Comparison of Rapid Antigen Tests' Performance Between Delta and Omicron Variants of SARS-CoV-2 A Secondary Analysis From a Serial Home Self-testing Study

Apurv Soni*, Carly Herbert, Andreas Filippaios, John Broach, Andres Colubri, Nisha Fahey, Kelsey Woods, Janvi Nanavati, Colton Wright, Taylor Orwig, Karen Gilliam, Vik Kheterpal, Thejas Suvarna, Chris Nowak, Summer Schrader, Honghuang Lin, Laurel O'Connor, Caitlin Pretz, Didem Ayturk, Elizabeth OrvekJulie Flahive, Peter Lazar, Qiming Shi, Chad Achenbach, Robert Murphy, Matthew Robinson, Laura Gibson, Pamela Stamegna, Nathaniel Hafer, Katherine Luzuriaga, Bruce Barton, William Heetderks, Yukari C. Manabe, David McManus

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

23 Scopus citations

Abstract

Background: It is important to document the performance of rapid antigen tests (Ag-RDTs) in detecting SARS-CoV-2 variants. Objective: To compare the performance of Ag-RDTs in detecting the Delta (B.1.617.2) and Omicron (B.1.1.529) variants of SARS-CoV-2. Design: Secondary analysis of a prospective cohort study that enrolled participants between 18 October 2021 and 24 January 2022. Participants did Ag-RDTs and collected samples for reverse transcriptase polymerase chain reaction (RT-PCR) testing every 48 hours for 15 days. Setting: The parent study enrolled participants throughout the mainland United States through a digital platform. All participants self-collected anterior nasal swabs for rapid antigen testing and RT-PCR testing. All Ag-RDTs were completed at home, whereas nasal swabs for RT-PCR were shipped to a central laboratory. Participants: Of 7349 participants enrolled in the parent study, 5779 asymptomatic persons who tested negative for SARS-CoV-2 on day 1 of the study were eligible for this substudy. Measurements: Sensitivity of Ag-RDTs on the same day as the first positive (index) RT-PCR result and 48 hours after the first positive RT-PCR result. Results: A total of 207 participants were positive on RT-PCR (58 Delta, 149 Omicron). Differences in sensitivity between variants were not statistically significant (same day: Delta, 15.5% [95% CI, 6.2% to 24.8%] vs. Omicron, 22.1% [CI, 15.5% to 28.8%]; at 48 hours: Delta, 44.8% [CI, 32.0% to 57.6%] vs. Omicron, 49.7% [CI, 41.6% to 57.6%]). Among 109 participants who had RT-PCR-positive results for 48 hours, rapid antigen sensitivity did not differ significantly between Delta- and Omicron-infected participants (48-hour sensitivity: Delta, 81.5% [CI, 66.8% to 96.1%] vs. Omicron, 78.0% [CI, 69.1% to 87.0%]). Only 7.2% of the 69 participants with RT-PCR-positive results for shorter than 48 hours tested positive by Ag-RDT within 1 week; those with Delta infections remained consistently negative on Ag-RDTs. Limitation: A testing frequency of 48 hours does not allow a finer temporal resolution of the analysis of test performance, and the results of Ag-RDTs are based on self-report. Conclusion: The performance of Ag-RDTs in persons infected with the SARS-CoV-2 Omicron variant is not inferior to that in persons with Delta infections. Serial testing improved the sensitivity of Ag-RDTs for both variants. The performance of rapid antigen testing varies on the basis of duration of RT-PCR positivity.

Original languageEnglish (US)
Pages (from-to)1685-1693
Number of pages9
JournalAnnals of internal medicine
Volume175
Issue number12
DOIs
StatePublished - Dec 2022

Funding

Grant Support: By the NIH RADx Tech program under grant 3U54HL143541-02S2 and by NIH Clinical and Translational Science Award grant UL1TR001453. Salary support was received from NIH grants U54HL143541, R01HL141434, R01HL137794, R61HL158541, R01HL137734, and U01HL146382 (Drs. Soni and McManus); U54EB007958-13 (Drs. Manabe and Robinson); and AI272201400007C and UM1AI068613 (Dr. Manabe).

ASJC Scopus subject areas

  • Internal Medicine

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