Artikel
A unified framework towards rapid diagnostic test development and evaluation during outbreaks with emerging infections
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Autoren
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Antonia Zapf
- Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
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Madhav Chaturvedi
- Institute of Epidemiology and Social Medicine, University of Münster, Münster, Germany
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Denise Köster
- Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
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Nicole Rübsamen
- Institute of Epidemiology and Social Medicine, University of Münster, Münster, Germany
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André Karch
- Institute of Epidemiology and Social Medicine, University of Münster, Münster, Germany
| Veröffentlicht: | 19. August 2022 |
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Gliederung
Text
Introduction: The development and evaluation of diagnostic tests for emerging infectious agents is a critical step in different phases of epi- and pandemics. While diagnostic tests are considered to be developed for guidance of individual patient care, their results contribute substantially to public-health decision-making. Diagnostic studies evaluating tests regarding their accuracy for emerging infectious agents face numerous challenges [1]. These include a high urgency of availability and consequently narrow time frames, steadily changing pathogen characteristics calling for repeated re-evaluation of diagnostic tests and constantly adapting application areas and testing aims leading to new target populations and different study objectives.
Methods: Based on the problems encountered and lessons learned during the different phases of the SARS-CoV-2 pandemic, we present here an interdisciplinary proposal for a unified framework towards rapid diagnostic test development, validation, and evaluation during outbreaks with emerging infections. We argue that there is a feedback loop between evaluation of diagnostic tests regarding their accuracy and integration of these results, especially sensitivity and specificity, in modelling studies, and public health decision-making. The resulting measures then again directly affect testing strategies, application areas of diagnostic tests, and the way the tests need to be evaluated.
Discussion: We propose that future test evaluation platforms need to account for this feedback loop to optimize usability for real-life decision-making, and learn from decision-making theory, e.g. by incorporating value of information analysis results from the modelling field in the development of diagnostic study designs [2]. Pragmatic adaptive and seamless diagnostic studies performed in an ongoing available panel throughout the epidemic provide a perfect methodological approach for the evaluation of tests under these circumstances, and must be further adapted to this research field [3]. Cluster-randomized diagnostic test-treatment studies need to be considered as the final step for providing evidence for the effectiveness of test strategies during new epi- and pandemics.
The authors declare that they have no competing interests.
The authors declare that an ethics committee vote is not required.
References
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- Zapf A, Stark M, Gerke O, Ehret C, Benda N, Bossuyt P, et al. Adaptive trial designs in diagnostic accuracy research. Stat Med. 2020;39(5):591–601.
