Evidence map›Paper›PMID 38114235›Full record

ArticleBMJ global health2023

Expert guidance on target product profile development for AMR diagnostic tests.

Till T Bachmann, Konstantinos Mitsakakis, John P Hays, Alex van Belkum, Aman Russom, Gerd Luedke, Gunnar Skov Simonsen, Gyorgy Abel, Harald Peter, Herman Goossens and 10 more

Abstract read
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Article in BMJ global health, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Point of care antimicrobial susceptibility testing.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2026
    Review
  2. Review
  3. Rapid diagnosis of urinary tract infection with miniaturised point-of-care cultivation on a dipstick.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2025
    Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Till T BachmannCenter for Inflammation Research, University of Edinburgh, Edinburgh, UK till.bachmann@ed.ac.uk.ORCID 0000-0001-6121-2021
Konstantinos MitsakakisLaboratory for MEMS Applications, IMTEK-Department of Microsystems Engineering, University of Freiburg, Freiburg, Germany.
John P HaysDepartment of Medical Microbiology & Infectious Diseases, Erasmus University Medical Centre (Erasmus MC), Rotterdam, Netherlands.ORCID 0000-0001-9183-4497
Alex van BelkumBioMérieux Open Innovation & Partnerships, La Balme Les Grottes, France.
Aman RussomDivision of Nanobiotechnology, KTH Royal Institute of Technology, Stockholm, Sweden.
Gerd LuedkeCuretis GmbH, Holzgerlingen, Germany.
Gunnar Skov SimonsenDepartment of Microbiology and Infection Control, University Hospital of North Norway, Tromsø, Norway.
Gyorgy AbelDivision of Pathology and Laboratory Medicine, Lahey Hospital & Medical Center, Burlington, Massachusetts, USA.
Harald PeterBranch Bioanalytics and Bioprocesses, Fraunhofer Institute for Cell Therapy and Immunology, Potsdam, Germany.ORCID 0000-0002-3956-6373
Herman GoossensVaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp, Antwerp, Belgium.
Jacob Moran-GiladDepartment of Health Policy and Management, School of Public Health, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
Jordi VilaDepartment of Clinical Microbiology, Biomedical Diagnostic Centre (CDB), Hospital Clínic, School of Medicine, University of Barcelona, Barcelona, Spain.ORCID 0000-0002-8025-3926
Karsten BeckerUniversity Hospital Münster, Münster, Germany.ORCID 0000-0002-6391-1341
Pieter MoonsVaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp, Antwerp, Belgium.
Rangarajan SampathFoundation for Innovative New Diagnostics (FIND), Geneva, Switzerland.
Rosanna W PeelingDepartment of Clinical Research, London School of Hygiene and Tropical Medicine Faculty of Infectious and Tropical Diseases, London, UK.
Saturnino LuzUsher Institute, University of Edinburgh, Edinburgh, UK.ORCID 0000-0001-8430-7875
Tjeerd van StaaHealth eResearch Centre, Farr Institute for Health Informatics Research, University of Manchester, Manchester, UK.
Valentina Di GregoriSan Pier Damiano Hospital GVM Care and Research, Ravenna, Italy.
JPIAMR AMR-RDT Working Group

Funding

Medical Research Council MR/P026222/1
6 · The paper itself

Abstract

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.

Indexed as

Diagnostic Tests, RoutineDrug Resistance, MicrobialHumansdiagnostics and toolsinfections, diseases, disorders, injuriespublic health

Identifiers

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.