{"doi":"10.1101/2022.02.27.22271090","title":"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","abstract":"Background: 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.","journal":"medRxiv","year":2022,"id":296679,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":21,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.8213,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2022-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":750963,"name":"Carly Herbert","orcid":"0000-0001-8972-0474","position":1,"is_corresponding":false},{"id":965031,"name":"Andreas Filippaios","orcid":"0000-0003-0082-5507","position":2,"is_corresponding":false},{"id":626407,"name":"John Broach","orcid":"0000-0002-6581-2232","position":3,"is_corresponding":false},{"id":251100,"name":"Andrés Colubri","orcid":"0000-0001-5559-9661","position":4,"is_corresponding":false},{"id":727668,"name":"Nisha Fahey","orcid":"0000-0001-9059-1470","position":5,"is_corresponding":false},{"id":942387,"name":"Kelsey Woods","orcid":"0000-0003-3633-3512","position":6,"is_corresponding":false},{"id":983987,"name":"Janvi Nanavati","orcid":null,"position":7,"is_corresponding":false},{"id":983576,"name":"Colton Wright","orcid":"0000-0003-2399-1815","position":8,"is_corresponding":false},{"id":983577,"name":"Taylor Orwig","orcid":"0000-0002-4899-7677","position":9,"is_corresponding":false},{"id":938485,"name":"Karen Gilliam","orcid":null,"position":10,"is_corresponding":false},{"id":227521,"name":"Vik Kheterpal","orcid":"0000-0002-4752-4229","position":11,"is_corresponding":false},{"id":915507,"name":"Thejas Suvarna","orcid":"0000-0002-4811-0298","position":12,"is_corresponding":false},{"id":915506,"name":"Chris Nowak","orcid":"0000-0002-5947-9525","position":13,"is_corresponding":false},{"id":915508,"name":"Summer Schrader","orcid":"0000-0002-5678-8613","position":14,"is_corresponding":false},{"id":24806,"name":"Honghuang Lin","orcid":"0000-0003-3043-3942","position":15,"is_corresponding":false},{"id":915514,"name":"Laurel O’Connor","orcid":"0000-0003-4681-992X","position":16,"is_corresponding":false},{"id":942386,"name":"Caitlin Pretz","orcid":"0000-0002-5272-003X","position":17,"is_corresponding":false},{"id":772933,"name":"Didem Ayturk","orcid":"0000-0003-1309-8388","position":18,"is_corresponding":false},{"id":545672,"name":"Elizabeth Orvek","orcid":"0000-0001-6974-6263","position":19,"is_corresponding":false},{"id":490567,"name":"Julie Flahive","orcid":"0000-0002-2786-7144","position":20,"is_corresponding":false},{"id":626408,"name":"Péter Lázár","orcid":"0000-0002-0744-1461","position":21,"is_corresponding":false},{"id":724588,"name":"Qiming Shi","orcid":"0000-0001-5829-4345","position":22,"is_corresponding":false},{"id":283131,"name":"Chad J. 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