Verification of a novel point-of-care HbA device in real world clinical practice by comparison to three high performance liquid chromatography instruments.

INTRODUCTION

A real world clinical study was designed and conducted to evaluate the performance of a novel point-of-care device for determination of glycated haemoglobin A (HbA), A1C EZ 2.0, in daily clinical practice.

MATERIALS AND METHODS

Five hundred and fourteen subjects were included in this study, and divided into three groups. HbA was measured by A1C EZ 2.0 and three different high performance liquid chromatography (HPLC) devices: Bio-Rad Variant II Turbo, Tosoh HLC-723 G8 and Premier Hb9210 separately. Precision of A1C EZ 2.0 was also evaluated.

RESULTS

Results obtained from A1C EZ 2.0 and all HPLC devices are correlated. Passing-Bablok regression analysis shows the equation of A1C EZ 2.0 results against the mean of HPLC devices with corresponding 95% confidence intervals (95% CI) for the intercept and slope is y = 0.10 (- 0.17 to 0.10) + 1.00 (1.00 to 1.04) x. Bland-Altman difference plot shows that the mean relative difference between A1C EZ 2.0 and Variant II Turbo, G8, Hb9210 and all HPLC results is 2.5%, 0.6%, 0.4% and 1.1%, respectively. In addition, 121 pairs of results determined by using both venous and capillary blood prove that the difference of two kinds of blood sample causes no notable variation when measured by A1C EZ 2.0. Precision study gives 2.3% and 1.9% of total coefficient of variation for normal and abnormal HbA sample in A1C EZ 2.0.

CONCLUSIONS

HbA values measured by A1C EZ 2.0 were in good accordance with the results obtained with the reference HPLC devices.