A unified framework for diagnostic test development and evaluation during outbreaks of emerging infections

Abstract Evaluating diagnostic test accuracy during epidemics is difficult due to an urgent need for test availability, changing disease prevalence and pathogen characteristics, and constantly evolving testing aims and applications. Based on lessons learned during the SARS-CoV-2 pandemic, we introdu...

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Main Authors: Madhav Chaturvedi, Denise Köster, Patrick M. Bossuyt, Oke Gerke, Annette Jurke, Mirjam E. Kretzschmar, Marc Lütgehetmann, Rafael Mikolajczyk, Johannes B. Reitsma, Nicole Schneiderhan-Marra, Uwe Siebert, Carina Stekly, Christoph Ehret, Nicole Rübsamen, André Karch, Antonia Zapf
Format: Article
Language:English
Published: Nature Portfolio 2024-12-01
Series:Communications Medicine
Online Access:https://doi.org/10.1038/s43856-024-00691-9
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author Madhav Chaturvedi
Denise Köster
Patrick M. Bossuyt
Oke Gerke
Annette Jurke
Mirjam E. Kretzschmar
Marc Lütgehetmann
Rafael Mikolajczyk
Johannes B. Reitsma
Nicole Schneiderhan-Marra
Uwe Siebert
Carina Stekly
Christoph Ehret
Nicole Rübsamen
André Karch
Antonia Zapf
author_facet Madhav Chaturvedi
Denise Köster
Patrick M. Bossuyt
Oke Gerke
Annette Jurke
Mirjam E. Kretzschmar
Marc Lütgehetmann
Rafael Mikolajczyk
Johannes B. Reitsma
Nicole Schneiderhan-Marra
Uwe Siebert
Carina Stekly
Christoph Ehret
Nicole Rübsamen
André Karch
Antonia Zapf
author_sort Madhav Chaturvedi
collection DOAJ
description Abstract Evaluating diagnostic test accuracy during epidemics is difficult due to an urgent need for test availability, changing disease prevalence and pathogen characteristics, and constantly evolving testing aims and applications. Based on lessons learned during the SARS-CoV-2 pandemic, we introduce a framework for rapid diagnostic test development, evaluation, and validation during outbreaks of emerging infections. The framework is based on the feedback loop between test accuracy evaluation, modelling studies for public health decision-making, and impact of public health interventions. We suggest that building on this feedback loop can help future diagnostic test evaluation platforms better address the requirements of both patient care and public health.
format Article
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institution OA Journals
issn 2730-664X
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publisher Nature Portfolio
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series Communications Medicine
spelling doaj-art-c33065e9d5364447bf9184d64bc077da2025-08-20T02:35:46ZengNature PortfolioCommunications Medicine2730-664X2024-12-014111110.1038/s43856-024-00691-9A unified framework for diagnostic test development and evaluation during outbreaks of emerging infectionsMadhav Chaturvedi0Denise Köster1Patrick M. Bossuyt2Oke Gerke3Annette Jurke4Mirjam E. Kretzschmar5Marc Lütgehetmann6Rafael Mikolajczyk7Johannes B. Reitsma8Nicole Schneiderhan-Marra9Uwe Siebert10Carina Stekly11Christoph Ehret12Nicole Rübsamen13André Karch14Antonia Zapf15Institute of Epidemiology and Social Medicine, University of MünsterInstitute of Medical Biometry and Epidemiology, University Medical Center Hamburg-EppendorfAmsterdam University Medical Centers, University of Amsterdam, Epidemiology and Data ScienceDepartment of Clinical Research, University of Southern DenmarkDepartment of Infectious Disease Epidemiology, NRW Centre for HealthJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht UniversityInstitute of Medical Microbiology, Virology and Hygiene, University Medical Center Hamburg-EppendorfInstitute for Medical Epidemiology, Biometrics and Informatics, Interdisciplinary Center for Health Sciences, Medical Faculty of the Martin Luther University Halle-WittenbergJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht UniversityNMI Natural and Medical Sciences Institute at the University of TübingenDepartment of Public Health, Health Services Research and Health Technology Assessment, Institute of Public Health, Medical Decision Making and Health Technology Assessment, UMIT- University for Health Sciences, Medical Informatics and TechnologyRoche Diagnostics GmbHRoche Diagnostics GmbHInstitute of Epidemiology and Social Medicine, University of MünsterInstitute of Epidemiology and Social Medicine, University of MünsterInstitute of Medical Biometry and Epidemiology, University Medical Center Hamburg-EppendorfAbstract Evaluating diagnostic test accuracy during epidemics is difficult due to an urgent need for test availability, changing disease prevalence and pathogen characteristics, and constantly evolving testing aims and applications. Based on lessons learned during the SARS-CoV-2 pandemic, we introduce a framework for rapid diagnostic test development, evaluation, and validation during outbreaks of emerging infections. The framework is based on the feedback loop between test accuracy evaluation, modelling studies for public health decision-making, and impact of public health interventions. We suggest that building on this feedback loop can help future diagnostic test evaluation platforms better address the requirements of both patient care and public health.https://doi.org/10.1038/s43856-024-00691-9
spellingShingle Madhav Chaturvedi
Denise Köster
Patrick M. Bossuyt
Oke Gerke
Annette Jurke
Mirjam E. Kretzschmar
Marc Lütgehetmann
Rafael Mikolajczyk
Johannes B. Reitsma
Nicole Schneiderhan-Marra
Uwe Siebert
Carina Stekly
Christoph Ehret
Nicole Rübsamen
André Karch
Antonia Zapf
A unified framework for diagnostic test development and evaluation during outbreaks of emerging infections
Communications Medicine
title A unified framework for diagnostic test development and evaluation during outbreaks of emerging infections
title_full A unified framework for diagnostic test development and evaluation during outbreaks of emerging infections
title_fullStr A unified framework for diagnostic test development and evaluation during outbreaks of emerging infections
title_full_unstemmed A unified framework for diagnostic test development and evaluation during outbreaks of emerging infections
title_short A unified framework for diagnostic test development and evaluation during outbreaks of emerging infections
title_sort unified framework for diagnostic test development and evaluation during outbreaks of emerging infections
url https://doi.org/10.1038/s43856-024-00691-9
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