Accuracy of Rapid Antigen Testing Across SARS-CoV-2 Variants
12 Pages Posted: 9 Mar 2022
Date Written: March 1, 2022
Abstract
Variants of SARS-CoV-2 have mutations in the viral genome that may alter the accuracy of rapid diagnostic tests. Molecular tests can be affected by single point mutations, whereas antigen tests may require multiple mutations to change the confirmation of viral protein epitopes. The Omicron variant has numerous mutations in the spike and nucleocapsid proteins, which has raised concerns about the analytical and clinical accuracy of rapid antigen testing. We conducted an analytical accuracy study of two FDA-approved rapid antigen tests—SCoV-2 Ag Detect™ Rapid Test (InBios International, Seattle) and BinaxNOW™ COVID-19 Ag CARD; (Abbott Laboratories, Chicago)—using three using replication-competent variants or strains, including Omicron (B.1.1.529/BA.1), Delta (B.1.617.2), and a wild-type of SARS-CoV-2 (USA-WA1/2020). This study provides analytical and clinical performance data to demonstrate the preserved accuracy of rapid antigen testing across SARS-CoV-2 variants among symptomatic adults. Since rapid antigen tests may correlate with recovery of replication-competent SARS-CoV-2 and appear to retain accuracy across variants, ongoing home-based rapid antigen testing programs may be an important intervention to reduce global SARS-CoV-2 transmission.
Note:
Funding Information: The study was supported by InBios International Inc., which had no role in the data analyses, interpretation, or reporting of these results. Dr. Drain reports receiving grant support, paid to his institution, from the National Institutes of Health, the Centers for Disease Control and Prevention, and the Bill and Melinda Gates Foundation.
Conflict of Interests: None.
Keywords: SARS-CoV-2, Omicron, variants, rapid antigen test, rapid diagnostic test
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