Standards Development

Scope

This document is applicable to the control and approval of in vitro diagnostic reagents used in animal health for the detection, and/or absolute quantification of pathogen-specific nucleic acids (DNA or RNA) by PCR (e.g. endpoint PCR, real-time PCR, reverse transcription-PCR).

Purpose

The purpose of the EN 18000 series is to facilitate the mutual recognition of the work of the animal health in vitro diagnostic reagent control organisations at European level (or even more widely) and thus to eventually allow the use of strategic reagents controlled by a single third-party control organisation for a given disease.

The EN 18000 series establishes the requirements for the control of in vitro diagnostic reagents in animal health. This series is divided into three parts.

- The first part concerns terms and defiitions, and the submission of a reagent dossier to a control organization for control and approval.

- The second part concerns the specific aspects of the control by such organizations of an immunological diagnostic reagent.

- This document, the third part, concerns the specific aspects of the control by such organizations of a polymerasechain reaction (PCR) diagnostic reagent for the detection or quantification of pathogen-specific nucleic acids. It involves control organizations (CO) and applicants (including their subcontractors, when relevant).

Like any standard, this document is intended to be voluntary and, if its use is prescribed by a competent authority or any other animal health stakeholder, it will be up to them to determine for which diseases this document will be applied by the control bodies they have designated for this purpose.