Coronavirus Ag Rapid Test Cassette (Swab)
have been placed on the European Market, based on the following performance characteristics (which are also included in the IFU included in each test kit)

Coronavirus Ag Rapid Test Cassette (Swab)
Method
Coronavirus Ag Rapid Test Cassette
Total Results
Relative Sensitivity: 86.7% Relative Specificity: 100% Accuracy: 96.3%

Coronavirus Ag Rapid Test Cassette (Swab)
The CE mark has been applied as the products fit the definition of an in vitro diagnostic medical device as defined in the IVD Directive and are classified as a general IVD products as they are not included in List A or List B, and they are not intended to be used by lay users.
Please note that this