Timely and accurate laboratory testing is an essential part of tackling the COVID-19 pandemic. A survey of 47 laboratories in 30 EU and European Economic Area (EEA) countries, published in mid-February 2020, identified a lack of positive control materials as one of the top three challenges faced by the laboratories for the reliable implementation of coronavirus tests. On 1st April 2020 it was announced that scientists at the European Commission’s Joint Research Centre (JRC) - which is one of the major developers and producers of reference materials in the world - had designed a positive control material to facilitate the quality control of the detection of SARS-CoV-2 (the virus strain that causes COVID-19) in testing laboratories.
In practice, the JRC-designed control material is a synthetic, non-infectious part of the virus, which allows companies producing coronavirus tests and testing laboratories to check their testing kits: if their test does not detect the control material, it will not detect the real virus either. The control material will enable the harmonisation of coronavirus tests in Europe, ensuring their high quality to avoid false negatives. Because the new control material is based on the part of the virus that has remained stable after the virus has mutated, it is fully compatible with the official methods to detect the presence of SARS-CoV-2 that are recommended by the Word Health Organization and applied in the EU, Asia and the USA. The material can also be used to benchmark and validate the numerous test kits currently developed worldwide.
The control material was manufactured by a German biotech company based on a JRC design, and then validated by JRC laboratory experts. Initially 3000 samples were prepared, to be dispatched to testing laboratories across the EU, including the major reference virology centres as well as hospitals. The 3000 samples are highly concentrated, making it possible to check up to 60 million tests in the EU. Samples will also be made available to the wider EU testing community, with priority given to government-appointed laboratories, as well as the research community.
This news item is based a press release of the European Commission on 1 April 2020 (see web-link below).
European Commission, Joint Research Centre (JRC)
CAPTION FOR FIGURE: [ The new control material, which will enable the verification of up to 60 million coronavirus laboratory tests throughout the EU, was developed in the laboratories of the European Commission’s Joint Research Centre (JRC) in Geel, Belgium. ©EU 2020 ]