XP CEN/TS 16835-1

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1 : isolated cellular RNA

Le présent document donne des recommandations pour la manipulation, la documentation et le traitement des spécimens de sang total veineux destinés à l'analyse de l'ARN cellulaire pendant la phase pré-analytique, avant d'effectuer un essai moléculaire. Il concerne les spécimens collectés dans des tubes de prélèvement de sang total veineux. Il est applicable aux tests de diagnostic moléculaire in vitro (par exemple laboratoires de diagnostic in vitro, clients de laboratoires, concepteurs et fabricants de tests de diagnostics in vitro, institutions et organisations commerciales travaillant dans la recherche biomédicale, les biobanques et les autorités réglementaires) . ¿ Les profils d'ARN cellulaire sanguin peuvent changer de manière significative après le prélèvement. Par conséquent, des mesures spécifiques doivent être prises pour assurer la bonne qualité des échantillons de sang en vue de l'analyse de l'ARN cellulaire et de son stockage.¿

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