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