Guidance for the design and reporting of studies evaluating the clinical performance of tests for present or past SARS-CoV-2 infection

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 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. The implementation and accuracy of SARS-CoV-2 tests have major implications for individuals and communities, balancing the potential consequences of continued infection against the need for public health measures, such as the restriction of movements and social activities. Decision making in the current pandemic requires a clear understanding of the clinical performance and limitations of testing. This article provides guidance to assist researchers design robust diagnostic accuracy studies, assist publishers and peer reviewers to assess such studies, and support clinicians and policy makers in their evaluation of the evidence on SARS-CoV-2 testing for clinical and public health decisions. The guidance aims to ensure that studies evaluating the diagnostic accuracy of SARS-CoV-2 tests are conducted as rigorously as possible, in an efficient and timely way.