Commission issues guidelines on coronavirus testing

As part of the European Roadmap towards lifting coronavirus containment measures, the Commission presented guidelines on coronavirus testing methodologies.

The guidance aims to support Member States in effectively using testing tools in the context of their national strategies and during the different stages of the pandemic, including when phasing out confinement measures. The Commission also aims to ensure that high-quality tools are available to assess the performance of the tests.

Stella Kyriakides, Commissioner for Health and Food Safety, said: “The capacity to perform large-scale testing is key to detecting and slowing down the coronavirus pandemic and is a crucial pre-condition for a gradual return to our normal way of life. The main priority for us all is to fight the virus and protect our citizens from further exposure and infection, and to do so, we need to know where the virus is. This is a cornerstone of our roadmap towards lifting coronavirus containment measures.”

The availability of reliable data over time is key to lifting containment measures. In order to achieve this, there needs to be sufficient monitoring of the progression of the coronavirus pandemic, including through large-scale testing.

In its guidelines, the Commission calls on manufacturers to produce “state of the art” testing kits. Although the science relating to testing is still evolving rapidly, this obligation is important as the information provided by these test kits is used for crucial public health decisions.

Given the importance of tests in the current situation and the rapid development of the pandemic, the Commission is also insisting on pooling resources for the validation of coronavirus tests at EU-level. It is important to centralise the validation and to share the results at the EU and international level.

In order to ensure the highest possible testing quality, make sure that tests are correctly used and further align the evaluation and validation of test device performance, the Commission is proposing to launch the following actions in the coming weeks:

• an assessment of common approaches in national strategies;
• the sharing of information on the performance of tests;
• the establishment of a network of coronavirus reference laboratories across the EU to facilitate the exchange of information, and the management and distribution of control samples;
• the drafting of further guidance on performance evaluation and conformity assessment following additional dialogue with the industry and national competent authorities;
• making available tools for assessment of performance, such as reference materials and common methods for the comparison of devices;
• the fight against counterfeit devices through international cooperation and cooperation between Member States’ authorities;
• the coordination of supply and demand by EU instruments such as the Clearing House, rescEU and joint procurement;
• solidarity between Member States by ensuring a fair distribution of available stocks and laboratory equipment focussing on where they are most needed.

Original source: European Commission
Published on 15 April 2020