Large-scale testing for COVID-19 is necessary to monitor the spread of the coronavirus and prevent further transmissions. The Commission’s recommendation for a common COVID-19 testing approach in Europe follows its communication on Short-Term EU Health Preparedness for COVID-19 Outbreaks.
On 18 December 2020, the Commission signed a framework contract with Abbott and Roche for the purchase of over 20 million rapid antigen tests. The tests were distributed to all EU countries.
The Commission has adopted a recommendation on COVID-19 testing strategies, including the use of rapid antigen tests. It sets out key elements to be considered for national, regional or local testing strategies such as:
- their scope
- priority groups
- key points linked to testing capacities and resources
- indications as to when rapid antigen testing may be appropriate
Rapid antigen tests
Given the diversity of tests available, the recommendation provides guidance, based on World Health Organisation guidelines, on criteria to select rapid antigen tests. They should meet the minimum requirements of 80% sensitivity and 97% specificity.
The EU Health Security Committee has agreed on a common list of COVID-19 rapid antigen tests that Member States mutually recognise, as well as a common standardised set of data to be included in COVID-19 test result certificates. This framework, called for by the Council Recommendation of 21 January 2021, is continuously reviewed and updated. Manufacturers can submit data on rapid antigen tests available on the market to be included in the list.
The European Centre for Disease Prevention and Control (ECDC) has published technical guidance on COVID-19 self-tests, including details on their availability and possible impacts on the implementation of prevention and control measures, and their clinical performance compared to the “gold standard” RT-PCR tests.
Validation of tests
The Commission has published guidelines on coronavirus test methodologies to support EU countries in their national containment strategies.
The In Vitro Diagnostic Devices and Test Methods Database collects all publicly available information on performance of CE-marked in vitro diagnostic medical devices as well as in-house laboratory-developed devices and related test methods for COVID-19.
Tracking the virus and its variants
In order to track variants of the virus, a number of positive tests is submitted for more detailed examination via genome sequencing. EU countries are encouraged to sequence at least 5% and preferably 10% of positive test results. Based on reported sequencing data, ECDC prepares overviews of variants of interest and variants of concern in the EU and EEA.
Another way of tracking the virus and its variants is monitoring wastewater.
On 17 March 2021, the Commission adopted a recommendation asking the Member States to put in place wastewater monitoring to track COVID-19 and its variants, share the data with competent health authorities for early detection of the presence of the virus, and identify clusters.
National contact tracing and warning apps
National contact tracing and warning apps can be voluntarily installed and used to warn users if they have been in the proximity of a person who is reported to have tested positive for coronavirus. In the case of an alert, the app may provide relevant information from health authorities, such as advice to get tested or to self-isolate, and who to contact.