Guidance for the design and reporting of studies evaluating the clinical performance of tests for present or past SARS-CoV-2 infection
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ArticleAuthor/s
Doust, JennyBell, Katy J.L.
Leeflang, Mariska MG
Dinnes, Jacqueline
Lord, Sally J
Mallet, Sue
van de Wijgert, Janneke HHM
Sandberg, Sverre
Adeli, Khosrow
Deeks, Jonathan J
Bossuyt, Patrick M
Horvath, Andrea R
Abstract
Testing for SARS-CoV-2 infection is key in managing the current pandemic. More than 1700 preprints and peer reviewed journal articles evaluating tests for SARS-CoV-2 infection have been published as of January 2021. However, evaluations of these studies have identified many ...
See moreTesting for SARS-CoV-2 infection is key in managing the current pandemic. More than 1700 preprints and peer reviewed journal articles evaluating tests for SARS-CoV-2 infection have been published as of January 2021. However, evaluations of these studies have identified many methodological issues, leading to a high risk of bias and difficulties applying the results in practice. Better guidance is urgently needed on the conduct and interpretation of these studies. This article outlines the principles for defining the intended purpose of the test; study population selection; reference standard, test timing; and other critical considerations for the design, reporting, and interpretation of diagnostic accuracy studies.
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See moreTesting for SARS-CoV-2 infection is key in managing the current pandemic. More than 1700 preprints and peer reviewed journal articles evaluating tests for SARS-CoV-2 infection have been published as of January 2021. However, evaluations of these studies have identified many methodological issues, leading to a high risk of bias and difficulties applying the results in practice. Better guidance is urgently needed on the conduct and interpretation of these studies. This article outlines the principles for defining the intended purpose of the test; study population selection; reference standard, test timing; and other critical considerations for the design, reporting, and interpretation of diagnostic accuracy studies.
See less
Date
2021Source title
British Medical JournalVolume
372Publisher
BMJ Publishing GroupFunding information
NHMRC 1174523
National Institute for Health Research (NIHR)
Canadian Institutes of Health Research
NIHR Birmingham Biomedical Research Centre
NSW Health COVID-19 Research Grants Round 1—2020: Improved Confirmatory Diagnosis of SARS-CoV-2 infection using Protein Mass Spectrometry.
Licence
Creative Commons Attribution-NonCommercial 4.0Faculty/School
Faculty of Medicine and Health, Sydney School of Public HealthShare