, Germany (författare)
  • Hays, John P.Department of Medical Microbiology & Infectious Diseases, Erasmus University Medical Centre (Erasmus MC), Rotterdam, Netherlands (författare)
  • van Belkum, AlexBioMérieux Open Innovation & Partnerships, La Balme Les Grottes, France (författare)
  • Russom, Aman,Prof.1976-KTH,Nanobioteknologi,Division of Nanobiotechnology, KTH Royal Institute of Technology, Stockholm, Sweden(Swepub:kth)u1go6jxm (författare)
  • Luedke, GerdCuretis GmbH, Holzgerlingen, Germany (författare)
  • Simonsen, Gunnar SkovDepartment of Microbiology and Infection Control, University Hospital of North Norway, Tromsø, Norway; Faculty of Health Sciences, UiT - The Arctic University of Norway, Tromsø, Norway (författare)
  • Abel, GyorgyDivision of Pathology and Laboratory Medicine, Lahey Hospital & Medical Center, Burlington, Massachusetts, USA; Department of Pathology, Harvard Medical School, Boston, Massachusetts, USA (författare)
  • Peter, HaraldBranch Bioanalytics and Bioprocesses, Fraunhofer Institute for Cell Therapy and Immunology, Potsdam, Germany, Branch Bioanalytics and Bioprocesses (författare)
  • Goossens, HermanVaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp, Antwerp, Belgium; Department of Medical Microbiology, Antwerp University Hospital, Antwerp, Belgium (författare)
  • Moran-Gilad, JacobDepartment of Health Policy and Management, School of Public Health, Ben-Gurion University of the Negev, Beer-Sheva, Israel (författare)
  • Vila, JordiDepartment of Clinical Microbiology, Biomedical Diagnostic Centre (CDB), Hospital Clínic, School of Medicine, University of Barcelona, Barcelona, Spain (författare)
  • Becker, KarstenUniversity Hospital Münster, Münster, Germany (författare)
  • Moons, PieterVaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp, Antwerp, Belgium; Department of Medical Microbiology, Antwerp University Hospital, Antwerp, Belgium (författare)
  • Sampath, RangarajanFoundation for Innovative New Diagnostics (FIND), Geneva, Switzerland (författare)
  • Peeling, Rosanna W.Department of Clinical Research, London School of Hygiene and Tropical Medicine Faculty of Infectious and Tropical Diseases, London, UK (författare)
  • Luz, SaturninoUsher Institute, University of Edinburgh, Edinburgh, UK (författare)
  • van Staa, TjeerdHealth eResearch Centre, Farr Institute for Health Informatics Research, University of Manchester, Manchester, UK (författare)
  • Di Gregori, ValentinaSan Pier Damiano Hospital GVM Care and Research, Ravenna, Italy (författare)
  • Center for Inflammation Research, University of Edinburgh, Edinburgh, UKLaboratory for MEMS Applications, IMTEK-Department of Microsystems Engineering, University of Freiburg, Freiburg, Germany; Hahn-Schickard, Freiburg, Germany (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:BMJ Global Health: BMJ Publishing Group8:122059-7908

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