Analytical Goals for Glucose Analyses

Fraser, Callum G.

doi:10.1177/000456328602300403

Cited by 24 publications

(2 citation statements)

References 46 publications

(9 reference statements)

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“…The latter issue was addressed in a 1986 review article by Fraser which defined the analytical goals for glucose measurement (both for laboratory assays and POCT analysers) based on biological variation. 2 The goals suggested were a zero bias and a between-batch coefficient of variation (%CV) 2.2%.2 A quarter of a century later the American Association for Clinical Biochemistry/National Academy of Clinical Biochemistry proposed an intermediate goal of limiting total allowable error for 95% of samples to ,15% at glucose concentrations of 5.6 mmol/L and to ,0.8 mmol/L at glucose concentrations ,5.6 mmol/L. 3 Both papers, separated by a divide of 25 years, lamented that the proposed targets may not be achievable at present!…”

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Observations from the archives: the evolution of point-of-care testing

O’Kane¹

2013

Ann Clin Biochem

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Point-of-care testing (POCT) is now a multi-billion pound international industry which features large in the responsibilities of most clinical biochemistry laboratories. POCT arose from the vision of laboratory scientists, clinicians and the diagnostics industry that the rapid availability of test results might expedite clinical decision-making and improve patient outcomes. Advances in diagnostic testing tend to evolve through a series of overlapping stages. Firstly, there is the development of the required new technology accompanied by excitement and optimism as potential clinical applications are identified. The second stage is marked by rigorous analytical and clinical evaluation to define the benefits and limitations of the new test as compared with existing tests. The third stage is characterized by increasing adoption of the test (often before an evidence base for its impact on patient outcomes has been established).It is fascinating to look back over the 50 years of the Annals of Clinical Biochemistry and discover the evolution of POCT documented in its pages. The measurement of capillary blood glucose at the bedside was one of the first POCT tests to attain widespread use from the early 1980s onwards. A 1981 Annals paper described how more comprehensive metabolic information could be obtained by patients undertaking self-sampling at home and applying capillary blood to boric acid impregnated filter paper. The strips were sent to the laboratory, the blood eluted and glucose, lactate and 3-hydroxybutyrate measured using continuous flow enzymatic assays.1 In the small clinical study undertaken in ambulatory subjects with diabetes, the authors noted abnormalities in the concentrations of hydroxybutyrate and lactate and pondered the significance of these. They proposed that this technique would prove a useful research tool to understand better the metabolic disturbance in diabetes. Thirty years on, capillary hydroxybutyrate measurement increasingly forms a routine part of the management of diabetic ketoacidosis and also for patient self-monitoring.In the late 1980s and early 1990s there followed a series of papers describing analytical assessment of POCT equipment (generally glucose meters). These followed a similar format of comparing analytical performance of the POCT instrument to the laboratory assay and a conclusion as to whether performance was adequate or not. This conclusion was generally based on the authors' expert opinion as to what constituted an acceptable standard of analytical performance rather than an objective consideration of required performance criteria. The latter issue was addressed in a 1986 review article by Fraser which defined the analytical goals for glucose measurement (both for laboratory assays and POCT analysers) based on biological variation. 2 The goals suggested were a zero bias and a between-batch coefficient of variation (%CV) 2.2%.2 A quarter of a century later the American Association for Clinical Biochemistry/National Academy of Clinical Biochemistry proposed an interme...

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Observations from the archives: the evolution of point-of-care testing

O’Kane¹

2013

Ann Clin Biochem

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An assessment of the suitability of the Glucometer 4 blood glucose system for near‐patient testing

Powell

1994

Practical Diabetes International

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The performance of a new system for near‐patient monitoring of blood glucose levels based on the reference hexokinase/glucose‐6‐phosphate dehydrogenase method was evaluated in a routine out‐patient diabetes clinic. The system includes features designed to overcome operator dependency of results. Within‐batch precision was 1.1‐4.2% coefficient of variation, while between‐batch coefficients of variation of 2.6‐6.7% were achieved. The new system was assessed to be suitable for use by nurses and patients.

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Performance of the Reflocheck system used outside the laboratory by trained non‐laboratory personnel

1987

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We have tested the performance of the Reflocheck glucose monitor in both the laboratory and in hospital wards. The Reflocheck performed well in the laboratory (r=0.94, y=0.92 x + 0.64, n = 113). Results from the wards were compared by taking replicate samples onto filter paper for subsequent analysis in the laboratory. However, despite the use of trained nursing staff, 55% of results were outside the ± 20% limits of analytical acceptability. The question is raised as to the robustness and suitability of the Reflocheck system for the measurement of blood glucose outside the laboratory.

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Analytical Goals for Glucose Analyses

Cited by 24 publications

References 46 publications

Observations from the archives: the evolution of point-of-care testing

Observations from the archives: the evolution of point-of-care testing

An assessment of the suitability of the Glucometer 4 blood glucose system for near‐patient testing

Performance of the Reflocheck system used outside the laboratory by trained non‐laboratory personnel

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