The initial control procedure is the first phase of a certification procedure.
To comply manufacturers or distributors should meet the minimum criteria and be “fit for purpose” as defined by Sciensano’s experts of the National Reference Laboratories, in concertation with FASFC, based on the OIE guidelines in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, 2014: Principles and methods of validation of diagnostic assays for infectious diseases.
Sciensano executes the administrative and technical evaluation of the reagents according to the minimum criteria (cfr.SOP/4.3/03).
In some specific cases, Sciensano accepts a previously published list of validated reagents from an EU member state:
(1) Either based on mutual recognition of the validation procedure of the foreign NRL making use of the minimum criteria (cfr.SOP/5.2/03).
(2) Either an alternative simplified procedure may be initiated in accordance with the concerned National Reference Laboratory (NRL). This procedure will regard the kit’s former certification by the European Reference laboratory (EURL) or another European National Reference Laboratory as a basis for approval for the Belgian market. In this case, the applicant should submit the document confirming approval as well as the validation dossier that was submitted to the EURL or European NRL and which led to the kit’s certification to the Diagnostic Control e-mail address.
Please note that passing a batch control is still required each time a new batch is to be released on the Belgian market.
Diagnostic reagents (kits) which comply are published on the list of certified diagnostic reagents
diagnostic control if you want to participate in an initial control procedure. You do not have to wait for an open call to request a supplementary initial certification procedure.
The second phase of the certification procedure consists of a batch control for each batch of these validated diagnostic reagents (kits) destined for the Belgian market.