• 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 Orvek, Julie 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, and David McManus.
• Program in Digital Medicine and Division of Clinical Informatics, Department of Medicine, and Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, Massachusetts (A.S.).
• Ann. Intern. Med. 2022 Dec 1; 175 (12): 168516921685-1692.

BackgroundIt is important to document the performance of rapid antigen tests (Ag-RDTs) in detecting SARS-CoV-2 variants.ObjectiveTo 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.DesignSecondary 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.SettingThe 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.ParticipantsOf 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.MeasurementsSensitivity 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.ResultsA 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.LimitationA 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.ConclusionThe 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.Primary Funding SourceNational Heart, Lung, and Blood Institute of the National Institutes of Health.

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