Sensitivity of rapid antigen tests for COVID-19 during the Omicron variant outbreak

Abstract

BackgroundRapid antigen tests have been used to prevent the spread of the coronavirus disease 2019 (COVID-19); however, there have been concerns about their decreased sensitivity to the Omicron variant.AimsIn this study, we compared the sensitivity and specificity of the rapid antigen and the polymerase chain reaction (PCR) tests among the players and staff members of the Japan Professional Football League and clubs. Furthermore, we evaluated the relationship between the sensitivity and the duration from the onset of the symptoms to testing, the manufacturer of the rapid antigen test kits, and the PCR test analyte.Design and methodsThis was a retrospective observational study. We used 656 results from both the rapid antigen and PCR tests for COVID-19 using the analytes collected on the same day from January 12 to March 2, 2022, during the Omicron variant outbreak in Japan.ResultsThe sensitivity of the rapid antigen test compared with the PCR test was 0.63 (95% confidence interval: 0.54–0.72) and the specificity was 0.998 (95% confidence interval: 0.995–1.000). There were no significant associations between the sensitivity and the duration from the onset of the symptoms to testing (including asymptomatic cases in the category), vaccination status, manufacturer of the rapid antigen test kit or PCR analyte (P > 0.05) with small effect sizes (Cramer’s V or φ: ≤ 0.22).ConclusionsEven during the Omicron outbreak, the sensitivity of the rapid antigen tests did not depend on the duration from the onset of the symptoms to testing.

Field assessment of BinaxNOW antigen tests as COVID-19 treatment entry point at a community testing site in San Francisco during evolving omicron surges

“…To date, SARS-CoV-2 antigen assays, despite having lower sensitivity for viral detection than RT-PCR, have proven an important resource for rapid detection of persons with high levels of virus [1]. However, there is heterogeneity in assays, and there have been mixed reports on changes of rapid antigen performance for detection of omicron variants from in vitro and clinical studies [21][22][23][24][25][26][27]. There was even formal recommendations against use of certain antigen tests for omicron detection by the US FDA in 2022 [28].…”

Field assessment of BinaxNOW antigen tests as COVID-19 treatment entry point at a community testing site in San Francisco during evolving omicron surges

“…To date, SARS-CoV-2 antigen assays, despite lower sensitivity than RT-PCR, have proven an important resource for rapid detection of persons with high levels of virus [1]. However, there is heterogeneity in assays, and there have been mixed reports on changes of rapid antigen performance for detection of omicron variants from in vitro and clinical studies [21][22][23][24][25][26][27]. There was even formal recommendations against use of certain antigen tests for omicron detection by the US FDA in 2022 [28].…”