Longitudinal assessment of diagnostic test performance over the course of acute SARS-CoV-2 infection

Rebecca L Smith, Laura L Gibson, Pamela P Martinez, Ruian Ke, Agha Mirza, Madison Conte, Nicholas Gallagher, Abigail Conte, Leyi Wang, Rick Fredrickson, Darci C Edmonson, Melinda E Baughman, Karen K Chiu, Hannah Choi, Tor W Jensen, Kevin R Scardina, Shannon Bradley, Stacy L Gloss, Crystal Reinhart, Jagadeesh YedetoreAlyssa N Owens, John Broach, Bruce Barton, Peter Lazar, Darcy Henness, Todd Young, Alastair Dunnett, Matthew L Robinson, Heba H Mostafa, Andrew Pekosz, Yukari C Manabe, William J Heetderks, David D McManus, Christopher B Brooke

Research output: Working paper


What is already known about this topic? Diagnostic tests and sample types for SARS-CoV-2 vary in sensitivity across the infection period. What is added by this report? We show that both RTqPCR (from nasal swab and saliva) and the Quidel SARS Sofia FIA rapid antigen tests peak in sensitivity during the period in which live virus can be detected in nasal swabs, but that the sensitivity of RTqPCR tests rises more rapidly in the pre-infectious period. We also use empirical data to estimate the sensitivities of RTqPCR and antigen tests as a function of testing frequency. What are the implications for public health practice? RTqPCR tests will be more effective than rapid antigen tests at identifying infected individuals prior to or early during the infectious period and thus for minimizing forward transmission (provided results reporting is timely). All modalities, including rapid antigen tests, showed gt;94screening using rapid antigen tests 2-3 times per week can be an effective strategy to achieve high sensitivity (gt;95 for identifying infected individuals.Competing Interest StatementThe authors have declared no competing interest.Funding StatementThis study was funded by the NIH RADx-Tech program under 3U54HL143541-02S2. The views expressed in this manuscript are those of the authors and do not necessarily represent the views of the National Institute of Biomedical Imaging and Bioengineering; the National Heart, Lung, and Blood Institute; the National Institutes of Health, or the U.S. Department of Health and Human Services. Sofia 2 devices and associated supplies were provided to Carle Foundation Hospital by Quidel, however Quidel played no role in the design of the study or the interpretation or presentation of the data. Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:This study was approved by the Western Institutional Review Board, and all participants consented freely.All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesAll code used in analyses can be found here: https://github.com/rlsdvm/CovidDetectAnalysishttps://github.com/rlsdvm/CovidDetectAnalysis
Original languageEnglish (US)
PublisherCold Spring Harbor Laboratory Press
Number of pages12
StateIn preparation - Mar 20 2021

Publication series

PublisherCold Spring Harbor Laboratory Press


  • Coronavirus
  • COVID-19
  • severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
  • Novel coronavirus
  • 2019-nCoV
  • Pandemic

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