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Design and implementation of a digital site-less clinical study of serial rapid antigen testing to identify asymptomatic SARS-CoV-2 infection.
Soni, Apurv; Herbert, Carly; Pretz, Caitlin; Stamegna, Pamela; Filippaios, Andreas; Shi, Qiming; Suvarna, Thejas; Harman, Emma; Schrader, Summer; Nowak, Chris; Schramm, Eric; Kheterpal, Vik; Behar, Stephanie; Tarrant, Seanan; Ferranto, Julia; Hafer, Nathaniel; 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, Stephenie; Blodgett, Allison; Trippe, Elizabeth; Barcus, Mary; Goldberg, Brittany; Roth, Kristian; Stenzel, Timothy; Heetderks, William; Broach, John; McManus, David.
  • Soni A; Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA.
  • Herbert C; Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, USA.
  • Pretz C; Division of Health System Science, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA.
  • Stamegna P; Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA.
  • Filippaios A; Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA.
  • Shi Q; Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA.
  • Suvarna T; Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA.
  • Harman E; Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA.
  • Schrader S; Division of Health System Science, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA.
  • Nowak C; University of Massachusetts Center for Clinical and Translational Science, University of Massachusetts Chan Medical School, Worcester, MA, USA.
  • Schramm E; CareEvolution, LLC, Ann Arbor, MI, USA.
  • Kheterpal V; CareEvolution, LLC, Ann Arbor, MI, USA.
  • Behar S; CareEvolution, LLC, Ann Arbor, MI, USA.
  • Tarrant S; CareEvolution, LLC, Ann Arbor, MI, USA.
  • Ferranto J; CareEvolution, LLC, Ann Arbor, MI, USA.
  • Hafer N; CareEvolution, LLC, Ann Arbor, MI, USA.
  • Robinson M; Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA.
  • Achenbach C; Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA.
  • Murphy RL; Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA.
  • Manabe YC; University of Massachusetts Center for Clinical and Translational Science, University of Massachusetts Chan Medical School, Worcester, MA, USA.
  • Gibson L; Division of Infectious Disease, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • Barton B; Division of Infectious Disease, Department of Medicine, Havey Institute for Global Health, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
  • O'Connor L; Division of Infectious Disease, Department of Medicine, Havey Institute for Global Health, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
  • Fahey N; Division of Infectious Disease, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • Orvek E; Division of Infectious Disease, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA.
  • Lazar P; Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, USA.
  • Ayturk D; Department of Emergency Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA.
  • Wong S; Department of Pediatrics, University of Massachusetts Chan Medical School, Worcester, MA, USA.
  • Zai A; Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, USA.
  • Cashman L; Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, USA.
  • Rao LV; Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, USA.
  • Luzuriaga K; Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, USA.
  • Lemon S; Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, USA.
  • Blodgett A; Quest Diagnostics, Marlborough, MA, USA.
  • Trippe E; Quest Diagnostics, Marlborough, MA, USA.
  • Barcus M; University of Massachusetts Center for Clinical and Translational Science, University of Massachusetts Chan Medical School, Worcester, MA, USA.
  • Goldberg B; Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, USA.
  • Roth K; University of Massachusetts Center for Clinical and Translational Science, University of Massachusetts Chan Medical School, Worcester, MA, USA.
  • Stenzel T; 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.
  • Heetderks W; 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.
  • Broach J; 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.
  • McManus D; 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.
J Clin Transl Sci ; 7(1): e120, 2023.
Article en En | MEDLINE | ID: mdl-37313378
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.
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Texto completo: 1 Banco de datos: MEDLINE Tipo de estudio: Observational_studies / Risk_factors_studies Idioma: En Año: 2023 Tipo del documento: Article
Texto completo
Imprimir
XML
PubMed Links
Search on Google

Texto completo: 1 Banco de datos: MEDLINE Tipo de estudio: Observational_studies / Risk_factors_studies Idioma: En Año: 2023 Tipo del documento: Article