Self-test received notified body approved CE marking on April 1, 2021 A home test for the rapid qualitative detection of SARS-CoV-2 virus antigen in anterior nasal swabs within 7 days of symptom onset Performance Characteristics Sample type: nasal swab Time to result: 15-20 min Sensitivity: 96.77% Specificity: 99.20% Accuracy: 98.72% Layperson study statistics: o 99.10% of non-professionals carried out the test without requiring assistance o 97.87% of different types of results were interpreted correctly Kit Components: 1 Rapid SARS-CoV-2 Antigen Test Card (sealed foil pouch) 1 sterilized swab 1 extraction tube 1 sample extraction buffer IFU 1 tube stand
