Diagnostic performance, user acceptability, and safety of unsupervised SARS-CoV-2 rapid antigen-detecting tests performed at home

Abstract

Background: One strategy for reducing spread of COVID-19 is to contain the infection with broad screening, isolating infected individuals, and tracing contacts. This strategy requires widely available, reliable SARS-CoV-2 testing. To increase testing, rapid antigen detection tests (RADTs) were developed for self-sampling, self-testing, and self-interpretation. This study examined diagnostic performance, user acceptability, and safety of nasal self-RADTs compared with polymerase chain reaction (PCR) testing.

Methods: Self-RADT kits were distributed at a public COVID-19 test center in Aarhus, Denmark or delivered to participants. Participants reported test results and test preferences. During enrollment, participants reported occurrence and duration of symptoms consistent with COVID-19. Sensitivity and specificity of self-RADT, relative to oropharyngeal PCR testing, were calculated.

Results: Among 827 participants, 102 showed positive PCR test results. Sensitivities of the self-RADTs were 65.7% (95% confidence interval [CI]: 49.2-79.2; DNA Diagnostic) and 62.1% (95% CI: 50.1-72.9; Hangzhou), and specificities were 100% (95% CI: 99.0-100; DNA Diagnostic) and 100% (95% CI: 98.9-100; Hangzhou). The sensitivities of both self-RADTs appeared higher in symptomatic participants than in asymptomatic participants. Two of every 3 participants preferred self-RADT over PCR test.

Conclusion: Self-performed RADTs were reliable, user-acceptable, and safe among laypeople as a supplement to professionally collected oropharyngeal PCR testing.

Keywords: Antigen test; COVID-19; Diagnostics; Rapid test; SARS-CoV-2; Self-testing.