. 2023 May 10;7(1):e120.

doi: 10.1017/cts.2023.540. eCollection 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^#^{1

2

3}, Carly Herbert^#¹, Caitlin Pretz¹, Pamela Stamegna¹, Andreas Filippaios¹, Qiming Shi^{1

3

4}, Thejas Suvarna⁵, Emma Harman⁵, Summer Schrader⁵, Chris Nowak⁵, Eric Schramm⁵, Vik Kheterpal⁵, Stephanie Behar¹, Seanan Tarrant¹, Julia Ferranto¹, Nathaniel Hafer⁴, Matthew Robinson⁶, Chad Achenbach⁷, Robert L Murphy⁷, Yukari C Manabe⁶, Laura Gibson⁸, Bruce Barton², Laurel O'Connor⁹, Nisha Fahey¹⁰, Elizabeth Orvek², Peter Lazar², Didem Ayturk², Steven Wong², Adrian Zai², Lisa Cashman¹¹, Lokinendi V Rao¹¹, Katherine Luzuriaga⁴, Stephenie Lemon², Allison Blodgett⁴, Elizabeth Trippe¹², Mary Barcus¹², Brittany Goldberg¹², Kristian Roth¹², Timothy Stenzel¹³, William Heetderks¹⁴, John Broach⁹, David McManus^{1

3

15}

Affiliations

¹ Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA.
² Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, USA.
³ Division of Health System Science, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA.
⁴ University of Massachusetts Center for Clinical and Translational Science, University of Massachusetts Chan Medical School, Worcester, MA, USA.
⁵ CareEvolution, LLC, Ann Arbor, MI, USA.
⁶ Division of Infectious Disease, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
⁷ Division of Infectious Disease, Department of Medicine, Havey Institute for Global Health, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
⁸ Division of Infectious Disease, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA.
⁹ Department of Emergency Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA.
¹⁰ Department of Pediatrics, University of Massachusetts Chan Medical School, Worcester, MA, USA.
¹¹ Quest Diagnostics, Marlborough, MA, USA.
¹² 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.
¹³ OHT7 Office of Product Evaluation and Quality, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA.
¹⁴ National Institute of Biomedical Imaging and Bioengineering, NIH, Via Contract with Kelly Services, Bethesda, MD, USA.
¹⁵ Division of Cardiology, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA.

^# Contributed equally.

PMID: 37313378
PMCID: PMC10260333
DOI: 10.1017/cts.2023.540

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

Apurv Soni et al. J Clin Transl Sci. 2023.

. 2023 May 10;7(1):e120.

doi: 10.1017/cts.2023.540. eCollection 2023.

Authors

Affiliations

¹ Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA.
² Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, USA.
³ Division of Health System Science, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA.
⁴ University of Massachusetts Center for Clinical and Translational Science, University of Massachusetts Chan Medical School, Worcester, MA, USA.
⁵ CareEvolution, LLC, Ann Arbor, MI, USA.
⁶ Division of Infectious Disease, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
⁷ Division of Infectious Disease, Department of Medicine, Havey Institute for Global Health, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
⁸ Division of Infectious Disease, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA.
⁹ Department of Emergency Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA.
¹⁰ Department of Pediatrics, University of Massachusetts Chan Medical School, Worcester, MA, USA.
¹¹ Quest Diagnostics, Marlborough, MA, USA.
¹² 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.
¹³ OHT7 Office of Product Evaluation and Quality, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA.
¹⁴ National Institute of Biomedical Imaging and Bioengineering, NIH, Via Contract with Kelly Services, Bethesda, MD, USA.
¹⁵ Division of Cardiology, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA.

^# Contributed equally.

PMID: 37313378
PMCID: PMC10260333
DOI: 10.1017/cts.2023.540

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: Covid-19; digital trial; point-of-care diagnostics; rapid antigen tests; study recruitment.

PubMed Disclaimer

Conflict of interest statement

VK is principal, and TS, SS, CN, ES, and EH are employees of the health care technology company CareEvolution, which was contracted to configure the smartphone study app, provide operational and logistical support, and collaborate on overall research approach. LS and LR are employees of Quest Diagnostics LLC, which was contracted to provide direct-to-consumer kits, logistical support for nationwide RT-PCR testing, and operational support for producing molecular testing results. DDM reports consulting and research grants from Bristol-Myers Squibb and Pfizer, consulting and research support from Fitbit, consulting, and research support from Flexcon, research grant from Boehringer Ingelheim, consulting from Avania, non-financial research support from Apple Computer, consulting/other support from Heart Rhythm Society. YCM has received tests from Quanterix, Becton-Dickinson, Ceres, and Hologic for research-related purposes, consults for Abbott on subjects unrelated to SARS-CoV-2, and receives funding support to Johns Hopkins University from miDiagnostics. LG is on a scientific advisory board for Moderna on projects unrelated to SARS-CoV-2. AS receives non-financial support from CareEvolution for collaborative research activities. Additional authors declare no financial or nonfinancial competing interests.

Figures

**Figure 1.**
Weekly test us at home study enrollment.

**Figure 2.**
CONSORT diagram of test us at home.

**Figure 3.**
Test us at home enrollment by state and month, October 2021–January 2022.

See this image and copyright information in PMC

Update of

Finding a Needle in a Haystack: Design and Implementation of a Digital Site-less Clinical Study of Serial Rapid Antigen Testing to Identify Asymptomatic SARS-CoV-2 Infection.
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 RL, Manabe YC, Gibson L, 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, Trippe E, Barcus M, Goldberg B, Roth K, Stenzel T, Heetderks W, Broach J, McManus D. Soni A, et al. medRxiv [Preprint]. 2023 Jan 23:2022.08.04.22278274. doi: 10.1101/2022.08.04.22278274. medRxiv. 2023. Update in: J Clin Transl Sci. 2023 May 10;7(1):e120. doi: 10.1017/cts.2023.540. PMID: 35982663 Free PMC article. Updated. Preprint.

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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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

Update of

References

Grants and funding

LinkOut - more resources

Full Text Sources

Miscellaneous