ECAT Assay Procedures. A Manual of Laboratory Techniques

Transcription

1 ECAT Assay Procedures A Manual of Laboratory Techniques

2 ECAT Assay Procedures A Manual of Laboratory Techniques European Concerted Action on Thrombosis and Disabilities of the Commission of the European Communities Edited by J. Jespersen Department of Clinical Chemistry Rlbe County Hospital In Esbjetrg Esbjerg, Denmark R. M. Bertina Haemostasis and Thrombosis Research Unit University Hospital,, F. Haverkate IWO-TNO, ^ SPRINGER SCIENCE+BUSINESS MEDIA, B.V.

3 British Library Cataloguing in Publication Data ECAT assay procedures : a manual of laboratory techniques I. Jespersen, J. II. Bertina, R. M. (Rogier M) III. Haverkate, F ISBN Library of Congress Cataloging in Publication Data ECAT assay procedures: a manual of laboratory techniques/european Concerted Action on Thrombosis and Disabilities of the Commission of the European Communities; edited by J. Jespersen, R. M. Bertina, F. Haverkate. p. cm. Includes bibliographical references and index. ISBN ISBN (ebook) DOI / Blood coagulation tests. 2. Thrombosis Risk factors. 3. Thrombosis Diagnosis. I. Jespersen, Jorgen. II. Bertina, Rogier M. III. Haverkate, F. (Frits), IV. European Concerted Action on Thrombosis and Disabilities (Committee). V. Commission of the European Communities. [DNLM: 1. Diagnosis, Laboratory methods. 2. Hemostatics analysis laboratory manuals. 3. Thrombosis blood laboratory manuals. QY 25 E17] RB45.3.E dc20 DNLM/DLC for Library of Congress CIP Copyright 1992 by Springer Science+Business Media Dordrecht Originally published by Kluwer Academic Publishers in 1992 Softcover reprint of the hardcover 1st edition 1992 All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior permission from the publishers, Springer Science+Business Media, B.V. Typeset by Technical Keying Services, Manchester.

4 Contents Preface List of Contributors vii ix 1 Quality assessment of haemostatic assays 1 S. G. Thompson and J. M. Thomson 2 Blood collection and preparation: pre-analytical variation 13 J. M. Thomson 3 Beta-thromboglobulin and platelet factor 4 21 D. S. Pepper and C. V. Prowse 4 The activated partial thromboplastin time (APTT) 35 L. Poller and J. M. Thomson 5 The prothrombin time test 41 L. Poller 6 Fibrinogen 47 G. A. Marbet and F. Duckert 7 Factor VII clotting activity 57 G. A. Marbet and F. Duckert 8 Factor VIII clotting activity 65 P. M. Mannucci and A. Tripodi 9 Von Wille brand factor 71 P. M. Mannucci and R. Coppola 10 Antithrombin-III activity and antigen 77 J. Conard 11 Protein C activity and antigen 85 R. M. Bertina v

5 ECAT ASSAY PROCEDURES 12 Protein S antigen 99 R. M. Bertina 13 Fibrinopeptide A (FPA) 109 A. Haeberli 14 Thrombin-antithrombin III complexes 117 J. Harenberg 15 Euglobulin clot lysis time 125 P. C. Cooper and F. E. Preston 16 Tissue type plasminogen activator antigen (t-pa Ag) 131 I. Juhan- Vague and M. C. Alessi 17 Tissue-type plasminogen activator activity assay 139 J. H. Verheijen 18 Plasminogen activator inhibitor activity assay 147 E. K. O. Kruithof 19 Plasminogen activator inhibitor antigen 151 E. K. O. Kruithof 20 Plasminogen activity 155 P. J. Gaffney 21 (X2-Antiplasmin activity 165 C. Kluft 22 Plasmin-(X2-antiplasmin complexes 173 E. Hattey, M. Haumer, A. Binder and B. R. Binder 23 Plasma histidine-rich glycoprotein (HRG) 185 J. Gram 24 Quantitative enzyme immunoassays for degradation products of fibrinogen (FgDp), fibrin (FbDp) and total of FgDp and FbDp (TDP) 191 W. Nieuwenhuizen 25 BP peptide 205 A. Haeberli 26 The venous occlusion test in fibrinolysis assays 213 J. Jespersen 27 List of manufacturers 217 Index 225 vi

6 Preface This book offers a description of current and recently developed laboratory assays in the field of haemostasis and thrombosis. It is the result of a unique cooperation between experts from more than 60 institutes in 12 European countries, brought together by the ECA T (European Concerted Action on Thrombosis and Disabilities) under the auspices of the Commission of the European Communities in Brussels, Belgium. The ECAT, which was initiated in 1981, designed and performed three prospective clinical studies to establish haemostatic factors as risk indicators of thrombosis. Included were patients with angina pectoris at risk from myocardial infarction, patients undergoing angioplasty at risk from re-stenosis, and patients receiving hip replacement at risk from deep venous thrombosis. Assay procedures were chosen, training courses for technicians held, and essential reagents were supplied from a central source. A quality control assessment scheme served to compare assay results both within and between laboratories. In the angina pectoris study, centres determined most of the assays locally; in the other two studies assays were performed centrally. The need for further quality assessment in Europe led to a separate activity coordinated by Dr J. F. Davidson in Glasgow, including coagulation inhibitors and plasminogen as risk factors for familial venous thrombosis. The Editors hope the ECA T Assay Procedures book will contribute to further harmonization ofhaemostasis assays, and ultimately to their standardization. The need for this is evident from the failure of the ECA T quality controls to demonstrate an obvious improvement in the agreement in haemostasis assay results between laboratories. This book has been preceded by two editions produced for internal use only. Each assay was assessed by an expert who functioned in the ECA T as representative of a reference laboratory. An assay committee coordinated the activities. Each chapter in this book is written by the assay expert. Most of the chapters give a detailed description of the assay recommended for use in ECA T and briefly mention alternatives. For this reason we have included a list of firms marketing kits and vii

7 reagents at the back of the book. The Editors will be happy to receive critical comments, as well as suggestions for reagents and assays. They can be included in the next updated version which will be prepared as soon as the need arises. The Editors are indebted to the Commission of the European Communities, to all ECA T participants who directly or indirectly were of great value, and in particular to Professor F. Duckert, Basel, who did most of the pioneering work. Esbjerg,, 1991 Jorgen Jespersen Rogier Bertina Frits Haverkate viii

8 List of Contributors M. C. ALESSI MD PhD Laboratoire Hematologie University Hospital, La Timone Marseilles France ROGIER M. BERTINA PhD Haemostasis and Thrombosis Research Unit University Hospital A. BINDER PhD Technoclone Ltd. Vienna Austria BERND R. BINDER MD Laboratory for Clinical Experimental Physiology University of Vienna Austria JACQUELINE CONARD PhD Laboratoire Central d'hematologie Hotel-Dieu Paris France PETER C. COOPER Department of Haematology Royal Hallamshire Hospital Sheffield R. COPPOLA PhD A. Bianchi Bonomi Hemophilia and Thrombosis Center and Institute of Internal Medicine University of Milano Milano Italy FRANf;OIS DUCKERT Dr i. Sc Dr mecl h c Coagulation Laboratory Kontonsspital Basel Basel Switzerland PATRICK J. GAFFNEY PhD DSc National Institute for Biological Standards and Control Potters Bar London J,RGEN GRAM MD DSc Department of Clinical Chemistry Ribe County Hospital in Esbjerg Esbjerg Denmark ANDRE HAEBERLI PhD Department of Medicine University of Bern Inselspital Bern Switzerland JOB HARENBERG MD PhD 1st Department of Medicine Faculty of Clinical Medicine Mannheim University of Heidelberg Klinikum Mannheim Mannheim Germany ix

9 LIST OF CONTRIBUTORS E. HATTEY BScI Laboratory for Clinical Experimental Physiology University of Vienna Austria M. HAUMER Laboratory for Clinical Experimental Physiology University of Vienna Austria F. HAVERKATE MD IWO-TNO J~RGEN JESPERSEN MD DSc Department of Clinical Chemistry Ribe County Hospital in Esbjerg Esbjerg Denmark IRENE JUHAN-VAGUE MD PhD Laboratoire Hematologie University Hospital, La Timone Marseilles France CORNELIS KLUFT PhD IWOTNO EGBERT K. O. KRUITHOF PhD Hematology Laboratory Department of Medicine University Hospital Lausanne Switzerland WILLEM NIEUWENHUIZEN PhD IWOTNO DUNCAN S. PEPPER PhD Scottish National Blood Transfusion Service Headquarters Laboratory Edinburgh LEON POLLER MD DSc Reference Laboratory for Anticoagulant Reagents and Control Withington Hospital Manchester F. ERIC PRESTON MD Department of Haematology Royal Hallamshire Hospital Sheffield CHRISTOPHER V. PROWSE PhD Scottish National Blood Transfusion Service National Science Laboratory Edinburgh SIMON G. THOMPSON MA Medical Statistics Unit London School of Hygiene and Tropical Medicine London JEAN M. THOMSON PhD Reference Laboratory for Anticoagulant Reagents and Control Withington Hospital Manchester PIER M. MANNUCCI MD PhD A. Bianchi Bonomi Hemophilia and Thrombosis Center and Institute of Internal Medicine University of Milano Milano Italy GERMAN A. MARBET MD Coagulation Laboratory Kantonsspital Basel Basel Switzerland x A. TRIPODI PhD A. Bianchi Bonomi Hemophilia and Thrombosis Center and Institute of Internal M~dicine University of Milano Milano Italy JAN H. VERHEIJEN PhD IWOTNO