Nurse-based evaluation of point-of-care assays for glycated haemoglobin

Clin Chim Acta. 2006 Mar;365(1-2):257-63. doi: 10.1016/j.cca.2005.09.003. Epub 2005 Oct 3.

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.

MeSH terms

  • Chromatography, High Pressure Liquid
  • Diabetes Mellitus / blood
  • Glycated Hemoglobin A / analysis*
  • Humans
  • Monitoring, Physiologic / methods
  • Nursing*
  • Point-of-Care Systems*
  • Reproducibility of Results

Substances

  • Glycated Hemoglobin A