Comparison of Rapid Antigen Tests' Performance between Delta (B.1.61.7; AY.X) and Omicron (B.1.1.529; BA1) Variants of SARS-CoV-2: Secondary Analysis from a Serial Home Self-Testing Study [preprint]
Broach, John P.
Ayturk, M. Didem
Orvek, Elizabeth Aaker
Flahive, Julie M.
Gibson, Laura L.
Hafer, Nathaniel S.
Barton, Bruce A.
McManus, David D.
RADx Clinical Studies Core team and Test Us At Home Investigators
UMass Chan AffiliationsDivision of Cardiovascular Medicine, Department of Medicine
Division of Infectious Diseases and Immunology, Program in Molecular Medicine
UMass Center for Clinical and Translational Science
Department of Pediatrics
Program in Bioinformatics and Integrative Biology
Department of Microbiology and Physiological Systems
Department of Emergency Medicine
Division of Clinical Informatics, Department of Medicine
Department of Population and Quantitative Health Sciences
Program in Digital Medicine, Department of Medicine
rapid antigen tests
Immunology and Infectious Disease
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AbstractBackground: There is a need to understand the performance of rapid antigen tests (Ag-RDT) for detection of the Delta (B.1.61.7; AY.X) and Omicron (B.1.1.529; BA1) SARS-CoV-2 variants. Methods: Participants without any symptoms were enrolled from October 18, 2021 to January 24, 2022 and performed Ag-RDT and RT-PCR tests every 48 hours for 15 days. This study represents a non-pre-specified analysis in which we sought to determine if sensitivity of Ag-RDT differed in participants with Delta compared to Omicron variant. Participants who were positive on RT-PCR on the first day of the testing period were excluded. Delta and Omicron variants were defined based on sequencing and date of first RT-PCR positive result (RT-PCR+). Comparison of Ag-RDT performance between the variants was based on sensitivity, defined as proportion of participants with Ag-RDT+ results in relation to their first RT-PCR+ result, for different duration of testing with rapid Ag-RDT. Subsample analysis was performed based on the result of participants' second RT-PCR test within 48 hours of the first RT-PCR+ test. Results: From the 7,349 participants enrolled in the parent study, 5,506 met the eligibility criteria for this analysis. A total of 153 participants were RT-PCR+ (61 Delta, 92 Omicron); among this group, 36 (23.5%) tested Ag-RDT+ on the same day, and 84 (54.9%) tested Ag-RDT+ within 48 hours as first RT-PCR+. The differences in sensitivity between variants were not statistically significant (same-day: Delta 16.4% [95% CI: 8.2-28.1] vs Omicron 28.2% [95% CI: 19.4-38.6]; and 48-hours: Delta 45.9% [33.1-59.2] vs. Omicron 60.9% [50.1-70.9]). This trend continued among the 86 participants who had consecutive RT-PCR+ result (48-hour sensitivity: Delta 79.3% [60.3-92.1] vs. Omicron: 89.5% [78.5-96.0]). Conversely, the 38 participants who had an isolated RT-PCR+ remained consistently negative on Ag-RDT, regardless of the variant. Conclusions: The performance of Ag-RDT is not inferior among individuals infected with the SARS-CoV-2 Omicron variant as compared to the Delta variant. The improvement in sensitivity of Ag-RDT noted with serial testing is consistent between Delta and Omicron variant. Performance of Ag-RDT varies based on duration of RT-PCR+ results and more studies are needed to understand the clinical and public health significance of individuals who are RT-PCR+ for less than 48 hours.
Soni A, Herbert C, Filippaios A, Broach J, Colubri A, Fahey N, Woods K, Nanavati J, Wright C, Orwig T, Gilliam K, Kheterpal V, Suvarna T, Nowak C, Schrader S, Lin H, O'Connor L, Pretz C, Ayturk D, Orvek E, Flahive J, Lazar P, Shi Q, Achenbach C, Murphy R, Robinson M, Gibson L, Stamegna P, Hafer N, Luzuriaga K, Barton B, Heetderks W, Manabe YC, McManus D. Comparison of Rapid Antigen Tests' Performance between Delta (B.1.61.7; AY.X) and Omicron (B.1.1.529; BA1) Variants of SARS-CoV-2: Secondary Analysis from a Serial Home Self-Testing Study. medRxiv [Preprint]. 2022 Mar 2:2022.02.27.22271090. doi: 10.1101/2022.02.27.22271090. PMID: 35262091; PMCID: PMC8902878. Link to preprint on medRxiv.
Permanent Link to this Itemhttp://hdl.handle.net/20.500.14038/30738
This article is a preprint. Preprints are preliminary reports of work that have not been certified by peer review.
Full author list omitted for brevity. For the full list of authors, see article.