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 from individuals with or without symptoms or other
epidemiological reasons to suspect COVID-19

Performance Characterisitics
Sample tyep: nasal swab Time to result: 15-20 minutes
Sensitivity: 97.70% Specificity: 99.84% Accuracy:98.97%
Layperson study statistics
99.84% of non-professionals carried out the test without requiring assistance
99.82% of different types of results were interpreted correctly.

Specifications
1 Test/kit
Catalog No.: 1N40C5-2
Kit components:
1 Rapid SARS-CoV-2
Antigen Test Card (sealed foil pouch)
1 sterilized swab
1 extraction tube
1 sample extraction buffer
IFU
Tube holder on back of box

5 Tests/Kit
Catalog No.: 1N40C5-4
Kit components:
5 Rapid SARS-Cov-2
Antigen Test Card (sealed foil pouch)
5 Sterilized swabs
5 extraction tubes
5 sample extraction buffer
IFU
1 tube stand

20 Tests/Kit
Catalog No.: 1N40C5-6
Kit components:
20 Rapid SARS-Cov-2
Antigen Test Card (sealed foil pouch)
20 Sterilized swabs
20 extraction tubes
20 sample extraction buffer
IFU
1 tube stand