Coronavirus – a new validation procedure for serological tests

In April 2020, the Belgian Federal Agency for Medicines and Health Products (FAMHP) and Sciensano set up an extraordinary validation procedure for serological tests for SARS-CoV-2. The procedure turned out to be effective during the initial phase of the pandemic. The situation being experienced by the manufacturers and distributors of these tests and by the clinical laboratories carrying out the tests has now returned to normal. This is why a staged return to the conventional way of working is now being implemented.

The reliability of serological tests on the market during the initial phase of the pandemic had not been clearly established and documented in all cases. The FAMHP and Sciensano therefore decided to draw up a list of tests that satisfy certain minimum criteria. 

Part of that procedure involved clinical laboratories in Belgium carrying out validations of serological tests. The results of those validations were then shared centrally. This way of working offered several advantages:

  • It made more sparing use of reagents (this was useful whenever there was a shortage or potential shortage) and samples (not every laboratory had access);
  • It reduced the workload of individual laboratories;
  • Validations were carried out under controlled conditions and on patients in Belgium.

This procedure proved to be effective during the initial phase of the pandemic. Since then, the clinical laboratories and the manufacturers and distributors of serological tests have adjusted to the pandemic. A staged return to the conventional way of working that is also used for other IVD (in-vitro diagnostic) tests is therefore justified.

That is the reason why a new, interim procedure based on the verification of performance data has now been put into place. That procedure still provides the ability to define minimum criteria that tests must fulfil before they can be included on the list of recommended tests, but it is less time-consuming.

Last updated on
06/10/2020