Coronavirus - Consultation between the FAMHP and the clinical labs about the serological tests for COVID-19

At the initiative of the FAMHP, a consultation took place on 3 September 2020 with the representatives of the clinical laboratories and Sciensano, during which the FAMHP explained the method for the validation of all serological tests for COVID-19. After the consultation, all parties decide that it is advisable to organize better consultation and more intensive cooperation between government and clinical laboratories.

Following press articles on the validation of the serological tests for COVID-19, a consultation meeting was organized on 3 September 2020 with all clinical laboratories involved on the initiative of Xavier De Cuyper, administrator general of the FAMHP.

This meeting provided an opportunity to clarify criticisms from the press articles and allowed clinical laboratories to express their concerns. The FAMHP wanted to place in the right context all actions taken to guarantee the quality of the tests from the FAMHP-Sciensano list and to provide strategic stocks at national level.

The role of each party was clarified with mutual respect: the clinical laboratories have the responsibility and scientific expertise for the biological tests they use. The FAMHP and Sciensano are the competent authorities that are respectively responsible for the quality of the IVD products that are placed on the market and the correct use of these products according to the applicable quality standards (ISO 15189).

For the sake of transparency, Sciensano has explained the control actions currently carried out through audits that apply to each laboratory in case of non-compliance with quality standards.

All those involved were positive about this approach, in particular to organize a more intensive collaboration between the clinical laboratories and the FAMHP by providing structural consultation. Outside the current situation regarding COVID-19, there are many important topics to discuss for the parties involved.

Consultative body

In order to give shape to this collaboration, the FAMHP will take an initiative in the coming weeks to set up a body consisting of representatives of clinical laboratories to support initiatives in this essential domain. Every voice can be expressed via this new consultative body and in this way the expertise of the clinical laboratories is optimally taken into account in the decision-making by the FAMHP. During this meeting, various constructive paths have already been taken, such as making blood serum available via biobanks to facilitate future cooperation.

Last updated on
10/09/2020