Comparative Performance of a Rapid SARSCoV-2 Antigen Test with RT-PCR for the Diagnosis of COVID-19

Background: The aim of this study was to estimate the diagnostic precision of the rapid COVID-19 antigen test DyonCovid-Ag compared to the gold standard method Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) for the diagnosis of SARS-CoV-2 infection. Methods: This prospective cohort study examined samples from non-hospitalized adults and children with possible SARS-CoV-2 infection from 01/2021–12/2021. The samples were double tested using the rapid SARS-CoV-2 antigen test DyonCovid-Ag and an RT-qPCR for SARS-CoV-2. Demographic data and clinical symptoms were also collected. Results: A total of 782 individuals with median age 36.6 years (IQR: 28-48) were included in this study. The positivity for SARS-CoV-2 was 128/782 (16.4%) with RT-qPCR and 123/782 (15.7%) with RAT. The concordance of positive samples between two methods was high (123/128, 96.1%), with only five false negative but no false positive results. The sensitivity and specificity of the RAT were estimated at 96.1% (95%CI: 91.1-98.7%) and 100% (95%CI: 99.4-100.0%), respectively. Accuracy was estimated at 99.4% (95%CI: 98.5-99.8%). Conclusion: DyonCovid-Ag RAT was highly sensitive and specific and could facilitate timely diagnosis in point-of-care settings.