Generation of False-Positive SARS-CoV-2 Antigen Results with Testing Conditions outside Manufacturer Recommendations: A Scientific Approach to Pandemic Misinformation

Author:

Patriquin Glenn12,Davidson Ross J.1234,Hatchette Todd F.1234,Head Breanne M.5,Mejia Edgard5,Becker Michael G.5ORCID,Meyers Adrienne5,Sandstrom Paul5,Hatchette Jacob6,Block Ava6,Smith Nicole6,Ross John6,LeBlanc Jason J.1234ORCID

Affiliation:

1. Division of Microbiology, Department of Pathology and Laboratory Medicine, Nova Scotia Health (NSH), Halifax, Nova Scotia, Canada

2. Department of Pathology, Dalhousie University, Halifax, Nova Scotia, Canada

3. Department of Medicine (Infectious Diseases), Dalhousie University, Halifax, Nova Scotia, Canada

4. Department of Microbiology and Immunology, Dalhousie University, Halifax, Nova Scotia, Canada

5. National Microbiology Laboratory (NML), Public Health Agency of Canada (PHAC), Winnipeg, Manitoba, Canada

6. Praxes Medical Group, Halifax, Nova Scotia, Canada

Abstract

With the Panbio severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen test being deployed in over 120 countries worldwide, understanding conditions required for its ideal performance is critical. Recently on social media, this kit was shown to generate false positives when manufacturer recommendations were not followed.

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Cell Biology,Microbiology (medical),Genetics,General Immunology and Microbiology,Ecology,Physiology

Reference30 articles.

1. Tools and Techniques for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)/COVID-19 Detection

2. Public Health Agency of Canada (PHAC). 2020. Interim guidance on the use of rapid antigen detection tests for the identification of SARS-CoV-2 infection. https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/guidance-documents/use-rapid-antigen-detection-tests.html. Accessed 9 September 2021.

3. World Health Organization (WHO). 2020. Antigen-detection in the diagnosis of SARS-CoV-2 infection using rapid immunoassays. Interim guidance. https://www.who.int/publications/i/item/antigen-detection-in-the-diagnosis-of-sars-cov-2infection-using-rapid-immunoassays. Accessed 9 September 2021.

4. US Food and Drug Administration. 2020. In vitro diagnostics EUAs. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas#individual-molecular. Accessed 9 September 2021.

5. Health Canada. 2020. Authorized medical devices for uses related to COVID-19: list of authorized testing devices. https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/authorized/list.html. Accessed 9 September 2021.

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