CEN/TC 469 - Animal Health

This document specifies the control and approval of in vitro diagnostic reagents used in animal health for the detection, and/or absolute quantification of pathogen-specific nucleic acid (DNA or RNA) by PCR (e.g. endpoint PCR, real-time PCR, reverse transcription-PCR).
This document is applicable to diagnostic reagents as a priority for infectious diseases (due to bacteria, viruses, fungi, or parasites, including genetic markers associated with pathogenicity, such as antimicrobial resistance or toxin production) and associated animal species for which harmonization of practices in this area is needed, i.e. those for which the national, regional or international regulatory framework provides for the control of trade in animals and/or animal products and/or the definition of a health status (absence of infection) of areas, establishments or individuals. Anyhow, all reagents designated by the competent authorities fall under the scope of this document. Nevertheless, the authorities or any other animal health stakeholder can choose to derogate in specific and very limited situations such as emerging, exotic or rare diseases.
This document is not applicable to all existing diagnostic reagents, in particular those for which certain parameters described in this document cannot be validly evaluated in accordance with international requirements, due, e.g. to the absence of a specific reference standard and/or accessible and duly validated reference materials.
The PCR diagnosis usually involves the use of a nucleic acid extraction and/or purification reagent, and a PCR reagent. The PCR method (when applicable) involves the successive use of these distinct reagents. PCR reagent control can be performed if the applicant provides evidence of the validity of the PCR reagent for use in the animal health diagnostic analysis, by proving its diagnostic performances with nucleic acid extracts obtained from the different matrices described in the instruction for use. The control of a complete PCR method by the applicant and the control organization is performed only if the PCR reagent cannot be dissociated from an nucleic acid extraction and/or purification systems. This document does not cover the control of the nucleic acid extraction and/or purification reagents, only.
This document does not cover the step in which the user verifies a reagent (analysis method adoption).
NOTE   Prion diseases are not included in the scope of this third part of the EN 18000 series. Unlike other infectious diseases, prion diseases are not diagnosed using PCR assays because prions lack a nucleic acid component and consist solely of an abnormally folded conformer of the normal host protein.

The level of requirements presented in the EN 18000 series has been established as a priority for infectious diseases (bacterial, viral, fungal or parasitic) and associated animal species for which harmonization of practices in this area is needed, i.e. those for which the national, regional or international regulatory framework provides for the control of trade in animals and/or animal products and/or the definition of a health status (absence of infection) of areas, establishments or individuals.
The EN 18000 series is therefore not intended to be applicable to all existing diagnostic reagents, in particular those for which certain parameters described in this standard cannot be validly evaluated in accordance with international requirements, due e.g. to the absence of a specific reference standard and/or accessible and duly validated reference materials.
This second part describes the control, in the above-described framework, of in vitro reagents for immunological analyses with a qualitative expression of results used in animal health. It involves control organizations (CO) and applicants (including their subcontractors, when relevant).

The level of requirements presented in the EN 18000 series has been established as a priority for infectious diseases (bacterial, viral, fungal or parasitic) and associated animal species for which harmonization of practices in this area is necessary, i.e. those for which the national, regional or international regulatory framework provides for the control of trade in animals and/or animal products and/or the definition of a health status (absence of infection) of areas, establishments or individuals.
The EN 18000 series is therefore not intended to be applicable to all existing diagnostic reagents, in particular those for which certain parameters described in this standard cannot be validly evaluated in accordance with international requirements due, e.g. to the absence of a specific reference method and/or accessible and duly validated reference materials.
This first part describes the general and specific elements constituting the dossier for the submission of an animal health in vitro diagnostic reagent, in the above-described framework, to the control and approval by a control organization. Its purpose is to provide the applicant submitting an animal disease in vitro diagnostic reagent to control with the general input for the preparation of the control application file. It describes the optimal administrative and technical information regarding the applicant and the reagent required for the application file for initial control and for a batch-to-batch control respectively. It specifies, in particular, the validation parameters of the method using the reagent (objectives, methodology, criteria and results) according to international standards.
NOTE   This document does not cover the step in which the user verifies a reagent (refer to section 3.1 for definition).

This document specifies a common data exchange format (i.e., format of the messages and the dictionary of all the items that compose the message) between the prescribers and the laboratories in the animal health sector.
This document is intended for prescribers (purchasers) and service providers in charge of collecting samples and conducting analyses (including analysis laboratories) that want to computerize and standardize their data exchanges, particularly in the animal health sector.
This document excludes the code lists that are required for unambiguous data exchange.