Flexible and Innovative Connectivity Solution to Support National Decentralized Infectious Diseases Point-of-Care Testing Programs in Primary Health Services: Descriptive Evaluation Study.

BACKGROUND: Molecular point-of-care (POC) testing for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) has been available in regional and remote primary health services in Australia as part of a decentralized POC testing program since 2016 and for SARS-CoV-2 from 2020. As there was no suitable existing connectivity infrastructure to capture and deliver POC test results to a range of end users, a new system needed to be established. OBJECTIVE: The aim of the study is to design, implement, and optimize a connectivity system to meet clinical management, analytical quality management, and public health surveillance needs. METHODS: We used commercially available e-messaging technology coupled with adapted proprietary software to integrate a decentralized molecular POC testing platform (GeneXpert) in primary health services and interface with end-user databases. This connectivity infrastructure was designed to overcome key barriers to the implementation, integration, and monitoring of these large multijurisdictional infectious disease POC testing networks. Test result messages were tailored to meet end-user needs. Using centrally captured deidentified data, we evaluated the time to receipt of test results and completeness of accompanying demographic data. RESULTS: From January 2016 to April 2020, we operationalized the system at 31 health services across 4 jurisdictions and integrated with 5 different patient management systems to support the real-time delivery of 29,356 CT/NG and TV test results to designated recipients (patient management system and local clinical and central program databases). In 2019, 12,105 CT/NG and TV results were delivered, and the median time to receipt of results was 3.2 (IQR 2.2-4.6) hours, inclusive of test runtime. From May 2020 to August 2022, we optimized the system to support rapid scale-up of SARS-CoV-2 testing (105 services; 6 jurisdictions; 71,823 tests) and additional sexually transmissible infection testing (16,232 tests), including the electronic disease-specific notifications to jurisdictional health departments and alerts for connectivity disruption and positive results. In 2022, 19,355 results were delivered with an overall median transmission time of 2.3 (IQR 1.4-3.1) hours, 2.2 (IQR 1.2-2.3) hours for SARS-CoV-2 (n=16,066), 3.0 (IQR 2.0-4.0) hours for CT/NG (n=1843), and 2.6 (IQR 1.5-3.8) hours for TV (n=1446). Demographic data (age, sex, and ethnicity) were completed for 99.5% of test results in 2022. CONCLUSIONS: This innovative connectivity system designed to meet end-user needs has proven to be sustainable, flexible, and scalable. It represents the first such system in Australia established independent of traditional pathology providers to support POC testing in geographically dispersed remote primary health services. The system has been optimized to deliver real-time test results and has proven critical for clinical, public health, and quality management. The system has significantly supported equitable access to rapid diagnostics for infectious diseases across Australia, and its design is suitable for onboarding other POC tests and testing platforms in the future.

Point-of-care testing for haemoglobin A1c in remote Australian Indigenous communities improves timeliness of diabetes care.

INTRODUCTION: In remote Australia timely access to pathology results and subsequent follow-up of patients for treatment is very challenging due to the long distances to the nearest laboratory. Point-of-care testing (POCT) offers a practical solution for pathology service provision in such remote communities. Since 2008, POCT for haemoglobin A1c (HbA1c) has been conducted in remote Northern Territory (NT) health centres for diabetes management of Indigenous patients through the national Quality Assurance in Aboriginal and Torres Strait Island Medical Services (QAAMS) Program. METHODS: Point-of-care testing HbA1c results performed on Indigenous diabetes patients in the NT from July 2008 to April 2011 was accessed via the NT's electronic patient information system. Patients who had three or more HbA1c results performed by POCT across this period were assessed to determine their overall change in glycaemic control. An audit of 40 of these Indigenous diabetes patients (who exhibited a decrease in HbA1c levels of more than 1.5%) was undertaken to compare clinical and operational efficiency of POCT versus laboratory testing over an equivalent time period (15 months). RESULTS: No change in glycaemic control was observed when these patients received laboratory HbA1c testing prior to the introduction of POCT. Long turnaround times for receipt of results and follow-up consultation with patients were identified during this period, compared to immediate receipt and actioning of results using POCT. Frequency of HbA1c testing was higher with POCT than for the laboratory. CONCLUSIONS: This audit demonstrates that POCT can significantly improve the timeliness and clinical follow-up of pathology results in remote locations, while also reinforcing the clinical and cultural effectiveness of POCT and its critical role in assisting to improve diabetes management in Indigenous Australians.

Design, implementation and initial assessment of the Northern Territory Point-of-Care Testing Program.

OBJECTIVE: The objective of the study was to improve pathology services in selected remote health centres from the Northern Territory (NT) through the implementation of a quality managed point-of-care pathology testing (POCT) service. DESIGN: Study of the efficacy of the POCT service after 1 year and qualitative survey of POCT device operators. SETTING: The study was set in thirty-three remote health centres in the NT administered by the NT Department of Health. PARTICIPANTS: Remote health centre staff at participating remote health centres participated in the study. INTERVENTIONS: The introduction of the i-STAT device to perform on-site POCT. MAIN OUTCOME MEASURES: The main outcome measures used in the study were the number of remote staff trained, volume of testing performed and satisfaction of POCT device operators. RESULTS: One hundred and sixty-four health professional staff were trained to perform i-STAT POCT during the first year of the program. A total of 2290 POCT tests were performed on the i-STAT. The volume of testing consistently increased across the year. Tests for international normalised ratio were the most frequently performed (averaging 70 tests per month). Stakeholder satisfaction with the i-STAT device was high, with a statistically significant improvement in satisfaction levels with pathology service provision being reported after the introduction of POCT. Greater than 80% of respondents stated POCT was more convenient than the laboratory service and assisted in the stabilisation of acutely ill patients. CONCLUSIONS: The NT POCT Program has been operationally effective and well received by staff working as i-STAT POCT operators in remote health centres. Retention of remote health centre staff is the most significant challenge to ensuring the program's long-term viability.

Change of HbA1c reporting to the new SI units.

An international consensus statement recommends that dual reporting of haemoglobin A (HbA(1c)) levels--in the current units (percentage) and Système International (SI) units (mmol/mol)--be used as an interim measure for a 2-year transition period before progressing towards the use of SI units only. This recommendation is supported by the Australasian Association of Clinical Biochemists, the Australian Diabetes Educators Association, the Australian Diabetes Society and the Royal College of Pathologists of Australasia. The SI units are a true measure of HbA(1c) and remove potential confusion between HbA(1c) values and blood glucose values.

Sustained Quality and Service Delivery in an Expanding Point-of-Care Testing Network in Remote Australian Primary Health Care.

CONTEXT.­: Since 2008, the Northern Territory Point-of-Care Testing Program has improved patient access to pathology testing for acute and chronic disease management for remote health services. OBJECTIVE.­: To evaluate the analytical quality, service delivery, and clinical utility of an expanding remote point-of-care testing network. DESIGN.­: Four years (2016-2019) of data on analytical quality, test numbers, and training statistics and 6 months of clinical point-of-care testing data from Abbott i-STATs at remote health services throughout the Northern Territory were analyzed to assess analytical performance, program growth, and clinical utility. RESULTS.­: From 2016 to 2019, point-of-care test numbers increased, with chemistry and blood gas testing more than doubling to 8500 and 6000 tests, respectively, troponin I testing almost doubling (to 6000), and international normalized ratio testing plateauing at 8000 tests. Participation in quality control and proficiency testing was high, with quality comparable to laboratory-based analytical goals. A shift toward flexible training and communication modes was noted. An audit of point-of-care test results demonstrated elevated creatinine, associated with chronic kidney disease management, as the most common clinically actionable patient result. CONCLUSIONS.­: The Northern Territory Point-of-Care Testing Program provides high quality point-of-care testing within remote primary health services for acute and chronic patient management and care. Clinical need, sound analytical performance, flexibility in training provision, and effective support services have facilitated the sustainability of this expanding point-of-care testing model in the remote Northern Territory during the past 11 years.

Comparative performance of two point-of-care analysers for lipid testing.

The aim of this study was to compare the analytical performance of the Cholestech LDX and CardioChek PA lipid point-of-care devices to a CDC-certified laboratory. Inter-assay imprecision (n=10) for blood samples from 2 patients with different lipid profiles was 3.0% for total cholesterol, 2.6% for triglyceride, 5.2% for HDL cholesterol and 6.2% for calculated LDL cholesterol on the Cholestech, and 4.4% for total cholesterol, 4.8% for triglyceride, 7.0% for HDL cholesterol and 7.4% for calculated LDL cholesterol on the Cardiochek. In a patient comparison study (n=100), correlation coefficients (r) between the POCT and laboratory methods were greater than 0,90 for all tests for the Cholestech and greater than 0.84 for all tests for the Cardiochek. The mean difference (bias) between the results obtained on the Cholestech LDX and the laboratory method was not statistically significant; however the mean difference between the CardioChek and the laboratory method was statistically significant for total, HDL and LDL cholesterol (one way analysis of variance with Scheffe post-hoc test). The Cholestech LDX met the NCEP goal for total error for all analytes except LDL cholesterol. The CardioChek PA system met the NCEP total error goal for triglyceride but not the other lipid analytes. We conclude that the Cholestech LDX device is a suitable POCT device for cardiovascular risk assessment in the primary care setting, while the CardioChek device requires more study and refinement.

Point-of-care testing improves diabetes management in a primary care clinic in South Africa.

INTRODUCTION: Diabetes is a major health problem in South Africa. DiabCare Africa found just 47% of diabetes patients had a hemoglobin A1c (HbA1c) test for their management in the previous year. METHODS: Patients attending an urban diabetes clinic near Johannesburg, run by Project HOPE, accessed HbA1c (and urine albumin:creatinine ratio) point-of-care testing (POCT) as part of a quality-assured international program called ACE (Analytical and Clinical Excellence). Patients who had two or more HbA1c POC tests from 2012 to 2014 were assessed to determine their change in glycaemic control. RESULTS: The mean (±SD) HbA1c in this group of diabetes patients (n=131) fell significantly from 9.7%±2.4 (83mmol/mol) at their first POCT measurement to 8.4%±2.4 (68mmol/mmol/mol) at their most recent POCT measurement (paired t-test p<0.01). The average time between first and most recent HbA1c test was 15 months. The number of diabetes patients achieving optimal glycaemic control (HbA1c≤6.5-7.5% [48-58mmol/mol) increased by 125%, while the number with very poor glycaemic control (HbA1c>10% [86mmol/mol]) halved. An association was observed between degree of glycaemic control and increasing albuminuria in this cohort. DISCUSSION: POCT has promoted change in clinical practice by facilitating greater accessibility to HbA1c testing.

The impact of point of care testing on diabetes services along Victoria's Mallee Track: results of a community-based diabetes risk assessment and management program.

INTRODUCTION: In the State of Victoria in Australia, diabetes is considered one of the top 10 health problems for people living in the rural Mallee Track region (which is centred on the town of Ouyen and extends west to the border with South Australia). A project entitled 'Diabetes Management Along the Mallee Track' was conducted through a Rural Chronic Disease Initiative (RCDI) program grant from the Australian Government's Department of Health and Ageing, Canberra, with the aim of improving the delivery of diabetes services in this region. The project's aims were achieved through the implementation of a community risk assessment program and the establishment of an integrated, multidisciplinary 'one-stop' service for the management of people with diabetes. The use of on-site point-of-care (POC) pathology testing equipment was the key component of both arms of the project. METHODS: Community risk assessment sessions were held in seven towns across the Mallee Track region using a local settings approach. Risk assessment included POC pathology testing for glucose and lipids, as well as blood pressure, age, personal and family history of diabetes, smoking status, and self-assessed weight and level of exercise. The multidisciplinary 'one-stop' service for the management of people with diabetes involved having a single appointment with their local GP, during which time they met the local diabetes educator and podiatrist as well as the GP, and on-site POC testing (POCT) performed for haemoglobin A1c (HbA1c), urine albumin : creatinine ratio (ACR), lipids and glucose. A written survey was conducted among patients with diabetes, local GPs and local health professionals to assess the level of satisfaction with the project and the use of POCT, and to assist policy development for the future planning and development of diabetes services along the Mallee Track region. RESULTS: Risk assessment: 320 adults were assessed for their risk of diabetes during community sessions (representing approximately 20% of the adult population of the region). Two-thirds of people tested had equivocal random blood glucose levels (5.1-11.0 mmol/L), while hypertension and high cholesterol were found in more than one-third. Management of established diabetes: 49 people with known, established diabetes were initially entered into a Central Diabetes Register (with 5 more joining the register since). These diabetes patients (n = 54) have now been monitored by POCT for a mean of 10 months (range 3-18 months). Since the introduction of the 'one-stop shop', the percentage of persons achieving optimal glycaemic control (HbA1c <7%) has increased by 30% (from 33% to 63%), the percentage achieving controlled glycaemia (HbA1c < 8%) has increased by 32% (59% to 91%), while the number exhibiting poor control has reduced by 7% (13% to 6%). The mean HbA1c has fallen from 7.6% at the commencement of the program to 7.1% (p = 0.03, paired t-test). Falls in cholesterol and blood pressure were also observed. Satisfaction with new management services for diabetes: 36 patients with diabetes (73% of all known diabetes patients in the region at the time) completed satisfaction questionnaires. There was overwhelming support within this group for the use of POCT as part of their management, because it was convenient, encouraged self-management and enhanced doctor-patient relationships. The proportion of patients with diabetes who were satisfied/very satisfied with the available diabetes services was significantly greater following the introduction of the project (before: n = 18 (64%), after: n = 29 (91%), chi2 = 6.10, p = 0.01). Doctors agreed that the immediate availability of POCT results at the time of consultation was convenient for them, contributed positively to patient compliance and improved their relationship with the patient. Health professionals felt confident in using the POC analysers and believed the program had raised community awareness about diabetes and enhanced community ownership. CONCLUSION: Point-of-care pathology testing has enabled the introduction of a community-friendly risk assessment program for diabetes and provided a convenient and rapid service for monitoring the control of diabetes in people with established disease in the Victorian Mallee Track region. The number of diabetes patients accessing diabetes services has more than doubled since the introduction of the program. All community and health professional groups surveyed agreed that the POC model delivered as part of this project should be available to all people throughout the Mallee Track region. The model, although conducted in a small rural community, has the potential to form a suitable template for the broader introduction of POCT services for diabetes in rural and remote communities across Australia. As an independent measure of the success of the program, the Australian Government's Department of Health and Ageing selected the Diabetes Management Along the Mallee Track project as one of three demonstration projects from the RCDI grants for showcasing to all rural health services in Australia through the production of an education resource called 'Building Healthy Communities'.

Influence of geography on the performance of quality control testing in the Australian Government's point of care testing in general practice trial.

OBJECTIVE: To investigate the influence of geography on quality control (QC) testing in the point of care testing (PoCT) in general practice trial. DESIGN AND METHODS: Within-practice imprecision for QC testing for HbA1c, urine albumin:creatinine ratio, lipids and international normalised ratio was calculated for each geographic region. RESULTS: There was no significant difference between the region of testing and within-practice imprecision, except for triglyceride and HDL cholesterol. CONCLUSIONS: PoCT was conducted to an equivalent analytical standard across geographic regions.

Cultural and clinical effectiveness of the 'QAAMS' point-of-care testing model for diabetes management in Australian aboriginal medical services.

The national Quality Assurance for Aboriginal Medical Services (QAAMS) Program, in which point-of-care testing (POCT) for haemoglobin A(1c) (HbA(1c)) and urine albumin: creatinine ratio (ACR) is performed for diabetes management in 65 Australian Aboriginal medical services, is now embedded in the practice of diabetes care across Indigenous Australia. This paper documents the results of a detailed survey to assess levels of satisfaction with the QAAMS HbA(1c) Program among three key stakeholder groups-doctors, POCT operators and patients with diabetes. Both doctors and patients with diabetes agreed that the immediacy of POCT results contributed positively to patient care, improved the doctor-patient relationship, and made the patient more likely to be both compliant and self-motivated to improve their diabetes control. Both POCT operators and patients with diabetes reported improved satisfaction with their diabetes services after the introduction of POCT. The paper also provides evidence from two participating medical services that POCT has been an effective tool in improving the delivery of pathology services and clinical outcomes for both individuals and groups of patients with diabetes. A statistically significant reduction in HbA(1c) from 9.3% (+/- 2.0) to 8.6% (+/- 2.0) was observed in 74 diabetes patients 12 months after commencing POCT (p = 0.003, paired t-test). An improvement in the percentage of patients achieving glycaemic targets and a reduction in the percentage of patients with poor control was also observed in this group. These data provide evidence that the QAAMS POCT model delivers a culturally and clinically effective service for diabetes management in Aboriginal Australia.

The analytical quality of point-of-care testing in the 'QAAMS' model for diabetes management in Australian aboriginal medical services.

Type 2 diabetes mellitus and its major complication, renal disease, represent one of the most significant contemporary health problems facing Australia's Indigenous Aboriginal People. The Australian Government-funded Quality Assurance for Aboriginal Medical Services Program (QAAMS) provides a framework by which on-site point-of-care testing (POCT) for haemoglobin A1c (HbA(1c)) and now urine albumin:creatinine ratio (ACR) can be performed to facilitate better diabetes management in Aboriginal medical services. This paper provides updated evidence for the analytical quality of POCT in the QAAMS Program. The median imprecision for point-of-care (POC) HbA(1c) and urine ACR quality assurance (QA) testing has continually improved over the past six and half years, stabilising at approximately 3% for both analytes and proving analytically sound in Aboriginal hands. For HbA(1c), there was no statistical difference between the imprecision achieved by QAAMS and laboratory users of the Bayer DCA 2000 since the QAAMS program commenced (QAAMS CV 3.6% +/- 0.52, laboratory CV 3.4% +/- 0.42; p = 0.21, paired t-test). The Western Pacific Island of Tonga recently joined the QAAMS HbA(1c) Program indicating that the QAAMS model can also be applied internationally in other settings where the prevalence of diabetes is high.

Point-of-care testing of HbA1c and blood glucose in a remote Aboriginal Australian community.

OBJECTIVES: To assess the accuracy of point-of-care (POC) measurements of capillary blood glucose and glycosylated haemoglobin (HbA(1c)) levels in a remote Aboriginal community with high diabetes prevalence. DESIGN: Cross-sectional study comparing POC capillary glucose and HbA(1c) results with those from corresponding venous samples measured in a reference laboratory. PARTICIPANTS AND SETTING: 152 residents aged 11-76 years (representing 76% of population aged over 11 years) had POC glucose measurement in November 2003; 88 with POC glucose level > or = 5.0 mmol/L, or self-reported diabetes, had POC HbA(1c) and laboratory glucose and HbA(1c) measurements. MAIN OUTCOME MEASURES: POC fasting capillary levels of glucose (HemoCue Glucose 201 analyser, Medipac Scientific, Sydney) and HbA(1c) (DCA 2000+ analyser, Bayer Australia, Melbourne); correlation and mean difference between capillary POC and venous blood laboratory measurements of glucose and HbA(1c). RESULTS: Mean and median POC capillary glucose levels were 7.99 mmol/L and 6.25 mmol/L, respectively, while mean and median laboratory venous plasma glucose concentrations were 7.63 mmol/L and 5.35 mmol/L. Values for POC capillary HbA(1c) and laboratory HbA(1c) were identical: mean, 7.06%; and median, 6.0%. The correlation coefficient r for POC and laboratory results was 0.98 for glucose and 0.99 for HbA(1c). The mean difference in results was 0.36 mmol/L for glucose (95% CI, 0.13-0.62; limits of agreement [LOA], - 2.07 to 2.79 mmol/L; P = 0.007) and < 0.01% for HbA(1c) (95% CI, - 0.07% to 0.07%; LOA, - 0.66% to 0.66%; P = 0.95), respectively. CONCLUSIONS: POC capillary HbA(1c) testing, in particular, offers an accurate, practical, community-friendly way of monitoring diabetes in rural and remote clinical settings. POC capillary glucose results should be confirmed by a laboratory test of venous plasma if the results are likely to significantly influence clinical decisions.