Evaluation of the quality of diagnostic reagents for analyses of animal disease tests

Ministerial Decree identifying analyses for the quality control of diagnostic reagents for which the national reference laboratories are responsible and laying down the procedure for this control

The purpose of this draft Ministerial Decree is to identify the analyses for which the reference laboratories [laboratoires nationaux de référence – LNRs] control the quality of the diagnostic reagents (principle task of the LNRs), as well as to lay down the procedure for this control in accordance with Article 3 of the Royal Decree of 3 August 2012 relating to the approval of those laboratories carrying out analyses related to food chain safety.

The list of pathologies concerned was determined according to the needs of the laboratories based on the current epidemiological situation at national level and the official control programmes resulting from them. The quality control of the diagnostic kits takes place in two phases: an administrative phase, which makes it possible to verify that the firm marketing the kit can provide all the required evidence of quality and efficiency, followed by a technical phase, during which the kit is subject to a series of technical criteria which it must meet.

In order to be able to react quickly to a sudden change in the country’s epidemiological situation and in the interests of collaboration and sharing of knowledge at European level between the different reference laboratories, this text allows the national LNR to accept diagnostic reagents, the quality of which has been controlled in a similar procedure by an LNR from another EU Member State or belonging to EFTA.