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dc.contributor.authorSoni, Apurv
dc.contributor.authorHerbert, Carly
dc.contributor.authorLin, Honghuang
dc.contributor.authorPretz, Caitlin
dc.contributor.authorStamegna, Pamela
dc.contributor.authorOrwig, Taylor
dc.contributor.authorWright, Colton
dc.contributor.authorTarrant, Seanan
dc.contributor.authorBehar, Stephanie
dc.contributor.authorSuvarna, Thejas
dc.contributor.authorSchrader, Summer
dc.contributor.authorHarman, Emma
dc.contributor.authorNowak, Chris
dc.contributor.authorKheterpal, Vik
dc.contributor.authorRao, Lokinendi V
dc.contributor.authorCashman, Lisa
dc.contributor.authorOrvek, Elizabeth
dc.contributor.authorAyturk, Didem
dc.contributor.authorLazar, Peter
dc.contributor.authorWang, Ziyue
dc.contributor.authorBarton, Bruce
dc.contributor.authorAchenbach, Chad J
dc.contributor.authorMurphy, Robert L
dc.contributor.authorRobinson, Matthew
dc.contributor.authorManabe, Yuka
dc.contributor.authorWang, Biqi
dc.contributor.authorPandey, Shishir
dc.contributor.authorColubri, Andrés
dc.contributor.authorO'Connor, Laurel
dc.contributor.authorLemon, Stephenie C
dc.contributor.authorFahey, Nisha
dc.contributor.authorLuzuriaga, Katherine L
dc.contributor.authorHafer, Nathaniel
dc.contributor.authorHeetderks, William
dc.contributor.authorBroach, John
dc.contributor.authorMcManus, David D
dc.date.accessioned2022-11-28T16:03:53Z
dc.date.available2022-11-28T16:03:53Z
dc.date.issued2022-08-06
dc.identifier.citationSoni A, Herbert C, Lin H, Pretz C, Stamegna P, Orwig T, Wright C, Tarrant S, Behar S, Suvarna T, Schrader S, Harman E, Nowak C, Kheterpal V, Rao LV, Cashman L, Orvek E, Ayturk D, Lazar P, Wang Z, Barton B, Achenbach CJ, Murphy RL, Robinson M, Manabe Y, Wang B, Pandey S, Colubri A, Oâ Connor L, Lemon SC, Fahey N, Luzuriaga KL, Hafer N, Heetderks W, Broach J, McManus DD. Performance of Screening for SARS-CoV-2 using Rapid Antigen Tests to Detect Incidence of Symptomatic and Asymptomatic SARS-CoV-2 Infection: findings from the Test Us at Home prospective cohort study. medRxiv [Preprint]. 2022 Aug 6:2022.08.05.22278466. doi: 10.1101/2022.08.05.22278466. PMID: 35982680; PMCID: PMC9387089.en_US
dc.identifier.doi10.1101/2022.08.05.22278466en_US
dc.identifier.pmid35982680
dc.identifier.urihttp://hdl.handle.net/20.500.14038/51336
dc.descriptionThis article is a preprint. Preprints are preliminary reports of work that have not been certified by peer review.en_US
dc.description.abstractBackground: Performance of Rapid Antigen Tests for SARS-CoV-2 (Ag-RDT) varies over the course of an infection, and their performance is not well established among asymptomatic individuals. Objective: Evaluate performance of Ag-RDT for detection of SARS-CoV-2 in relation to onset of infection for symptomatic and asymptomatic participants. Design setting and participants: Prospective cohort study conducted from October 2021 to February 2022 among participants > 2 years-old from across the US who enrolled using a smartphone app. During each testing encounter, participants self-collected one nasal swab and performed Ag-RDT at home; at-least fifteen minutes later, a second nasal swab was self-collected and shipped for SARS-CoV-2 RT-PCR at a central lab. Both nasal swabs were collected 7 times at 48-hour intervals (over approximately 14 days) followed by an extra nasal swab collection with home Ag-RDT test 48-hours after their last PCR sample. Each participant was assigned to one of the three emergency use authorized (EUA) Ag-RDT tests used in this study. This analysis was limited to participants who were asymptomatic and tested negative by antigen and molecular test on their first day of study participation. Exposure: SARS-CoV-2 positivity was determined by testing a single home-collected anterior nasal sample with three FDA EUA molecular tests, where 2 out 3 positive test results were needed to determine a SARS-CoV-2 positive result. Onset of infection was defined as day on which the molecular PCR comparator result was positive for the first time. Main outcomes and measures: Sensitivity of Ag-RDT was measured based on testing once (same-day), twice (at 48-hours) and thrice (at 96 hours). Analysis was repeated for different Days Post Index PCR Positivity (DPIPP) and stratified based on symptom-status on a given DPIPP. Results: A total of 7,361 participants enrolled in the study and 5,609 were eligible for this analysis. Among 154 eligible participants who tested positive for SARS-CoV-2 infection based on RT-PCR, 97 were asymptomatic and 57 had symptoms at onset of infection (DPIPP 0). Serial testing with Ag-RDT twice over 48-hours resulted in an aggregated sensitivity of 93.4% (95% CI: 89.1-96.1%) among symptomatic participants on DPIPP 0-6. Among the 97 people who were asymptomatic at the onset of infection, 19 were singleton RT-PCR positive, i.e., their positive test was preceded and followed by a negative RT-PCR test within 48-hours. Excluding these singleton positives, aggregated sensitivity on DPIPP 0-6 for two-time serial-testing among asymptomatic participants was lower 62.7% (54.7-70.0%) but improved to 79.0% (71.0-85.3%) with serial testing three times at 48-hour interval. Discussion: Performance of Ag-RDT within first week of infection was optimized when asymptomatic participants tested three-times at 48-hour intervals and when symptomatic participants tested two-times separated by 48-hours.en_US
dc.language.isoenen_US
dc.relationNow published in Annals of Internal Medicine, doi:https://doi.org/10.7326/m23-0385
dc.relation.ispartofmedRxiven_US
dc.relation.urlhttps://doi.org/10.1101/2022.08.05.22278466en_US
dc.rightsThe copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission.en_US
dc.subjectInfectious Diseases (except HIV/AIDS)en_US
dc.subjectSARS-CoV-2en_US
dc.subjectRapid Antigen Testsen_US
dc.subjectUMCCTS funding
dc.titlePerformance of Rapid Antigen Tests to Detect Symptomatic and Asymptomatic SARS-CoV-2 Infection [preprint]en_US
dc.typePreprinten_US
dc.source.journaltitlemedRxiv : the preprint server for health sciences
dc.source.countryUnited States
dc.identifier.journalmedRxiv : the preprint server for health sciences
dc.contributor.departmentPrevention Research Center
dc.contributor.departmentCenter for Clinical and Translational Scienceen_US
dc.contributor.departmentEmergency Medicineen_US
dc.contributor.departmentMedicineen_US
dc.contributor.departmentMicrobiology and Physiological Systemsen_US
dc.contributor.departmentMorningside Graduate School of Biomedical Sciencesen_US
dc.contributor.departmentPediatricsen_US
dc.contributor.departmentPopulation and Quantitative Health Sciencesen_US
dc.contributor.departmentProgram in Molecular Medicineen_US
dc.contributor.departmentBiostatistics and Health Services Researchen_US
dc.contributor.studentCarly Herbert


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