A Practical Guide to Global Point-Of-Care Testing [1 ed.] 9781486305193, 9781486305186

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Written for a broad range of practicing health professionals from the fields of medical science, health science, nursing, medicine, paramedic science, Indigenous health, public health, pharmacy, aged care and sports medicine, A Practical Guide to Global Point-of-Care Testing will also benefit university students studying these health-related disciplines.

EDITOR: MARK SHEPHARD

The book is divided into three major themes: the management of POCT services, a global perspective on the clinical use of POCT, and POCT for specific clinical settings. Chapters within each theme are written by experts and explore wide-ranging topics such as selecting and evaluating devices, POCT for diabetes, coagulation disorders, HIV, malaria and Ebola, and the use of POCT for disaster management and in extreme environments. Figures are included throughout to illustrate the concepts, principles and practice of POCT.

A PRACTICAL GUIDE TO GLOBAL

A Practical Guide to Global Point-of-Care Testing shows health professionals how to set up and manage POCT services under a quality-assured, sustainable, clinically and culturally effective framework, as well as understand the wide global scope and clinical applications of POCT.

POINT-OF-CARE TESTING

Point-of-care testing (POCT) refers to pathology testing performed in a clinical setting at the time of patient consultation, generating a rapid test result that enables informed and timely clinical action to be taken on patient care. It offers patients greater convenience and access to health services and helps to improve clinical outcomes. POCT also provides innovative solutions for the detection and management of chronic, acute and infectious diseases, in settings including family practices, Indigenous medical services, community health facilities, rural and remote areas and in developing countries, where health services are often geographically isolated from the nearest pathology laboratory.

A PRACTICAL GUIDE TO GLOBAL POINT-OF-CARE TESTING Editor: Mark Shephard

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A PRACTICAL GUIDE TO GLOBAL POINT-OF-CARE TESTING Editor: Mark Shephard

© CSIRO 2016 All rights reserved. Except under the conditions described in the Australian Copyright Act 1968 and subsequent amendments, 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, duplicating or otherwise, without the prior permission of the copyright owner. Contact CSIRO Publishing for all permission requests. National Library of Australia Cataloguing-in-Publication entry A practical guide to global point-of-care testing / Mark Shephard OAM (editor). 9781486305186 (paperback) 9781486305193 (epdf) 9781486305209 (epub) Includes bibliographical references and index. Point-of-care testing. Medicine, Preventive. Preventive health services. Pathology. Diagnostic services. Medical technology. Shephard, Mark, editor. 616.07 Published by CSIRO Publishing Locked Bag 10 Clayton South VIC 3169 Australia Telephone: +61 3 9545 8400 Email: [email protected] Website: www.publish.csiro.au Cover: The artwork on the cover depicts the many linkages that point-of-care testing can facilitate between the patient, the health professional, the health-care service and the community. It was inspired by artwork by Aimee Manion. Set in 10/13 Minion Pro and ITC Stone Sans Edited by Peter Storer Editorial Services Cover design by David Heinrich, Medical Illustration and Media, Flinders Medical Centre, Adelaide Typeset by Desktop Concepts Pty Ltd, Melbourne Index by Bruce Gillespie Printed in China by 1010 Printing International Ltd CSIRO Publishing publishes and distributes scientific, technical and health science books, magazines and journals from Australia to a worldwide audience and conducts these activities autonomously from the research activities of the Commonwealth Scientific and Industrial Research Organisation (CSIRO). The views expressed in this publication are those of the author(s) and do not necessarily represent those of, and should not be attributed to, the institutions with which they are affiliated, the publisher or CSIRO. The copyright owner shall not be liable for technical or other errors or omissions contained herein. The reader/user accepts all risks and responsibility for losses, damages, costs and other consequences resulting directly or indirectly from using this information. Original print edition: The paper this book is printed on is in accordance with the rules of the Forest Stewardship Council . The FSC promotes environmentally responsible, socially beneficial and economically viable management of the world’s forests.

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Contents

1

About the Editor

vi

Contributors

vii

Preface

xiii

An introduction to point-of-care testing and its global scope and application

1

Mark Shephard

THEME 1 2

THE MANAGEMENT OF POINT-OF-CARE TESTING SERVICES

Principles of establishing and managing a point-of-care testing service

15 16

Mark Shephard

3

Selection and evaluation of point-of-care testing devices

29

Mark Shephard

4

Training and competency assessment for device operators

46

Mark Shephard

5

Quality management of point-of-care testing devices

54

Mark Shephard, Anne Shephard, Wayne Dimech and Susan Best

6

Use of connectivity for managing point-of-care testing results

66

Bridgit McAteer, Brooke Spaeth, Volker Harms and Anne Shephard

7

Regulation and accreditation of point-of-care testing services

76

Ian Farrance, Andrew Griffin and Mark Shephard

8

How to evaluate the effectiveness of point-of-care testing

87

Richard Woodman, Tessa McCormack, Julie Ratcliffe and Mark Shephard

THEME 2 9

A GLOBAL PERSPECTIVE ON THE CLINICAL USE OF POINT-OF-CARE TESTING

Point-of-care testing for diabetes: glucose

103 104

Mark Shephard, Jonathan Shaw and Paul Zimmet

10

Point-of-care testing for diabetes: haemoglobin A1c

119

Mark Shephard, Jonathan Shaw and Paul Zimmet

11

Point-of-care testing for kidney disease Mark Shephard and Timothy Mathew

132

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A Practical Guide to Global Point-of-Care Testing

12

Point-of-care testing for cardiovascular disease

147

Heather Halls, Anne Shephard and Ken Sikaris

13

Point-of-care testing for the management of oral anticoagulants

158

Paul Harper and Bronwyn Sheppard

14

Point-of-care testing for markers of haematology disorders

171

Michelle Williamson

15

Point-of-care testing for electrolytes and acid-base imbalances

185

Cameron Martin

16

Point-of-care testing of cardiac markers

197

Per Venge, Bertil Lindahl and Heather Halls

17

Point-of-care testing for chlamydia, gonorrhoea and trichomoniasis

207

Lisa Natoli, Louise Causer, Lara Motta, Mark Shephard and Rebecca Guy

18

Point-of-care testing for syphilis

220

Igor Toskin, Maurine M Murtagh, James Kiarie and Rosanna W Peeling

19

Point-of-care testing for HIV

232

Damian Conway, Phillip Keen and Rebecca Guy

20

Point-of-care testing for hepatitis

245

Nitika Pant Pai, Paul Baum and Robert Luo

21

Rapid influenza diagnostic tests: clinical usage and significance

256

Caroline Chartrand, Christian Renaud and Nicolas Tremblay

22

Point-of-care testing for malaria

266

David Bell and Jane Cunningham

23

Point-of-care testing for active tuberculosis

279

Catherine Hogan and Madhukar Pai

24

Point-of-care testing for Ebola and other highly infectious threats: principles, practice, and strategies for stopping outbreaks

291

Gerald J Kost

25

Point-of-care testing for C-reactive protein

306

Rogier Hopstaken and Lara Harmans

26

Point-of-care testing for drugs of abuse Santiago Vazquez and Brooke Spaeth

316

Contents

THEME 3 27

POINT-OF-CARE TESTING FOR SPECIFIC CLINICAL SETTINGS

Point-of-care testing in general practice

331 332

Mark Shephard and Michael Kidd

28

Point-of-care testing in rural, remote and Indigenous settings

343

Mark Shephard, Louise Causer and Rebecca Guy

29

Point-of-care testing in the hospital setting

355

Geoff Herd and Samarina MA Musaad

30

Point-of-care testing for paramedic services

369

Hugh Grantham and Timothy Pointon

31

Point-of-care testing for disaster management

378

Mark Shephard, Paul Arbon and Gerald J Kost

32

Point-of-care testing and extreme environments – the Australian Antarctic Division

393

Roland Watzl and Jeff Ayton

33

Point-of-care testing in sports science

406

Lynda Norton and Kevin Norton

34

Point-of-care testing in the pharmacy

420

Geoff Herd

35

Point-of-care testing with ultrasound

431

Michael Jong, Margo Wilson, Tia Renouf and Michael Parsons

36

Stakeholder perspectives on point-of-care testing

438

Wilton Braund, Brooke Spaeth, Malcolm Auld, Justin Busbridge, Lauren Foohey and Connie Mardis

CONCLUSION 443 37

A 2020 vision for point-of-care testing

444

Mark Shephard Index 452

v

About the Editor Professor Mark Shephard OAM, BSc (Hons), MSc, MAIMS, MAACB, FFSc (RCPA), PhD is Director of the Flinders University International Centre for Point-of-Care Testing. He has extensive experience in research and management of large point-of-care testing networks across Australia and internationally; including roles as Program Manager of the national Quality Assurance for Aboriginal and Torres Strait Islander Medical Services (QAAMS) Point-of-Care Testing Program for diabetes management; Chair of the Management Committee of the Northern Territory Point-of-Care Testing Program for acute care pathology testing; a Chief Investigator for the TTANGO (Test, Treat and Go) point-of-care testing research program for sexually transmitted infections; and Program Manager of the international ACE (Analytical and Clinical Excellence) Point-of-Care Testing Program for diabetes management operating in seven countries. In regard to teaching, Mark is the Course Coordinator and principal lecturer for the Flinders University’s Graduate Certificate in Global Point-of-Care Testing, the first postgraduate academic qualification in the field of point-of-care testing, and Topic Coordinator and principal lecturer for ‘Point-ofCare Testing – Application, Management and Effectiveness’, taught in the Bachelor of Medical Science degree at Flinders University. Mark has served as Chair of the Australasian Association of Clinical Biochemists (AACB) Point of Care T ­ esting

Working Party (2004–05), Co-Chair of the Australian Institute of Medical Scientists (AIMS) Working Committee on Point-of-Care Testing for Infectious Disease and Drugs of Abuse (2010–2013), and was a member of the Australian Government’s National Pathology Accreditation Advisory Council (NPAAC) Point-of-Care Testing Drafting Committee (2013–2015), which developed national guidelines for the conduct of point-of-care testing in Australia. In 2009, Mark was the recipient of a Distinguished Alumni Award from Flinders University in recognition of his significant contributions to the improvement of Aboriginal health in Australia and his services to the University. In 2011, Mark was elected as a Founding Fellow of the Royal College of Pathologists of Australasia (RCPA) Faculty of Science. In 2013, Mark was appointed as the inaugural Chair of the WONCA (World Organization of Family Doctors) Special Interest Group on Global Point-of-Care Testing. Since 2014, Mark has been a member of the World Health Organization’s Technical Consultation on Point-of-Care Diagnostic Tests for Sexually Transmitted Infections. Mark has authored more than 100 peer-reviewed published papers and book chapters in the national and international literature. Mark was the recipient of the Medal of the Order of Australia (OAM) in the 2006 Queen’s Birthday Australian Honours list and an Australian of the Year Award in 2004. These awards acknowledged Mark’s work in pointof-care testing.

Contributors Paul Arbon, PhD, AM, FACN Matthew Flinders Distinguished Professor Dean, School of Nursing and Midwifery Flinders University Adelaide, South Australia Australia Chapter 31 Malcolm Auld, RN, Grad Cert Remote Health Practice Professional Practice Nurse Primary Health Care – Remote Central Australia Health Service Northern Territory Government Alice Springs, Northern Territory Australia Chapter 36 Jeff Ayton, MBBS, MPH&TM, FACRRM, FRACGP, FACTM, AFFTM, DRANZCOG DA(UK) Chief Medical Officer Australian Antarctic Division Kingston, Tasmania Australia Chapter 32 Paul Baum, MD, PhD Director Clinical Science Roche Molecular Systems, Inc Pleasanton CA, USA Assistant Adjunct Professor of Medicine University of California San Francisco CA, USA Chapter 20 David Bell, MBBS, MTropHealth, MRCP, FAFPHM, PhD Director, Global Health Technologies The Global Good Fund/Intellectual Ventures Laboratory Bellevue WA, USA Chapter 22 Susan Best, MAppSci, MASM, MBA Director National Serology Reference Laboratory Fitzroy, Victoria Australia Chapter 5

Wilton Braund, MBBS, FRACP Endocrinologist Endocrine SA Tennyson Centre Kurralta Park, South Australia Clinical Director Medical Communications Associates Blackwood, South Australia Australia Chapter 36 Matthew Justin Busbridge, RN, MRemoteIndigHlth, MSc(Adv Pract Nurs), BSc(Nurs), BA(Econ) Advance Practice Nurse and Remote Area Nurse Northern Territory Australia Chapter 36 Louise Causer, MBBS, MScPH, DTM&H Lecturer The Kirby Institute University of New South Wales Sydney, New South Wales Australia Chapter 17 & 28 Caroline Chartrand, MD, MSc, FRCPC Associate Professor (Clinics) – Department of Pediatrics Université de Montréal – CHU Sainte-Justine Montréal, Québec Canada Chapter 21 Damian Conway, MB BCh, MMed, PhD, FAChSHM, MRCGP, DRCOG Kirby Institute University of New South Wales Sydney, New South Wales Australia Chapter 19 Jane Cunningham, MD, FRCPC Technical Officer Global Malaria Programme World Health Organization Geneva

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A Practical Guide to Global Point-of-Care Testing

Switzerland Chapter 22 Wayne Dimech, B App Sci, MASM, MBA, FAIMS, FFSc (RCPA) General Manager National Serology Reference Laboratory Fitzroy, Victoria Australia Chapter 5 Ian Farrance, BSc, MCB, FAACB, FRCPath Associate, RMIT University Discipline of Laboratory Medicine School of Health and Biomedical Sciences Bundoora, Victoria Australia Chapter 7 Lauren Foohey, MT ASCP, MPH Senior Director of Global Marketing Siemens Healthcare Point of Care Business Area Norwood MA, USA Chapter 36 Professor Hugh Grantham, ASM, MBBS, FRACGP Professor of Paramedics Assistant Dean for Student Affairs Paramedics, School of Medicine Flinders University Adelaide, South Australia Australia Chapter 30 Andrew Griffin, CSc, FIBMS, CSci Deputy Section Manager – Clinical and Legal Services National Association of Testing Authorities Camberwell, Victoria Australia Chapter 7 Rebecca Guy, BAppSc, MAppEpid, PhD Associate Professor The Kirby Institute University of New South Wales Sydney, New South Wales Australia Chapters 17, 19 & 28 Lara Harmans, MSc Researcher

Saltro Diagnostic Centre Utrecht Netherlands Chapter 25 Heather Halls, BSc (Hons), MSc, MSocSci Associate Lecturer Flinders University International Centre for Point-ofCare Testing Flinders University Adelaide, South Australia Australia Chapter 12 & 16 Volker Harms, Nat Dip Chem Path Director Integrated Software Solutions Pty Ltd Sydney, New South Wales Australia Chapter 6 Paul L Harper, MD, MBChB, FRCP, FRACP Consultant Haematologist Palmerston North Hospital Palmerston North New Zealand Chapter 13 Geoff Herd, NZCS, Dip MLT, Dip MLS, MAppSci Point-of-Care Testing Coordinator Whangarei Hospital Northland District Health Board Whangarei New Zealand Chapters 29 & 34 Catherine Hogan, MDCM, MSc Fellow Infectious Diseases and Medical Microbiology McGill University Montreal Canada Chapter 23 Rogier Hopstaken, MD, PhD General Practitioner/POCT specialist Saltro Diagnostic Centre Utrecht Netherlands Chapter 25

Contributors

Michael Jong, MBBS, MRCP(UK), CHE, FCFP, FRRMS Professor Northern Family Medicine Program Memorial University of Newfoundland Labrador Health Centre Happy Valley-Goose Bay, Newfoundland Canada Chapter 35

Bertil Lindahl, MD, PhD Professor Department of Medical Sciences and Uppsala Clinical Research Center Uppsala University Uppsala Sweden Chapter 16

Phillip Keen, BA Kirby Institute University of New South Wales Sydney, New South Wales Australia Chapter 19

Robert Luo, MD, MPH Director Clinical Science Roche Molecular Systems, Inc Adjunct Clinical Faculty Department of Pathology School of Medicine Stanford University Stanford CA, USA Chapter 20

James Kiarie, Professor, MBChB, MMed, MPH Coordinator Human Reproduction Team Department of Reproductive Health and Research World Health Organization Geneva Switzerland Chapter 18 Professor Michael Kidd AM, FAHMS, MBBSHons (Melbourne), MD (Monash), DCCH (Flinders), DipRACOG, FRACGP, FACHI, FACNEM (Hon), FRCGP (Hon) UK, FRNZCGP (Hon) New Zealand, FAFPM (Hon) Malaysia, FHKCFP (Hon) Hong Kong, FCGPSL (Hon) Sri Lanka, MAICD Executive Dean and Matthew Flinders Distinguished Professor Faculty of Medicine, Nursing and Health Sciences Flinders University Adelaide, South Australia Australia President, World Organization of Family Doctors (WONCA) Chapter 27 Gerald J Kost, MD, PhD, MS, FACB Emeritus Professor and Director Point-of-Care Testing Center for Teaching and Research (POCT•CTR™) School of Medicine, University of California, Davis CA, USA President and CEO, Knowledge Optimizationx® Davis CA, USA Chapters 24 & 31

Connie Mardis, MEd POC Value Ambassador Siemens Healthcare Point of Care Business Area Norwood MA, USA Chapter 36 Cameron Martin, BAppSc (MT), MAppSc (MLS-Haem), MTM Coordinator, State-Wide Point of Care Testing Pathology Queensland Royal Brisbane and Womens Hospital Herston, Queensland Australia Chapter 15 Timothy H Mathew, AM, MBBS, FRACP Consultant Nephrologist Kent Town, South Australia Australia Chapter 11 Bridgit McAteer, DipAppSc (Nursing), Grad Cert Primary Health Care Research Scientist Flinders University International Centre for Point-ofCare Testing Flinders University Adelaide, South Australia Australia Chapter 6

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A Practical Guide to Global Point-of-Care Testing

Tessa McCormack, BMedSc, MPH Research Scientist Flinders University International Centre for Point-ofCare Testing Flinders University Adelaide, South Australia Australia Chapter 8 Lara Motta, BMedSc (Hons) Research Scientist Flinders University International Centre for Point-ofCare Testing Flinders University Adelaide, South Australia Australia Chapter 17 Maurine M. Murtagh, MBA, MPhil, JD Chief Executive Officer The International Diagnostics Centre London School of Hygiene & Tropical Medicine London, UK Chapter 18 Samarina MA Musaad, MBBS, FRCPA, MAACB, FAACB, PgDipPH Chemical Pathologist Labtests (Healthscope) Mt Wellington, Auckland New Zealand Chapter 29

Adelaide, South Australia Australia Chapter 33 Madhukar Pai, MD, PhD Canada Research Chair in Translational Epidemiology and Global Health Professor Department of Epidemiology and Biostatistics and Occupational Health McGill University Montréal, Québec Canada Chapter 23 Nitika Pant Pai, MD, MPH, PhD Associate Professor Department of Medicine Division of Clinical Epidemiology McGill University Montréal, Québec Canada Chapter 20 Michael Parsons, MD, CCFP (EM) Assistant Program Director Assistant Professor, Discipline of Emergency Medicine Cross-appointed, Discipline of Family Medicine Memorial University of Newfoundland St. John’s, Newfoundland Canada Chapter 35

Lisa Natoli, MPH, PhD Burnet Institute Melbourne, Victoria Australia Chapter 17

Rosanna W Peeling, PhD Professor and Chair, Diagnostics Research Director, International Diagnostics Centre London School of Hygiene & Tropical Medicine London, UK Chapter 18

Kevin Norton, BEd (PE) Hons, MA, PhD Professor of Exercise Science School of Health Sciences University of South Australia Adelaide, South Australia Australia Chapter 33

Timothy Pointon, BSc (Hons), GradCertClinEd, MPA Lecturer in Paramedics Paramedics, School of Medicine Flinders University Adelaide, South Australia Australia Chapter 30

Lynda Norton, RN, Grad Dip Crit Care Nursing, MPH, PhD Lecturer Flinders University Faculty of Medicine, Nursing and Health Sciences

Julie Ratcliffe, PhD, MSc, BA (Hons) Professor Flinders Health Economics Group School of Medicine Flinders University

Contributors

Adelaide, South Australia Australia Chapter 8 Tia Renouf, MD, CCFP (EM), FCFP Associate Professor and Chair Discipline of Emergency Medicine Memorial University of Newfoundland St. John’s, Newfoundland Canada Chapter 35 Christian Renaud, MD, MSc, FRCPC Assistant Professor (Clinics) – Department of Microbiology, Infectious Diseases, and Immunology Université de Montréal – CHU Sainte-Justine Montréal, Québec Canada Chapter 21 Jonathan Shaw, MD, FRACP, FRCP (UK), FAAHMS Associate Professor Domain Head, Cardiometabolic Risk Baker IDI Heart and Diabetes Institute Melbourne, Victoria Australia Chapters 9 & 10 Anne Shephard, BSc (Hons) Research Associate Assistant Manager, QAAMS Program Flinders University International Centre for Point-ofCare Testing Flinders University Adelaide, South Australia Australia Chapters 5, 6 & 12 Mark Shephard, OAM, BSc (Hons), MSc, MAACB, MAIMS, FFSc (RCPA), PhD Professor and Director Flinders University International Centre for Point-ofCare Testing Flinders University Adelaide, South Australia Australia Chapters 1,2,3,4,5,7,8,9,10,11,17,27,28,31,37 Bronwyn Sheppard, Dip Med Lab Tech (NZ) Business Manager Roche Diagnostics Asia Pacific

Singapore Chapter 13 Ken Sikaris, BSc (Hons), MBBS, FRCPA, FAACB, FFSc Associate Professor Chemical Pathologist Melbourne Pathology Collingwood, Victoria Australia Chapter 12 Brooke Spaeth, BMedSc (Hons) Point-of-Care Coordinator Northern Territory Point-of-Care Testing Program Flinders University International Centre for Point-ofCare Testing Flinders University Adelaide, South Australia Australia Chapters 6, 26 & 36 Igor Toskin, MD, Professor, PhD, DSc Department of Reproductive Health and Research World Health Organization Geneva Switzerland Chapter 18 Nicolas Tremblay, MSc PhD Candidate in Molecular Biology Centre de Recherche du Centre Hospitalier de l’Université de Montréal (CRCHUM) Montréal, Québec Canada Chapter 21 Santiago Vazquez, PhD, BSc (Hons) Laboratory Manager Drug Toxicology Unit NSW Forensic & Analytical Science Service Macquarie Hospital North Ryde, New South Wales Australia Chapter 26 Per Venge, MD, PhD Professor Department of Medical Sciences University of Uppsala Uppsala

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Sweden Chapter 16

Canada Chapter 35

Roland Watzl, MBBS, FACRRM Deputy Chief Medical Officer Australian Antarctic Division Kingston, Tasmania Australia Chapter 32

Richard Woodman, BSc (Hons), MMedSci, PhD Professor and Director for Epidemiology and Biostatistics School of Medicine Flinders University Adelaide, South Australia Australia Chapter 8

Michelle Williamson, BAppSc (MLS) Technical Services Manager Alere ANZPI East Brisbane, Queensland Australia Chapter 14 Margo Wilson, MD, CCFP (EM) Clinical Assistant Professor Northern Family Medicine Program Memorial University of Newfoundland Labrador Health Centre Happy Valley-Goose Bay, Newfoundland

Paul Zimmett, AO, MD, PhD, FRACP, FRCP, FACE, FACN, FAFPHM, FTSE Director Emeritus Victor Smorgon Diabetes Centre Baker IDI Heart and Diabetes Institute Adjunct Professor Monash University Melbourne, Victoria Australia Chapter 9 & 10

Preface MY PERSONAL JOURNEY WITH POINT-OFCARE TESTING How did my journey in the field of point-of-care testing (POCT) come about? My work in the field of POCT was initially conceived when my interests within and outside my professional career intersected during the mid-1990s. From the late 1970s to the mid-1990s, I worked as a medical scientist in the clinical biochemistry laboratory at Flinders Medical Centre in Adelaide, the capital city of South Australia. My main areas of scientific work were the development and evaluation of diagnostic methods for pathology tests for the management of diabetes, renal and cardiovascular disease, and the fields of quality assurance and analytical performance standards for pathology tests. In the latter part of this period, I also had responsibility for conducting POCT for haemoglobin A1c (HbA1c), a long-term marker of glycaemic control, using a device called the DCA 2000 device (at the time distributed by Bayer Diagnostics) on patients attending the weekly diabetes clinic at Flinders Medical Centre. Across the 1980s and 1990s, my wife and I travelled widely across all of Australia’s deserts – from the Gibson and Great Sandy, to the Simpson, Strzelecki and Great Victoria Deserts. As a result of our travels, we visited many Aboriginal communities. I felt a strong connection with the community elders who were humble yet passionate about looking after their remote desert lands. At the same time, I observed first-hand the appalling level of poverty and the significant burden of chronic disease in rural and remote Indigenous Australia, which concerned me greatly. Delivery of mainstream health (and laboratory) services to these communities was very poor, the turnaround of laboratory test results was slow, while of most concern was the extreme difficulty in getting chronic disease patients to return for a follow-up visit to enable their doctor to act on laboratory results and mediate treatment. I wondered whether POCT could have a niche in Indigenous communities, due to its portability, convenience and immediacy of result. I also wondered whether health professionals working in these remote locations, particularly Aboriginal Health Workers – Aboriginal people living and working in the community and skilled in the practice of primary health care – could be trained

to conduct POCT in their own health services. Little did I realise that the ‘fit’ for POCT in this primary care setting would be near perfect and that it would embark me on a career change that has been fulfilling and stimulating. I left the laboratory at Flinders Medical Centre in 1996 and began my journey with just a series of ideas and a vision in my head. I took a position at the Renal Unit at Flinders Medical Centre and started the ‘Umoona Kidney Project’ in a remote Aboriginal community, 850 km north of Adelaide. This project was a renal disease prevention and management program, which used POCT for the detection of microalbuminuria as its centrepiece. POCT was very much in its infancy in Australia at this time and the Umoona Kidney Project became the first community-based program to use POCT in an Indigenous setting in this country. This project gave me a solid grounding in how to work with Indigenous people in a culturally safe manner and how to set up a qualityassured and sustainable POCT model in the field. Two years later, I attended a conference on renal disease in Indigenous peoples at Uluru (Ayers Rock) in the heart of outback Australia’s Northern Territory. At the conference dinner I sat next to a delegate named Janet Streatfield, whom I had never met before. I discovered Janet worked with the Australian Government Department of Health and Ageing and her section was responsible for enacting recommendations of the National Diabetes Strategy 1998. One of those recommendations was that a trial of the DCA 2000 POCT device for measuring HbA1c should be conducted in Aboriginal Community Controlled Health Services in Australia. Janet lamented that she wasn’t sure how to go about this. I said: ‘I think I may be able to help you’. The concept for the ‘QAAMS’ (Quality Assurance for Aboriginal and Torres Strait Islander Medical Services) Program was seeded at this fateful meeting. A short while later, in July 1999, I became Program Manager of QAAMS, which has now grown to be the largest national POCT field program in Australia and has been continuously funded by the Australian Government to the present day. POCT has consumed my professional life for the past 20 years and it has been a life-changing experience. I’ve watched the field mature rapidly on a local, regional and global basis. I’ve witnessed first-hand the impact POCT

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can have on the way pathology services are delivered in primary care settings. Most importantly however, I have learnt that POCT is founded upon the people you meet and the partnerships you form. Our Centre recently introduced a POCT service for diabetes at a rural location in Papua New Guinea, through a partnership with the local provincial government and local health services. For the first time, the diabetes specialist at the clinic was able to measure HbA1c on her diabetes patients. She said: ‘Point-of-care testing has been an answer to my prayers…’ I’ve also seen the impact of introducing POCT into the teaching curricula for undergraduate and postgraduate students at Flinders University. Students ‘understand’ POCT: it’s hands-on, it’s relevant, it’s away from the tedium of the laboratory bench, and it has a clearly defined place in community medicine. These thoughts are echoed by students across disciplines, from those studying medical science, health science, medicine, nursing, paramedics, public health or Indigenous health. POCT has taken me on an amazing journey in life. I come to work every day, ready to be inspired and challenged by the adventures of a new day. To me, the more challenging the environment for POCT, the more exciting is the task ahead.

THE PURPOSE OF THIS BOOK ON POINT-OFCARE TESTING AND ITS INTENDED AUDIENCE There are now several outstanding books on POCT in the global literature, most notably those written by the distinguished team of Professor Christopher Price and Dr Andrew St John, and those by Professor Gerald Kost – colleagues whom I have known and respected for many years. These works are of the highest academic order. This book aims to fill a separate and distinctive niche in the book literature on this subject area, by providing a practically orientated guide to POCT for a target audience comprising: (i) a range of health professionals working in primary care settings where POCT is needed; and (ii) undergraduate and postgraduate university students from around the world who are studying relevant disciplines such as medicine, medical, health or paramedic sciences, nursing, Indigenous/rural or remote health, and public health. The text is written by the principal author/ editor and selected Australian and global experts. It is designed to be easy to read, yet authoritative and of sound academic rigour.

The book is divided into three main themes. The first theme ‘sets the scene’ for POCT by providing the reader with a solid understanding of the principles and practice of POCT in a primary care setting. The practical orientation of this theme is designed to enable readers to set up and manage their own POCT services safely and sustainably in their own regions and/or countries. Themes 2 and 3 represent the core of the book and aim to provide an understanding of the global scope, the clinical applications of POCT spanning chronic, acute and infectious diseases, and some of the unique clinical settings in which POCT can be used.

ACKNOWLEDGEMENTS The greatest pleasure I have derived from my research work has been the opportunity to work with so many dedicated teams of community health professionals across Australia. The teams of the doctors, nurses, allied health professionals and Aboriginal Health Workers who have all embraced our point-of-care testing models are too numerous to list individually, but I acknowledge that their commitment to conducting point-of-care testing ‘at the grassroots’ has been a constant source of inspiration to me. I must just mention several colleagues, who have been with me for the majority of this journey together: Malcolm Auld, Glennis Barnes, Tony Burgoyne, Dr David Dunn, Angela Dufek, John Louden, Kay Mundraby and Christopher O’Brien. A number of senior colleagues have supported and inspired me along my journey, and include: Dr Lindsay Barratt, Dr Kathy Paizis and Dr Tim Matthew AM; Professor Lucie Walters, Professor Jennene Greenhill, Professor Paul Worley and Professor Michael Kidd AM; Dr Ken Sikaris, Associate Professor Rebecca Guy, Associate Professor John Oliver, Janice Gill and Lloyd Penberthy. A special thanks to Professor Callum Fraser also helped shape my early career as a medical scientist. From industry, I must acknowledge Dean Whiting, Linda Walsh, Lauren Foohey, Yvette Kruger, Patrick Tete, Bronywn Sheppard and (the late) Barry Young OAM. Barry believed in my vision when no-one else would and he provided me with crucial funding support to ‘kickstart’ my career in point-of-care testing. My research work would not have been possible without the continuing support of the Australian Government Department of Health and I thank their staff for their assistance and commitment to my point-of-care

Preface

testing work over many years: Marion Dunlop, Jan Streatfield, Jacquie Millard, Wendy Akers, John Bacon, Jonathan Wraith, Pamela McKittrick, Fifine Cahill and Louis Young. Heartfelt thanks are also extended to my staff at the Flinders University International Centre for Point-ofCare Testing, who have worked so diligently for me and who have demonstrated unwavering loyalty over many years: Kelly Andrewartha, David Badger, Narelle Brown, Hayden Francis, Heather Halls, Karan Lavender, Bridgit McAteer, Tessa McCormack, Cheryl Marshall, Beryl Mazzachi, Rebeka Milloss, Lara Motta, Nicola Robinson, Pauline Rudevics, Anne Shephard, Claire Simon, Brooke

Spaeth, Lori Tietz and Les Watkinson. Particular thanks are extended to Narelle Brown, who tirelessly helped me with the administrative and organisational aspects of the book project, and Pauline Rudevics, who managed the permissions required for the book. David Heinrich and Julie Caddy are also thanked for preparing most of the artwork for the book. Finally special thanks to my wife Anne for her continuing patience and tolerance with my book writing and my point-of-care testing work over so many years, and to my children Matthew and Emily of whom I am so proud. Professor Mark Shephard OAM

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1 An introduction to point-of-care testing and its global scope and application Mark Shephard

Summary Point-of-care testing (POCT) refers to pathology testing performed in a clinical setting at the time of patient consultation, generating a test result that contributes to an immediate informed clinical decision being made and acted upon for patient care. POCT is the fastest growing sector of the diagnostic industry globally. POCT has its origins in the hospital environment but has now devolved to a range of community-based primary care settings. POCT provides innovative opportunities to improve delivery of pathology services for the detection and management of chronic, acute and infectious diseases, and has a particular niche in rural and remote primary health settings globally, including developing countries. The capacity to link POCT devices from rural or remote sites to a central management point has enhanced the ability to develop large-scale POCT networks and streamline the delivery of POCT services.

SETTING THE SCENE FOR POINT-OF-CARE TESTING To set the scene for introducing POCT, consider the following three scenarios:

Health-care setting 1 An elderly patient in an urban nursing home is incapacitated and in a wheelchair. She has long-standing type 2 diabetes and is on insulin. She is required to go to the hospital every 3 months for a blood test to check her diabetes control. This routine task is difficult for the patient due to her immobility, she can’t find a carpark easily, there is a lack of access for wheelchairs, and she has to wait 2 h for her appointment and a blood test. A week later, she has to return for a follow-up visit to hospital to get her result and discuss treatment with her doctor. Consider how much easier for the patient it would be if she could have her blood test, get her result within a few minutes, and receive treatment on-site in the nursing home. Health-care setting 2 A male patient on warfarin therapy is required to have regular blood tests to monitor his coagulation status and adjust his dose of warfarin. The patient lives in a remote outback community 500 km from the nearest town (and laboratory). He has to drive 6  h on corrugated outback roads to town every 4 weeks to have his blood tests, stay in town for a day to get his result and then drive 500  km home again. 1

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A Practical Guide to Global Point-of-Care Testing

Consider how much better it would be for this patient if he could have his blood test, get the result, and have his dose of warfarin adjusted on-site in his own home and community. Health-care setting 3 A patient with a history of heart disease presents at a remote health service at 3 am with crushing chest pain radiating down his arms. Has the patient had a heart attack? The health service has no diagnostic testing available and so the patient is evacuated to the nearest tertiary hospital to have the relevant laboratory tests performed to answer this question. Evacuation is by helicopter at a cost of A$15 000. Consider how much better it would be for the patient if the cardiac tests were performed on-site at the remote health centre, where a heart attack could possibly be ruled out, the patient could then be stabilised on-site and the need for the costly retrieval averted. In each case, access to POCT could potentially provide the answer to solving these issues.

WHAT IS POINT-OF-CARE TESTING? The origins of POCT can be traced to the very beginnings of diagnostic pathology in the 15th century when urine specimens were tested and inspected at the patient’s bedside, at their point of care. POCT is therefore not strictly a new discipline of medical science but one that has had a significant re-emergence over the past 20 years. There have been many different definitions of POCT proposed by numerous authors and professional groups, a representative sample of which are shown in Table 1.1. In addition, a multitude of acronyms have been used to describe this mode of health service delivery. These include terms such as near patient testing (NPT), rapid diagnostic testing (RDT), as well as several historical expressions such as bedside testing, physician office testing, alternate or off-site testing, ancillary testing and decentralised testing. The variety of definitions and lack of standardisation of a single accepted terminology for POCT reflect the relative youthfulness of this field. For the purpose of this book, which focusses on the use of POCT in the primary care environment, I have developed two working

­ efinitions. The first is short and abbreviated and can be d used when trying to explain POCT simply and briefly in layman’s terms. Point-of-care testing is ‘pathology testing performed in a clinical setting at the time of patient consultation, generating a rapid test result that enables timely clinical action for patient care.’ The second is more detailed and deliberately used when I am training health professionals or teaching students about POCT. This definition encompasses all the elements that are essential to the safe conduct of POCT outside the laboratory. Point-of-care testing is ‘pathology testing that is performed on behalf of the treating medical practitioner by a trained operator in an on-site clinical setting at the time of patient consultation, allowing a test result of desired analytical quality to be generated and to be used to take immediate, informed clinical action that contributes to an improved health outcome for the patient.’ The various phrases in this more detailed definition can be broken down further to explain POCT more fully (Table 1.2). First, POCT is a pathology investigation: generally a clinical biochemistry, haematology, microbiology or pharmacology test. POCT can generate quantitative results (i.e. generate a number or value) or qualitative results (detecting the presence or absence of a disease or substance). POCT is most commonly, but not exclusively, performed on small portable in vitro medical devices. The term in vitro simply means that the fluid to be tested (e.g. blood) is collected from the body, loaded on to the device and tested ‘outside the body’. The term ‘device’ includes benchtop instruments, hand-held devices and test strips. POCT normally requires a small sample volume (generally ranging from 5 to 50 µL of capillary whole blood, urine or other fluids) to conduct the test, making the sample collection process simple, convenient, less stressful and less invasive for the patient. The test should only be performed by a POCT operator who has undergone training and certification in performing patient testing and conducting quality testing procedures on the POCT device; these practices ensure that results of acceptable analytical quality (equivalent to

1 – An introduction to point-of-care testing and its global scope and application

Table 1.1.  Representative examples of different definitions of POCT over the past 20 years Definition of POCT

Reference source

‘Testing at the point of patient care, wherever that medical care is needed’

Kost 1995

‘Those analytical patient testing activities provided within the institution, but performed outside the physical facilities of clinical laboratories …’

College of American Pathologists 1998

‘Any kind of test performed outside the central hospital laboratory, usually at the patient’s bedside’

Mor and Waisman 2000

‘Testing that is performed close to the patient’

Hicks et al. 2001

‘Any type of testing undertaken close to the patient to enable a decision to be made on the care of that patient’

Price 2001

‘A pathology investigation by or on behalf of the treating medical practitioner on-site, at the time of and for use during consultation’

Guibert et al. 2001

‘Any test that is performed at the time at which the test result enables a decision to be made and an action taken that leads to an improved health outcome’

Price and St John 2005

‘Testing that is performed near or at the site of a patient with the result leading to a possible change in the care of the patient’

ISO 2006

‘An investigation carried out in a clinical or non-clinical setting, or in the patient’s home, for which the result is available without reference to a laboratory, perhaps rapidly enough to affect immediate patient management’

Dean 2006

‘[Rapid diagnostic tests] RDT’s are immunoassays that are simple to perform, give results without the need for laboratory equipment, are accurate and can provide on-site (negative) results with a single visit’

Chiu et al. 2011

‘A form of testing in which the analysis is performed where healthcare is provided close to or near the patient’

Australian Government 2013

‘Point-of-care testing devices are in-vitro devices that are used for testing outside the laboratory Musaad and Herd 2013 and in the vicinity of patients …’ ‘Tests designed to be used at or the site where the patient is located, that do not require permanent dedicated space, and that are performed outside the physical facilities of the clinical laboratories’

College of American Pathologists 2015

‘POC testing is diagnostic testing that will result in a clear and actionable management decision such as when to start treatment or to require a confirmatory test, within the same clinical encounter’.

Pai et al. 2015

Table 1.2.  Dissecting the definition of POCT Definition

Context

Pathology test

Clinical biochemistry, haematology, microbiological, pharmacological. Quantitative or qualitative.

Device

Mainly in vitro using small sample volumes (µL)

Trained operator

Training and certification of POCT operators is crucial

Outside the laboratory

In numerous hospital or community/primary care settings

At time of consultation

POCT brings pathology closer to the patient and doctor

Analytical quality

Quality of result is paramount. Speed must not compromise quality.

Immediate clinical action

POCT result is available in under 10 min generally, but the real impact of POCT comes from implementing effective and timely treatments rather than from the test itself

Improved patient outcome

Overarching goal of pathology testing is to maximise health benefit to the patient

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A Practical Guide to Global Point-of-Care Testing

Table 1.3.  Examples of health-care settings where POCT is now used Hospital-based

Community-based

Other settings

Emergency department

General practice/physician office

Disaster management

Adult intensive care unit

Pharmacy

Extreme environments

Neonatal intensive care unit

Community health clinic

Military

Coronary care unit

Aboriginal medical service

Space research

Operating theatre

Retrieval unit

Ward

Workplace

Outpatient clinic

Veterinary clinic Leisure facility Sports medicine Home care

that of the laboratory) are generated for patient care. The operator may be one of many health-care professionals including, for example, a doctor, nurse, primary healthcare worker, diabetes educator, pharmacist, paramedic and even the patient. The clinical settings in which POCT can be conducted are numerous, comprising hospital-based, communitybased and other diverse locations (Table 1.3). By conducting POCT on-site at the time of the patient encounter, POCT brings pathology testing closer or ‘nearer’ to the patient and to the doctor. The speed of the pathology result for the treating medical practitioner is a key feature of POCT. Critically, however, speed must not compromise the analytical quality of the result, which is of paramount importance. Further, as Pai et al. (2015) state: ‘the impact of a POC test comes from implementing effective treatments rather than from the test itself. Thus, moving rapidly through the test-and-treat cycle in the same clinical encounter is the most important goal for any POC testing program.’ With the development of evidence-based laboratory medicine, an overarching goal of pathology testing, whether POCT or laboratory-based, is to maximise the health outcome benefit for the patient. An underlying theme across evidence-based POCT research is that POCT itself will not deliver improved health outcomes unless it is linked closely to defined clinical pathways and POC test results are actioned clinically within a defined timeframe. Pai et al. (2015) have recently challenged conventional product-oriented definitions of POCT that restrict POCT to a particular class of product (e.g. based on cost, size or where or by whom the test is performed). They argue that the definition of POCT should be goal-oriented, with the rapid initiation of correct treatment the most critical

e­ lement of any POC test. They contend this approach is more inclusive and more reflective of the diverse spectrum of settings where POCT is used (from hospitals to resource-limited settings) and is ‘closer to what all patients want from their care providers’.

POINT-OF-CARE TESTING ‘IN REAL TIME’ With this understanding of what POCT is, how does POCT function ‘in real time’? A typical POCT process is summarised and compared with the laboratory testing process in Fig. 1.1. With POCT, a patient visits his/her primary care clinic in the community, a sample (just of a few microlitres) is taken, loaded on a point-of-care device by a trained POCT device operator, the result is available in just a few minutes, and the patient sees the doctor during their appointment to review the results and have their management/treatment actioned on the spot. As a general rule, a patient in a community setting whose local doctor has requested laboratory tests will visit a pathology collection centre, have a venous sample drawn from the arm (usually 5–10 mL of blood) and the sample is then transported to the nearest laboratory (which, for a remote community in a country such as Australia, could be several hundred kilometres away and may take several days to reach the laboratory by road courier). Once received by the laboratory, the sample often requires centrifugation to separate the red cells from the serum/ plasma, and the serum/plasma is then loaded on to the laboratory analyser by a trained medical scientist or technician. A result is generated, which is then sent back to the requesting doctor (either electronically or in hard copy form; if the latter, then again the return of the result may

1 – An introduction to point-of-care testing and its global scope and application

Fig. 1.1.  Comparing the POC and laboratory test pathways.

take several days in remote locations). The patient is then contacted by the health service and a separate appointment is required for the patient to return to their health service and visit the doctor to discuss the result. The potential benefits of POCT from a patient, operational and clinical perspective intuitively appear obvious from these simple scenarios, but are they real in practice? The short answer is ‘yes’ and the evidence base for the benefits (as well as the limitations) of POCT will be explored as a constant point of discussion throughout the book.

THE INCREASED GLOBAL UPTAKE OF POINTOF-CARE TESTING Since the re-emergence of POCT in the late 1980s, the uptake of POCT in the global health sector has burgeoned, mainly in the Western developed world. Globally,

the POCT market has been estimated to be worth US$3  billion in 1997, US$5.4  billion in 2002 (Freedman 2002), US$9.6  billion by 2005 (Huckle 2006), and US$15  billion in 2011 (St John and Price 2014). With a compound annual growth rate estimated between 4 and 8%, the global market value is expected to reach US$18 billion by 2016 and US$24 billion by 2017/2018 (St John and Price 2014; Lehr 2013). St John and Price (2014) note these market sales represent the sum of ‘over the counter’ or ‘non- professional’ self-testing products, such as blood glucose and pregnancy tests, and the ‘professional market’, which includes sales to all major health-care sectors (Table 1.4). By country/region, the USA dominates the global market share with ~55% of total sales, followed by Europe 30% and Asia around 12% (St John and Price 2014). Fig. 1.2 shows the growth in POCT sales within the European market from 2006 to 2015.

Table 1.4.  Global market sales of diagnostic products 2011 (Source: adapted from St John and Price 2014) Sector

Market sales

Percentage of total diagnostic market sales

Percentage of total POCT market sales

Total IVD diagnostic market sales

US$51 billion

–

–

US$15 billion

29%

–

US$5.66 billion

11%

38%

US$9.34 billion

18%

62%

Total POCT market sales ‘Professional’ POCT product market

salesa

‘Non-professional’ POCT product market salesb aHospital b‘Over

and primary care sectors including critical care, chronic disease, infectious disease, coagulation and haematology POCT products the counter’ products for glucose and pregnancy self-testing

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A Practical Guide to Global Point-of-Care Testing

Fig. 1.2.  Growth in the European POCT market 2006–2015. (Source: Figure from Ramachandran R (2010) used with permission from Frost and Sullivan)

Blood glucose testing represents the largest POCT market sector, followed by pregnancy and critical care testing (St John and Price 2014). Importantly, POCT for infectious diseases is undergoing rapid market development due to the advances in molecular testing technology, and there is likely to be a major surge in sales of these products in the coming years.

WHAT ARE THE DRIVERS OF THE POINT-OFCARE TESTING ‘REVOLUTION?’ The escalating interest in POCT has been driven by several factors (Table 1.5). First, there is now greater emphasis on placing the patient at the centre of the health-care process. The patient of the 21st century is more knowledgeable of disease conditions and has higher expectations of the healthcare system in terms of quality and convenience of care (Price et al. 2004). Second, care of patients with chronic conditions is being devolved away from the hospital to a range of

­ rimary care environments conducive to POCT, ­including p general practice, Indigenous medical services, community health clinics and pharmacies. The way in which laboratory services are provided has also changed. The majority of hospital-based pathology testing is now performed on high throughput, batch-orientated analytical systems in large core laboratories, creating a niche for smaller volume, needs-specific POCT to be undertaken by regional satellite laboratories and primary care settings (Price et al. 2004). Early critics of POCT argued that the speed of analysis was compromised by lack of quality of the POCT result (Jahn and Van Aken 2003). However, over the last decade, POCT device manufacturers have invested heavily in modern design, new technologies and ‘good manufacturing practice’ to ensure most modern POCT devices are now analytically sound and ‘fit for use’ in primary care settings. There have been significant advances in POCT technology including: ●● ●●

Table 1.5.  Examples of drivers of the POCT revolution in the 21st century Driver of POCT Greater emphasis on patient-focussed care

●●

Changes in health-care practices Advances in POCT technology Connectivity of modern POC test systems

●●

reduction in the size of devices (miniaturisation) simplicity of device operation (reflecting the desire of manufacturers to meet the market demand of enabling POCT devices to be used away from the laboratory by non-laboratory-trained health professionals) improved reproducibility of manufacturing processes for both devices and reagents (thereby reducing between-batch variability for the latter) advances in analytical techniques (including the advent of microfluidics, improved sensor design, and

1 – An introduction to point-of-care testing and its global scope and application

Table 1.6.  Selected examples of POC tests currently available (by medical science discipline). This list is not meant to be exhaustive. Discipline

Disease/condition

Examples of POC tests

Clinical biochemistry

Diabetes

Glucose, HbA1c, lactate

Renal disease

Urea and creatinine, urine albumin:creatinine ratio (ACR)

Cardiovascular disease

Lipids

Acute respiratory and metabolic disorders

Electrolytes and blood gases

Acute cardiac disorders

Troponin I and T, B-type natriuretic peptide (BNP), N-terminal pro B-type natriuretic peptide (NT-proBNP)

Anaemia

Haemoglobin

Coagulation disorders/ haemostasis

International Normalised Ratio (INR), platelets, activated partial prothrombin time (APTT)

General haematology

Full blood count including red blood cells and related indices, haemoglobin; white blood cells and differential counts

Sexually transmitted infections

HIV, syphilis, chlamydia, gonorrhoea, trichomoniasis

Other blood borne viruses

Hepatitis B and C

Vector-mediated

Malaria, dengue fever

Respiratory infection (specific and general)

Influenza, tuberculosis, Group A Streptococcus, C-reactive protein, procalcitonin

Substance abuse

Major drug classes (e.g. amphetamine type substances, benzodiazepines, cannabis and metabolites, cocaine and metabolites, opiates)

Haematology

Microbiology

Pharmacology

●●

●●

●●

tailoring molecular-based technologies to POCT platforms) rapid expansion of the range of tests and test profiles that can be performed by POCT (Table 1.6). the ability to conduct specialised tests on small sample volumes of the order of 5–100 µL advances in connectivity standards; that is, the ability to electronically capture POC test results and transfer them to a clinical or laboratory patient information system (Mor and Waisman 2000; Price and St John 2005).

Also as a general rule, the applicability of POCT increases with increasing degrees of remoteness due largely to the difficulty of accessing laboratory pathology services in a timely manner. This theme is explored throughout the book and is particularly relevant to Chapter 28.

ADVANTAGES AND BENEFITS OF POINT-OFCARE TESTING The use of POCT in the primary care setting has practical advantages for the patient, the health professional performing POCT, the treating practitioner, the health service and community overall (Table 1.7).

Patient Patient satisfaction with the convenience and accessibility of POCT is generally high because pathology testing and consultation with the doctor occurs in the same visit, avoiding the need for a follow-up consultation to obtain pathology results and reducing anxiety levels associated with waiting for a laboratory result (Shephard 2006). Only a small volume of blood or urine (generally