Control of diagnostic reagents

Last updated on 25-6-2018 by Pierre Daubresse

As part of official control programs against animal diseases , various commercial reagents of diagnostic kits are used by FASFC -approved laboratories.

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. A diagnostic reagent that passed the two phases of the certification procedure, is approved for use on the Belgian market in the framework of official programs.

This quality control is performed according to Sciensano’s procedure SOP/4.3/03 and the Ministerial Decree designating the analyses for which National Reference Laboratories are charged with the quality control of the diagnostic reagents and for the establishment of the control’s procedure (C − 2014/18136).

This certification procedure consists of two phases:

  1. Initial control of a diagnostic reagent from manufacturers or distributors  
  2. Batch control of certified diagnostic reagents

More information about how to submit a diagnostic reagent for control with regard to use on the Belgian market.

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