Comparison of three different HbA1c measurement methods – the Atellica^®CH930, Capillary 3 Tera, and BioRad Variant Turbo II

Abstract

Aim

HbA1c measurement is very useful for the follow-up and detection of glycemic disorder, since it is easier and faster test and is independent of the patient's fasting status. In this study, we aimed to perform the comparative evaluation of 3 different methods for HbA1c measurement including capillary electrophoresis, immunoturbidimetric assay and high-performance liquid chromatography-HPLC.

Materials and methods

This study comprised 134 leftover whole blood samples obtained from the subjects submitted for routine HbA1c testing. All blood samples were collected in EDTA-containing vacutainer tubes. The HbA1c levels were measured simultaneously using three different methods. Bias estimation, method agreement and concordance between the pairwise methods comparisons were evaluated by Bland–Altman plot and Passing–Bablok regression test.

Results

HbA1c levels ranged from 3.8% to 13.4% and measured by three different methods to make the comparison. The median values of samples based on immunoturbidimetric method (6.05%, IQR = 1.80) were higher than capillary electrophoresis method (5.90%, IQR = 1.80) and HPLC (5.85%, IQR = 1.80) method. The study group was classified into three subgroups based on the HbA1c levels measured with the HPLC method: Group 1 (n = 57) was composed of subjects with HbA1c levels less than 5.7%, Group 2 (n = 35) had HbA1c levels between 5.7% and 6.4%, Group 3 (n = 42) had HbA1c levels equal and more than 6.5%.

Conclusion

To our knowledge, there is no study evaluating the HbA1c measurement on the Atellica^® CH 930 Analyzer. We compared the Atellica^®CH930 Analyzer with both HPLC and capillary electrophoresis. The Atellica^®CH930 Analyzer showed acceptable performance and a strong correlation with both mentioned methods.

Keywords:

• Glycated hemoglobin A
• electrophoresis
• immunoassay
• chromatography
• diabetes mellitus

Disclosure statement

The authors report there are no competing interests to declare.

Ethical approval

The ethics committee of Ankara City Hospital Clinical Research Ethics Committee approved this study (REF number: E1-211647).