Transfusion Microbiology Edited by John A

Cambridge University Press 978-0-521-45393-6 - Transfusion Microbiology Edited by John A. J. Barbara, Fiona A. M. Regan and Dame Marcela Contreras Frontmatter More information

Transfusion Microbiology

© Cambridge University Press www.cambridge.org Cambridge University Press 978-0-521-45393-6 - Transfusion Microbiology Edited by John A. J. Barbara, Fiona A. M. Regan and Dame Marcela Contreras Frontmatter More information

Transfusion Microbiology

Edited by

Professor John A. J. Barbara, MA (Cantab), MSc, PhD, FIBiol, FRCPath Formerly Head of National Transfusion Microbiology Laboratories, National Blood Service, UK Emeritus Consultant in Microbiology to NHS Blood and Transplant Visiting Professor in Transfusion Microbiology, University of the West of England, Bristol, UK Dr Fiona A. M. Regan NHSBT and Hammersmith Hospitals NHS Trust, London, UK Professor Dame Marcela Contreras, MD, FRCPath, FRCP, FMedSci, DBE Royal Free and University College Hospitals Medical School, London, UK Formerly Director of Diagnostics, Development and Research, National Blood Service, UK

CAMBRIDGE UNIVERSITY PRESS Cambridge, New York, Melbourne, Madrid, Cape Town, Singapore, Sa˜o Paulo, Delhi

Cambridge University Press The Edinburgh Building, Cambridge CB2 8RU, UK

Published in the United States of America by Cambridge University Press, New York

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# Cambridge University Press 2008

This publication is in copyright. Subject to statutory exception and to the provisions of relevant collective licensing agreements, no reproduction of any part may take place without the written permission of Cambridge University Press.

First published 2008

Printed in the United Kingdom at the University Press, Cambridge

A catalogue record for this publication is available from the British Library

Library of Congress Cataloguing in Publication Data

Transfusion microbiology / edited by John A. Barbara, Fiona A. M. Regan, Dame Marcela C. Contreras. p. ; cm. Includes bibliographical references and index. ISBN 978-0-521-45393-6 (hardback) 1. Bloodborne infections. 2. Blood–Transfusion–Complications. I. Barbara, John A. J. II. Regan, Fiona A. M. III. Contreras, Marcela. [DNLM: 1. Blood Transfusion–adverse effects. 2. Blood-Borne Pathogens. 3. Disease Transmission–prevention & control. 4. Infection Control–methods. WB 356 T77291 2008] RA642.B56T73 2008 615’.39–dc22 2008006740

ISBN 978-0-521-45393-6 hardback

Cambridge University Press has no responsibility for the persistence or accuracy of URLs for external or third-party internet websites referred to in this publication, and does not guarantee that any content on such websites is, or will remain, accurate or appropriate.

Every effort has been made in preparing this publication to provide accurate and up-to-date information which is in accord with accepted standards and practice at the time of publication. Although case histories are drawn from actual cases, every effort has been made to disguise the identities of the individuals involved. Nevertheless, the authors, editors and publishers can make no warranties that the information contained herein is totally free from error, not least because clinical standards are constantly changing through research and regulation. The authors, editors and publishers therefore disclaim all liability for direct or consequential damages resulting from the use of material contained in this publication. Readers are strongly advised to pay careful attention to information provided by the manufacturer of any drugs or equipment that they plan to use.

This book is dedicated to the memory of Dr David Dane and Dr Colin Cameron who, together with Moya Briggs, in 1970, identified the infectious agent of hepatitis B and who for the next two decades worked to advance all aspects of transfusion microbiology.

Dr Colin Cameron Dr David Dane Moya Briggs

CONTENTS

List of contributors ix Annexe: Testing for prions Foreword David J. Anstee and Gary Mallinson 148 Roger Y. Dodd xiii Preface xv Section 2: Selection and testing 153 Acknowledgements xvii Glossary xviii 10 Blood donor selection and qualification Virge James 153 Introduction: Transfusion-transmitted infections, then and now 11 Current serological methods of testing and John A. J. Barbara and Roger Eglin 1 automation Peter D. Rogan 159 Section 1: Agents 9

1 Hepatitis viruses 12 Confirmatory testing and donor Denis M. Dwyre and Paul V. Holland 9 re-admission Alan D. Kitchen and Brian C. Dow 173 2 Antibody to hepatitis B core antigen Joan O’Riordan 25 13 The strategy for applications of nucleic acid testing 3 Herpes viruses Paul R. Grant and Richard S. Tedder 183 Eleftherios C. Vamvakas and Gary E. Tegtmeier 35 14 Nucleic acid testing: general view 4 Retroviruses W. Kurt Roth 193 Brian C. Dow, Eberhard W. Fiebig and Michael P. Busch 59 15 Nucleic acid testing: the US approach 5 Parvovirus B19 (human erythroviruses) Susan L. Stramer 203 Kevin E. Brown 67 16 Nucleic acid testing: the UK approach 6 Emerging viruses in transfusion Roger Eglin 209 Jean-Pierre Allain 75 17 Quality in the screening of Annexe: Respiratory viruses: SARS and influenza donations for transfusion-transmissible John A. J. Barbara 83 infections John A. J. Barbara and Alan D. Kitchen 217 7 Bacterial contamination in blood and blood components 18 Microbiological blood testing and new Carl P. McDonald and M. A. Blajchman 87 technologies Juraj Petrik 227 Annexe: Syphilis Brian C. Dow 110 19 Processing and components: leucodepletion and pathogen 8 The protozoan parasites reduction David A. Leiby and Silvano Wendel 117 Rebecca Cardigan, Chris Prowse and Lorna M. Williamson 239 9 Prion diseases Marc L. Turner, Patricia E. Hewitt, Moira Bruce 20 Fractionated products and James W. Ironside 141 Peter R. Foster and Carol Bienek 259

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Contents

Section 3: Surveillance, risk and regulation 305 25 How to assess risk: prospective studies and calculations 21 Serious hazards of transfusion (SHOT); Kate Soldan and Katy Davison 329 haemovigilance Elizabeth M. Love 305 26 Risk management Arturo Pereira 341 22 Investigation of post-transfusion infection Patricia E. Hewitt and Chris Moore 311 27 The regulatory environment in Europe Virge James 363 23 Notification of donors with significant microbiological test results 28 Blood safety in developing countries Patricia E. Hewitt and Chris Moore 317 Jean-Pierre Allain, Elizabeth Vinelli and Yasmin Ayob 369 24 Researching the natural history of transfusion- transmitted infections: the UK hepatitis C (HCV) Index 381 national register Helen Harris 323 The colour plates are situated between pages 140 and 141

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CONTRIBUTORS

Jean-Pierre Allain, MD, PhD, FRCPath, AcMedSc Rebecca Cardigan, PhD Department of Haematology Head of Components Development The Division of Transfusion Medicine NHS Blood and Transplant Cambridge Cambridge Blood Centre Cambridge, UK Cambridge, UK Katy Davison, MSc David J. Anstee, PhD, FRCPath, FMedSci Scientist (Epidemiology) Bristol Institute for Transfusion Sciences Immunization Department NHS Blood and Transplant Health Protection Agency Bristol, UK Centre for Infections Colindale, London, UK Yasmin Ayob,MD National Blood Centre Roger Y. Dodd, PhD Kuala Lumpur, Malaysia Vice President, Research and Development American Red Cross John A. J. Barbara, MA, MSc, PhD, FIBiol, FRCPath Holland Laboratory Emeritus Consultant in Microbiology to NHS Blood and Rockville, MD, USA Transplant and Visiting Professor in Transfusion Microbiology University of the West of England Brian C. Dow, BSc, PhD, CSci, FIBMS Bristol, UK Consultant Clinical Microbiologist Head, Scottish National Blood Transfusion Service Carol Bienek, BSc, PhD National Microbiology Reference Unit Protein Fractionation Centre West of Scotland Transfusion Centre Scottish National Blood Transfusion Service Glasgow, UK Edinburgh, UK Denis M. Dwyre,MD M. A. Blajchman, MD, FRCP(c) Assistant Professor, Department of Pathology Canadian Blood Services and McMaster University University of California Davis Medical Center Hamilton, Ontario, Canada Sacramento, CA, USA

Kevin E. Brown,MD Roger Eglin, BSc, MSc, PhD Consultant Medical Virologist Head, National Transfusion Laboratories Unit Head, Immunisation and Diagnosis NHS Blood and Transplant Virus Reference Department Colindale, London, UK Centre for Infections Health Protection Agency Eberhard W. Fiebig,MD London, UK Associate Professor/Vice Chair UCSF Department of Laboratory Medicine Moira Bruce, PhD Chief, Laboratory Medicine Service Institute for Animal Health San Francisco General Hospital Neuropathogenesis Unit San Francisco, California, USA Edinburgh, UK Peter R. Foster, BSc, MSc, PhD, CS, CSci, CEng, FIChemE Michael P. Busch, MD, PhD Protein Fractionation Centre Director, Blood Systems Research Institute Scottish National Blood Transfusion Service Vice President Research and Scientific Programs Edinburgh, UK Blood Systems, Inc. and Professor of Laboratory Medicine University of California, USA

Contributors

Paul R. Grant, PhD Carl P. McDonald, BSc, MSc, PhD Head of Molecular Diagnostics Head of Bacteriology Department of Virology NHS Blood and Transplant University College London Hospitals Colindale, London, UK London, UK Gary Mallinson, BSc, PhD Helen Harris, BSc, PhD Bristol Institute for Transfusion Sciences Clinical Scientist, Epidemiology Research Associate NHS Blood and Transplant Immunization Department Bristol, UK Health Protection Agency, Centre for Infections Colindale, London, UK Chris Moore, BSc, MBBS Associate Specialist in Transfusion Microbiology Patricia E. Hewitt, FRCP, FRCPath c/o NHS Blood and Transplant Colindale Consultant Specialist in Transfusion Microbiology Colindale, London, UK NHS Blood and Transplant, Colindale, London, UK Joan O’Riordan, MCRP, FRCPath Consultant Haematologist Paul V. Holland,MD Irish Blood Transfusion Service Clinical Professor of Medicine and Pathology National Blood Centre University of California, Dublin, Ireland Davis Medical Center Sacramento, CA, USA and Scientific Director, Delta Blood Bank Arturo Pereira, MD, PhD Stockton, CA, USA Service of Hemotherapy and Haemostasis Hospital Clinic James W. Ironside, CBE, FRCPath, FRCPEdin, FMedSci, FRSA Barcelona, Spain Professor of Clinical Neuropathology National CJD Surveillance Unit Juraj Petrik, PhD University of Edinburgh Head, Microbiology Research and Development Western General Hospital Scottish National Blood Transfusion Service Edinburgh, UK TTI Department Royal (Dick) Veterinary College Virge James, BM, BCh, MA, DM, FRCPath Edinburgh, UK NHS Blood and Transplant Sheffield, UK Chris Prowse, MA, DPhil, FRCPath Research Director Alan D. Kitchen, PhD National Science Laboratory Head, National Transfusion Microbiology Scottish National Blood Transfusion Service Reference Laboratory Edinburgh, UK NHS Blood and Transplant Colindale, London, UK Peter D. Rogan, MPhil, BA FIBMS David A. Leiby, PhD NHS Blood and Transplant Chief of Parasitology Manchester, UK American Red Cross Holland Laboratory Rockville, MD, USA W. Kurt Roth,MD Professor of Medicine, CEO Elizabeth M. Love, MB, ChB, FRCP, FRCPath GFE Blut mbH, Consultant Haematologist (Transfusion Medicine) Altenhoeferallee 3, Lead Clinician for Blood and Tissues Safety Assurance Frankfurt am Main, Germany NHS Blood and Transplant Manchester Blood Centre and Central Manchester and Kate Soldan, BA, MSc, PhD Manchester Children’s Hospitals University NHS Trust Epidemiologist, HIV/STI Department Manchester, UK Health Protection Agency Centre for Infections Colindale, London, UK

Contributors

Susan L. Stramer, PhD Eleftherios C. Vamvakas, MD, PhD Executive Scientific Officer University of Ottowa Faculty of Medicine American Red Cross Department of Pathology and Laboratory Medicine Gaithersburg, MD, USA Ottawa, ON, Canada

Richard S. Tedder, MA, MB, BChir, FRCP, FRCPath Elizabeth Vinelli,MD Professor of Medical Virology Programa Nacional de Sangre Centre for Virology Comayaguela, Honduras University College London Hospitals NHS Trust London, UK Silvano Wendel, MD, PhD Medical Director, Blood Bank Gary E. Tegtmeier, PhD Hospital S´ırio Libanesˆ Community Blood Center of Greater Kansas City Sao˜ Paulo, Brazil Kansas City Missouri, USA Lorna M. Williamson, BSc, MD, FRCP, FRCPath Reader in Transfusion Medicine, University of Cambridge Marc L. Turner, MB, ChB, MBA, PhD, FRCP, FRCPath Medical Director Professor of Cellular Therapy NHS Blood and Transplant University of Edinburgh Cambridge, UK Clinical Director/Consultant Haematologist Edinburgh and S.E. Scotland Blood Transfusion Centre Royal Infirmary of Edinburgh Edinburgh, Scotland

FOREWORD

Microbiology has been intertwined with transfusion medicine Undoubtedly, these and other fields of science contribute to from the outset. It was not long after the development of transfu- transfusion microbiology, but it is not a one-way street. The need sion as we know it, that viral hepatitis was recognized as an inevi- to maintain transfusion safety has stimulated excellence in the table and largely intractable complication of transfusion. More development of sensitive and accurate screening assays, but it has than fifty years later, we are almost in control of this, and other also directly provoked extraordinary achievements, such as the transfusion-transmissible viruses, but we are, in common with collaboration of transfusion scientists and molecular biologists others, facing the unexpected problems of emerging infections. that led to the characterization of hepatitis C virus. This was the Human immunodeficiency virus, the first of these, was, and still very first virus to be fully characterized solely from its genomic is, an enormous human tragedy. As such, it taught us that blood sequence. It does not take much thought to recognize many such safety must be managed by action, not words. Further unpredict- examples of the contributions of transfusion-based studies to our able challenges have appeared and will continue to beset us. In understanding of pathogens. 1950, who could have dreamed that artificial changes in the way This wonderful book covers all of these issues, and many more, that cattle are fed would result in a crisis in the perception of in extraordinary detail, from the familiar agents of the past, such transfusion safety? Even in 2001, we did not predict the impact of as hepatitis B virus, to the bizarre world of prions. Means to West Nile virus on blood safety – in part because experience had control the safety and quality of blood are fully covered, from told us that acute infections were rarely transmitted by transfusion. donor selection and testing to haemovigilance. Quality, regula- John Barbara, one of the editors of this book, coined the term tion and risk assessment are equally well managed. The careful ‘transfusion microbiology’, which turns out to be a discipline much reader of this book may, or may not, become a fully-fledged greater than the sum of its parts. Managing the risk of transfusion- transfusion microbiologist, but will certainly gain a full apprecia- transmitted infection involves knowledge of a wide range of tion of the field and will have learned from the best of experts. pathogens, of their pathology and epidemiology, and of the strange I have reserved my final comment for the final chapter. I sus- interface between human infection, risk behaviour, truthfulness pect that most readers of this book will live and work in a devel- and motivation. Furthermore, the practitioner of transfusion micro- oped country where disproportionate resources are directed biology must have a grip on the finer points of laboratory detection towards reducing transfusion risks to immeasurably low levels. of infection and infectivity, and of the unfamiliar disciplines of We must also stop and consider the toll on human life that is quality systems and regulatory scrutiny. Also, a working knowledge exacted by the inadequate levels of blood safety that are available of transfusion medicine and of the immune status of transfused to the inhabitants of the developing world. Let us all work to patients are needed. Constant surveillance of information about ameliorate this, the biggest of blood safety problems. seemingly unconnected infectious diseases is also required. Roger Y. Dodd

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PREFACE

Prior to the early 1970s infections transmitted by transfusion were Inevitably, ‘new’ infectious agents will emerge that are relatively common. In developed countries the introduction of potentially pathogenic, which will have to be assessed in routine screening for hepatitis B virus infection marked the terms of the degree of risk to recipients of blood. The way in beginning of the recognition, and implementation of systematic which these risks are addressed will continue to evolve. measures to reduce the risk from transmission, of viruses by Available options for prevention of transmission will have to blood transfusion. Currently, extensive measures are taken in be assessed not only in terms of efficacy but also in terms of many countries to ensure that blood transfusion poses a minimal cost-effectiveness and, in many countries, prioritized against microbiological hazard to recipients. Continual refinements to other demands for health care resources. Expectations from donor selection criteria, microbiological testing, technologies, the public and the media of infectious risks of blood transfu- processes such as leucodepletion, viral inactivation and asso- sion will always play a part in decision making and these ciated quality management systems seek to improve the safety perceptions of risk themselves may also have to be addressed. even further, yet there is a diminishing safety yield for ever esca- Ultimately, decisions regarding the introduction of new ‘safety’ lating costs with each new intervention. In less affluent countries, measures for the blood supply will be taken by the political the level of risk from transfusion-transmitted infections is often powers who will be governed by the precautionary principle undetermined and there is a chronic insufficiency of blood and the fear of litigation. donors. The few donors available may well be non-voluntary and this adds to the potential risk from transfusion infections. John A. J. Barbara Fortunately, progress is being made in several regions in estab- Fiona A. M. Regan lishing voluntary, non-remunerated, blood donor panels. So what Marcela Contreras does the future hold in the field of transfusion microbiology?

ACKNOWLEDGEMENTS

The editors would like to express their gratitude for the tremen- Kitchen, Dr Roger Eglin and Dr Brian Dow for their extensive dous secretarial support over the duration of this endeavour, support with this project. particularly to Tahera Lakha, Carmel McGinn, Marina Mobed In addition to our very patient and hardworking contributors to and Faye Fisher; without their help this book would have never the chapters, we would also like to thank Dr Cees L. van der Poel been completed. and Dr David Howell for their advice. We would also like to thank many of our colleagues for their Professor John A. J. Barbara, Dr Fiona Regan and input in a reviewing capacity, with particular thanks to Dr Alan Professor Marcela Contreras

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GLOSSARY

Abbreviations for major viruses are included in this glossary. Other viruses will be covered in individual chapters.

AIDS Acquired immunodeficiency syndrome IBCT Incorrect blood component transfused ALT Alanine aminotransferase IHA Indirect haemagglutination assay Anti-HBc Antibody to hepatitis B core antigen IVIg Intravenous immunoglobulin Anti-HBe Antibody to hepatitis e antigen IVDU Intravenous drug user Anti-HBs Antibody to hepatitis B surface antigen LCR Ligase chain reaction AST Aspartate aminotranferase LD Leucodepletion ATL Adult T-cell leukaemia and lymphoma LDH Lactate dehydrogenase ATR Acute transfusion reaction (within 24 hours) MCD Multicentre Castleman’s disease BCBL Body cavity based lymphoma MHRA Medicines and Healthcare Products B19V Parvovirus B19 Regulatory Agency bDNA Branched DNA signal amplification assay NANBH Non-A, non-B hepatitis CARD Catalyzed reporter deposition NASBA Nucleic acid sequence based amplification CIE Counter immune electropheresis NAT Nucleic acid testing CCD Charge coupled device camera NBS National Blood Service, England and N. Wales CHIKV Chikungunya fever virus NIBSC National Institute for Biological Standards CJD Creutzfeld-Jakob disease and Control CMV Cytomegalovirus PBMC Peripheral blood monocyte cells CPMP Committee for Proprietary PCC Prothrombin complex concentrate Medicinal Products PCR Polymerase chain reaction DALy Disability adjusted life year PI/PR Pathogen inactivation/pathogen reduction DID Double immune diffusion POEMS Polyneuropathy, organomegaly, DTR Delayed transfusion reaction endocrinopathy, M protein and skin (beyond 24 hours) changes EC European Commission PrP Prion protein EIA Enzyme linked immunosorbent assay PTP Post-transfusion purpura EMEA European Medicines (evaluation) Agency PRCA Pure red cell aplasia EQAS External quality assurance system QA Quality assurance EU European Union QC Quality control FDA Food and Drugs Agency QALY Quality adjusted life year FFP Fresh frozen plasma RCA Rolling circle amplification GBV-C/HGV GB virus-C/Hepatitis G virus RPHA Reverse passive haemagglutination assay GMP Good manufacturing practice RIBA Recombinant immunoblot assay HAM HTLV-I associated myelopathy RLS Resonance light scatter HAV Hepatitis A virus RPR Rapid plasma reagin test HBeAg Hepatitis B e antigen SACTTI Standing Advisory Committee on HBsAg Hepatitis B surface antigen Transfusion Transmitted Infection HBV Hepatitis B virus SARS Severe acute respiratory syndrome HCC Hepatocellular carcinoma SD Solvent detergent HCV Hepatitis C virus SEN-V SEN virus HDV Hepatitis D virus SFV Simian foamy virus HEV Hepatitis E virus SHOT Serious hazards of transfusion HHV8 Human herpes virus 8 SNP Single nucleic acid polymorphisms HIV Human immunodeficiency virus SNBTS Scottish National Blood Transfusion Service HPA Health Protection Agency SPC Statistical process control HRP Horseradish peroxidase SPM Statistical process monitoring HSV Herpes simplex virus SPR Surface plasmon resonance HTLV Human T-cell lymphotropic virus TAC Transient aplastic crisis

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Glossary

TACO Transfusion-associated circulatory TSA Tyramide signal amplification overload TSP Tropical spastic paraparesis TA-GVHD Transfusion-associated graft versus TTI Transfusion transmitted infection host disease TTV TT virus TMA Transcription mediated amplification vCJD Variant Creutzfeld-Jakob disease TPHA Treponema pallidum haemagglutination VDRL Venereal diseases research laboratory assay VZV (Herpes) varicella-zoster virus TPPA Treponema pallidum particle agglutination WHO World Health Organization assay WNV West Nile virus TRALI Transfusion related acute lung injury WP Window period (of an infection)

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