SARS-CoV-2 Rapid Antigen Test Nasal

• Rapid chromatographic immunoassay for the qualitative detection of the nucleocapsid protein of SARS-CoV-2 present in human nasal specimens


• In clinical studies, the SARS-CoV-2 Rapid Antigen Test Nasal showed a relative sensitivity of 90.6% (Ct value ≤ 30; 95 % CI: 75.0 % – 98.0 %) and a specificity of 98.6% for professionally collected samples


• For self-collected samples, a sensitivity of 84.4 % (Ct value ≤ 30; 95 % CI: 67.2 % – 94.7 %) and a specificity of 99.2% was detected


• Overall, the studies contained 468 symptomatic and asymptomatic individuals


• Test is intended to detect antigen from SARS-CoV-2 in individuals suspected of COVID-19 or with known or suspected exposure to SARS-CoV-2