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False-Positive Results in Rapid Antigen Tests for SARS-CoV-2

Educational Objective
To identify the key insights or developments described in this article

Concerns have been raised whether rapid antigen tests for SARS-CoV-2 can result in false-positive test results1,2 and undermine pandemic management for COVID-19. This study investigated the incidence of false-positive results in a large sample of rapid antigen tests used to serially screen asymptomatic workers throughout Canada.

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Article Information

Accepted for Publication: December 20, 2021.

Published Online: January 7, 2022. doi:10.1001/jama.2021.24355

Corresponding Author: Joshua S. Gans, PhD, Rotman School of Management, University of Toronto, 105 St George St, Toronto, ON M5S3E6, Canada (joshua.gans@utoronto.ca).

Author Contributions: Drs Goldfarb and Rosella had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Goldfarb, Agrawal, Sennik, Stein, Rosella.

Acquisition, analysis, or interpretation of data: Gans, Goldfarb, Agrawal, Sennik, Rosella.

Drafting of the manuscript: Gans, Goldfarb.

Critical revision of the manuscript for important intellectual content: Goldfarb, Agrawal, Sennik, Stein, Rosella.

Statistical analysis: Goldfarb, Rosella.

Obtained funding: Agrawal, Sennik, Stein.

Administrative, technical, or material support: Gans, Goldfarb, Agrawal, Sennik.

Supervision: Agrawal, Sennik.

Conflict of Interest Disclosures: All authors are members of the Steering Committee of the Creative Destruction Lab Rapid Screening Consortium (CDL RSC; a nonprofit organization in Canada). Dr Agrawal reported serving on the boards of Genpact and Sanctuary.

Funding/Support: The CDL RSC was founded with financial support from 12 corporations: Air Canada, CPP Investments, Genpact, Loblaw Companies Limited, Magna, MDA, Maple Leafs Sports & Entertainment Partnership, Nutrien, Rogers, Scotiabank, Shoppers Drug Mart, and Suncor and received funding from the Safe Restart Agreement from the Government of Canada (Health Canada).

Role of the Funder/Sponsor: The funders 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: We thank Kyle Robinson, PhD, Devon Elke, HBSc, and Evgenia Gatov, MPH (all paid employees of CDL RSC, Toronto, Ontario, Canada), for assistance in collating the data.

References
1.
Kretschmer  A , Kossow  A , Grüne  B , Schildgen  O , Mathes  T , Schildgen  V .  False positive rapid antigen tests for SARS-CoV-2 in the real-world and their economic burden.   J Infect. Published online August 17, 2021. doi:10.1016/j.jinf.2021.08.020PubMedGoogle Scholar
2.
Ogawa  T , Fukumori  T , Nishihara  Y ,  et al.  Another false-positive problem for a SARS-CoV-2 antigen test in Japan.   J Clin Virol. 2020;131:104612. doi:10.1016/j.jcv.2020.104612 PubMedGoogle Scholar
3.
Kanji  JN , Proctor  DT , Stokes  W ,  et al.  Multicenter postimplementation assessment of the positive predictive value of SARS-CoV-2 antigen-based point-of-care tests used for screening of asymptomatic continuing care staff.   J Clin Microbiol. 2021;59(11):e0141121. doi:10.1128/JCM.01411-21 PubMedGoogle Scholar
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