TY - JOUR
T1 - Nurse-based evaluation of point-of-care assays for glycated haemoglobin
AU - St John, A.
AU - Davis, Timothy
AU - Goodall, I.
AU - Townsend, M.A.
AU - Price, C.P.
PY - 2006
Y1 - 2006
N2 - 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. (c) 2005 Elsevier B.V. All rights reserved.
AB - 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. (c) 2005 Elsevier B.V. All rights reserved.
U2 - 10.1016/j.cca.2005.09.003
DO - 10.1016/j.cca.2005.09.003
M3 - Article
C2 - 16202401
SN - 0009-8981
VL - 365
SP - 257
EP - 263
JO - Clinica Chimica Acta
JF - Clinica Chimica Acta
IS - 1-2
ER -
