Design and implementation of a digital site-less clinical study of serial rapid antigen testing to identify asymptomatic SARS-CoV-2 infection
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Published:2023
Issue:1
Volume:7
Page:
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ISSN:2059-8661
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Container-title:Journal of Clinical and Translational Science
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language:en
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Short-container-title:J. Clin. Trans. Sci.
Author:
Soni ApurvORCID, Herbert CarlyORCID, Pretz Caitlin, Stamegna Pamela, Filippaios AndreasORCID, Shi Qiming, Suvarna Thejas, Harman Emma, Schrader Summer, Nowak Chris, Schramm Eric, Kheterpal Vik, Behar Stephanie, Tarrant Seanan, Ferranto Julia, Hafer NathanielORCID, Robinson Matthew, Achenbach Chad, Murphy Robert L., Manabe Yukari C., Gibson Laura, Barton Bruce, O’Connor Laurel, Fahey Nisha, Orvek Elizabeth, Lazar Peter, Ayturk Didem, Wong Steven, Zai Adrian, Cashman Lisa, Rao Lokinendi V., Luzuriaga Katherine, Lemon StephenieORCID, Blodgett Allison, Trippe Elizabeth, Barcus Mary, Goldberg Brittany, Roth Kristian, Stenzel Timothy, Heetderks William, Broach John, McManus David
Abstract
Abstract
Background:
Rapid antigen detection tests (Ag-RDT) for SARS-CoV-2 with emergency use authorization generally include a condition of authorization to evaluate the test’s performance in asymptomatic individuals when used serially. We aim to describe a novel study design that was used to generate regulatory-quality data to evaluate the serial use of Ag-RDT in detecting SARS-CoV-2 virus among asymptomatic individuals.
Methods:
This prospective cohort study used a siteless, digital approach to assess longitudinal performance of Ag-RDT. Individuals over 2 years old from across the USA with no reported COVID-19 symptoms in the 14 days prior to study enrollment were eligible to enroll in this study. Participants throughout the mainland USA were enrolled through a digital platform between October 18, 2021 and February 15, 2022. Participants were asked to test using Ag-RDT and molecular comparators every 48 hours for 15 days. Enrollment demographics, geographic distribution, and SARS-CoV-2 infection rates are reported.
Key Results:
A total of 7361 participants enrolled in the study, and 492 participants tested positive for SARS-CoV-2, including 154 who were asymptomatic and tested negative to start the study. This exceeded the initial enrollment goals of 60 positive participants. We enrolled participants from 44 US states, and geographic distribution of participants shifted in accordance with the changing COVID-19 prevalence nationwide.
Conclusions:
The digital site-less approach employed in the “Test Us At Home” study enabled rapid, efficient, and rigorous evaluation of rapid diagnostics for COVID-19 and can be adapted across research disciplines to optimize study enrollment and accessibility.
Publisher
Cambridge University Press (CUP)
Cited by
3 articles.
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