Accuracy of Rapid Antigen Testing Across SARS-CoV-2 Variants

12 Pages Posted: 9 Mar 2022

See all articles by Paul K. Drain

Paul K. Drain

University of Washington - Department of Global Health; University of Washington - Department of Medicine; University of Washington - Department of Epidemiology

Meagan Bemer

University of Washington

Jennifer F. Morton

University of Washington

Ronit Dalmat

University of Washington

Hussein Abdille

University of Washington

Katherine Thomas

University of Washington - Department of Global Health

Timsy Uppal

University of Nevada, Reno

Derrick Hau

University of Nevada, Reno

Heather R. Green

University of Nevada, Reno

Marcellene A. Gates-Hollingworth

University of Nevada, Reno

David P. AuCoin

University of Nevada, Reno

Subhash C. Verma

University of Nevada, Reno

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

Suggested Citation

Drain, Paul K. and Bemer, Meagan and Morton, Jennifer F. and Dalmat, Ronit and Abdille, Hussein and Thomas, Katherine and Uppal, Timsy and Hau, Derrick and Green, Heather R. and Gates-Hollingworth, Marcellene A. and AuCoin, David P. and Verma, Subhash C., Accuracy of Rapid Antigen Testing Across SARS-CoV-2 Variants (March 1, 2022). Available at SSRN: https://ssrn.com/abstract=4047361 or http://dx.doi.org/10.2139/ssrn.4047361

Paul K. Drain (Contact Author)

University of Washington - Department of Global Health ( email )

Seattle, WA 98195
United States

University of Washington - Department of Medicine ( email )

Box 356340
1925 N.E. Pacific Street
Seattle, WA 98195-6340
United States

University of Washington - Department of Epidemiology ( email )

Seattle, WA
United States

Meagan Bemer

University of Washington

Seattle, WA 98195
United States

Jennifer F. Morton

University of Washington

Seattle, WA 98195
United States

Ronit Dalmat

University of Washington

Seattle, WA 98195
United States

Hussein Abdille

University of Washington

Seattle, WA 98195
United States

Katherine Thomas

University of Washington - Department of Global Health

Seattle, WA
United States

Timsy Uppal

University of Nevada, Reno

1664 N. Virginia St
Reno, NV 89557
United States

Derrick Hau

University of Nevada, Reno

1664 N. Virginia St
Reno, NV 89557
United States

Heather R. Green

University of Nevada, Reno

1664 N. Virginia St
Reno, NV 89557
United States

Marcellene A. Gates-Hollingworth

University of Nevada, Reno

1664 N. Virginia St
Reno, NV 89557
United States

David P. AuCoin

University of Nevada, Reno

1664 N. Virginia St
Reno, NV 89557
United States

Subhash C. Verma

University of Nevada, Reno

1664 N. Virginia St
Reno, NV 89557
United States

Do you have negative results from your research you’d like to share?

Paper statistics

Downloads
61
Abstract Views
414
Rank
638,193
PlumX Metrics