Standards Development

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 pathogenspecific 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.

Purpose

This proposal is based on the French standard NF U47-311 “Animal health analysis methods — Control of PCR reagents used in animal health” with the objective to define and harmonise a reference guide on diagnostic reagents control. It is the third of the three parts of the standard proposed on the control of reagents.

This proposal aims at addressing the need to harmonise and facilitate, at European level and more widely, the control for marketing authorisation purpose of diagnostic reagents used in animal health (immunological and molecular methods). This is particularly important for diseases listed by European regulations for which health statuses are defined or for which sanitary controls on trade are required; statuses and controls being most often based on the results of approved diagnostic tests.

Up to now, there are no guidelines for implementing the control of animal health diagnostic reagents (performance criteria and experimental designs), neither at European nor at international level. Hence, there are as many different control procedures as different countries in Europe, which complicates the task of suppliers or manufacturers (at a cost) and users. The establishment of European standards, including the content of the files submitted for evaluation and of the reports, would therefore facilitate at term the mutual recognition of such reagents or even the centralisation of controls by Laboratory designated by the competent authorities such as European Reference Laboratories (EURLs) for example.