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Point-of-care (POC) testing enables rapid pathology results to be utilised in primary care settings for timely clinical decision-making and treatment during a patient consultation and can contribute to public health surveillance and responses. Large-scale POC testing networks (supporting 100 or more rural and remote health services) now operate for chronic, acute and infectious diseases across the length and breadth of Australia. Sound operator training, quality management and digital connectivity systems, in addition to strong clinical and cultural governance, underpin these networks, mitigate risks to patient safety, and facilitate scalability. Real-world examples from our Australian-based POC testing networks highlight how contemporary global health problems, such as diabetes, acute medical crises and the COVID-19 pandemic response can be addressed by the judicious application of POC testing in primary care settings. The recent role POC testing played in supporting First Nations communities of Australia during the pandemic serves as a template for and provides learned experiences that can be translated or adapted to other countries should or when future global security issues arise. The potential to use POC testing as an adjunctive diagnostic tool to support and enhance global health security needs to be balanced against the limitations of using this innovative technology.
Flinders University International Centre for Point-of-Care Testing, Adelaide, Australia
Susan Matthews
Flinders University International Centre for Point-of-Care Testing, Adelaide, Australia
Louise Causer
Kirby institute, University of New South Wales, Sydney, Australia
Belinda Hengel
Kirby institute, University of New South Wales, Sydney, Australia
Rebecca Guy
Kirby institute, University of New South Wales, Sydney, Australia
*Address all correspondence to: mark.shephard@flinders.edu.au
1. Introduction
Point-of-care (POC) testing is a transformational medical technology that is the fastest growing sector of the pathology industry globally; the global market size was estimated to be US$33 billion in 2022 and growing to US$100 billion by 2032, with a compound annual growth rate of 12.2% [1]. POC testing enables pathology tests to be performed on a patient during a medical consultation in a setting outside the clinical laboratory with results available in a short time frame that facilitates timely clinical decision-making and treatment, leading to improved patient outcomes. POC testing can also contribute meaningfully to public health surveillance and actions in the face of ongoing or emerging epidemics or pandemics, by facilitating diagnosis in high- or special-risk population sub-groups or local communities that are not readily serviced by traditional pathology services.
The settings in which POC testing can be undertaken is ever increasing and includes primary care facilities such as general practices and First Nations medical services as well as pharmacies, workplaces, sports medicine, military services, extreme environments (including polar research stations), and contexts such as disaster management and (as will be described later in this chapter) epidemic or pandemic responses [2].
The advantages of conducting POC testing in primary care settings are profound. The patient-centredness of the POC testing process provides a convenient, accessible and accepted service for consumers, while the speed of result delivery reduces patient anxiety and facilitates more timely diagnosis and appropriate clinical management. The trained POC testing operator who performs the test for their local community has an increased sense of responsibility and empowerment. The consulting medical practitioner can make an evidence-based, informed clinical decision based on the results provided and institute management more rapidly. Operational efficiencies for health service workflow including averted medical evacuations can be achieved, while the portability of POC testing devices also enables them to be used in community outreach, mobile vans or localised outbreak settings. Across a network of primary care services, a significant local workforce capacity with readiness, resilience and competence to perform POC testing can be created [3].
Point-of-care (POC) testing has specific relevance for rural or remote primary care environments, where geographic isolation and long distances from the nearest pathology service can lead to traditional laboratory processes being compromised; sample integrity becomes a major issue due to harsh transport conditions while long turnaround times for results to be returned to remote services result in loss to follow-up of patient care [4, 5].
While performed in variable patient and community centric settings and offering enhanced portability compared to traditional laboratory pathology services, at its core, POC testing remains a medical science discipline; requiring specialised training and competency assessment of non-laboratory health professionals and adherence to standard operating procedures and technical requirements to reduce pre-analytical, analytical and post-analytical errors associated with the test result/s. Such processes are paramount to ensure that results generated by POC testing technologies are analytically valid and pose minimal risk to patient safety. The continuous surveillance of operator competency, device function and analytical quality through the field use of routine laboratory practices such as quality control (QC) and external quality assurance testing (EQA, also known to as proficiency testing)—where services test samples with assigned values of an analyte—underpins the use of POC testing in primary care environments.
Australia has been a pioneer and leader in both the application of POC testing in primary care—particularly services supporting Aboriginal and Torres Strait Islander (now more commonly referred to as First Nations) communities—for the past 25 years. Large-scale POC testing networks (involving close to 100 or more rural and remote First Nations health services) now operate for chronic, acute and infectious diseases across the length and breadth of Australia (Table 1); these are managed for the Australian Government by specialist POC testing network providers including the Flinders University International Centre for Point-of-Care Testing and the Kirby Institute, University of New South Wales, in collaboration with peak First Nations bodies and leadership groups, rather than by traditional pathology laboratories [2, 4, 5, 6].
Examples of large-scale POC testing networks in Australia.
Haemoglobin A1c.
Albumin:creatinine ratio.
Severe Acute Respiratory Syndrome Coronavirus-2.
Flinders University International Centre for Point-of-Care Testing.
National Aboriginal Community Controlled Health Organisation.
Kirby Institute, University of New South Wales.
The QAAMS (Quality Assurance for Aboriginal and Torres Strait Islander Medical Services) Program enables POC testing for the diagnosis and management of diabetes as well as the detection of early renal disease in over 200 First Nations communities throughout Australia. The Program, managed by the Flinders International Centre for Point-of-Care Testing, has been funded continuously since 1999 by the Australian Government and remains the largest POC testing network in Australia. The analytical quality of POC testing in this program has been shown to be equivalent to that of Australasian laboratories and has met profession-derived analytical benchmarks for the past 20 years for both haemoglobin A1c (HbA1c) and urine albumin:creatinine ratio (UACR) [7, 8]. Statistically significant improvements in glycaemic control have been observed in First Nations patients with diabetes both within and between communities [9, 10]. The QAAMS Program has led to health policy change, whereby POC testing is now embedded into pathways for the diagnosis and management of First Nations people with diabetes. This includes the reimbursement of POC test cartridges through the Australian government medical rebate scheme, which is available to actively enrolled QAAMS participants.
The Northern Territory (NT) POC Testing Program operates in every remote health facility in the Northern Territory of Australia. The Territory’s land mass, 5.5 times larger than the United Kingdom, is extremely remote and sparsely populated and is amongst the most challenging environments in Australia to conduct POC testing. The NT POC Testing Program, funded by the Northern Territory Government since 2008 and managed by the Flinders International Centre for Point-of-Care Testing, has revolutionised pathology service delivery in the Territory, particularly for acute medical emergencies such as acute myocardial infarction, acute respiratory disorders, acute renal disease and acute blood loss [11, 12]. The ability to perform opportunistic tests for cardiac troponin, blood gases, electrolytes and creatinine, and haemoglobin, respectively, have enabled efficient triage of acutely ill patients [13]. The device’s international normalised ratio (INR) test also enables the management of patients on warfarin therapy. Through the on-site capacity to rule in or rule out the need for the medical evacuations of a patient, the NT POCT Program is estimated to save the Northern Territory Government more than AUS$21 million per annum [14]. In a further health policy change, POC testing has also been integrated into clinical pathways for acute care in Northern Territory local clinical guidelines [15].
The National Emergency Syphilis Response (ESR) and the Aboriginal and Torres Strait Islander COVID-19 POC Testing Programs were initiated and funded by the Australian Government (then) Department of Health during the past 5 years and delivered in partnership with National Aboriginal Community Controlled Health Organisation (NACCHO).
The ESR program responded to an outbreak of infectious syphilis and its subsequent rapid spread through First Nations communities across northern, central, western and southern Australia. POC testing using lateral flow technology (manual test strips for the detection of Treponema pallidum antibodies) was implemented to increase the uptake of syphilis screening in these communities. With information on past syphilis history from the jurisdictional registers, a patient with a reactive POC testing result was able to be offered immediate intramuscular treatment with antibiotics (benzathine benzylpenicillin) in an attempt to break onward or vertical transmission of the disease. The reactive POC test was followed up with confirmatory laboratory testing to differentiate between active and past syphilis infection. An independent report on the program commissioned by the Australian Government found that the program (through the National Aboriginal Community Controlled Health Organisation [NACCHO] and its partners, including the Flinders University International Centre for Point-of-Care Testing (who managed the training and quality systems for field POC testing) had developed a highly successful blueprint for the design of future First Nations health and wellbeing initiatives [16].
The Aboriginal and Torres Strait Islander COVID-19 POC Testing Program was implemented by the Australian Government through the Aboriginal and Torres Strait Islander COVID-19 Advisory Group as part of the emergency response to the COVID pandemic which swept the world (including Australia) in early 2020 [6]. Leveraged from knowledge and expertise gained through an existing smaller molecular-based POC testing program for sexually transmitted infections (refer Section 3.2 for details), the COVID-19 POC Testing Program was managed and delivered on behalf of the Government by the Kirby Institute at the University of New South Wales (the Kirby) and the Flinders University International Centre for Point-of-Care Testing (ICPOCT). The COVID-19 pandemic took molecular-based POC testing into unchartered waters. The POC testing response needed to be swift, flexible and adaptable to the changing requirements (and subsequent testing frameworks and public health responses) as the pandemic evolved in Australia, while remaining complementary to high throughput, urban laboratory test facilities. All the while, this program took place in an environment where global cartridge supply was limited. As a global security issue, the world had not faced such a level of ‘uncertainty’ or ‘unknown’ for more than 100 years since the Spanish influenza epidemic that killed 50 million people and infected a third of the world’s population (500 million) in 1918 [17]. On this basis, global medical device regulatory bodies fast-tracked molecular-based SARS-CoV-2 diagnostic tests (and later SARS-CoV-2 antigen and antibody tests) from development to market through the application of emergency-use only (EUO) authorisation and cartridge supply allocations. This enabled rapid access and distribution of SARS-CoV-2 POC tests facilitating early adoption of POC testing in empowering First Nations health services to enable swift results which then triggered prompt community-based, public health responses. As such, this POC testing model serves as a testing framework template that can be readily adopted in high-risk populations to complement other broader testing strategies should future global security issues arise.
The core elements of the QAAMS, NT POC Testing and Aboriginal and Torres Strait Islander COVID-19 POC Testing Programs are similar and represent the progression of the field of POC testing across the last two and a half decades; they include:
A defined clinical or public health need
Political will and funding support from Government
Strong clinical and cultural governance
Targeted site selection to improve equity of access to diagnostic testing for high and special risk populations with linkage to care
Engagement with key stakeholder groups (including partners and community)
Documentation of policies, guidelines, risk assessment and mitigation strategies and quality management processes
Sound training and competency assessment for POC testing operators
Analytical quality surveillance systems*
Scientific and technical support services
Supply logistics (for testing cartridges/strips and other consumables), and
Connectivity and reporting systems (the electronic transfer of POC test results into patient management systems and/or notification systems).
*However, it should be noted that due to the EUO authorisation of SARS-COV-2 POC tests and the need for rapid scale-up, extensive in-situ, post-market assay verification studies were performed to a lesser extent prior to field implementation in the COVID-19 POC Testing program, than for the QAAMS and NT POC Testing programs.
Table 2 compares and contrasts these key elements across the QAAMS (chronic disease), NT POC Testing Program (acute care) and the Aboriginal and Torres Strait Islander COVID-19 POC Testing (infectious disease) networks.
Core element
QAAMS program
NT POC testing program
Aboriginal and Torres Strait Islander COVID-19 POC testing program
Clinical/Public health need
Rates of diabetes three-fold higher in First Nations people; Diabetes-related mortality in First Nations people four-times higher than non-Indigenous population [18]
Acute medical episodes leading cause of mortality/morbidity in the Northern Territory; High costs of medical retrievals [11, 14].
Emergency response to global COVID-19 pandemic; First Nations people more susceptible to severe illness/complications from COVID-19 [6]
Funding source
Australian Government
NT Government
Australian Government
Governance
Program Management Committee including Clinical Support Officer and First Nations Leadership Forum
Program Management Committee including Clinical Support Officer and representative from peak First Nations body
Overseen by National Aboriginal and Torres Strait Islander COVID-19 Advisory Group; Program Clinical Advisory Group
Site selection
Targeted at high-risk population subgroups in services with diabetes as a health priority
Initially prioritised to larger health services serving larger population sizes, but now operating in every remote health service in NT
Site inclusion criteria developed to target high- and special risk remote populations, with sites approved by jurisdictional and national governance committees
Stakeholders (examples)
Industry (Siemens) Peak State/Territory First Nations bodies
Industry (Abbott) Peak Territory First Nations body (AMSANT)
Industry (Cepheid) Peak National First Nations body (NACCHO), Jurisdictional pathology services and public health departments
Policies, guidelines and risk/quality management
Aligns with latest NPAAC Requirements for POC Testing in Australia (2021) [19]
Aligns with latest NPAAC Requirements for POC Testing in Australia (2021) [19]
Aligns with latest NPAAC Requirements for POC Testing in Australia (2021) [19] and policies from PHLN [20] and CDN Australia [21]
Training
Flexible training options, including face-to-face, annual training workshops and web-based training available 24 hrs per day/7 days per week; Written and practical competency assessment
Flexible training options, including face-to-face training and web-based available 24 hrs per day/7 days per week; Written and practical competency assessment
Face-to-face training not available due to travel restrictions to First Nations health services during pandemic; Prerequisite modules on infection control and personal protective equipment; Written and practical competency assessment, Practical using Facetime on mobile phone
Device/technology
Siemens DCA system/immunoassay
Abbott i-STAT 300/mainly electrochemical
Cepheid GeneXpert /molecular-based (PCR)
Analytical quality
QC and EQA (both monthly)
QC (monthly) and EQA at selected hub sites (monthly)
QC (both ‘positive’ and ‘negative’ controls) and EQA (2 samples quarterly)
Scientific support
Working week 9 am–5 pm
Working week 9 am–5 pm
Working week 9 am–5 pm and telephone hotline 24 hrs per day/7 days per week for review of positive (or presumptive positive) patient results
Supply logistics
Provided by Siemens
Provided by Abbott
Provided by Logistics Support team from Kirby Institute
Connectivity
Uni-directional capture of de-identified results required, but not universally implemented due to different PMSs used across Program
Uni-directional capture of de-identified results (from device to central database at Flinders University); manual entry of results by operator into Territory-wide PMS
Uni-directional capture of de-identified results (to central database at Kirby) and identified data to multiple end-users (including PMS, pathology repositories, and jurisdictional departments of health); Public-facing and internal-facing dashboard reports; Mandatory reporting of (identified) notifiable infections
Table 2.
The key elements of three working POC testing networks in Australia.
NPAAC = National Pathology Accreditation Advisory Council; NACCHO = National Aboriginal Community Controlled Health Organisation; AMSANT = Aboriginal Medical Services Alliance Northern Territory; QC = quality control; EQA = external quality assurance; PHLN = Public Health Laboratory Network; CDN = Communicable Disease Network; PMS = patient management system.
With the core quality elements implemented and the networks operating routinely, clinical, cultural, operational and cost benefits can be realised through accessing POC testing technology. Further, the research impacts of POC testing permeate many research types and levels, as shown in Table 3.
Research
Elements
Medical science research
Device evaluation—pre- and post-field evaluation and implementation, ease-of-use, comparison to previous technologies.
Analytical equivalence to the laboratory and ability to meet analytical benchmarks—most fundamental and most important in terms of patient risk/safety.
Implementation science research
Training and quality surveillance systems—innovation/creativity. Discrete end-user acceptability studies—patient, clinician, health service, community levels. Linkage to care.
Translational research
Transferability of networks across chronic, acute and infectious diseases
Transferability of networks between services, between jurisdictions (national) and internationally.
Scalability of networks from pilot to national to international models.
Public health research
Impacts at community level—equity of access/stakeholder acceptability.
Impacts at health service level—building workforce capacity/resilience.
Impacts at health system level—economic benefits. Impacts at health system level—disease burden, population health and wellbeing; early warning for disease surveillance and emerging. Pandemics. Impacts on health system policy and identification of sustainable funding.
Table 3.
Examples of multi-faceted research impacts of POC testing.
3. The Aboriginal and Torres Strait Islander COVID-19 POC testing program—A template for addressing future global security events
3.1 Setting the scene
Coronavirus disease (COVID-19) is a highly infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-COV-2). While the origin of the virus remains problematic, the first cases of the virus appeared in Wuhan, China in December 2019 and spread rapidly across the globe. In Australia, the first case was reported on 25 January 2020 [22]. The World Health Organisation (WHO) declared the outbreak a ‘public health emergency of international concern’ 5 days later and a global pandemic on 11 March 2020 [23]. Across the subsequent 30 months, there have been a series of peaks and troughs in the number of COVID-19 infections in Australia, corresponding most often to the appearance of new coronavirus variants of concern. By August 2023, the WHO Coronavirus (COVID-19) dashboard reported that there had been over 769 million confirmed cases of COVID-19 globally, including 6.95 million deaths due to the virus [24]. Within Australia, the WHO dashboard reported over 11.5 million cases and 22,618 deaths [24]. While the virus is still circulating in the Australian population, its impact on the general population following widespread vaccination roll-out continues to subside for the present.
Despite widespread international travel restrictions, when the virus first hit Australian shores, the Australian Government were particularly concerned about the potential risk of severe impact of the virus on the country’s First Nations people [6, 25]. First Nations people, particularly those living in remote communities, experience high rates of comorbidities including diabetes, cardiovascular disease and obesity, rendering them at higher risk of contracting serious illness and/or complications from the virus, similar to those documented in these communities during the H1N1 influenza outbreak in 2010 [26]. Many First Nations people in remote communities live in large households, making physical distancing problematic and culturally challenging and increasing the risk of infectious disease transmission. As explained previously, people living in remote communities are geographically isolated from regional pathology laboratories and therefore have limited access to testing when needed. Further, early in the pandemic, there was a limited understanding of the mechanisms of disease progression, a high burden on emergency and intensive care equipment and resources, minimal experimental treatment regimens and no vaccines available for the disease; as a result, expected mortality rates would be higher than if these options were available. The National Aboriginal and Torres Strait Islander COVID-19 Advisory Group was convened early in 2020, and recognised the importance of ensuring rapid, robust, and tailored COVID-19 responses for remote communities that were led by First Nations peoples.
3.2 A pivotal role for POC testing
To overcome justifiable concerns about the impact of COVID-19 on First Nations people, the Australian Government sought to support POC testing as a significant tool in the community-led emergency response in regional and remote settings. Firstly, through QAAMS, the NT POC Testing Program, the ESR Syphilis program and an existing molecular STI POC testing program called TTANGO (Test, Treat and Go) [27, 28], POC testing was a well-accepted technology in First Nations communities that had proven culturally safe, clinically and operationally effective and cost effective. Secondly, through TTANGO, molecular-based POC testing using the Cepheid GeneXpert system (the same system on which SARS-CoV-2 testing could be performed) had been systematically introduced into remote First Nations communities over the past decade for sexually transmitted infections (STI) for chlamydia, gonorrhoea and trichomoniasis at primary health services. The TTANGO POC testing network was being managed for the Australian Government through the Kirby-Flinders ICPOCT partnership and had been scaled-up from a randomised controlled trial (involving 12 sites) through a translational research phase and, at the start of the pandemic, to a routine implementation phase across 31 communities [27, 28]. There was also already a significant STI POC testing operator workforce in place who were competent in the operation of the GeneXpert system and had sound knowledge of quality management practices. Suitable and adaptable support infrastructure was also in place (supply chain logistics and connectivity). The Government therefore leveraged this established POC testing network to implement and rapidly expand a new program for SARS-CoV-2 testing using these same and additional GeneXpert devices. Importantly, the peak regulatory body overseeing medical devices and diagnostic tests in Australia—the Therapeutic Goods Administration (TGA)—had approved the use of a new SARS-CoV-2 assay for EUO on the GeneXpert system in March 2020 [29]. Two months later (May 2020), the WHO issued a statement that the GeneXpert SARS-CoV-2 assay (and other molecular-based technologies) could be performed ‘on the bench, without the need for a biosafety cabinet, when the local risk assessment so dictates and proper precautions [re infection control] are in place’ [30]. Further operator safety options were available within the COVID-19 POC Testing program through the direct provision of personal protective equipment (PPE) for enrolled health services and later the validation of a specific molecular transport media (rather than the recommended viral transport medium), capable of inactivating high titre (greater than 1 × 107 copies/mL) SARS-CoV-2 virus within 2 minutes of contact between the sample swab and media [31].
The GeneXpert system comprised a four-module GeneXpert device (allowing four tests to be performed at the same time), a laptop with proprietary software to enable the testing process, and a barcode scanner. In some larger community health services, or during local outbreaks, two GeneXpert devices were synchronously linked to form a higher throughput eight module device. A single-use, self-contained, disposable test cartridge performed a real-time, reverse transcriptase polymerase chain reaction (RT- PCR) test in situ, initially identifying nucleic acid material (RNA) from the SARS-CoV-2 virus (specifically the nucleocapsid (N-gene) and the viral envelope (E-gene) targets) and amplifying this material through thermal cycling to generate a fluorescent signal in a positive sample [6, 32]. Initially, test results (positive [detecting both N and E-gene targets], presumptive positive [detecting E-gene only], or negative) were available in just 45 minutes. Initially, a nasopharyngeal swab sample was collected (this was later expanded to include oropharyngeal and deep nasal swabs), placed into a 3 mL molecular transport medium tube, before mixing, and then loading into the testing cartridge using a transfer pipette. Further development of the Cepheid GeneXpert SARS-CoV-2 assay included validation for specific variants of concern as the pandemic progressed.
3.3 Which services to prioritise?
In addition to those services already with a GeneXpert device being used for STI POC testing, remote health services which were located a significant distance from a laboratory, and which had SARS-CoV-2 testing capacity, were prioritised for a device. Specifically, they needed to be more than 2 hours’ drive from the closest laboratory, have at least three staff members to ensure capacity to perform testing, and either service a community of at least 500 First Nations people (a so-called ‘hub’ site) or provide centralised testing to ‘spoke’ communities with a total population of more than 500 people [6, 25].
3.4 Ramping up the program in rapid time!
The Kirby Institute and Flinders ICPOCT were formally contracted by the Government in April 2020 to deliver the program [6, 25]. As mentioned, the Government purchased additional GeneXpert devices to supplement those already in operation through the TTANGO STI Program and announced the COVID-19 POC Testing Program would begin operation in May 2020.
An intense period of work between April and May 2020, including extensive engagement with stakeholders, resulted in the development of policies and procedures regarding governance, the development of comprehensive training resources, quality management procedures, risk assessment and mitigation strategies, and specifications for a connectivity system not only to report results into multiple patient management systems (PMS) but also into jurisdictional public health notification systems. It was imperative that all these documents met standards that were expected by key stakeholder groups including the National Pathology Accreditation Advisory Council (NPAAC), who oversaw national requirements for the conduct of POC testing in Australia as well as produced a complimentary guidance document for POC testing during the pandemic; the Public Health Laboratory Network (PHLN), an expert panel of microbiologists representing Australasian laboratories; and the Communicable Diseases Network (CDN), who had disseminated national guidelines on COVID-19. The quality and value-add of molecular COVID-19 POC testing (and other COVID-19 testing practices such as waste-water surveillance testing) was under intense scrutiny by these bodies, who were responsible for developing and revising a national COVID-19 testing framework throughout the pandemic.
The program was overseen by the National Aboriginal and Torres Strait Islander COVID-19 Advisory Group; this group compromised senior representatives from NACCHO, CEOs and public health medical officers from Aboriginal Community Controlled Health Services (ACCHS), State/Territory ACCHS peak bodies and health representatives from federal and State/Territory Governments. In addition, a Program Clinical Advisory Group monitored the program on a more regular basis. The operational teams from the Kirby Institute and Flinders ICPOCT, responsible for day-to-day activities of the program, reported to both groups as required.
The development of flexible training resources and a competency assessment process for trained operators was particularly challenging given the short scale-up timeframe available in combination with the restricted travel into remote communities early (prior to widespread COVID-19 vaccination regimes). Prior to GeneXpert POC training, all trainees had to first complete prerequisite training modules in infection control, hand hygiene and the donning and doffing of personal protective equipment (PPE), which were separate to the GeneXpert training program developed by Flinders ICPOCT. Underpinned by detailed risk assessments and standard operating procedures including key risk mitigation steps, GeneXpert operator training resources included a PowerPoint presentation, a series of visual posters which provided step-by-step guides on how to perform patient, QC and EQA testing and how to interpret and action GeneXpert SARS-CoV-2 results (with assistance from a scientific hotline). As travel to First Nations communities was prohibited during the pandemic, training was delivered via an online platform by a team of Flinders ICPOCT scientists. Competency assessment involved both written and practical components; with face-to-face training not being a viable option during the pandemic, ICPOCT scientists observed POC testing trainee operators conduct a QC test in real-time via a mobile phone app (FaceTime). Flinders ICPOCT commenced online training on 14 May 2020.
The GeneXpert training and competency process, as well as the external prerequisite training, was time consuming, relatively intensive and often difficult to schedule; however, the trade-off was the high quality of test results, as evidenced by a very low rate of unsuccessful tests (0.7%) and excellent performance with QC and EQA testing; for the latter testing mode, the mean concordance with expected EQA results was greater than 98% for both ‘positive’ and ‘negative’ samples [33].
False negative test results (from either the laboratory or POC testing) were of particular concern during the pandemic in Australia, as such a patient with COVID-19 could be unsuspectingly transmitting the infection throughout the community while assuming they were ‘negative’. In contrast, a false positive result could initiate an unnecessary public health response including, in some settings where isolation was not available or feasible, the evacuation of an individual from community and relocation to a designated COVID-19 quarantine facility.
The training framework for POC testing in primary care settings must align with regulatory frameworks in a given country, with the complexity of the POC test process and the personal or public health risk classification assigned to the test determining the intensity/level of training needed [34]. For a simple lateral flow test of low complexity and low personal and/or no public health risk, for example a pregnancy test, which has minimal steps and is easily read, operator training and competency assessment can be relatively basic and can potentially be delegated to ‘advanced’ trainers or local ‘POC testing champions’. However, for a test of high complexity with high public health risk (such as SARS-CoV-2, HIV or hepatitis B/C), training and competency assessment needs to be targeted and rigorous.
A quality management system to support SARS-CoV-2 patient testing was rapidly implemented and involved services conducting both QC and EQA testing. For EQA testing, two blinded samples were tested every 3 months; these samples were prepared by the Royal College of Pathologists of Australasia (RCPA) Quality Assurance Programs Pty Ltd., one of two accredited EQA providers in Australia [33]. Both QC and EQA results were regularly reviewed by the scientific team and corrective action initiated if required. Strict maintenance, cleaning and risk mitigation procedures were also implemented at the service, which later extended to ‘single-bagging’ of the disposable sample transfer pipette (placing the used pipette into a specimen bag and sealing prior to disposal) or ‘double bagging’ of each used cartridge (placing the used cartridge into two specimen bags and sealing prior to disposal). These enhanced disposal procedures have been drafted in consultation with the manufacturer for inclusion in an improved IFU (instructions for use) sheet to further reduce biological and/or amplicon contamination risk.
Technical and scientific support for field operators was established from 9 am to 5 pm Monday to Friday by ICPOCT scientists, and a 24-hour telephone hotline service was operated initially by an ICPOCT scientist and later by Kirby staff to support services when a ‘positive’ case was identified and facilitate the local public health response.
Logistic support provided by Program staff included support for the initial software and hardware set-up of GeneXpert devices and the supply of testing cartridges, full PPE (gowns, gloves, face shields, masks) and consumables. Due to a global shortage of cartridges, cartridge supplies were procured at the national level and allocated accordingly to laboratories and to the Aboriginal and Torres Strait Islander COVID-19 POC Testing Program, with a sharing of cartridge resources between all stakeholders to accommodate high throughput testing sites and local outbreaks. Supplies were then managed and distributed to services dependent upon anticipated need by the Program logistic team. The program was also flexible in responding to the need to deploy GeneXpert resources to services experiencing transient outbreak levels of COVID-19 infections.
A connectivity reporting system, based on that established for the STI program [35], was modified and expanded to ensure de-identified patient SARS-CoV-2 results were captured in real-time by the program’s central database, integrated into the service’s patient management system and also directed to jurisdictional health departments for integration into their notifiable infections databases for mandatory public health surveillance purposes.
3.5 Rolling out the program
POC testing for SARS-CoV-2 in First Nations communities began in May 2020 and a program website with information for participants and training resources was launched in June. From June to October 2020, 80 health services were systematically integrated into the program, with over 5000 tests performed. By November 2020, all 86 sites initially selected to join the program were active, just under 7400 tests had been performed and the first positive cases in the community were identified. Positive test results were immediately followed up and actioned by the program with an ensuing rapid public health response implemented by the responsible clinician and public health team as required which included isolation of the community member and rapid testing of close family contacts to prevent the spread of infection in the community.
By August 2022, 105 services were engaged in the program, more than 900 operators had been trained and the cumulative number of SARS-CoV-2 patient tests performed exceeded 72,600 (Figure 1).
Figure 1.
Map showing general location of hub and spoke sites participating in the Aboriginal and Torres Strait Islander COVID-19 program.
With the introduction of lateral flow rapid antigen point-of-care testing (RATs), prioritisation of molecular POC testing was tailored accordingly to support management of more severely ill patients and maintain staffing in remote clinics.
3.6 Impact and benefits of the Aboriginal and Torres Strait Islander COVID-19 POCT program
The Australian Government committed a total of $27 Million dollars to the COVID-19 POC Testing program. This investment provided a more than solid return. An independent review of the program, commissioned by the Government, prepared a report on the program in December 2022 (which was released publicly in July 2023) [25]. The report concluded:
“In summary the Program has been highly successful. It has achieved its intended aim of improved health outcomes for First Nations people through better access to COVID-19 testing. It is estimated that the Program has avertedbetween 23,000 and 122,000 infectionsthat would be likely to have arisen in the 40 days after the first infection was identified in a remote First Nations community. It is estimated that the Program has avoidedbetween AUS$337 million and $1.8 billion in health costs.The key factors that underpinned this success were well informed and culturally competent governance, the GeneXpert system and the technical support given by the Kirby Institute and Flinders University, and the model of care provided by the ACCHS sector”.
A summary of the Program’s key outcomes, adapted from this report [25], is provided in Table 4.
Outcome
Short-term
Long-term
For patients
Morbidity and mortality associated with COVID-19 was reduced.
High quality care was received in the most appropriate setting.
For community
The spread of COVID-19 transmission was broken in these communities.
Sustainability of health services in remote communities during the pandemic was improved.
Confidence in the communities’ capacity to handle COVID-19 was improved.
Confidence in the health service was improved and people were more willing to engage with treatment and care.
For the health system
Unnecessary medial isolations or evacuations were avoided.
POC testing devices were rapidly deployed to other locations of epidemiological concern.
Costs and impacts on other health services (e.g. hospital admissions, primary care interactions) were reduced.
Provision of support to remote health services created networks and built knowledge of support (‘resilience’) for future pandemics.
Capacity and autonomy in the testing of other infectious diseases was enhanced.
Table 4.
Key short- and long-term outcomes from the program.
4. Lessons learned and their transferability to other countries
While considered generally low throughput and higher cost (compared to laboratory testing), POC testing can be a practical adjunctive diagnostic tool to support a timely response to a global health security issue, whether it be an infectious disease pandemic (as the world has just experienced) or a major natural or human-initiated disaster. POC testing forms part of an overall diagnostic solution and has niche application in such events, particularly in circumstances where laboratory testing is not readily available (e.g. remote communities), a rapid time to result is required, high- and special-risk subpopulations exist and where the rate of community transmission of the disease places burden on or exceeds the local pathology laboratory capacity. This applies particularly to low- and middle-income countries (LMIC and MIC) where access to traditional laboratory testing is often limited by geographic remoteness and loss to follow-up can be high.
The dynamic nature of global disease transmission or disaster events and the need to learn ‘on the run’ often in the face of a paucity of evidence, as occurred with the recent COVID-19 pandemic, means that POC testing needs to be nimble and adaptive in its application. ‘Just in time’ training, the ability for POC testing to be rapidly scaled up in a cost-effective and timely manner, and capacity to leverage both existing technology that may already be available in the field and a workforce ready POC testing operator base are examples of strategies that can enhance health security preparedness and responsiveness.
Planning and preparedness for using POC testing as a supplementary tool in global health security scenarios is the key to the ultimate effectiveness of this technology. In the post-COVID era now upon the world, most countries are reflecting on how to prepare for future infectious diseases and significant adverse events. Planning for how and when to use POC testing optimally should be a crucial component of preparedness and should be built into regional, national and international policy documents on global security incident management. POC testing should be integrated to meet local, specific community as well as broader public health needs, while also complying to general pathology regulation requirements. How well that planning is undertaken—particularly the identification of enablers and barriers to uptake—will have a significant bearing on the clinical usefulness and efficiency of POC testing in the field. Embedding POC testing in remote primary care practice (as has occurred in our Australian models) has not only raised awareness of the broad clinical, cultural and operational utility of POC testing but also built an experienced and resilient workforce of POC testing operators who were able to adapt readily to the new and immediate challenge presented by COVD-19.
Key lessons learned from the Australian experience of utilising POC testing, which can be transferable to other settings around the world, are summarised as a checklist in Table 5 [36].
Checklist
Comment
Government
Political and funding support from government is critical.
Governance
Strong governance structure involving multidisciplinary stakeholders, including government, clinical, public health, industry, health services and consumer advocates is essential.
Engagement with community
Investment in community engagement and awareness of the benefits of introducing POC testing for its intended purpose is paramount.
Linkage to policy
Embedding POC testing practice into national health policy for addressing global security issues must be prioritised.
Linkage of POC devices and test clusters to clinical pathways
Streamlining the use of POC testing device and test clusters into established clinical management pathways for triage and treatment is important.
‘Fit for purpose’ POC devices and test clusters
POC devices and test clusters that are analytically ‘fit for purpose’ should be selected and evaluated; that is, they are appropriate for the clinical setting in the context of the population to be tested and the clinical conditions to be considered.
The original ASSURED and now redefined REASSURED criteria [37,38] are simple tools developed for primary care and community settings in LMIC. In particular, these criteria recognise that ‘no diagnostic tool is perfect’ and that it is important to assess the ‘trade-off’ between accuracy, accessibility and affordability when selecting a ‘fit-for-purpose’ POC testing opportunity.
Complexity/risk of POC test systems
In past years, there was an assumption that POC testing in primary care settings should be restricted to devices of low complexity (e.g. rapid diagnostic test strips); however, the Australian example has shown that devices of high complexity linked with tests with high public health risk (e.g. SARS-CoV-2) can be performed safely in community settings in the event of a major disease outbreak.
Linkage between specialist POC network providers and laboratory pathology providers
Supportive and complementary relationships between these two groups should be built, particularly if ‘front-line’ POC testing requires follow-up laboratory testing and/or confirmation, other supplementary tests (e.g. multiplex respiratory test panels) or specific referral testing (e.g. genotyping).
Management of reagent stocks and consumables
A successful and responsive POC testing network must prioritise:
Established relationships/processes with industry suppliers for supply of devices, reagents and quality testing products at competitive pricing.
Contingencies for stockpiling and prioritisation when supplies are limited during periods of surge capacity.
Strategies for maintenance of supply chain during transport.
Consideration of refrigeration/power requirements at health service level.
Supply of ancillary equipment e.g. personal protective equipment.
Training and competency
Training and competency must involve:
Pre-event preparedness training to build an informed and event-ready workforce, including regional POC testing champions.
‘Just in time’ training for rapid mobilisation of testing workforce when an event occurs.
Innovative mechanisms for observed competency assessment, when travel to remote health services is restricted or not possible.
Contingency training options for when face-to-face training is not available (e.g. during community lockdowns).
Risk mitigation and quality management
A risk management matrix should be used to assess risks to operator and patient safety versus perceived benefits of introducing POC testing.
POC testing should be undertaken within a documented and systematic quality management framework, which conforms to in-country regulatory requirements.
Automated early warning systems for anomalous results and trends should be implemented and monitored.
Escalation of incidents/adverse events for review at the clinical governance level (e.g. through a safety review committee) and reporting to regulatory bodies (as required) is critical.
POC testing quality management procedures should be embedded into preparedness activities in advance of a global event occurring.
Connectivity solutions
Elements of a practical connectivity solution should include:
Environmentally robust connectivity capability (to work e.g. in extremes of temperature which may occur in a global event).
Barcoding to facilitate positive patient identification.
Strategies to deal with patients who are unable to be identified.
Flexible connectivity systems, including jurisdictional notification where required.
Table 5.
Checklist to maximise the potential of POC testing in a global security event.
5. Acknowledging the limitations of and barriers to the adoption of POC testing
While the evidence that POC testing can be a complementary diagnostic tool in global events is clear, several limitations and barriers remain as an obstacle to the widespread uptake of this technology.
Certainly, if all the enablers listed in the previous table are not in place to support POC testing uptake—notably lack of political will; poor governance; disengagement of stakeholders; and lack of policy, regulation or quality management procedures—then it is certain that POC testing will fail. Other factors that limit effectiveness also need to be considered and are summarised in Table 6.
Limitations
Comment
Maintaining a sustainable workforce
Staff turnover, especially in remote locations, represents the most significant challenge for sustainable POC testing.
Flexible training options (both for delivery of training and for training resources) that are tailored to the needs of the health professionals being trained can be part of the solution to reduce the impact of staff turnover.
Opportunities for retraining beyond initial competency expiratory dates must be part of POC testing policy to minimise risk to patient safety.
Awareness of limitations of the POC test method used
Common limitations of and interferences for individual test methods should be noted from manufacturer’s IFU (instructions for use) and recorded in quality management documents.
Temperature and humidity limits for device operation should also be noted/documented as field conditions may preclude routine device operation if these parameters are exceeded.
Potential for overuse/misuse of POC test
POC test should only be used for its intended clinical purpose, as defined in policy documents. Outside this scope should be considered ‘off label’ use, which requires additional validation as an in-house, in-vitro diagnostic test.
Unavailability of suitable quality materials to monitor analytical performance
For some POC tests, particularly in the event of a new disease outbreak e.g., commercially available, robust QC and EQA materials may not be manufactured or available.
Engagement of field operators regarding the importance of QC and EQA testing is critical; without an understanding of why quality testing is needed and subsequent investment from operators, the POC test system may fail and risk to patient safety is increased.
Non-conformance with agreed procedures for QC and EQA testing can increase risk to patient safety.
Cost of introducing a POC test system
Without government support in terms of block funding or rebates for testing, costs of introducing POC testing may be prohibitive. If so, scalability of POC testing networks to regional or national levels in the event of an outbreak may be impracticable.
Table 6.
Limiting factors for the uptake of POC testing in a global security event.
Utilising a variety of analytical methodologies and device types, point-of-care testing has proven a valuable tool in improving equity of access to pathology services in high-risk, remote communities within Australia and has been an invaluable and complementary diagnostic aid in assisting the COVID-19 pandemic surveillance and public health response in this country.
Specifically, molecular-based POC testing offers rapid detection of individual active infection and thus has broad application in the context of future global security, especially considering the predicted upsurge in emerging infectious diseases, the development of multiplexed assays to detect related disease types simultaneously and the possible device simplification and miniaturisation of POC tests through the application of microfluidic technologies (e.g. that may combine molecular-based methods in a lateral flow type format). Ideally, post-market assay evaluation and verification studies are required for the provision of integral, robust evidence prior to scaling-up quality POC testing. Such studies should be comprehensively performed and reported prior to the widespread implementation of any new diagnostic test or technology. However, in the advent of rapid diagnostic toolkits for disaster management, new infectious disease outbreaks or future pandemics, extensive field evaluation performed outside of the laboratory setting is often not possible. Under these circumstances, it is even more pertinent that POC testing is underpinned by robust training and quality management systems specifically adapted for different environmental settings using non-laboratory staff, combined with appropriate clinical governance and linkage to care.
In conclusion, POC testing has the potential to deliver equity of access to pathology testing in remote communities and broader public health impact in high- and special-risk populations during events of global significance. Fundamental to the successful implementation of POC testing is recognition that POC testing is founded in medical science and requires the following complimentary elements: strong leadership and investment from Governments; a solid governance structure to support POC testing field programs; sound preparation for implementation of POC testing including comprehensive training and competency, quality management and connectivity systems, the flexible and nimble repurposing of multiplex devices if available, adaptable redistribution and reprioritisation for testing cartridges when supplies are low. In this context, the real-world application of POC testing serves as a complementary, yet important, diagnostic tool should or when future global health security issues arise.
This book chapter is written on behalf of the large, multidisciplinary POC testing teams at the Kirby Institute and the Flinders University International Centre for Point-of-Care Testing. The authors acknowledge and thank the Australian Government Department of Health and Aged Care for their support in funding the QAAMS, ESR, TTANGO and Aboriginal and Torres Strait Islander COVID-19 POC Testing networks. The Northern Territory Government is also acknowledged for funding the NT acute care POC testing program. The authors acknowledge the contribution to these networks of many stakeholders including the National Aboriginal Community Controlled Health Organisation (NACCHO); Indigenous Leaders Forum and Groups, participating Aboriginal community controlled and government health services; national, jurisdictional and local Aboriginal Community Controlled Health Organisations; national, State and Territory health departments, and other government services; our industry and academic partners; pathology providers and most importantly, the dedicated health professional staff working as POC testing operators in our networks.
The authors have no conflict of interest to declare.
References
1.Precedence Research, Ottawa, Canada. Healthcare: Point-of-Care Testing Market. Report Code 2270 [Internet]. 2023. Available from: https://www.precedenceresearch.com/pointof-care-testing-market [Accessed: 26 August 2023]
2.Shephard M, Shephard A, Matthews S, Andrewartha K. The benefits and challenges of point-of-care testing in rural and remote primary care settings in Australia. Archives of Pathology and Laboratory Medicine. 2020;144(11):1372-1380. DOI: 10.5858/arpa.2020-0105-RA
3.Shephard M. An introduction to point-of-care testing and its global scope and application. In: Shephard M, editor. A Practical Guide to Global Point-of-Care Testing. Melbourne, Australia: CSIRO Publishing; 2016. pp. 1-14
4.Shephard M, Matthews S, Markus C, de Courcy-Ireland E, Duckworth L, Haklar I, et al. Pathology testing at the point of patient care: Transformational change for rural communities. In: Rusangwa C, editor. Rural Health - Investment, Research and Implications. London, UK: IntechOpen; 2023. pp. 1-29. DOI: 10.5772/intechopen.109769
5.Spaeth B, Matthews S, Shephard M. Patient-centred point-of-care testing: A life-changing technology for remote health care. In: Onal A, editor. Primary Health Care. London, UK: IntechOpen; 2021. pp. 1-15. DOI: 10.5772/intechopen.100375
6.Hengel B, Causer L, Matthews S, Smith K, Andrewartha K, Badman S, et al. A decentralised point-of-care testing model to address inequities in the COVID-19 response. The Lancet Infectious Diseases. 2020;21(7):e183-e190. DOI: 10.1016/S1473-3099(20)30859-8
7.Shephard M, Shephard A, McAteer B, Regnier T, Barancek K. Results from 15 years of quality surveillance for a national Indigenous point-of-care testing program for diabetes. Clinical Biochemistry. 2017;50:1159-1163. DOI: 10.1016/j.clinbiochem.2017.07.007
8.Regnier T, Shephard M, Shephard A, Graham P, DeLeon R, Shepherd S. Results form 16 years of quality surveillance of urine albumin to creatinine ratio testing for a national Indigenous point-of-care testing program. Archives of Pathology and Laboratory Medicine. 2020;144:1199-1203. DOI: 10.5858/arpa.2020-0106-OA
9.Shephard M. Clinical and cultural effectiveness of the ‘QAAMS’ point-of-care testing model for diabetes management in Australian Aboriginal medical services. Clinical Biochemist Reviews. 2006;27:161-170
10.Spaeth BA, Shephard MDS, Schatz S. Point-of-care testing for haemoglobin A1c in remote Australian Indigenous communities improves timeliness of diabetes care. Rural and Remote Health. 2014;14:2849. Available from: http://www.rrh.org.au/articles/printviewnew.asp?ArticleID=2849
11.Matthews S, Spaeth B, Duckworth L, Richards J, Prisk E, Auld M, et al. Sustained quality and service delivery in an expanding point-of-care testing network in remote Australian primary care. Archives of Pathology and Laboratory Medicine. 2020;144(11):1381-1391. DOI: 10.5858/arpa.2020-0105-RA
12.Shephard M, Spaeth B, Mazzachi B, Auld M, Schatz S, Loudon J, et al. Design, implementation and initial assessment of the Northern Territory point-of-care testing program. Australian Journal of Rural Health. 2012;20:16-21. DOI: 10.1111/j.1440-1584.2011.01243.x
13.Spaeth BA, Shephard MDS, Omond R. Clinical application of point-of-care testing in the remote primary health care setting. Quality in Primary Care. 2017;25:164-175
14.Spaeth BA, Kaambwa B, Shephard MDS, Omond R. Economic evaluation of point-of-care testing in the remote primary health care setting of Australia’s Northern Territory. ClinicoEconomics and Outcomes Research. 2018;10:269-277. DOI: 10.2147/CEOR.S160291
15.Remote Primary Health Care Manuals. Manuals [Internet]. 2022. Available from: https://remotephcmanuals.com.au/ [Accessed: 26 August 2023]
16.Equity Economics. Blueprint for the Future: Evaluation of NACCHO’s Role under the Enhanced Syphilis Response. A Report Prepared for the National Aboriginal Community Controlled Health Organisation (NACCHO). 2021. pp. 2-5
17.Centers for Disease Control and Prevention. Pandemic (H1N1 Virus). 1918. Available from: https://www.cdc.gov/flu/pandemic-resources/1918-pandemic-h1n1.html [Accessed: 26 August 2023]
18.Ride K, Burrow S. Review of diabetes among Aboriginal and Torres Strait Islander people. Journal of the Australian Indigenous HealthInfoNet. 2022;3(2):3. DOI: 10.14221/aihjournal.v3n2.1
19.National Pathology Accreditation Advisory Council (NPAAC). NPAAC Requirements for Point of Care Testing. 2nd ed. Australian Government Department of Health [Internet]; 2021. Available from: https://www1.health.gov.au/internet/main/publishing.nsf/Content/35DE5FC4786CBB33CA257EEB007C7BF2/$File/DT0002469%20-%20NPAAC%20-%20Requirements%20for%20point%20of%20care%20testing%20Second%20edition%202021%20-%2020211215.pdf [Accessed: 26 August 2023]
20.Public Health Laboratory Network. PHLN Guidance on Laboratory Testing for SARS-CoV-2 (The Virus that Causes COVID-19). Available from: https://www.health.gov.au/sites/default/files/documents/2022/01/phln-guidance-on-laboratory-testing-for-sars-cov-2-the-virus-that-causes-covid-19.pdf [Accessed: 26 August 2023]
21.Communicable Disease Network Australia. Coronavirus (COVID-19). CDNA National Guidelines for Public Health Units. Available from: https://www.health.gov.au/resources/publications/coronavirus-covid-19-cdna-national-guidelines-for-public-health-units?language=en [Accessed: 26 August 2023]
22.Ministers. Australian Government Department of Health and Aged Care. First Confirmed Case of Novel Coronavirus in Australia. Media Release January 25, 2020. Available form: https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/first-confirmed-case-of-novel-coronavirus-in-australia [Accessed: 26 August 2023]
23.Australian Government Department of Health and Aged Care. About Coronavirus (COVID-19). Available from: https://www.health.gov.au/topics/covid-19/about#:~:text=The%20World%20Health%20Organization%20(WHO)%20declared%20the%20novel%20coronavirus%20(pandemic%20declaration%20is%20still%20active [Accessed: 26 August 2023]
24.World Health Organization Coronavirus (COVID-19) Dashboard. Available from: https://covid19.who.int/ [Accessed: 26 August 2023]
25.Nous Group. Department of Health and Aged Care. Evaluation of COVID-19 Point-of-Care Testing in Remote and First Nations Communities. 2022. Available from: https://www.health.gov.au/sites/default/files/2023-05/evaluation-of-covid-19-point-of-care-testing-in-remote-and-first-nations-communities_0.pdf [Accessed: 26 August 2023]
26.Flint SM, David JS, Su J-Y, Oliver-Landy EP, Rogers BA, Goldstein A, et al. Disproportionate impact of pandemic (H1N1) 2009 influenza on Indigenous people in the top end of Australia’s Northern Territory. Medical Journal of Australia. 2010;192:617-622. DOI: 10.5694/j.1326-5377.2010.tb03654.x
27.Causer LM, Guy RJ, Tabrizi SN, Whiley DM, Speers DJ, Ward J, et al. Molecular test for chlamydia and gonorrhoea used at point of care in remote primary healthcare settings: A diagnostic test evaluation. Sexually Transmitted Infections. 2018;94:340-345. DOI: 10.1136/sextrans-2017-053443
28.Guy RJ, Ward J, Causer LM, Natoli L, Badman SG, Tangey A, et al. Molecular point-of-care testing for chlamydia and gonorrhoea among Indigenous people attending primary health services: A cross-over cluster randomised controlled trial. Lancet Infectious Diseases. 2018;18:1117-1126. DOI: 10.1016/S1473-3099(18)30429-8
29.Australian Government Department of Health: Therapeutic Goods Administration. COVID-19 Test Kits Included on the ARTG for Legal Supply in Australia. Available from: https://www.tga.gov.au/resources/covid-19-test-kits/xpertr-xpress-sars-cov-2 [Accessed: 26 August 2020]
30.World Health Organization. Laboratory Biosafety Guidance Related to Coronavirus Disease (COVID-19). Interim Guidance. May 13, 2020. Available from: https://www.who.int/publications/i/item/laboratory-biosafety-guidance-related-to-coronavirus-disease-(covid-19) [Accessed: 26 August 2023]
31.van Bockel D, Munier CML, Turville S, Badman SG, Walker G, Stella AO, et al. Evaluation of commercially available viral transport medium (VTM) for SARS-CoV-2 inactivation and use in point-of-care (POC) testing. Viruses. 2020;12(11):1208. DOI: 10.3390/v12111208
32.Al-Kindi N, Al-Shukri I, Al-Rashdi A, Al-Siyabi N, Al Mahruqi S, Al-Kindi H, et al. Validation of GeneXpert testing for SARS-CoV-2 RNA in eight hospital laboratories in Oman. The Pan African Medical Journal. 2021;40. Article 2. DOI: 10.11604/pamj.2021.40.2.27224
33.Andrewartha K, Shephard M, Milic, M, Miller K, Malinsky E, Byers D, et al. Quality assurance testing for SARS-CoV-2 RNA detection in the Aboriginal and Torres Strait Islander COVID-19 point-of-care testing program. In: Presented as a Poster at the 1st Australasian Conference on POC Testing for Infectious Diseases (POC 23 Conference); 14-15 March 2023; Sydney, Australia. Available from: https://researchnow.flinders.edu.au/en/publications/quality-assurance-testing-for-sars-cov-2-rna-detection-in-the-abo
34.Therapeutic Goods Administration. Classification of IVD Medical Devices. Available from: https://www.tga.gov.au/sites/default/files/classification-ivd-medical-devices.pdf [Accessed: 26 August 2023]
35.Saha A, Andrewartha K, Badman S, Tangey A, Smith K, Sandler S, et al. A flexible and innovative connectivity solution to support national decentralised infectious diseases point-of-care testing programs in primary health services in Australia. Journal of Medical Internet Research. 2023;25:e46701. DOI. 10.2196/46701
36.Shephard M, Arbon P, Kost G. Point-of-care testing for disaster management. In: Shephard M, editor. A Practical Guide to Global Point-of-Care Testing. Melbourne, Australia: CSIRO Publishing; 2016. pp. 378-392
37.Mabey D, Peeling RW, Ustanowski A, Perkins MD. Diagnostics for the developing world. Nature Reviews Microbiology 2002;2:231-240. DOI: https://doi.org/10.1038/nrmicro841
38.Land KJ, Boeras DI, Chen X-S, Ramsay AR, Peeling RW. REASSURED diagnostics to inform disease control strategies, strengthen health systems and improve patient outcomes. Nature Microbiology. 2019;4:46-54. DOI: 10.1038/s41564-018-0295-3
Written By
Mark Shephard, Susan Matthews, Louise Causer, Belinda Hengel and Rebecca Guy
Submitted: 31 August 2023Reviewed: 30 October 2023Published: 23 November 2023
Open access peer-reviewed chapter - ONLINE FIRST
