Validation
Validation is a process that determines the fitness of an assay, which has been properly developed, optimised and standardised, for an intended purpose. Methods used in the official control must be validated in accordance with internationally accepted scientific protocols accordingly to the Regulation EU 2017/625.
EURL makes available in the restricted area (CIRCAB), reports to declare the validation of the recommended methods. Therefore this methods could be used by EU-NRLs after a limited verification to determine whether the assay complies with validation criteria, in the context of the intended application.
In case of EU-NRL using a method / kit not described by EURL, validation data must be available in the EU-NRL, according to the OIE validation chapter, and agree to the minimum validation criteria stablished by the EURL in the Manual of diagnosis.
To retain the status of a validated assay a quality assurance programme have to be performed. Reproducibility (Stage 3 in the OIE Manual) is assessed through external quality control programmes such as proficiency testing.
A validated assay must be continuously assessed to assure it maintains its fitness for purpose. In this framework, it is suitable to analyze all new strains emerged in order to demonstrate that validated methods are fit to detect them and/or specific antibodies against it. To perform this relevant task, EURL ask for to all EU-NRLs to share the biological material from outbreaks in their countries to be tested in EURL, included in the EURL collection and sent in the Proficiency test to be analyzed by all EU-NRLs.