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. 2022 Oct 18;6(10):e35426.
doi: 10.2196/35426.

Feasibility of At-Home Serial Testing Using Over-the-Counter SARS-CoV-2 Tests With a Digital Smartphone App for Assistance: Longitudinal Cohort Study

Carly Herbert  1 , John Broach  2   3 , William Heetderks  4 , Felicia Qashu  5 , Laura Gibson  6 , Caitlin Pretz  1 , Kelsey Woods  1 , Vik Kheterpal  7 , Thejas Suvarna  7 , Christopher Nowak  7 , Peter Lazar  8 , Didem Ayturk  8 , Bruce Barton  8 , Chad Achenbach  9 , Robert Murphy  9 , David McManus  1   10 , Apurv Soni  1   8
Affiliations

Feasibility of At-Home Serial Testing Using Over-the-Counter SARS-CoV-2 Tests With a Digital Smartphone App for Assistance: Longitudinal Cohort Study

Carly Herbert et al. JMIR Form Res. .

Abstract

Background: The ongoing SARS-CoV-2 pandemic necessitates the development of accurate, rapid, and affordable diagnostics to help curb disease transmission, morbidity, and mortality. Rapid antigen tests are important tools for scaling up testing for SARS-CoV-2; however, little is known about individuals' use of rapid antigen tests at home and how to facilitate the user experience.

Objective: This study aimed to describe the feasibility and acceptability of serial self-testing with rapid antigen tests for SARS-CoV-2, including need for assistance and the reliability of self-interpretation.

Methods: A total of 206 adults in the United States with smartphones were enrolled in this single-arm feasibility study in February and March 2021. All participants were asked to self-test for COVID-19 at home using rapid antigen tests daily for 14 days and use a smartphone app for testing assistance and to report their results. The main outcomes were adherence to the testing schedule, the acceptability of testing and smartphone app experiences, and the reliability of participants versus study team's interpretation of test results. Descriptive statistics were used to report the acceptability, adherence, overall rating, and experience of using the at-home test and MyDataHelps app. The usability, acceptability, adherence, and quality of at-home testing were analyzed across different sociodemographic, age, and educational attainment groups.

Results: Of the 206 enrolled participants, 189 (91.7%) and 159 (77.2%) completed testing and follow-up surveys, respectively. In total, 51.3% (97/189) of study participants were women, the average age was 40.7 years, 34.4% (65/189) were non-White, and 82% (155/189) had a bachelor's degree or higher. Most (n=133/206, 64.6%) participants showed high testing adherence, meaning they completed over 75% of the assigned tests. Participants' interpretations of test results demonstrated high agreement (2106/2130, 98.9%) with the study verified results, with a κ score of 0.29 (P<.001). Participants reported high satisfaction with self-testing and the smartphone app, with 98.7% (157/159) reporting that they would recommend the self-test and smartphone app to others. These results were consistent across age, race/ethnicity, and gender.

Conclusions: Participants' high adherence to the recommended testing schedule, significant reliability between participants and study staff's test interpretation, and the acceptability of the smartphone app and self-test indicate that self-tests for SARS-CoV-2 with a smartphone app for assistance and reporting is a highly feasible testing modality among a diverse population of adults in the United States.

Keywords: COVID-19; MyDataHelps smartphone app; SARS-CoV-2; digital health; mHealth; mobile health; pandemic; rapid tests; self test; serial self-testing.

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Conflict of interest statement

Conflicts of Interest: CN and VK are employees of CareEvolution. DM has received personal fees and grants from Bristol Myers Squibb, Pfizer, Flexcon, and Fitbit; personal fees for editorial work from Heart Rhythm Society and from Avania for work on Data Safety Monitoring Boards; financial research support from Boehringer Ingelheim; and non-financial research support from Apple, Samsung, and Fitbit.

Figures

Figure 1
Figure 1
Usability and acceptability of self-tests.
Figure 2
Figure 2
Participants’ willingness to recommend smartphone app to others.
Figure 3
Figure 3
Participants’ interest in continuing to use the smartphone app after the study period.
Figure 4
Figure 4
Participants’ overall rating of the smartphone app.
Figure 5
Figure 5
Word cloud of participant interactions with study coordinators.
See this image and copyright information in PMC

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