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doi:10.1016/j.cca.2005.09.003 
Copyright © 2005 Elsevier B.V. All rights reserved.
Nurse-based evaluation of point-of-care assays for glycated haemoglobin
Andrew St Johna, 
, 
, Timothy M.E. Davisb, Ian Goodallc, Mary Anne Townsendd and Christopher P. Pricee
Received 20 July 2005;
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Abstract
Background
Various devices are now available to measure glycated haemoglobin (HbA1c) outside of the laboratory. The aim of this study was to assess the performance of these point-of-care instruments in the hands of non-laboratory trained personnel.
Methods
Two nursing staff tested samples from patients attending a diabetes research clinic using the following point-of-care devices for HbA1c-Metrica A1C Now, Bayer DCA 2000, Cholestech GDX and Axis-Shield Nycocard HbA1c. In addition they performed regular analysis of quality control samples. The effects on analytical performance of multiple operators as well as laboratory-trained staff, were also assessed. All measurements were compared to a boronate-affinity HPLC method in the central laboratory.
Results
The mean HbA1c difference of the point-of-care devices compared to the laboratory reference method ranged from − 0.31% to + 0.39%. Only the DCA device had a between batch imprecision of less than 5%. The analytical performance obtained by laboratory staff was similar to nursing staff for 3 devices and better for the Nycocard device.
Conclusions
On the basis of the results obtained by nursing staff, only the DCA of the devices tested, can be recommended for measurement of HbA1c outside of the laboratory.
Keywords: Glycated haemoglobin; HbA1c; Point of care testing; Analytical evaluation
Article Outline
- 1. Introduction
- 2. Materials and methods
- 2.1. Subjects and sample collection
- 2.2. HbA1c methods
- 2.3. Study design
- 2.4. Data analysis
- 3. Results
- 3.1. General performance
- 3.2. Assessment of accuracy and patient comparisons
- 3.3. Imprecision studies
- 3.4. Method manipulation studies
- 4. Discussion
- Acknowledgements
- References
