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

Madhav Chaturvedi,Denise Köster,Patrick M M Bossuyt,O. Gerke,Annette Jurke,M. Kretzschmar,Marc Lütgehetmann,R. Mikolajczyk,J. Reitsma,N. Schneiderhan-Marra,Uwe Siebert,Carina Stekly,Christoph Ehret,N. Rübsamen,A. Karch,A. Zapf

Published 2024 in Communications Medicine

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. Chaturvedi, Köster et al. discuss challenges faced by studies evaluating tests for emerging infectious agents. They propose a unified framework for test development, evaluation, and validation based on the feedback loop between test accuracy evaluation, use of accuracy estimates in modelling studies, and interventions based on modelling results.

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