Findings of Feasibility for Serial Testing Using Over-the-Counter SARS-CoV-2 Test with the Assistance of a Digital Smartphone App (Preprint)

BACKGROUND The ongoing pandemic necessitates the development of accurate, rapid, and affordable diagnostics to help curb SARS-CoV-2 disease transmission, morbidity, and mortality, as well as safely navigate social re-engagement. OBJECTIVE To describe the feasibility and acceptability of serial self-testing for SARS-CoV-2, including need for assistance and reliability of self-interpretation. METHODS A total of 206 adults in the United States with Smartphones were enrolled in this single-arm feasibility study during February and March 2021. All participants were asked to self-test for Covid-19 at home daily using an antigen-detection rapid diagnostic test over a 14-day period and use a smartphone application for testing assistance and to report their results. The main outcomes were adherence to the testing schedule, acceptability of testing and Smartphone application experiences, and reliability of participant versus study team interpretation of test results. RESULTS Among the 206 participants, 52% of study participants were women, the average age was 40.7 years, 34.43% were non-White, and half the sample (56.8%) had received a Bachelor’s degree or higher. Most participants (64.6%) showed high testing adherence. Participants’ interpretations of test results demonstrated high agreement (98.9%) with the study verified results, with a kappa score of 0.29 (p CONCLUSIONS Participant’s high adherence to the recommended testing schedule, significant reliability between participant and study staff test interpretation, and acceptability of the smartphone application and self-test indicate that self-tests for SARS-CoV-2 with a smartphone application for assistance and reporting is highly feasible among a diverse population of adults in the United States.