Summary of the EUGT French workshop on validation

Workshop report - The EUGT French workshop on validation

Paris, France

20-21st October 2011

All medical laboratories in France must, by law, be accredited according to ISO 15189 by November 2016. Since 2009, EuroGentest has organized a series of French-language workshops on accreditation, in partnership with and hosted by the Agence de la biom├ędecine, the French national agency overseeing genetic diagnostics. The first workshop on validation of diagnostic tests was held on 20-21 October. This workshop was a considerable challenge, notably because validation of methods represents one of the most difficult tasks to achieve in the process of preparation for accreditation. There were 29 participants, mostly molecular and cytogeneticists but also experts in quality. Eleven had already participated in a previous workshop. All had knowledge of ISO 15189 requirements, some had read the recommendations of Cofrac (the French accreditation body) and the EUGT paper (Mattocks et al., Eur J Hum Genet 2010; 18:1276-88), but almost none had real experience in the formal validation of methods.

Despite the challenge, the workshop was a success, with enthusiastic participation and exchange. Participants were particularly impressed by the interactive and didactic aspect of the training. Through practical exercises along with formal presentations, they understood the different categories of tests and the corresponding parameters to evaluate. They declare their intention to implement formal validation/verification of their tests, mostly using the templates and examples of validation provided.

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Copyright EuroGentest2 Coordination Action 2011 - EU Contract no.: FP7 - HEALTH-F4-2010-261469