Finding a Needle in the Haystack: Design and Implementation of a Digital Site-less Clinical Study of Serial Rapid Antigen Testing to Identify Asymptomatic SARS-CoV-2 Infection [preprint]
Authors
Soni, ApurvHerbert, 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, Rob
Manabe, Yuka
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 C.
Blodgett, Allison
Heetderks, William
Broach, John
McManus, David
UMass Chan Affiliations
Center for Clinical and Translational ScienceEmergency Medicine
Medicine
Morningside Graduate School of Biomedical Sciences
Pediatrics
Population and Quantitative Health Sciences
Document Type
PreprintPublication Date
2022-08-05Keywords
Infectious Diseases (except HIV/AIDS)SARS-CoV-2 Infection
Serial Rapid Antigen Testing
Asymptomatic
UMCCTS funding
Metadata
Show full item recordAbstract
Background: Over-the-counter rapid antigen tests for SARS-CoV-2 with an Emergency Use Authorization (EUA) in the United States generally include a condition of authorization to evaluate the test's performance in asymptomatic individuals when used serially. A goal of this study was to investigate the performance of SARS-CoV-2 antigen serial testing and generate data to support regulatory decisions. Objective: To describe a novel study design to evaluate serial use of rapid antigen tests in detecting SARS-CoV-2 virus among asymptomatic individuals. Design: Prospective cohort study using a decentralized approach. Eligible participants from across the U.S. could enroll and complete this study from their home environment through a study app. Participant enrollment was prioritized based on regional 7-day case rates, participants' vaccination status, and sociodemographic characteristics prior to enrollment.Prioritization criteria were adjusted on a daily or weekly basis. Enrolled participants were mailed rapid antigen tests and molecular comparator collection kits and asked to test every 48 hours for 15 days. Three companies' rapid antigen tests were used in the study; assignment of participant to a test was criteria-based and non-random, precluding head-to-head comparison between the tests. Participants: Mainland United States residents over 2 years old with no reported COVID-19 symptoms in the 14 days prior to study enrollment. Main measures: Participant demographics, COVID-19 vaccination status, and geographic distribution were used to understand the impact of the site-less recruitment and enrollment strategy. Key results: A total of 7,361 participants enrolled in the study between October 18, 2021 and February 15, 2022. Throughout the study, 369 participants tested positive for SARS-CoV-2, including 167 who were asymptomatic and tested negative on SARS-CoV-2 molecular assays to start the study. This exceeded the initial enrollment goals of 60 positive participants. We enrolled participants from 44 of the 48 mainland U.S. states, and geographic distribution of participants shifted in accordance with the changing COVID-19 prevalence nationwide. Conclusions: The novel, 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.Source
Soni A, Herbert C, Pretz C, Stamegna P, Filippaios A, Shi Q, Suvarna T, Harman E, Schrader S, Nowak C, Schramm E, Kheterpal V, Behar S, Tarrant S, Ferranto J, Hafer N, Robinson M, Achenbach C, Murphy R, Manabe Y, Barton B, O'Connor L, Fahey N, Orvek E, Lazar P, Ayturk D, Wong S, Zai A, Cashman L, Rao LV, Luzuriaga K, Lemon S, Blodgett A, Heetderks W, Broach J, McManus D. Finding a Needle in the Haystack: Design and Implementation of a Digital Site-less Clinical Study of Serial Rapid Antigen Testing to Identify Asymptomatic SARS-CoV-2 Infection. medRxiv [Preprint]. 2022 Aug 5:2022.08.04.22278274. doi: 10.1101/2022.08.04.22278274. PMID: 35982663; PMCID: PMC9387154.DOI
10.1101/2022.08.04.22278274Permanent Link to this Item
http://hdl.handle.net/20.500.14038/51337PubMed ID
35982663Notes
This article is a preprint. Preprints are preliminary reports of work that have not been certified by peer review.Rights
The 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.ae974a485f413a2113503eed53cd6c53
10.1101/2022.08.04.22278274