prEN 18000-3

Animal health diagnostic analyses - Control of in vitro diagnostic reagents – Part 3: Reagents for PCR techniques

Scope

The level of requirements presented in this standard has been established as a priority for infectious diseases (bacterial, viral, fungal or parasitic) and associated animal species for which harmonisation 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.
This standard 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 third part describes the control, in the above-described framework, of PCR reagents (e.g. endpoint PCR, real-time PCR, digital PCR, reverse transcription-PCR) for the detection, relative quantification, and/or absolute quantification of pathogen-specific nucleic acids (DNA or RNA). It involves control organisations (CO) and applicants (including their subcontractors, when relevant).
The PCR diagnosis usually involve the use of a nucleic acids extraction and/or purification reagent, and a PCR reagent. The PCR method involves the successive use of these distinct reagents.
The control of a PCR method shall be performed only if an extraction and purification method is fully described and associated with the PCR method and could be available for control. PCR reagent control can be performed if the applicant provides evidences of the validity of the PCR reagent for use in the animal health sector by characterising a complete PCR method. This document does not cover the control of the nucleic acids extraction and/or purification reagents.