Accuracy of Rapid Antigen Testing across SARS-CoV-2 Variants

Variants of SARS-CoV-2 have mutations in the viral genome that may alter the accuracy of rapid diagnostic tests. We conducted analytical and clinical accuracy studies of two FDA-approved rapid antigen tests—SCoV-2 Ag Detect™ Rapid Test (InBios International, Seattle) and BinaxNOW™ COVID-19 Ag CARD; (Abbott Laboratories, Chicago)—using three using replication-competent variants or strains, including Omicron (B.1.1.529/BA.1), Delta (B.1.617.2), and a wild-type of SARS-CoV-2 (USA-WA1/2020). Overall, we found non-significant differences in the analytical limit of detection or clinical diagnostic accuracy of rapid antigen testing across SARS-CoV-2 variants. This study provides analytical and clinical performance data to demonstrate the preserved accuracy of rapid antigen testing across SARS-CoV-2 variants among symptomatic adults.