ISO INTERNATIONAL STANDARD 20186-1 First edition 2019-02 Molecular in vitro diagnostic examinations Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA Analyses de diagnosticmoleculaire invitro-Specifications relatives auxprocessuspréanalytiquespourlesangtotalveineux Partie1:ARNcellulaireextrait Reference number ISO 20186-1:2019(E) @IS0 2019 IS0 20186-1:2019(E) COPYRIGHTPROTECTEDDOCUMENT @ISO2019 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 orIso's memberbody in the countryof therequester. ISO copyright office CP 401 : Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone:+41227490111 Fax:+41 22 749 09 47 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2019- All rights reserved IS0 20186-1:2019(E) Contents Page Foreword ..iv Introduction. 1 Scope. 2 Normative references 3 Terms and definitions ..1 4 General considerations. ..5 5 Outsidethelaboratory .6 5.1 Specimen collection .6 5.1.1 Informationaboutthespecimendonor/patient ..6 5.1.2 Selection of thevenous whole blood collection tube by the laboratory ..6 5.1.3 Venouswholebloodspecimencollectionfromthedonor/patientand stabilization procedures. ..6 5.1.4 Information about the specimen and storagerequirements atthe blood collection facility .7 5.2 Transport requirements ..8 6 Inside the laboratory .8 6.1 Specimenreception .8 6.2 Storage requirements. 8 6.3 Isolation of the cellular RNA .9 6.3.1 General .9 6.3.2 Usingblood collection tubeswith RNAprofile stabilizers .9 6.3.3 Using blood collection tubes without RNAprofile stabilizers. ..10 6.4 Quantityand qualityassessmentof isolated cellularRNA .10 6.5 Storage of isolated cellular RNA .11 6.5.1 General ..11 6.5.2 CellularRNAisolatedwithcommerciallyavailablekits 11 6.5.3 Cellular RNA isolated with the laboratory's own protocols .11 AnnexA (informative) Impact ofpre-examinationprocess steps on venous wholeblood cellular RNA profiles. .12 Annex B (informative) Influence of blood storage temperature on blood cellular RNAprofiles....16 Bibliography .19 @ IS0 2019 -All rights reserved iii