A decentralised point-of-care testing model to address inequities in the COVID-19 response.

The COVID-19 pandemic is growing rapidly, with over 37 million cases and more than 1 million deaths reported by mid-October, 2020, with true numbers likely to be much higher in the many countries with low testing rates. Many communities are highly vulnerable to the devastating effects of COVID-19 because of overcrowding in domestic settings, high burden of comorbidities, and scarce access to health care. Access to testing is crucial to globally recommended control strategies, but many communities do not have adequate access to timely laboratory services. Geographic dispersion of small populations across islands and other rural and remote settings presents a key barrier to testing access. In this Personal View, we describe a model for the implementation of decentralised COVID-19 point-of-care testing in remote locations by use of the GeneXpert platform, which has been successfully scaled up in remote Aboriginal and Torres Strait Islander communities across Australia. Implementation of the decentralised point-of-care testing model should be considered for communities in need, especially those that are undertested and socially vulnerable. The decentralised testing model should be part of the core global response towards suppressing COVID-19.

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.

Impact of point-of-care testing for white blood cell count on triage of patients with infection in the remote Northern Territory of Australia.

In Australia's Northern Territory (NT), acute infections are highly prevalent within Indigenous remote communities and difficulties in diagnosing the aetiology of infection are exacerbated by limited access to diagnostic tests. The objective of this study was to investigate the clinical effectiveness of point-of-care (POC) testing for total and 5-part differential white blood cell (WBC DIFF) counts for the triage of patients with possible acute infection. The HemoCue WBC DIFF POC device was introduced into 13 remote health clinics over a 6 month period. A retrospective clinical audit of patient cases meeting the selection criteria for three acute infections (sepsis, respiratory infection and appendicitis) were examined by four registrars in duplicate; one with POC test results available and the other with POC test results removed to determine if WBC DIFF results changed or assisted in patient triage. The number of changed outcomes provided a preliminary cost-benefit analysis. Sixty (23%) patient cases met the selection criteria for the clinical effectiveness analysis. POC test results changed the triage decision for 24 (41%) patients, of which 20 (34%) led to the prevention of an unnecessary medical retrieval and four (7%) indicated the patient had an acute infection which required a medical retrieval. POC test results assisted decision making for a further 13 (22%) patients. Cost savings related to avoiding unnecessary medical retrievals were estimated to be AU$481,440. Extrapolated NT-wide cost savings are projected to be AU$5.33 million per annum. POC testing for WBC DIFF counts aided clinical decision making for triaging patients with three common acute infections.

Economic evaluation of point-of-care testing in the remote primary health care setting of Australia's Northern Territory.

AIM: To determine the cost-effectiveness of utilizing point-of-care testing (POCT) on the Abbott i-STAT device as a support tool to aid decisions regarding the emergency medical retrievals of patients at remote health centers in the Northern Territory (NT) of Australia. METHODS: A decision analytic simulation model-based economic evaluation was conducted using data from patients presenting with three common acute conditions (chest pain, chronic renal failure due to missed dialysis session(s), and acute diarrhea) at six remote NT health centers from July to December 2015. The specific outcomes measured in this study were the number of unnecessary emergency medical retrieval prevented through POCT. Cost savings through prevented unnecessary medical retrievals for each presentation type were then determined and extrapolated to give per annum NT-wide estimates. RESULTS: POCT prevented 60 unnecessary medical evacuations from a total of 200 patient cases meeting the selection criteria (48/147 for chest pain, 10/28 for missed dialysis, and 2/25 for acute diarrhea). The associated cost savings were AUD $4,674, $8,034, and $786 per patient translating to NT-wide savings of AUD $13.72 million, $6.45 million, and $1.57 million per annum (AUD $21.75 million in total) for chest pain, missed dialysis, and acute diarrhea presentations, respectively. CONCLUSION: This study demonstrated that POCT when used to aid decision making for acutely ill patients delivered significant cost savings for the NT health care system by preventing unnecessary emergency medical retrievals.

Point-of-care testing facilitates screening and treatment for anaemia in women and children in rural Pakistan.

OBJECTIVE: To use point-of-care testing to screen and facilitate treatment for anaemia and to establish an estimate of the prevalence of anaemia in the local population. DESIGN: An uncontrolled before and after study design was used to evaluate the effectiveness of the intervention on the anaemia status of participants. SETTING: This study took place in a rural mountain community (population approximately 1000) in the Haripur district in northern Pakistan. PARTICIPANTS: Women of child-bearing age (15-49 years) and children (12-14 years) were included in this study. INTERVENTIONS: The intervention included point-of-care testing for haemoglobin, treatment with mebendazole and oral iron supplementation, and an education campaign about anaemia delivered by community health workers and medical students. MAIN OUTCOME MEASURES: The main outcome measure was an increase in blood haemoglobin over the study period. A secondary outcome measure was a positive change in anaemia status or classification post-intervention. RESULTS: Anaemia was initially detected in 64 (53%) women and 15 (47%) children. The mean haemoglobin concentration increased significantly (P < 0.001) from 118 to 130 g L-1 (women) and 120 to 130 g L-1 (children) post-intervention. Overall prevalence of anaemia in women (P < 0.001) and children (P < 0.001) decreased significantly (by 30% and 34%, respectively) post-intervention. CONCLUSIONS: Point-of-care testing used for the detection of anaemia in this rural community helped to identify the burden of disease and to reduce this significantly by way of rapid diagnosis, education and immediate medical intervention.

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.

Assessment of the Nova StatSensor whole blood point-of-care creatinine analyzer for the measurement of kidney function in screening for chronic kidney disease.

BACKGROUND: Point-of-care testing for creatinine using a fingerprick sample and resultant estimated glomerular filtration rate has potential for screening for chronic kidney disease in community settings. This study assessed the applicability of the Nova StatSensor creatinine analyzer for this purpose. METHODS: Fingerprick samples from 100 patients (63 renal, 37 healthy volunteers; range 46-962 micromol/L) were assayed using two StatSensor analyzers. Lithium heparin venous plasma samples collected simultaneously were assayed in duplicate using the isotope dilution mass spectrometry-aligned Roche Creatinine Plus enzymatic assay on a Hitachi Modular P unit. Method comparison statistics and the ability of the StatSensor to correctly categorise estimated glomerular filtration rate above or below 60 mL/min were calculated pre- and post-alignment with the laboratory method. RESULTS: StatSensor 1 creatinine results (y) were much lower than the laboratory (y=0.75x+10.2, average bias -47.3, 95% limits of agreement -208 to +113 micromol/L). For estimated glomerular filtration rates above or below 60 mL/min, 100% and 87% of results respectively agreed with the laboratory estimated glomerular filtration rate (79% and 96% post-alignment). StatSensor 2 statistics were similar. The 95% limits of agreement between StatSensor creatinine results were -35 to +34 micromol/L. CONCLUSIONS: Isotope dilution mass spectrometry alignment of the StatSensor will identify most patients with estimated glomerular filtration rate <60 mL/min, but there will be many falsely low estimated glomerular filtration rate results that require laboratory validation. Creatinine results need improvement.