Cookies on this website

We use cookies to ensure that we give you the best experience on our website. If you click 'Accept all cookies' we'll assume that you are happy to receive all cookies and you won't see this message again. If you click 'Reject all non-essential cookies' only necessary cookies providing core functionality such as security, network management, and accessibility will be enabled. Click 'Find out more' for information on how to change your cookie settings.

© 2014 Elsevier Ireland Ltd. Objective: WHO, IDF and ADA recommend HbA1c ≥6.5% (48mmol/mol) for diagnosis of diabetes with pre-diabetes 6.0% (42mmol/mol) [WHO] or 5.7% (39mmol/mol) [ADA] to 6.4% (47mmol/mol). We have compared HbA1c from several methods for research relating glycaemic markers. Research design and methods: HbA1c was measured in EDTA blood from 128 patients with diabetes on IE HPLC analysers (Bio-Rad Variant II NU, Menarini HA8160 and Tosoh G8), point of care systems, POCT, (A1cNow+ disposable cartridges and DCA 2000®+ analyser), affinity chromatography (Primus Ultra2) and the IFCC secondary reference method (Menarini HA8160 calibrated using IFCC SRM protocol). Results: Median (IQ range) on IFCC SRM was 7.5% (6.8-8.4) (58(51-68) mmol/mol) HbA1c with minimum 5.3%(34mmol/mol)/maximum 11.9%(107mmol/mol). There were positive offsets between IFCC SRM and Bio-Rad Variant II NU, mean difference (1SD), +0.33%(0.17) (+3.6(1.9) mmol/mol), r2=0.984, p<0.001 and Tosoh G8, +0.22%(0.20) (2.4(2.2) mmol/mol), r2=0.976, p<0.001 with a very small negative difference -0.04%(0.11) (-0.4(1.2) mmol/mol), r2=0.992, p<0.001 for Menarini HA8160. POCT methods were less precise with negative offsets for DCA 2000®+ analyser -0.13%(0.28) (-1.4(3.1) mmol/mol), r2=0.955, p<0.001 and A1cNow+ cartridges -0.70%(0.67) (-7.7(7.3) mmol/mol), r2=0.699, p<0.001 (n=113). Positive biases for Tosoh and Bio-Rad (compared with IFCC SRM) have been eliminated by subsequent revision of calibration. Conclusions: Small differences observed between IFCC-calibrated and NGSP certified methods across a wide HbA1c range were confirmed by quality control and external quality assurance. As these offsets affect estimates of diabetes prevalence, the analyser (and calibrator) employed should be considered when evaluating diagnostic data.

Original publication




Journal article


Diabetes Research and Clinical Practice

Publication Date





364 - 372