LAUSR

Background One strategy for reducing spread of COVID-19 is to contain the infection with broad screening, isolate infected individuals, and trace 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 to 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% 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 out of every three participants preferred self-RADT over PCR test. Conclusion Self-performed RADTs were reliable, user acceptable, and safe among laypeople as supplement to professionally collected oropharyngeal PCR testing.