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-care services are often geographically isolated from the nearest pathology laboratory.
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.
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.
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.
- Page 1Abstract
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.
- Page 16Abstract
There are many aspects to consider when setting up a routine POCT service and there needs to be a structured approach to the organisation and management of POCT. Multiple guidelines on how to establish and maintain a POCT service have been published by professional societies and expert panels representing many countries and/or regions of the world. Most of these guidelines share common principles that can be applied logically and systematically when establishing and maintaining a POCT service. In wider practice, the key principles recommended for setting up and managing a POCT service must be tailored and adapted to meet local needs and specific clinical settings.
- Page 29Abstract
This chapter provides an overview of the different types of point-of-care testing (POCT) devices currently available on the global market. A POCT device should be able to achieve equivalent analytical performance to a corresponding laboratory device. For POC tests where a quantitative result is obtained, there are two main indicators of analytical performance: accuracy and precision. For POC tests where a qualitative result is obtained, the main performance indicators are sensitivity, specificity, negative predicative value and positive predictive value. This chapter provides practical guidance on how to measure these performance indicators in clinical practice.
- Page 46Abstract
Point-of-care testing (POCT) should only be performed by health professionals who have undergone initial training and competency certification, who have their competency levels regularly assessed, and who participate in regular recertification. Training should be organised and delivered by a POCT Coordinator, who is usually a medical scientist or a senior nurse with wide experience in POCT. The content of the training manual will be determined by the nature of the POCT service being implemented and the needs of the organisation undertaking POCT. In a primary care setting, device operators are unlikely to have any previous training in laboratory medicine and therefore it is important to translate scientific and analytical concepts into images and messages that can be readily understood. Training should cover both the theory and practice of conducting POCT. At the completion of training, trainee competency should be assessed by written and practical means. Successful trainees should receive a competency certificate. Post-training surveillance of competency should be undertaken by regular review of quality control and proficiency testing results and through re-training and education updates. A register of all personnel receiving competency certificates should be maintained.
- Page 54Abstract
Quality control (QC) testing and proficiency testing (PT) are integral components of a quality system to monitor analytical performance in the laboratory and at the point of care. These two processes check the quality of a device’s performance by comparing observed results of QC testing or PT with a target with pre-set specifications. QC testing provides an immediate check of quality, while PT provides a delayed, peer-reviewed, external assessment of quality. However, many modern POCT devices now feature sophisticated in-built quality checks within their single use, disposable testing units. A tailored, flexible and balanced approach to quality surveillance is therefore required, taking into account the degree of the device’s technological sophistication, practicality, cost of QC/PT and size/scope of POCT networks.
- Page 66Abstract
Connectivity encompasses the electronic capture of test results from a POCT device and the transfer of those results to a local computer, systems databases or electronic medical records. The introduction of an international connectivity standard in 2002 helped to provide the framework for engineers to design devices and work station interfaces that allowed multiple types of POCT devices to communicate bidirectionally with data management systems or laboratory information systems. For connectivity to be successful, the set-up process must be seamless, reliable and involve both clinical and technical professional staff. Attributes of a connectivity solution should allow control and management of all aspects of remote POCT, from quality control, calibration and maintenance protocols through to result validation, and include training records for all certified operators, POCT site accounts and workload statistics, a complete audit trail and traceability of testing pathways for individual POCT sites.
- Page 76Abstract
This chapter summarises existing policies, procedures or guidelines that govern the use of point-of-care testing (POCT), and in particular any mandatory requirements and accreditation issues. In most countries, including Australia, there are no specific regulations preventing the use of POCT if used in the manner or for the purpose specified by the manufacturer. In a hospital or primary care setting, however, the operation of POCT devices should be implemented using a quality management approach with some form of accreditation strongly recommended. An international model for accreditation is described, which is directly applicable to POCT and includes three basic elements: regulation, standards and accreditation or audit by an independent authority.
- Page 87Abstract
This chapter describes the key issues to consider when designing and analysing a study to evaluate the effectiveness of point-of-care testing (POCT). To date, the quality of information relating to the effectiveness measures for POCT studies has been relatively poor; the purpose of this chapter is therefore to provide the reader with a systematic overview of how to frame a research study, select an appropriate study design and to collect and describe data to evaluate the effectiveness of POCT, using the appropriate statistical techniques.
- Page 104Abstract
Over the past several decades, significant changes in human behaviour, lifestyle and the environment have led to a rapid escalation in the prevalence of diabetes worldwide. The global burden of diabetes exceeded 150 million adults in the year 2000 and is predicted to reach 642 million by 2040. The prevention of diabetes and its micro- and macro-vascular complications should now be regarded as an essential component of public health strategies for all nations globally. Blood glucose monitoring by point-of-care testing (POCT) represents more than half of the global market sales of POCT products. There is a myriad of blood glucose meters available in today’s market. But how analytically sound are blood glucose meters and has the widespread global practice of blood glucose monitoring translated into improved outcomes for diabetes patients?
- Page 119Abstract
Haemoglobin A1c (HbA1c) is the universally accepted ‘gold standard’ pathology test for monitoring glycaemic control in patients with established diabetes. HbA1c provides a measure of glycaemic control over the preceding 3–4 months, reflecting the progressive glycation of haemoglobin during the life span of red blood cells. POC HbA1c testing is now widely used in primary care settings throughout the world and is one of the most topical, widely debated and researched subjects in the contemporary point-of-care testing (POCT) arena. Recently both the clinical use of HbA1c for the diagnosis of diabetes (as opposed to management of this condition) and the units for reporting HbA1c results (either a percentage or a new SI unit, mmol/mol) have been heavily debated in the medical/scientific literature. Both issues have implications for HbA1c measurement by POCT.
- Page 132Abstract
Chronic kidney disease (CKD) is a global public health problem. Escalation in CKD is driven by the increasing prevalence of diabetes, hypertension, obesity and ageing. CKD identification can be performed in primary care with point-of-care testing (POCT) as part of this approach. Two POC tests for the diagnosis and management of CKD are estimated glomerular filtration rate (eGFR), calculated from the blood/serum creatinine, and urine albumin:creatinine ratio (ACR). POCT for creatinine is limited by standardisation issues, differences between whole blood and serum/plasma matrices, and poor precision at low creatinine concentrations. Issues with urine ACR POCT include standardisation, sample requirements, and reporting and interpretation of urine albumin/ACR results.
- Page 147Abstract
Cardiovascular disease is a burgeoning global health issue, with common risk factors being obesity, hypertension, dysglycaemia and dyslipidaemia. Total cholesterol and HDL cholesterol are now considered the most relevant clinical markers of lipid dysfunction. POCT for lipids on capillary blood samples is widely available for assessment of cardiovascular risk and for management of patients with lipid disorders. Most POCT devices are portable and have connectivity capability, making them suitable for use in a range of community settings. Although most devices measure total cholesterol and triglyceride well, the analytical performance for HDL cholesterol is of major concern. There is some evidence for the clinical effectiveness of lipid POCT but cost effectiveness studies are lacking.
- Page 158Abstract
Warfarin is the most commonly used oral anticoagulant worldwide, with approximately 1% of the population in developed countries taking this medication. Warfarin has a narrow treatment range, where too much can cause life-threatening bleeding and not enough can increase the risk of thrombosis that can lead to major disability or even death. Patients on warfarin require a regular blood test, international normalised ratio (INR), to maintain safe control. Point-of-care testing (POCT) for INR is now used in several models of care including patient self-testing, pharmacy-based services and mobile services in remote regions. In this chapter, we review the data from clinical trials, meta-analyses and a Cochrane review that demonstrate the clinical and economic benefits of POCT for warfarin management. We also describe examples of successful models to illustrate the improved safety and clinical benefit as well as the greater convenience for patients.
- Page 171Abstract
The uptake of point-of-care testing (POCT) for haematology markers has continued to grow throughout the world due to the increasing demand to reduce turnaround times to improve patient care. Recent advances in technology have resulted in the development of numerous haematology devices designed to be used in a number of different clinical settings within hospitals and primary care facilities. This chapter will explore the clinical use and POCT devices available for measuring full blood count, platelet count, haemoglobin, white blood cells, coagulation markers (excluding INR) and D-dimer.
- Page 185Abstract
Routine blood gas and electrolyte analysis is a sophisticated and important part of both laboratory and point-of-care testing (POCT) in the 21st century. As the science of emergency medicine has advanced, so has gas and electrolyte analysis to where it is now a routine part of patient management in acute and intensive care situations. Scientific instrument manufacturers have risen to the challenge by designing and producing a range of reliable point-of-care analysers that fit applications from the smallest remote health clinic, to the largest emergency or intensive care unit. The laboratory, and laboratory scientists, have an important role to play in the education of clinicians who use and base patient management on results from these analysers.
- Page 197Abstract
The management of patients presenting at the emergency department with symptoms of chest pain and/or acute dyspnoea accounts for a significant amount of emergency care resources. In the work-up of these patients, the blood measurements of cardiac troponins and brain natriuretic peptides are recommended by current guidelines. The introduction of point-of-care testing (POCT) for these biomarkers has the potential to change the work flow in the emergency department by reducing length of stay, patient suffering and costs. However, to take advantage of POCT, the brain-to-vein-to-brain time has to be adjusted with the elimination of unnecessary delays before any clinical decision and action are taken.
- Page 207Abstract
Chlamydia, gonorrhoea and trichomoniasis contribute collectively to a significant global burden of sexually transmitted infections (STIs). In low-income settings, treatment of these three curable STIs has often been based on syndromic management, which fails to detect asymptomatic cases (false negatives) and may lead to overtreatment of others (false positives). Point-of-care testing (POCT) has the potential to reduce the delays in laboratory testing and treatment of these infections but, until recently, most POCT was performed using lateral flow immunochromatographic devices with poor clinical sensitivity. The advent of new molecular-based POC test platforms with laboratory-equivalent analytical performance is revolutionising this field of STI diagnosis. A range of new molecular-based devices are likely to enter the diagnostic market in coming years.
- Page 220Abstract
Simple, inexpensive point-of-care (POC) tests for screening maternal syphilis and facilitating treatment before the second trimester of pregnancy have been shown to prevent adverse pregnancy outcomes such as stillbirth and prematurity and save babies from congenital syphilis. Several new POC tests will soon be available and more on the horizon. Although deployment of POC tests can improve access to testing, including screening, case management and surveillance, the introduction of point-of-care testing (POCT) in the developing world has often been hampered by health system constraints as well as political, cultural, socioeconomic and behavioural factors. Implementation of POC tests must focus on advocacy, policy and guideline development, adequate training, quality assurance, data connectivity, supply chain management and monitoring of program effectiveness.
- Page 232Abstract
The human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) epidemics have been recognised by the United Nations as a global emergency, requiring an exceptional response to reduce new HIV transmissions and to diagnose and treat people with HIV and AIDS. Worldwide, half of the people with HIV remain undiagnosed, and less than half of those who have been diagnosed receive treatment. Point-of-care (POC) tests for screening, diagnosis and monitoring of HIV infection can greatly expand access to and uptake of HIV testing, and support clinical management, especially in low and middle income countries with limited laboratory infrastructure and high HIV prevalence. Most HIV POC tests for screening and diagnosis are relatively simple devices that can be used in clinical, community and outreach settings, and some can be self-administered. Molecular-based POC test platforms with laboratory-equivalent analytical performance are now available for some HIV monitoring tests, and more such devices are in the development pipeline.
- Page 245Abstract
In this chapter, we provide an overview of the burden of the global silent epidemics of hepatitis C and hepatitis B infections, quantifying the problem by region, and reviewing risk factors and modes of transmission. We provide a macro- and micro-perspective of their pathophysiology to understand the development of diagnostics better and to appreciate the distinction between screening and staging of hepatitis infections. Point-of-care (POC) diagnostic methods for hepatitis B and hepatitis C are then reviewed. Point-of-care testing (POCT), if effectively combined with improved combination treatment regimens, can potentially herald a turning point in the epidemic history of both these infections.
- Page 256Abstract
Influenza is a viral infection of the lower respiratory tract, which can afflict 5–10% of the world’s population each year. Rapid influenza diagnostic test (RIDT) kits are widely available and can detect both influenza A and B, although some do not distinguish between the two. These rapid tests have highly variable sensitivity due to a range of factors such as the type of influenza virus, the patient age, the duration of illness and the quality of specimen tested. Nonetheless, they occupy an important place in the diagnostic arsenal for influenza. Rapid portable molecular testing devices for influenza are now appearing on the diagnostic market.
- Page 266Abstract
Malaria, caused by Plasmodium spp. and carried by Anopheles spp. mosquitoes, is endemic in 97 countries. It is a major cause of mortality due to infectious disease, and disproportionally affects children. Clinically malaria is indistinguishable from the early stages of other co-endemic diseases, but presumptive treatment was standard practice for decades in high burden settings, largely due to lack of quality point-of-care testing (POCT). Over the last 15 years, the availability of accurate and affordable antigen-detecting malaria lateral flow assays/rapid diagnostic tests (RDTs) coupled with effective treatment has revolutionised malaria case management.
- Page 279Abstract
The incidence of tuberculosis declined throughout the 20th century but there has been a resurgence of the disease and it remains a significant cause of morbidity and mortality that disproportionately affects the poor. The recent introduction of molecular testing on the Cepheid GeneXpert® has facilitated a paradigm shift in tuberculosis diagnostics by allowing same-day diagnosis of tuberculosis with very high sensitivity, as well as simultaneous detection of rifampicin resistance; it has also inspired the development of new molecular tests that are likely to be affordable in decentralised settings. Tuberculosis point-of-care testing (POCT) alone will not have a clinical impact, unless rapid treatment is also ensured. Tuberculosis POCT must be delivered as part of an integrated package of ‘test and treat’ and not as a standalone test.
- Page 291Abstract
This chapter identifies key principles of point-of-care testing (POCT) for Ebola patients and others exposed to highly contagious diseases. It assesses evidence from recent crises: Ebola in West Africa and MERS in South Korea. Hospitals that admitted Ebola patients mitigated risk by using POCT for critical care support in isolation units. Principle-based strategies comprise: needs assessment; the SCP™; FAST•POC™; POCT•POD™; diagnostic centres; matrix education; point-of-care (POC) culture; and enhanced POC technologies for diagnosis, triage, de-risking, monitoring and stopping outbreaks. Epidemics incur huge economic penalties. POCT helps avoid these costs through early detection and accurate diagnosis, while preventing needless suffering and unnecessary loss of human life. Impactful medical outcomes plus significant return on investment (ROI) warrant substantial funding, anticipatory planning, and comprehensive training. Ebola and MERS proved unequivocally the importance of POCT. Countries should produce national POC testing policies and guidelines, so that POCT is properly supported, quality controlled and cleverly adapted to cultural expectations.
- Page 306Abstract
C-reactive protein (CRP) is a rapid and sensitive inflammation marker for diagnosis of disease. CRP point-of-care testing (POCT) is currently used by general practitioners (GPs) in a selective number of countries, mainly in Europe. Aided by similar guidelines, CRP is mostly used for diagnosis and antibiotic stewardship in adults with lower respiratory tract infections, but is also suggested for upper respiratory tract infections, diverticulitis, appendicitis and chronic obstructive pulmonary disease (COPD) exacerbations. Even though CRP correlates well with the severity of illness, it cannot determine aetiology nor can it accurately discriminate between bacterial and viral infections in general practice. So far, cost-effectiveness is mostly in the longer term: reduced antibiotic prescribing and quality-adjusted life years (QALYs) gained. There are currently several POC devices available for CRP (or even high sensitivity CRP) of acceptable quality for use in general practice.
- Page 316Abstract
The United Nations Office on Drug and Crime (UNODC) estimated that 246 million people between the ages of 15 and 64 years used an illicit drug in 2013. The advantages of point-of-care testing (POCT) for drugs of abuse are the ability to have results without delay and reduced cost of testing. Urine and oral fluid (saliva) are the preferred matrix analysed by POCT drugs of abuse devices, which use immunochromatography to detect the drug or drug metabolite. A range of devices is available for POC drug testing, from simple dipsticks, to cups with incorporated test strips, to instrument-based readers. POCT for drugs of abuse can be used in roadside drugs testing, workplace testing, judicial drug testing and rehabilitation clinics. The limitation of POCT for drugs of abuse is that a positive result needs confirmatory testing by a laboratory.
- Page 332Abstract
General practice, its practice teams and their primary health care relationships comprise the foundations of an effective health-care system. The current focus of general practice runs in parallel with the changing social context of health and with advances in technology and telehealth. Point-of-care testing (POCT) is an example of a rapidly evolving technology that has many advantages for general practice. The Point-of-Care Testing in General Practice Trial conducted in Australia (2005–2007) demonstrated the safety, clinical efficacy and acceptability of POCT in general practice for chronic diseases. Although the needs, utility and limitations of POCT in general practice are well characterised in developed countries, much work is needed to meet needs and overcome barriers for POCT in general practices in developing countries.
- Page 343Abstract
Rural and remote communities experience higher mortality rates and poorer health status than metropolitan regions. Nowhere is this health divide more profound than for Indigenous people. Point-of-care testing (POCT) has a particular niche within rural and remote health and its astute and practical application can be an ‘inventive solution’ for improving health-care delivery in these locations. This chapter showcases three current POCT models working in rural and remote Indigenous Australia that support the detection and/or management of chronic, acute and infectious diseases.
- Page 355Abstract
Point-of-care testing (POCT) is an essential component of laboratory testing in modern hospitals. It is not only surviving but flourishing in an era when patient-centred care is a focal point for health-care delivery and more care is devolved to the community. POCT is capable of reducing emergency department (ED) overcrowding, accelerating management, reducing hospital admissions, supporting appropriate treatment plans, and assisting and extending laboratory testing within the hospital. For successful implementation there needs to be a culture within hospitals that prioritises quality, an attitude that spotlights the patient, education on intricacies of POCT and managerial support.
- Page 369Abstract
Point-of-care testing (POCT) for paramedic services has evolved from the simplest POCT of blood glucose and ECG monitoring to a sophisticated and integrated use of POCT in assessment and monitoring of prehospital patients. This evolution has been rapid, as has the evolution of the professional paramedic. This chapter describes the role of POCT in the paramedic environment and discusses the issues associated with providing POCT in this diverse and challenging environment.
- Page 378Abstract
The number and severity of disasters, natural and human-initiated, has increased significantly during the past 25 years because of: increases in population, density and mobility; global interconnectedness; climate change and environmental degradation; emergence of old and new infectious diseases; and social and economic inequities.
Disaster management involves preparedness for, response to and recovery from, a disaster. Disaster management requires collaboration and coordination between health professionals, government and non-government agencies and communities. The capacity to use quality-assured, state-of the art, disaster-specific rapid point-of-care testing (POCT) within an integrated plan for clinical care facilitates evidence-based clinical decision making for rapid screening, diagnosis, triage, treatment and follow-up of acutely traumatised patients. However, environmental extremes encountered during or after a disaster can compromise the capacity of POCT devices to perform reliably.
- Page 393Abstract
Antarctica is one of the most remote places on Earth. Providing medical care, including point-of-care testing (POCT) services in such an extreme environment provides many unique challenges. The fact that each station in Antarctica has to be entirely self-sufficient for the 8 months of complete winter isolation dictates the complexity of the medical support model required. The Australian Antarctic Division (AAD) has nonetheless developed a robust and highly capable POCT diagnostic system to help with medical care in this extreme environment. Our system provides POCT capability on the ground at research stations, in the field, on ships and on aircraft. This POCT system has been field proven and consistently delivers high grade diagnostic information that will influence clinical decision making and decrease diagnostic uncertainty.
- Page 406Abstract
Professional sports environments involve training programs to maximise physical performance of athletes. This requires conditioning staff prescribing and monitoring training loads as well as medical monitoring to ensure athletes remain healthy. Point-of-care testing (POCT) facilitates rapid decision making and manipulation of training programs, as well as providing important feedback about recovery status and wellbeing. Several biomarkers have been established as reliable indicators of exercise-induced physiological changes in sports science. However, there is still a lack of clarity about the best indicators to measure when monitoring the various phases of training programs. This is a rapidly growing area of scientific research and is a promising area for further developments.
- Page 420Abstract
Pharmacists are readily accessible in the community and now act as members of multidisciplinary teams for disease management programs and for health screening. Access to pathology test results is a key element of disease management and can potentially be improved by using point-of-care testing (POCT) devices in a pharmacy setting as part of daily routine. The most common conditions for which POCT is used in pharmacies include diabetes, hyperlipidaemia, anticoagulant control and infectious disease screening. The use of POCT devices enhances professional development for pharmacists, shows a high level of acceptance by patients and can help to reduce overall costs of health care. Nonetheless, issues of reimbursement of costs, licensing and registration, ongoing pathology support, and acceptance by other medical and health professionals may provide obstacles to the implementation of POCT in this setting.
- Page 431Abstract
Ultrasound has become portable and even handheld. It is a very useful tool in rural and remote practices, especially where there is limited access to other diagnostic imaging services and where the primary health-care providers have to manage patients themselves without specialty backup. As an extension of the physical examination, point-of-care ultrasound (POCUS) allows clinicians to visualise selected anatomy and functions of the body in real time and enhances the accuracy of the clinical examination. It has become indispensable for physicians caring for patients in critical, emergency and urgent care settings. POCUS is especially valuable in rural practices.
- Page 438Abstract
There are a number of key stakeholders involved in the day-to-day operation of point-of-care testing (POCT) in primary care and hospital settings. Depending on the size/scope of the POCT program, stakeholders may include: the doctor actively managing the patient based on the POCT result; the POCT Coordinator or Regional Supervisor responsible for the organisation and management of POCT services at the network/regional level; the POCT operator who performs the POC test in situ; the patient, who is the consumer of the POCT service; and the industry partner who provided the POCT device and consumables for testing. This chapter provides a brief personal perspective from a representative of each of these stakeholders.
- Page 444Abstract
This brief concluding chapter consolidates and reflects upon many of the common themes presented throughout the book and provides an insight to the possible future of point-of-care testing (POCT) as we move towards the year 2020. Opportunities for technological innovation, new markets for POCT (with an emphasis on meeting the needs of resource-limited settings), prospects for new POCT research, and more streamlined integration of POCT in health systems will be explored.
