Sciensano controls the quality of diagnostic reagents used within official animal disease programs commissioned by the Federal Agency for the Safety of the Food Chain (FASFC). In this scope, we regularly launch calls for the Initial Control of commercial diagnostic reagents (such as ELISA or PCR kits) for the detection of specific antibodies or antigens. Diagnostic reagents that passed the two phases of the certification procedure, are allowed on the Belgian market in the framework of official programs.
Please note that in order to request certification of a diagnostic kit for a pathogen that is already part of an animal disease surveillance/control program, manufacturers or distributors do not need to wait for an open call. They may request such a supplementary initial certification procedure at any time (see “How to participate in an initial control procedure”).