TALLINN – Researchers at the Joint Research Center (JRC) of the European Commission have designed a new control material that laboratories can use to check the correct functioning of their coronavirus tests and to avoid false negatives.
"This is EU science in action when it is needed and where it is needed, to support the EU's response to the current crisis. The JRC quickly identified a potential gap in the management of the coronavirus outbreak and immediately set to work to fill that gap. The new control material has the potential to improve the EU’s capacity to respond to the virus outbreak and avoid valuable resources being wasted by inefficient tests," European Commissioner for Research and Innovation Mariya Gabriel, who is responsible for JRC, said in a press release.
"Quick and reliable laboratory testing is fundamental to our strategy against COVID-19. The work of EU scientists to develop test control material will enable the verification of up to 60 million laboratory tests throughout the EU. This is a major achievement by our researchers, which will be crucial for our exit strategy when the time comes to start lifting social distancing measures," European Commissioner for Health and Food Safety Stella Kyriakidou said.
A recent EU survey identified the lack of positive control materials as one of the top three challenges faced by laboratories for the reliable implementation of coronavirus tests. Responding to this need, JRC scientists have designed a positive control material to facilitate the quality control of the detection of SARS-CoV-2 in testing laboratories.
A positive control material guarantees that laboratory tests are working correctly and are harmonized. In particular, it is used to avoid that a test could give a negative result even if the person is positive. In practice, the JRC-designed control material is a synthetic, non-infectious part of the virus. It 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 harmonization of coronavirus tests in Europe, ensuring their high quality to avoid false negatives.
The control material was manufactured by a German biotech company on the basis of a JRC design, and then validated by JRC laboratory experts. Today, 3,000 samples are ready to be dispatched to the testing laboratories across the EU, including the major reference virology centers as well as hospitals. The samples are highly concentrated. In practice, only a very small quantity of the material is required to check one test. This means that one sample tube is enough for one laboratory to check up to 20,000 tests. Thus, the 3,000 samples that are now ready to make it possible to check up to 60 million tests throughout the EU. Samples will also be made available to the wider EU testing community, but priority will be given to laboratories appointed by their governments, as well as the research community.