Checking the quality of diagnostic reagents
Diagnostic reagents such as ELISAs and real-time PCRs are tools that are used to diagnose diseases. These are mostly offered in so-called (commercial) test kits. Before test kits can be distributed on the Belgian market in connection with official monitoring programs, their quality must first be checked. We organise this check, together with the National Reference Laboratories (NRL).
To identify and resolve any test-related problems in good time, we also organise consultations between the Federal Agency for the Safety of the Food Chain (FASFC), the accredited laboratories and the NRLs.
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Thanks to the monitoring programs organised by the FASFC to monitor the possible occurrence of certain animal diseases, timely measures can be taken to protect our livestock and our economy. The diagnostic reagents used in connection with this, must always be checked and approved. We coordinate both phases of this inspection:
- At the initial inspection, manufacturers and distributors are invited to take part in the inspection of the administrative file and the technical inspection of a certain diagnostic reagent. The list of test kits approved by the NRL can be consulted on our website.
- Finally, there is the batch control, in which each new batch that the manufacturer wishes to place on the market is rechecked. The list of new batches can be consulted on our website.