ISO INTERNATIONAL STANDARD 20186-2 First edition 2019-02 Molecular in vitro diagnostic examinations Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA Analyses de diagnostic moléculaire in vitro - Spécifications relatives aux processus préanalytiques pour le sang total veineux Partie 2: ADN génomique extrait Reference number ISO 20186-2:2019(E) osi @ IS0 2019 IS0 20186-2:2019(E) COPYRIGHTPROTECTEDDOCUMENT @ IS0 2019 All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either IsO at the address below or Iso's member body in the country of the requester. ISO copyright office CP 401 : Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +41 22 749 01 11 Fax: +41 22 749 09 47 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2019 - All rights reserved IS0 20186-2:2019(E) Contents Page Foreword ..iv Introduction. .. 1 Scope. ..1 2 Normative references 3 Terms and definitions 4 General considerations. ..5 5 Outside the laboratory .6 5.1 Specimen collection .6 5.1.1 Information about the specimen donor/patient. .6 5.1.2 Selection of the venous whole blood collection tube by the laboratory ..6 5.1.3 Venous whole blood specimen collection from the donor/patient and stabilization procedures.. .6 5.1.4 Information about the specimen and storage requirements at the blood collection facility 7 5.2 Transport requirements 6 Inside the laboratory .8 6.1 Specimen reception ..8 6.2 Storage requirements .8 6.3 Isolation of the genomic DNA .10 6.3.1 General .10 6.3.2 Examination provider's instructions available 10 6.3.3 Examination provider's instructions not available .10 6.4 Quantity and quality assessment of isolated genomic DNA. .11 6.5 Storage of isolated genomic DNA. .11 6.5.1 General. 11 6.5.2 Genomic DNA isolated with commercially available kits 11 6.5.3 Genomic DNA isolated with the laboratory's own protocols .12 Annex A (informative) Impact of pre-examination process steps on venous whole blood genomic DNA quality .13 Bibliography .19 @ IS0 2019 - All rights reserved ii