Standards Development

Scope

This document describes the control of in-vitro reagents for immunological analyses with a qualitative expression of results used in animal health. It involves control organisations, users and applicants (including its sub-contractors, when relevant).

The reagents are controlled when the regulations or authorities so require. Depending on the context of the analysis implementation (e.g. regulation) of reagents, the control may include an initial conformity control and several conformity controls of batches. 

Certain steps of the reagent control may be subcontracted by the control organisation, provided that it makes sure that the subcontractors possess the necessary skills (accreditation) and are independent. 

This document describes the minimum requirements for each of the steps of the control, without defining the criteria of conformity, which shall be defined beforehand by the control organisation according to the state of art (e.g., existing disease test specific standards, consensus conference recommendations, scientific literature, etc.). If necessary, or based on a particular risk or epidemiological context, additional controls may be performed that are not described in detail in this standard.

NOTE This document does not cover the step in which the user verifies a reagent.(refer to section 3.1 for definition)

Purpose

This proposal is based on the French standard XP U47-310 “Animal health analysis methods - Biological reagents control for the immunological techniques used in animal health” with the objective to define and harmonise a reference guide on diagnostic reagents control. It is the second 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 (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 appropriate reference laboratories, European Reference Laboratories (EURLs) for example.