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.
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.
Authors: Cynthia Fritschi; Laurie Quinn; Eileen D Hacker; Sue M Penckofer; Edward Wang; Marquis Foreman; Carol E Ferrans Journal: Diabetes Educ Date: 2012-06-19 Impact factor: 2.140
Authors: Mika Pa Laitinen; Jari Salmela; Leona Gilbert; Risto Kaivola; Topi Tikkala; Christian Oker-Blom; Jukka Pekola; Matti Vuento Journal: Nanotechnol Sci Appl Date: 2009-04-14
Authors: Shiela M Strauss; Mary Rosedale; Michael A Pesce; Caroline Juterbock; Navjot Kaur; Joe DePaola; Deborah Goetz; Mark S Wolff; Dolores Malaspina; Ann Danoff Journal: Point Care Date: 2014-12
Authors: Ruziana Mona Wan Mohd Zin; Zati Iwani Ahmad Kamil; Tuan Rosidah Tuan Soh; Mustaffa Embong; Wan Nazaimoon Wan Mohamud Journal: BMC Res Notes Date: 2013-12-18