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Biomarkers of Disease
An Evidence-based Approach

This new publication takes a critical, evidence-based look at the efficacy of new diagnostic tests
which are increasingly being used to evaluate organ damage and dysfunction. The use of bio-
markers is growing, with a steady stream of new products being brought out by the diagnostics
industry. Some of these assist in diagnosis, while others provide a means of monitoring the state
of progression of disease and the effectiveness of therapeutic options. However, in many cases,
the evidence which supports the use of these new methods as opposed to traditional biochemi-
cal tests has not yet been demonstrated, and it is intended that this volume will help clarify the
strengths and weaknesses of using these biomarkers across a wide range of applications and in
the various organs of the body. This approach will provide clinicians, pathologists, clinical bio-
chemists and medical laboratory scientists with an invaluable overview of the diverse applica-
tions of biomarkers in medicine.
Biomarkers of Disease
An Evidence-based Approach

Edited by

Andrew K. Trull, Lawrence M. Demers

David W. Holt, Atholl Johnston, J. Michael Tredger
and Christopher P. Price
  
Cambridge, New York, Melbourne, Madrid, Cape Town, Singapore, São Paulo

Cambridge University Press

The Edinburgh Building, Cambridge  , United Kingdom
Published in the United States of America by Cambridge University Press, New York
www.cambridge.org
Information on this title: www.cambridge.org/9780521811026

© Cambridge University Press 2002

This book is in copyright. Subject to statutory exception and to the provision of

relevant collective licensing agreements, no reproduction of any part may take place
without the written permission of Cambridge University Press.

First published in print format 2002

-
isbn-13 978-0-511-06438-8 eBook (NetLibrary)
-
isbn-10 0-511-06438-1 eBook (NetLibrary)

-
isbn-13 978-0-521-81102-6 hardback
-
isbn-10 0-521-81102-3 hardback

Cambridge University Press has no responsibility for the persistence or accuracy of

s for external or third-party internet websites referred to in this book, 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 book to provide accurate and up-to-date
information which is in accord with accepted standards and practice at the time of
publication. 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 publisher therefore disclaim all liability for direct or consequential
damages resulting from the use of material contained in this book. Readers are strongly
advised to pay careful attention to information provided by the manufacturer of any
drugs or equipment that they plan to use.
 Contents

List of contributors page x

Preface xxi

Part 1 Assessing and utilizing the diagnostic or prognostic

power of biomarkers

1 Evidence-based medicine: evaluation of biomarkers 3

R. Andrew Moore

2 Development of biomarkers: the industrial perspective 16

Andy Bufton

3 Statistical approaches to rational biomarker selection 24

Linda D. Sharples

4 Using intelligent systems in clinical decision support 32

Richard Jones

Part 2 Biomarkers of kidney disease and dysfunction

5 Biomarkers in renal disease 45

Christopher P. Price

6 The genetics of renal disease 56

Jean-Pierre Grünfeld, Bertrand Knebelmann

7 Early markers of nephrotoxicity for environmental and occupational

monitoring 66
Robert G. Price

v
vi Contents

8 The early detection of renal impairment in diabetes mellitus. The case

for microalbuminuria and other biomarkers 76
Carl E. Mogensen

Part 3 Biomarkers of bone disease and dysfunction

9 Bone turnover markers in clinical practice 99

Richard Eastell, Sheila Hart

10 Biomarkers of bone formation 115

Juha Risteli, Saila Kauppila, Arja Jukkola, Eevastiina Marjoniemi, Jukka Melkko,
Leila Risteli

11 Biochemical markers of bone resorption 122

Simon P. Robins

12 The clinical application of biomarkers in osteoporosis 133

Patrick Garnero

13 Sources of preanalytical variability in the measurement of biochemical

markers of bone turnover 140
Markus J. Seibel

14 Genetic approaches to the study of complex diseases: osteoporosis 159

Andre G. Uitterlinden

Part 4 Biomarkers of liver disease and dysfunction

15 Biomarkers of hepatic disease 167

Michael Oellerich

16 The immunogenetics of metabolic liver disease 177

Peter T. Donaldson

17 Toxicogenetic markers of liver dysfunction 190

J. Michael Tredger

18 Prognosis and management of patients with acute liver failure 199

Fin Stolze Larsen

19 Biomarkers in artificial and bioartificial liver support 211

Robin D. Hughes
vii Contents

20 Prognostic markers in liver disease 221

Martin Burdelski

21 Apoptosis: biomarkers and the key role of mitochondria 228

Kelvin Cain

22 Liver regeneration: mechanisms and markers 239

Nelson Fausto, Jean Campbell

23 Determinants of responses to viruses and self in liver disease 244

Michael P. Manns, Petra Obermayer-Straub

24 IL-6-type cytokines and signalling in inflammation 256

Peter C. Heinrich, Johannes G. Bode, Lutz Graeve, Serge Haan, Astrid Martens,
Gerhard Müller-Newen, Ariane Nimmesgern, Fred Schaper, Jochen Schmitz,
Elmar Siewert

Part 5 Biomarkers of gastrointestinal disease and dysfunction

25 Biomarkers in gastrointestinal disease 265

Humphrey J. F. Hodgson

26 Tumour markers in gastrointestinal disease 272

Anthony J. FitzGerald, Nicholas A. Wright

27 Markers of malabsorption: coeliac disease 281

H. Julia Ellis, Jocelyn S. Fraser, Paul J. Ciclitira

Part 6 Biomarkers in toxicology

28 Genomics and biomarkers in toxicology 291

Jonathan D. Tugwood, Katherine M. Beckett

29 Protein profiling and proteomic databases 299

Julio E. Celis, Pavel Gromov, Morten Østergaard, Hildur Pálsdóttir, Irina Gromova

30 Biomarkers for evaluating the safety of genetically modified foods 313

Ad A. C. M. Peijnenburg, Hubert P. J. M. Noteborn, Harry A. Kuiper
viii Contents

Part 7 Biomarkers of cardiovascular disease and dysfunction

31 The impact of biochemical tests on patient management 325

Paul O. Collinson

32 Cardiac natriuretic peptides in risk assessment of patients with acute

myocardial infarction or congestive heart failure 334
Johannes Mair

33 Serum markers of inflammation and cardiovascular risk 345

Juan Carlos Kaski

34 The clinical significance of markers of coagulation in acute coronary

syndromes 355
Lina Badimon, Antonio Bayés-Genís

35 Endothelin: what does it tell us about myocardial and endothelial

dysfunction? 365
John Pernow

36 Homocysteine: a reversible risk factor for coronary heart disease 374

John C. Chambers

37 Matrix metalloproteinases and their tissue inhibitors 379

Peter M. Timms, Stewart Campbell, Vinijar Srikanthan, Christopher P. Price

Part 8 Biomarkers of neurological disease and dysfunction

38 Biomarkers of neurodegenerative disorders 391

John M. Land

39 Traumatic brain injury: assessment by biochemical serum markers 398

Tor Ingebrigtsen, Bertil Romner

40 An overview of S-100
as a clinically useful biomarker of brain tissue

damage 406
John Azami, Basil F. Matta

Part 9 Biomarkers in transplantation

41 Monitoring heart and lung transplant patients 415

Marlene L. Rose
ix Contents

42 Monitoring liver transplant recipients 423

Andrew Trull

43 Chronic allograft damage index as a surrogate marker for chronic

allograft rejection 433
Serdar Yilmaz, Mark Nutley, Eero Taskinen, Timo Paavonen, Pekka Hayry

44 Advances in pharmacodynamic biomarkers for monitoring the response

to immunosuppressive drug therapy 442
Victor W. Armstrong

45 The use of biomarkers for monitoring the response to immunosuppressive

drug therapy 451
Atholl Johnston

46 Post-transplantation bone disease 461

Juliet E. Compston

47 Molecular diagnosis of cytomegalovirus disease 467

Aycan F. Hassan-Walker, Vincent C. Emery, Paul D. Griffiths

48 Diagnosis and monitoring of inflammatory events in transplant

recipients 474
Claus Hammer, Gudrun Höbbel, Stephanie Hammer, Peter Fraunberger, Bruno Meiser

Index 483
 Contributors

Victor W. Armstrong Katherine M. Beckett

Abteilung Klinische Chemie AstraZeneca
Zentrum Innere Medizin Macclesfield Site
Georg-August-Universität Göttingen Charterway
Robert-Koch-Strasse 40 Silk Road Business Park
Göttingen Macclesfield
Germany Cheshire
[email protected] SK10 2NA
UK
John Azami
Addenbrooke’s Hospital Johannes G. Bode
Hills Road Institute of Biochemistry
Cambridge RWTH Aachen
CB2 2QQ Pauweisstrasse 30
UK D-52074 Aachen
Germany
Lina Badimon
Cardiovascular Research Center Andy Bufton
IIBB/CSIC-HSCSP-UAB Abbott Diagnostics Division
Jordi Girona, 18–26 Abbott House
08034 Barcelona Norden Road
Spain Maidenhead
[email protected] Berkshire
SL6 4XF
Antonio Bayés-Genís UK
Cardiovascular Research Center [email protected]
IIBB/CSIC-HSCSP-UAB
Jordi Girona, 18–26 Martin Burdelski
08034 Barcelona Department of Paediatrics
Spain University Hospital Hamburg
Eppendorf
Martinistrasse 52

x
xi List of contributors

D-20246 Hamburg John C. Chambers

Germany National Heart and Lung Institute
[email protected] Hammersmith Hospital
Du Cane Road
Kelvin Cain London
MRC Toxicology Unit W12 0NN
Hodgkin Building UK
University of Leicester [email protected]
Lancaster Road
Leicester Paul J. Ciclitira
LE1 9HN Gastroenterology Unit
UK The Rayne Institute (KCL)
[email protected] St Thomas’ Hospital
Lambeth Palace Road
Jean Campbell London
Department of Pathology SE1 7EH
University of Washington School of UK
Medicine
Paul O. Collinson
Seattle
St George’s Hospital and Medical School
WA 98195
St George’s Hospital
USA
Cranmer Terrace
London
Stewart Campbell
SW17 0BE
Department of Clinical Biochemistry
UK
St Bartholomew’s and The Royal London
[email protected]
Hospitals
West Smithfield Juliet E. Compston
London Department of Medicine
EC1A 7BE Level 5 Box 157
UK Addenbrooke’s Hospital
Cambridge
Julio E. Celis CB2 2QQ
Department of Medical Biochemistry and UK
Danish Centre for Human Genome [email protected]
Research
University of Aarhus Laurence M. Demers
Ole Worms Allé Pennsylvania State University College of
Building 170 Medicine
DK-800 Aarhus C The M.S. Hershey Medical Center
Denmark 500 University Drive
[email protected] Hershey
PA 17033
USA
xii List of contributors

Peter T. Donaldson Nelson Fausto

Centre for Liver Research Department of Pathology
The School of Clinical Medical Sciences University of Washington School of
University of Newcastle Medicine
Newcastle upon Tyne Seattle
NE2 4HH WA 98195
UK USA
[email protected] [email protected]

Richard Eastell Anthony J. FitzGerald

Division of Clinical Science (NGHT) Department of Histopathology
Section of Medicine Hammersmith Hospital
Bone Metabolism Group Du Cane Road
Northern General Hospital London
Herries Road W12 0NN
Sheffield UK
S5 7AU
UK Jocelyn S. Fraser
r.eastell@sheffeld.ac.uk Gastroenterology Unit
The Rayne Institute (KCL)
H. Julia Ellis St Thomas’ Hospital
Gastroenterology Unit Lambeth Palace Road
The Rayne Institute (KCL) London
St Thomas’ Hospital SE1 7EH
Lambeth Palace Road UK
London
SE1 7EH Peter Fraunberger
UK Institute of Clinical Chemistry
[email protected] Klinikum Grosshadern
LM-University of Munich
Vincent C. Emery Munich
Department of Virology Germany
Royal Free and University College Medical
School Patrick Garnero
Rowland Hill Street Unité INSERM 403
London Hôpital E Herriot
NW3 2PF Pavillion F
UK 69437 Lyon Cedex 03
France
[email protected]
xiii List of contributors

Lutz Graeve Serge Haan

Institute of Biochemistry Institute of Biochemistry
RWTH Aachen RWTH Aachen
Pauweisstrasse 30 Pauweisstrasse 30
D-52074 Aachen D-52074 Aachen
Germany Germany

Paul D. Griffiths Claus Hammer

Department of Virology Institute of Surgical Research
Royal Free and University College Medical Klinikum Grosshadern
School LM-University of Munich
Rowland Hill Street Munich
London Germany
NW3 2PF [email protected]
UK
Stephanie Hammer
Pavel Gromov Institute of Surgical Research
Department of Medical Biochemistry Klinikum Grosshadern
University of Aarhus LM-University of Munich
Ole Worms Allé Munich
Building 170 Germany
DK-800 Aarhus C
Denmark Sheila Hart
Division of Clinical Science (NGHT)
Irina Gromova Section of Medicine
Department of Medical Biochemistry Bone Metabolism Group
University of Aarhus Northern General Hospital
Ole Worms Allé Herries Road
Building 170 Sheffield
DK-800 Aarhus C S5 7AU
Denmark UK

Jean-Pierre Grünfeld Aycan F. Hassan-Walker

Service de Néphrologie Department of Virology
Hôpital Necker Royal Free and University College Medical
161 rue de Sèvres School
75743 Paris Cedex 15 Rowland Hill Street
France London
[email protected] NW3 2PF
UK
[email protected]
xiv List of contributors

Pekka Hayry Humphrey J. F. Hodgson

Transplantation Laboratory Royal Free and University College School of
PO Box 21 (Haartmaninkatu 3) Medicine
00014 University of Helsinki Rowland Hill Street
Helskinki London
Finland NW3 2PF
pekka.hayry@helsinki.fi UK
[email protected]
Peter C. Heinrich
Institute of Biochemistry Tor Ingebrigtsen
RWTH Aachen Department of Neurosurgery
Pauweisstrasse 30 Tromsø University Hospital
D-52074 Aachen N-9038 Tromsø
Germany Norway
[email protected] [email protected]

Atholl Johnston
Gudrun Höbbel
Clinical Pharmacology
Institute of Surgical Research
St Bartholomew’s Hospital and the Royal
Klinikum Grosshadern
London School of Medicine and
LM-University of Munich
Dentistry
Munich
Charterhouse Square
Germany
London
EC1M 6BQ
David W. Holt
UK
The Analytical Unit
[email protected]
St George’s Hospital Medical School
London Richard Jones
SW17 0BE Directorate of Pathology
UK Leeds Teaching Hospitals NHS Trust and
University of Leeds
Robin D. Hughes Leeds
Institute of Liver Studies LS1 3EX
Guy’s, King’s and St Thomas’ School of UK
Medicine [email protected]
Bessemer Road
London Arja Jukkola
SE5 9PJ Department of Clinical Chemistry,
UK Oncology and Pathology
[email protected] University of Oulu
PO Box 5000
FIN-90014 University of Oulu
Oulu
Finland
xv List of contributors

Juan Carlos Kaski Fin Stolze Larsen

Coronary Artery Disease Unit Department of Haematology
Department of Cardiological Sciences Rigshospitalet
St George’s Hospital Medical School Copenhagen University Hospital
Cranmer Terrace Copenhagen
London Denmark
SW17 0BE [email protected]
UK
[email protected] Johannes Mair
Department of Internal Medicine
Saila Kauppila Division of Cardiology
Department of Clinical Chemistry, University of Innsbruck
Oncology and Pathology Anichstrasse 35
University of Oulu A-6020 Innsbruck
PO Box 5000 Austria
FIN-90014 University of Oulu [email protected]
Oulu
Finland Michael P. Manns
Department of Gastroenterology and
Bertrand Knebelmann Hepatology
Service de Néphrologie Medical School of Hannover
Hôpital Necker Carl-Neuberg Strasse 1
161 rue de Sèvres D-30625 Hannover
75743 Paris Cedex 15 Germany
France [email protected]

Harry A. Kuiper Eevastiina Marjoniemi

RIKILT (National Institute for Quality Department of Clinical Chemistry,
Control of Agricultural Products) Oncology and Pathology
Wageningen University and Research University of Oulu
Centre PO Box 5000
Wageningen FIN-90014 University of Oulu
The Netherlands Oulu
Finland
John M. Land
Neurometabolic Unit Astrid Martens
Institute of Neurology and National Institute of Biochemistry
Hospital RWTH Aachen
Queen Square Pauweisstrasse 30
London D-52074 Aachen
UK Germany
[email protected]
xvi List of contributors

Basil F. Matta Gerhard Müller-Newen

Perioperative Care Services Institute of Biochemistry
Addenbrooke’s Hospital RWTH Aachen
Hills Road Pauweisstrasse 30
Cambridge D-52074 Aachen
CB2 2QQ Germany
UK
[email protected] Ariane Nimmesgern
Institute of Biochemistry
Bruno Meiser RWTH Aachen
Department of Cardiothoracic Surgery Pauweisstrasse 30
Klinikum Grosshadern D-52074 Aachen
LM-University of Munich Germany
Munich
Hubert P. J. M. Noteborn
Germany
RIKILT (National Institute for Quality
Control of Agricultural Products)
Jukka Melkko
Wageningen University and Research Centre
Department of Clinical Chemistry,
Wageningen
Oncology and Pathology
The Netherlands
University of Oulu
PO Box 5000
Mark Nutley
FIN-90014 University of Oulu
Department of Surgery
Oulu
University of Calgary and Foothills Medical
Finland
Centre
Calgary
Carl E. Mogensen
Alberta
Medical Department M
Canada
Aarhus Kommunehospital
Aarhus University Hospital Petra Obermayer-Straub
DK-800 Department of Gastroenterology and
Aarhus Hepatology
Denmark Medical School of Hannover
[email protected] Carl-Neuberg Strasse 1
D-30625 Hannover
R. Andrew Moore Germany
Pain Research and Nuffield Department of
Anaesthetics Michael Oellerich
The Churchill Abteilung Klinische Chemie
Oxford Zentrum Inner Medizin
OX3 7LJ Georg-August-Universtät
UK Göttingen
[email protected] Germany
[email protected]
xvii List of contributors

Morten Østergaard Christopher P. Price

Department of Medical Biochemistry Bayer Diagnostics Division
University of Aarhus Stoke Court
Ole Worms Allé Stoke Poges
Building 170 Berks
DK-800 Aarhus C SL2 4LY
Denmark UK
[email protected]
Timo Paavonen
Transplantation Laboratory Robert G. Price
PO Box 21 (Haartmaninkatu 3) Division of Life Sciences
00014 University of Helsinki King’s College London
Helskinki 150 Stamford Street
Finland London
SE1 8WA
Hildur Pálsdóttir UK
Department of Medical Biochemistry [email protected]
University of Aarhus
Ole Worms Allé Juha Risteli
Building 170 Department of Clinical Chemistry,
DK-800 Aarhus C Oncology and Pathology
Denmark University of Oulu
PO Box 5000
Ad A. C. M. Peijnenburg FIN-90014 University of Oulu
RIKILT (National Institute for Quality Oulu
Control of Agricultural Products) Finland
Wageningen University and Research Centre juha.risteli@oulu.fi
Wageningen
The Netherlands Leila Risteli
[email protected] Department of Clinical Chemistry,
Oncology and Pathology
John Pernow University of Oulu
Department of Cardiology PO Box 5000
Karolinska Hospital FIN-90014 University of Oulu
S-171 76 Stockholm Oulu
Sweden Finland
[email protected]
xviii List of contributors

Simon P. Robins Markus J. Seibel

Skeletal Research Unit University of Sydney
Rowett Research Institute Department of Endochinology and
Bucksburn Metabolism C64
Aberdeen Level 6 – Medical Centre
AB21 9SB Concord Hospital
UK Sydney
[email protected] 2139 NSW
Australia
Bertil Romner Markus.Seible@
Department of Neurosurgery email.cs.nsw.gov.au
Lund University Hospital
S-22 185 Lund Linda D. Sharples
Sweden MRC Biostatistics Unit
[email protected] University Forvie Site
Robinson Way
Marlene L. Rose Cambridge
National Heart and Lung Institute CB4 3EU
Heart Science Centre UK
Harefield Hospital [email protected]
Harefield
Middlesex Elmar Siewert
UB9 6JH Institute of Biochemistry
UK RWTH Aachen
marlene.rose@harefield.nthames.nhs.uk Pauweisstrasse 30
D-52074 Aachen
Fred Schaper Germany
Institute of Biochemistry
RWTH Aachen Vinijar Srikanthan
Pauweisstrasse 30 Department of Clinical Biochemistry
D-52074 Aachen St Bartholomew’s and The Royal London
Germany Hospitals
West Smithfield
Jochen Schmitz London
Institute of Biochemistry EC1A 7BE
RWTH Aachen UK
Pauweisstrasse 30
D-52074 Aachen Eero Taskinen
Germany Transplantation Laboratory
PO Box 21 (Haartmaninkatu 3)
00014 University of Helsinki
Helskinki
Finland
xix List of contributors

Peter M. Timms Andre G. Uitterlinden

Department of Clinical Biochemistry Department of Internal Medicine/
St Bartholomew’s and The Royal London Department of Epidemiology and
Hospitals Biostatistics
West Smithfield Erasmus University Medical School
London Rotterdam
EC1A 7BE The Netherlands
UK [email protected]
[email protected]
Nicholas A. Wright
J. Michael Tredger Histopathology Unit
Institute of Liver Studies Imperial Cancer Research Fund
Guy’s, King’s and St Thomas’ School of Hammersmith Hospital
Medicine 44 Lincoln Inn Fields
Bessemer Road London
London WC2A 3PX
SE5 9PJ UK
UK [email protected]
[email protected]
Serdar Yilmaz
Andrew K. Trull
Division of Transplantation
Department of Pathology
Department of Surgery
Papworth Hospital
University of Calgary and Foothills Medical
Papworth Everard
Centre
Cambridge
Calgary
CB3 8RE
Alberta
UK
Canada
[email protected]

Jonathan D. Tugwood
AstraZeneca
Macclesfield Site
Charterway
Silk Road Business Park
Macclesfield
Cheshire
SK10 2NA
UK
[email protected]
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