Journal of Clinical and Translational Science (Jan 2023)
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. Manabe,
- Laura 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
Affiliations
- Apurv Soni
- ORCiD
- Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, USA Division of Health System Science, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA
- Carly Herbert
- ORCiD
- Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA
- Caitlin Pretz
- Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA
- Pamela Stamegna
- Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA
- Andreas Filippaios
- ORCiD
- Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA
- Qiming Shi
- Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA Division of Health System Science, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA University of Massachusetts Center for Clinical and Translational Science, University of Massachusetts Chan Medical School, Worcester, MA, USA
- Thejas Suvarna
- CareEvolution, LLC, Ann Arbor, MI, USA
- Emma Harman
- CareEvolution, LLC, Ann Arbor, MI, USA
- Summer Schrader
- CareEvolution, LLC, Ann Arbor, MI, USA
- Chris Nowak
- CareEvolution, LLC, Ann Arbor, MI, USA
- Eric Schramm
- CareEvolution, LLC, Ann Arbor, MI, USA
- Vik Kheterpal
- CareEvolution, LLC, Ann Arbor, MI, USA
- Stephanie Behar
- Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA
- Seanan Tarrant
- Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA
- Julia Ferranto
- Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA
- Nathaniel Hafer
- ORCiD
- University of Massachusetts Center for Clinical and Translational Science, University of Massachusetts Chan Medical School, Worcester, MA, USA
- Matthew Robinson
- Division of Infectious Disease, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA
- Chad Achenbach
- Division of Infectious Disease, Department of Medicine, Havey Institute for Global Health, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA
- Robert L. Murphy
- Division of Infectious Disease, Department of Medicine, Havey Institute for Global Health, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA
- Yukari C. Manabe
- Division of Infectious Disease, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA
- Laura Gibson
- Division of Infectious Disease, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA
- Bruce Barton
- Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, USA
- Laurel O’Connor
- Department of Emergency Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA
- Nisha Fahey
- Department of Pediatrics, University of Massachusetts Chan Medical School, Worcester, MA, USA
- Elizabeth Orvek
- Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, USA
- Peter Lazar
- Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, USA
- Didem Ayturk
- Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, USA
- Steven Wong
- Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, USA
- Adrian Zai
- Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, USA
- Lisa Cashman
- Quest Diagnostics, Marlborough, MA, USA
- Lokinendi V. Rao
- Quest Diagnostics, Marlborough, MA, USA
- Katherine Luzuriaga
- University of Massachusetts Center for Clinical and Translational Science, University of Massachusetts Chan Medical School, Worcester, MA, USA
- Stephenie Lemon
- ORCiD
- Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, USA
- Allison Blodgett
- University of Massachusetts Center for Clinical and Translational Science, University of Massachusetts Chan Medical School, Worcester, MA, USA
- Elizabeth Trippe
- Division of Microbiology, OHT7 Office of Product Evaluation and Quality, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA
- Mary Barcus
- Division of Microbiology, OHT7 Office of Product Evaluation and Quality, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA
- Brittany Goldberg
- Division of Microbiology, OHT7 Office of Product Evaluation and Quality, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA
- Kristian Roth
- Division of Microbiology, OHT7 Office of Product Evaluation and Quality, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA
- Timothy Stenzel
- OHT7 Office of Product Evaluation and Quality, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA
- William Heetderks
- National Institute of Biomedical Imaging and Bioengineering, NIH, Via Contract with Kelly Services, Bethesda, MD, USA
- John Broach
- Department of Emergency Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA
- David McManus
- Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA Division of Health System Science, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA Division of Cardiology, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA
- DOI
- https://doi.org/10.1017/cts.2023.540
- Journal volume & issue
-
Vol. 7
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.
Keywords
