Strong correlation and high comparability of capillary electrophoresis and three different methods for HbA1c measurement in a population without hemoglobinopathy

Abstract

The present study aimed to investigate the comparability of capillary electrophoresis (CE) and three different methods for HbA1c measurement. The 270 whole blood samples with normal hemoglobin profiles were analyzed for HbA1c values by the Roche turbidimetric inhibition immunoassay (TINIA), the Mindray enzymatic assay (EA), the Arkray high-performance liquid chromatography (HPLC) in comparison with the Sebia CE. The within-laboratory coefficient of variation of all four methods was within the accepted goal (<2%), showing good performance of all of these methods. Pairwise comparisons of HbA1c values obtained by CE and other methods were determined in both total group and subgroups (HbA1c levels of <6.5%, 6.5–8% and >8%). Mean differences of HbA1c values in all groups were very small in which the mean HbA1c value measured by EA was lower while those by TINIA and HPLC were higher than that of CE. The majority of different values were within the limits of agreement in Bland-Altman analysis, indicating good agreement between CE and the others. Less than 5% of percentage differences were out of the total allowable error limit in all groups, showing that differences of HbA1c values between CE and other methods were not clinically significant. Pairwise comparisons of HbA1c values of CE and the others in Passing-Bablok regression and Spearman rank correlation studies displayed high concordance and strong correlation in all groups. In conclusion, the present study showed strong correlation, high comparability and consistent results for HbA1c measurement between capillary electrophoresis and the other three different methods.

Keywords:

• Hemoglobin A1c
• capillary electrophoresis
• HPLC
• immunoassay
• enzymatic assay
• method comparison

Acknowledgments

We thank Firmer Co., Ltd., Drew Bio (Thailand) Co., Ltd. and Meditop Co., Ltd. for providing automation analyzers and reagents.

Authors’ contributions

Wilaiwan Sriwimol was the principal investigator, conceived, designed and performed the experiments, performed data curation and analyzed data, and was responsible for drafting and editing the manuscript. Pensiri Choosongsang designed and performed the experiment, analyzed data and edited the manuscript. Phattanapong Choosongsang performed the experiment and analyzed data. Pittaya Treerut, Baralee Muenniam and Paspimon Makkong collected specimens and performed the experiments. Anothai Pocathikorn reviewed and edited the manuscript. The final version of the article was reviewed and approved by all authors.

Disclosure statement

The authors declare no conflicts of interest.