The Evaluation of Analytical Performance of the Precision G Point-of-Care Glucometer
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Bogdan Solnica
Abstract
In this study analytical and functional performance of the Precision GTM “point-of-care” glucometer (MediSense Inc.) was evaluated. Studies were carried-out using capillary blood collected for routine monitoring of glycemia in diabetic patients. Each glucose test measurement with the glucometer was paralleled by the laboratory measurement of glucose on the same blood sample, using the GOD/PAP method. Mean accuracy error in the glucose concentration range of 1.1–33.3 mmol/l calculated for the glucometer vs. the laboratory method amounted to only 0.2%. However, for glucose concentrations below 4.4 mmol/l the mean accuracy error was 3.9%, and for the concentrations above 10.0 mmol/l it was 4.6%. Within-run CV for three concentration levels was 2.76%, 2.89%, and 4.22%, respectively. Linearity of the meter response in samples with glucose concentration ranging from 1.7 mmol/l to 16.7 mmol/l, expressed as the correlation coefficient r, yielded r=0.996 and linear regression equation [y1 = 0.996 y2–0.005], where y1 is the measured glucose concentration and y2 is the target glucose concentration calculated in diluted samples. Correlation studies on a set of 114 blood samples collected from patients and assayed by glucometer and by the laboratory method yielded a relationship expressed by the equation: y = 0.84x + 1.13 where y is glucometer read-out and x is glucose concentration obtained by the laboratory method. Passing-Bablok test showed a significant agreement between the glucometer measurements and the reference laboratory results in the studied glucose concentration range. The error grid analysis of series of the paired patient's samples showed that 95% of results were in the clinically acceptable zone A and 1% of results in zone
Copyright © 2001 by Walter de Gruyter GmbH & Co. KG
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- Acknowledgement
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Articles in the same Issue
- Contents
- Subject Index
- Author Index
- Summary of the 2nd Sino-European Congress of Laboratory Medicine
- Laboratory Diagnosis of Viral Hepatitis in China: The Present and the Future
- Molecular Diagnostics in China
- Detection of Usual and Atypical Aldehyde Dehydrogenase Alleles by Mismatch Amplification Mutation Assay
- Expression of Prostaglandin D Synthase in Ovarian Cancer
- Carrier Detection and Prenatal Diagnosis of Hemophilia A
- Detection of Oligoclonal Immunoglobulins in the Cerebrospinal Fluid by Immunofixation Electrophoresis
- 2nd Sino-European Congress of Laboratory Medicine – Strategies for Laboratory Diagnostics in Medicine
- The Problems and Strategy relevant to the Quality Management of Clinical Laboratories
- Computer Application to the Laboratory Management in Hospital
- The Basis of the Synovial Fluid Analysis
- Determination of Tumor Markers in Serum. Pitfalls and Good Practice
- Gas Chromatography-Mass Spectrometry Measurement of 6β-OH-Cortisol/Cortisol Ratio in Human Urine: A Specific Marker of Enzymatic Induction
- No Variation in Hsp70 mRNA Level during Cardiac Surgery in Pediatric Patients Evaluated by Semiquantitative RT-PCR
- Rapid Detection of Macroprolactin in tHe Form of Prolactin-Immunoglobulin G Complexes by Immunoprecipitation with Anti-human IgG-Agarose
- Molecular Characterization of Chromosome 22 Deletions by Short Tandem Repeat Polymorphism (STRP) in Patients with Conotruncal Heart Defects
- A Simple and Rapid Analysis of Triplet Repeat Diseases by Expand Long PCR
- The Effects of Peroxynitrite on Erythrocytes
- The Use of Hirudin as Universal Anticoagulant in Haematology, Clinical Chemistry and Blood Grouping
- Comparison of Different Immunoassays for CA 19-9
- The Evaluation of Analytical Performance of the Precision G Point-of-Care Glucometer
- On Painting and Philosophy: Sir Henry Raeburn
- Acknowledgement
- Meetings and Awards