ISO INTERNATIONAL STANDARD 20166-2 First edition 2018-12 Molecular in vitro diagnostic examinations Specifications for pre- examinations processes for formalin- fixed and paraffin-embedded (FFPE) tissue - Part 2: Isolated proteins Analyses de diagnostic moléculaire in vitro - Specifications relatives aux processus préanalytiques pour les tissus fixés au formol et inclus en paraffine (FFPE) - Partie 2: Protéines extraites Reference number IS0 20166-2:2018(E) ISO @ IS0 2018 IS0 20166-2:2018(E) COPYRIGHTPROTECTEDDOCUMENT @ IS0 2018 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: +4122 749 0111 Fax: +41 22 749 09 47 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2018 - All rights reserved IS0 20166-2:2018(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. ..1 2 Normative references 3 Terms and definitions ..1 4 General considerations. ..4 5 Outside the laboratory .5 5.1 Specimen collection .5 5.1.1 General .5 5.1.2 Information about the specimen donor/patient .6 5.1.3 Information about the specimen .6 5.1.4 Specimen processing 6 5.2 Transport requirements .7 Inside the laboratory .1 6 6.1 Information aboutthe reception ofthe specimen 7 6.2 Formalin fixation of the specimen or sample(s) .7 6.3 Evaluation of the pathology of the specimen and selection of the sample(s) .9 6.4 Post-fixation of frozen samples .9 6.5 Processing and paraffin embedding .10 6.6 Storage requirements. 10 6.7 Isolation of the total protein.. 11 6.7.1 General .11 6.7.2 General information for protein isolation procedures .11 6.7.3 Using commercial kits .11 6.7.4 Using the laboratories'own protocols 11 6.8 Quality assessment of isolated proteins 12 6.9 Storage of isolated total protein. .13 Annex A (informative) Examination of protein demonstrates changes of protein amounts during cold ischemia .14 Bibliography .18 @ IS0 2018 - All rights reserved iii