RE: Avacta PR company one of the best in the World7 Jun 2021 15:08
I think so and tbh even when the Europe registration comes, the market is now looking for more detail on cost/orders/capacity etc before the real rerate comes.
The below wording form that doc shows just how important the Spain work was as that's the ticket to meeting the criteria of c)
" A common list of COVID-19 rapid antigen tests that are considered appropriate for
use in the context of the situations described in the Council Recommendation, that are
in line with countries’ testing strategies and that:
a. carry CE marking;
b. meet the minimum performance requirements of = 90% sensitivity and = 97%
specificity; and
c. 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, and whether any difficulties occurred
as regards the required sensitivity criteria or other performance elements."