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Increased diagnostics are urgently needed to contain the spread of coronavirus disease 2019 (COVID-19). Home self-collected swabs may increase testing access while minimizing exposure risk to health care workers and depletion of personal protective equipment, allowing for early community detection of COVID-19. A comparison of unsupervised home self-collected swabs with clinician-collected nasopharyngeal swabs for COVID-19 diagnosis has not been well described.
This cross-sectional study was approved by the University of Washington institutional review board and follows the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline. Participants provided electronic informed consent. Study participants were recruited from symptomatic outpatients testing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)–positive and symptomatic health care workers presenting to drive-through clinics (eFigure and eAppendix in the Supplement). Participants were provided test kits for unsupervised home self-collection of a midnasal swab. Home swab performance was compared with clinician-collected nasopharyngeal swabs, which were collected by medical assistants and nurses. Cycle thresholds (Ct) are a semiquantitative measure of viral load. Positive test results for SARS-CoV-2 by both approaches were defined as true positives. Results with a positive clinician swab and negative home swab were defined as false negatives. Sensitivity was defined as true positives divided by the sum of true positives and false negatives. Cohen κ was calculated for agreement between the 2 qualitative test results. The threshold for statistical significance was set at 2-tailed P < .05.
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Accepted for Publication: June 29, 2020.
Published: July 22, 2020. doi:10.1001/jamanetworkopen.2020.16382
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2020 McCulloch DJ et al. JAMA Network Open.
Corresponding Author: Denise J. McCulloch, MD, MPH, UW Medicine, 750 Republican St, Chu Lab Room E630, Box 358061, Seattle WA 98109 (email@example.com).
Author Contributions: Dr McCulloch had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: McCulloch, Kim, Englund, Chu.
Acquisition, analysis, or interpretation of data: McCulloch, Wilcox, Logue, Greninger, Englund.
Drafting of the manuscript: McCulloch, Wilcox, Englund, Chu.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: McCulloch, Wilcox.
Obtained funding: Englund, Chu.
Administrative, technical, or material support: Kim, Logue, Greninger, Englund.
Supervision: Logue, Greninger, Chu.
Conflict of Interest Disclosures: Dr Chu reported consulting with GlaxoSmithKline and Merck and receiving research funding from Sanofi Pasteur, Cepheid, and Ellume outside of the submitted work. Dr Greninger reported receiving personal fees from Abbott Molecular outside of the submitted work. Dr Englund reported consulting with Sanofi Pasteur and Meissa Vaccines outside the submitted work. No other disclosures were reported.
Funding/Support: This work was supported by Gates Ventures.
Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Additional Contributions: Caitlin Wolf, BS, and Gregory Pepper, BS (both of University of Washington, Seattle), assisted with acquisition of data. Jay Shendure, MD, PhD (University of Washington, Seattle; Brotman Baty Institute, Seattle; and Howard Hughes Medical Institute, Chevy Chase, Maryland), assisted with concept and design, obtaining funding, and critical revision of the manuscript. James P. Hughes, PhD (Fred Hutchinson Cancer Research Center, Seattle, and University of Washington, Seattle), assisted with statistical analysis and critical revision of the manuscript. Michael J. Boeckh, MD, PhD (University of Washington, Seattle; Brotman Baty Institute, Seattle; and Fred Hutchinson Cancer Research Center, Seattle), Keith R. Jerome, MD, PhD (University of Washington, Seattle, and Fred Hutchinson Cancer Research Center, Seattle), and Michael Jackson, PhD (Kaiser Permanente Washington Health Research Institute, Seattle), assisted with critical revision of the manuscript. We also acknowledge the University of Washington medical students who volunteered to help with this study. None of these individuals received financial compensation for their contributions to the study.
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