Design and implementation of a digital site-less clinical study of serial rapid antigen testing to identify asymptomatic SARS-CoV-2 infection

Apurv Soni*, Carly Herbert, Caitlin Pretz, Pamela Stamegna, Andreas Filippaios, Qiming Shi, Thejas Suvarna, Emma Harman, Summer Schrader, Chris Nowak, Eric Schramm, Vik Kheterpal, Stephanie Behar, Seanan Tarrant, Julia Ferranto, Nathaniel Hafer, Matthew Robinson, Chad Achenbach, Robert L. Murphy, Yukari C. ManabeLaura Gibson, Bruce Barton, Laurel O'Connor, Nisha Fahey, Elizabeth Orvek, Peter Lazar, Didem Ayturk, Steven Wong, Adrian Zai, Lisa Cashman, Lokinendi V. Rao, Katherine Luzuriaga, Stephenie Lemon, Allison Blodgett, Elizabeth Trippe, Mary Barcus, Brittany Goldberg, Kristian Roth, Timothy Stenzel, William Heetderks, John Broach, David McManus

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

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.

Original languageEnglish (US)
Article numbere120
JournalJournal of Clinical and Translational Science
Volume7
Issue number1
DOIs
StatePublished - May 10 2023

Keywords

  • Covid-19
  • digital trial
  • point-of-care diagnostics
  • rapid antigen tests
  • study recruitment

ASJC Scopus subject areas

  • General Medicine

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