Europe – COVID-19 IVD quality problems drive EC guidelines

A “mismatch” between the expected and actual quality of coronavirus (COVID-19) tests has spurred new guidelines from the European Commission (EC). The guidelines are part of a roadmap to lifting the lockdown measures implemented to curb the spread of the disease across the European Union, according to an EC statement dated 15 April.
Governments across the European Union (EU) are working to step up testing capacity, recognizing that testing will play a key role in efforts to keep the virus under control as restrictions on populations are lifted. Companies have responded by introducing COVID-19 tests and scaling up their own operations to meet demand. Yet, along the way, EU officials think some organizations have failed to achieve expected standards.
“We have been working hard to analyze the information on the quality assurance of the coronavirus tests and devices that are currently being used. The results show that there is a mismatch between the existing quality and what could be expected to ensure good performance of the tests,” Mariya Gabriel, Commissioner for Innovation, Research, Culture, Education and Youth, said in a statement.

The mismatch has implications for European governments’ ability to lift lockdowns without causing a second surge in infections, according to the Commission. Governments will need reliable data current and previous infections to make decisions about which restrictions to lift — or reimplement — and when to do so.

To help EU member states gather the data they need, the Commission has created guidelines on the performance of in vitro diagnostic kits for COVID-19. All COVID-19 diagnostics are subject to directive 98/79/EC on IVDs but what that means in practice varies from test to test.