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The COVID-19 pandemic continues to pose a major threat to public health. As outlined in the Commission Communication on short-term EU health preparedness for COVID-19 outbreaks (1), robust testing strategies and sufficient testing capacities are essential aspects of preparedness and response to COVID-19, allowing for early detection of potentially infectious individuals and providing visibility on infection rates and transmission within communities. Moreover, they are a prerequisite to adequate contact tracing to limit the spread through prompt isolation.

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In line with Article 168(7) of the Treaty on the Functioning of the European Union (2), the definition of health policy as well as the organisation and delivery of health measures remain a national competence. EU Member States are thus responsible for deciding on the development and implementation of COVID-19 testing strategies, taking into consideration countries’ epidemiological and social situations.

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In 2013, the EU adopted Decision No 1082/2013/EU of the European Parliament and of the Council (3) in order to improve preparedness and capacities across Europe and to strengthen its capacity to monitor, rapidly detect and coordinate responses to health threats. Together with Decision No 1082/2013/EU, various tools (4) were launched to support and coordinate Member States’ response planning and actions when faced with cross-border health threats.

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A crucial element in the coordination of public health crises of Union relevance is the Health Security Committee (HSC). Its role is to reinforce the coordination of and sharing of best practice and information national preparedness and response planning, to promote the interoperability and intersectoral dimension of such activities, and to establish a mechanism for joint procurement of medical countermeasures.

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On 15 July 2020, the Commission adopted the Commission Communication on short-term EU health preparedness (5), which aims at ensuring the EU’s short-term health preparedness in case of further COVID-19 outbreaks in Europe. One of the action areas included in this Communication is to achieve, via the HSC, EU level agreement for aligned testing strategies and methodologies.

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The Council adopted a Recommendation on the gradual lifting of the temporary restrictions on non-essential travel into the EU on 30 June (6). This was done on the basis of a set of principles and objective criteria, including the health situation, the ability to apply containment measures during travel, reciprocity considerations and data from relevant sources such as the European Centre for Disease Prevention and Control (ECDC) and the World Health Organization (WHO).

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The Health Security Committee reached an agreement on 17 September 2020 on ‘EU health preparedness: Recommendations for a common EU testing approach for COVID-19’ (7), setting out various actions for consideration by countries when updating or adapting their testing strategies. The Recommendations aim to achieve an agreement on a coherent approach to COVID-19 testing across Europe. Its content is based on the situation in European countries early September 2020 and the respective testing strategies and objectives implemented at that moment.

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Member States should aim to avoid any travel bans. To safeguard the freedoms under the single market, any limitations should be applied in compliance with the general principles of Union law, in particular proportionality and non-discrimination, and should not extend beyond what is strictly necessary to safeguard public health.

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On 13 October 2020, the Council adopted a Recommendation on a coordinated approach to the restriction of free movement in response to the COVID-19 pandemic (8), which sets out, among others, more clarity on the measures applied to travellers from higher-risk areas (testing and self-quarantine) providing clear and timely information to the public.

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Effective testing plays a key role in ensuring the free movement of people and allowing the smooth functioning of the internal market. Since the outbreak of the COVID-19 pandemic, the field of diagnostic testing has been rapidly evolving and has underpinned the central role it plays in outbreak control. Recognising the importance of diagnostic tests, the EU is supporting its development through a number of EU Research and Innovation actions1. The accurate use of COVID-19 testing, in high volumes and by ensuring a rapid turn-around-time between the test request and result plays a significant role in reducing the spread of SARS-CoV-2. Currently, the most reliable methodology for testing of cases and contacts is the RT-PCR (reverse transcription polymerase chain reaction) based testing approach; such tests were among the earliest available when the pandemic reached the European continent.

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However, while RT-PCR testing rates have increased across the EU, resulting in the identification of more COVID-19 positive cases, particularly among younger individuals who are showing mild symptoms or who are asymptomatic, laboratories are struggling to ensure that sufficient resources and capacities are in place to keep up with demands. Consequently, this has resulted in shortages of RT-PCR testing materials and longer testing turn-around-times, thereby limiting the effective implementation of mitigation measures as well as swift contact tracing. To mitigate these shortages, the Commission has organised a Joint Procurement of Laboratory equipment on 19 March already, including testing kits and reagents for RT-PCR tests, in which 20 Member States participated.

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Despite the implementation of this Joint Procurement, Member States are faced again with problems of limited testing capacities and high testing turn-around-times, particularly in the current epidemiological context where Europe is experiencing a resurge in COVID-19 positive cases. In this context, Member States are increasingly turning to the possibility of using rapid or point of care tests (e.g. antigen tests), mostly in medical settings, and exploring their wider use. This new generation of faster and cheaper COVID-19 tests, allowing for a test result in often less than 30 minutes, are increasingly hitting the market.

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The WHO published on 11 September 2020 interim guidance on the use of rapid antigen tests for COVID-19 detection (9), offering countries with advice on the potential role played by these tests and the need for careful test selection. As stressed by WHO, while the rapid antigen tests may offer helpful solutions for the diagnosis of SARS-CoV-2 infection in a range of settings and scenarios, their clinical performance is not (yet) optimal and caution should be exercised.

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Among existing models, WHO recommends the use of rapid antigen tests that meet the minimum performance requirements of ≥ 80 % sensitivity and ≥ 97 % specificity, and should in particular be used when the availability of RT-PCR tests is temporarily limited or where prolonged turn-around-times preclude clinical utility. The use of rapid antigen tests for screening of individuals offers the potential for rapid identification of those individuals at greatest risk of spreading the infection, particularly in circumstances of high community transmission. Moreover, rapid antigen testing should be conducted by trained operators, in accordance with the manufacturer’s instructions and within the first 5-7 days following the onset of symptoms when viral loads are at their peak.

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Several Member States (10) have started to use rapid antigen tests in practice and have included their use in their national COVID-19 testing strategies. Additionally, the majority of Member States is currently carrying out validation studies or pilots to assess the clinical performance of rapid antigen tests in specific settings and for the diagnosis of SARS-CoV-2 infection among certain target populations. The Health Security Committee agreed at its meeting on 19 October 2020 that it will develop a common position on the use of rapid antigen tests, addressing, amongst other elements, the application of these tests and the use of their results.

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Particularly in the context of incoming travellers at airports, the use of rapid antigen tests has been assessed by the EU Healthy Gateways Joint Action (11). It provides, amongst others, an analysis of options for laboratory testing methods, the timing of testing of travellers, resources needed and practical arrangements at airports. This may also be relevant for travellers using other transport means.

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Moreover, the Commission recently requested the European Centre for Disease Prevention and Control (ECDC) and the European Union Aviation Safety Agency (EASA) to develop a protocol for safer air travel, including a proposal for a common EU Health Safety testing protocol at airports. The protocol should include elements such as timing of tests, target population, types of test and possible implementation at airports, and could be further expanded to cover other transport modes. The development of testing strategies, based on validated technologies for the specific context and on available capacities, should also inform approaches on quarantine or other restrictions, e.g. the mutual recognition of test results could adequately mitigate the risk of case importation to a level equivalent to or below the prevailing risk within the destination region and therefore lead to lifting of quarantine or other restrictions

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The development of testing strategies, based on validated technologies and available capacities, should also inform an EU policy on quarantine. The Commission has tasked the European Centre for Disease Prevention and Control (ECDC) to provide scientific guidance on quarantines with the view to proposing a European approach,