Assessment of the practicability and analytical performance of a point-of-care affinity chromatography haemoglobin A<sub>1c</sub> analyser for use in the non-laboratory setting

Shephard, Mark Douglas; Whiting, Malcolm J.

doi:10.1258/000456306778904722

Cited by 11 publications

(6 citation statements)

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“…The performance of these devices in this study was consistent with that found by other researchers (DCA 2000 [27][28][29][30][31][32][33][34][35][36][37] ; DCA Vantage [38][39][40]. During this study, the analytical quality of the established POCT devices and a number of new devices was assessed along with stakeholder satisfaction relating to the POCT service.…”

Section: Discussionsupporting

confidence: 87%

“…For HbA1c, the DCA 2000 and its successor, the DCA Vantage, were found to be generally equivalent, with both devices performing to a sound analytical standard. 36,[45][46][47][48][49] Overall, the performance of the Piccolo for measuring lipids was shown to be analytically sound, a finding that is consistent with other literature. Although analytically equivalent, the DCAVantage had a number of advantages over its predecessor, including better functionality for the input of patient data and patient test recall through a touch screen, the ability to identify and collate patient and quality test results, and the capacity for connectivity according to a recognized industry 23 and analytical goals for glucose derived from biological variation.…”

Section: Discussionsupporting

confidence: 77%

See 1 more Smart Citation

Optimizing Point-of-Care Testing for Diabetes Management in a Rural Australian General Practice

Motta¹,

Shephard²,

Halls³

et al. 2015

Point of Care: The Journal of Near-Patient Testing &Amp; Technology

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Since 2004, the Flinders University International Centre for Point-of-Care Testing has assisted the Mallee Track Health & Community Service with a point-of-care testing (POCT) service for diabetes management in rural Australia. The POCT devices originally implemented were the DCA 2000 (hemoglobin A1c) and the Cholestech (glucose, lipids). In recent years, new options for POCT have become available, including the DCA Vantage (hemoglobin A1c), the StatStrip (glucose), and the Piccolo (glucose, lipids). The analytical performance of the POCT devices was evaluated using a patient comparison study (n = 103) to measure accuracy and using on-site quality control testing to measure between-day imprecision. Stakeholder satisfaction was assessed using questionnaires for patients with diabetes (n = 60) and focus interviews with the POCT operator and general practitioner. The DCAVantage and Piccolo exhibited sound analytical performance. A statistically significant improvement in satisfaction with the new devices was reported by the patients (Fisher exact probability, P < 0.05). All stakeholders showed high levels of satisfaction with POCT in terms of convenience, acceptability, and confidence in test results. This study supports the effective use of POCT in rural general practice settings for diabetes management.D iabetes mellitus is a major health problem reaching epidemic proportions in many parts of the world. 1 There were approximately 371 million people living with diabetes worldwide in 2012, constituting 8.3% of the world's adult population. 2 In Australia, there are more than 1.7 million people living with diabetes, with prevalence set to double by 2025. 3,4 Diabetes causes significant morbidity and mortality, primarily from cardiovascular complications, renal and eye disease, and limb amputations. 5 In addition to the impact on the health of individuals with the disease, diabetes causes significant economic impact on individuals, families, health systems, and countries across the world. 6 Pathology testing plays a vital role in managing patients with diabetes and monitoring of complications of the disease. Pathology tests performed as part of a patient's diabetes review include glucose, hemoglobin A1c (HbA1c), urine albumin-creatinine ratio (ACR), and lipids (total cholesterol, high-and low-density lipoprotein [HDL and LDL] cholesterol, and triglyceride). 7,8 These tests can now be performed safely and effectively through pointof-care testing (POCT). Point-of-care testing is pathology testing performed in a clinical setting at the time of patient consultation.convenience, acceptability, and confidence in test results. Overall, the GP and the POCT operator were very satisfied with all aspects of the new POCT service. Limitations of This StudyOnly 1 POCT operator and 1 GP took part in this project, which meant that their satisfaction levels could not be statistically analyzed. Nonetheless, this staffing structure reflected the "realtime" nature of workflow within the MTH&CS clinic.Owing to the nature of this project f...

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Section: Discussionsupporting

confidence: 87%

Section: Discussionsupporting

confidence: 77%

Optimizing Point-of-Care Testing for Diabetes Management in a Rural Australian General Practice

Motta¹,

Shephard²,

Halls³

et al. 2015

Point of Care: The Journal of Near-Patient Testing &Amp; Technology

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“…However, our precision for the DCA2000+ were comparable to results reported by other studies. 16, 17 The analytical range of controls was narrower for the Afinion AS100 Analyzer that could also have contributed to better precision with this method. Another potential limitation of this study was the inclusion of 5 samples with hemoglobinopathies in the correlation.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the Afinion AS100 Point-of-Care Analyzer for Hemoglobin A1c

Arabadjief

Nichols

2009

Point of Care: The Journal of Near-Patient Testing &Amp; Technology

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An evaluation of a new Afinion AS100 Analyzer was conducted to assess analytical performance. Precision was estimated by analyzing 2 control and 3 patient samples twice a day for 10 days. Accuracy was established by analysis of 6 samples from the National Glycated Hemoglobin Standardization Program for a 3-day period. Agreement was correlated to a laboratory method, the Variant II Turbo Hemoglobin Testing System, and a point-of-care method, the DCA2000+ Hemoglobin A 1c System, using leftover EDTA samples from laboratory analysis (n = 110, range of results = 4.6%Y13.7% HbA 1c ). The Afinion AS100 Analyzer (0.9%Y1.8% coefficient of variation [CV]) displayed laboratory comparable precision (Variant II Turbo = 1.1%Y1.9% CV) that was superior to the DCA2000+ (2.9%Y3.3% CV) with minimal bias to the National Glycated Hemoglobin Standardization Program target concentrations (G0.2% HbA 1c average unit bias or 3.1%). The Afinion AS100 Analyzer had good agreement with both the Variant II Turbo and DCA2000+ with r of greater than 0.9837 and Sy.x of T0.22% and T0.29% HbA 1c , respectively. Staff found the analyzer easy to train and use, providing faster results than the DCA2000+ (3 minutes vs 6 minutes). The Afinion AS100 Analyzer will be recommended over the DCA2000+ when requests for future point-of-care HbA 1c are made in our health system.

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“…HbA 1c values were obtained by Bayer DCA 2000 + Chemistry Analyzer (Siemens Healthcare Diagnostics AS, Oslo, Norway), a fully automated method based on monoclonal antibodies (21).…”

Section: Methodsmentioning

confidence: 99%

Short-term continuous glucose monitoring: effects on glucose and treatment satisfaction in patients with type 1 diabetes mellitus; a randomized controlled trial

Langeland

Salvesen

Selle

et al. 2012

International Journal of Clinical Practice

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Objective: To assess whether 4 week's use of a continuous glucose monitoring (CGM) system improves glucose control, treatment satisfaction or health status, as compared to intensified conventional finger-prick measurements (ICFM) in patients with type 1 diabetes mellitus (DM1). Method: Thirty patients suffering from DM1 for more than three years and treated with either insulin pumps or multiple daily insulin injections, were included in a randomised controlled cross-over trial. They were Caucasians of both genders, between 18 and 50 years, and had moderately well controlled diabetes. The participants performed either ICFM or CGM for 4 weeks, followed by an 8 week's observation period. Thereafter they were crossed over to the opposite intervention. HbA(1c) , hypoglycaemic episodes, treatment satisfaction and health status were assessed at all meetings, although HbA(1c) was the primary endpoint. Results: At inclusion mean HbA(1c) was 7.8 ± 0.9 %. The mean change in HbA(1c) was -0.2 ± 0.1% and -0.2 ± 0.1% for the CGM and the ICFM periods, accordingly (p = 0.91). The mean changes in HbA(1c) during the combined treatment and observation periods were -0.1 ± 0.1% and -0.2 ± 0.1% for the CGM and the ICFM period, accordingly (p = 0.86). The frequency of severe hypoglycaemic episodes, treatment satisfaction and health status was also equal between the two interventions. No adverse events were observed.

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Assessment of the practicability and analytical performance of a point-of-care affinity chromatography haemoglobin A_1c analyser for use in the non-laboratory setting

Cited by 11 publications

References 4 publications

Optimizing Point-of-Care Testing for Diabetes Management in a Rural Australian General Practice

Optimizing Point-of-Care Testing for Diabetes Management in a Rural Australian General Practice

Evaluation of the Afinion AS100 Point-of-Care Analyzer for Hemoglobin A1c

Short-term continuous glucose monitoring: effects on glucose and treatment satisfaction in patients with type 1 diabetes mellitus; a randomized controlled trial

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Assessment of the practicability and analytical performance of a point-of-care affinity chromatography haemoglobin A1c analyser for use in the non-laboratory setting

Cited by 11 publications

References 4 publications

Optimizing Point-of-Care Testing for Diabetes Management in a Rural Australian General Practice

Optimizing Point-of-Care Testing for Diabetes Management in a Rural Australian General Practice

Evaluation of the Afinion AS100 Point-of-Care Analyzer for Hemoglobin A1c

Short-term continuous glucose monitoring: effects on glucose and treatment satisfaction in patients with type 1 diabetes mellitus; a randomized controlled trial

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Assessment of the practicability and analytical performance of a point-of-care affinity chromatography haemoglobin A_1c analyser for use in the non-laboratory setting