RE: Surescreen rejected15 Aug 2021 16:12
Thanks Energy.
Key points from: COUNCIL RECOMMENDATION
on a common framework for the use and validation of rapid antigen tests and the mutual recognition of COVID-19 test results in the EU
(2021/C 24/01)
- While cheaper and faster, rapid antigen tests have generally a lower test sensitivity than RT-PCR.
- Under the Regulation, rapid antigen tests will be subject to reinforced requirements on device performance and a thorough assessment by a notified body
- Effective testing contributes to the smooth functioning of the Internal Market as it allows for targeted isolation or quarantine measures
- Have been validated by at least one Member State as being appropriate for their use in the context of COVID-19, providing details on the methodology and results of such studies, such as the sample type used for validation, the setting in which the use of the test was assessed