Comparison of Hba1C Detection in Whole Blood and Dried Blood Spots Using an Automated Ion-Exchange HPLC System

Abstract

Aim: Hemoglobin A1c (HbA1c) is a widely recognized analyte for diagnosing and monitoring diabetes. Dried blood spot (DBS) constitutes a useful alternative to blood collection by venipuncture. Analytical and clinical validation of DBS use is, however, necessary before implementation. Results/methodology: HbA1c levels from whole blood or DBS from a cohort patients with diabetes were compared. DBS specimens were stable at ambient temperature. HbA1c detection on DBS was accurate, robust, and the correlation and agreement with whole blood values was excellent. Conclusion: This study provides for the first time a complete method comparison and validation under the ISO15189 guideline using an automated HPLC system. This approach constitutes, therefore, a useful tool for diagnosing diabetes.

Keywords::

• clinical biology
• DBS
• dried blood spot
• glycated hemoglobin
• HbA1c
• HPLC
• ion exchange
• ISO15189
• method validation

Financial & competing interests disclosure

This project was in part financed by the ANR project BUVAMASS. J Ducos and S Lehmann are nonmajority shareholders of the start-up-company Spot-To-Lab who provided the collection card and the extraction buffers. The CHU of Montpellier and Spot-To-Lab have a common program financed by the French Government (ANR BUVAMASS) to develop analyses on dried blood spot.

This funding was used for writing assistance to check the English of the paper.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

Acknowledgements

The authors acknowledge Axionlab and Spot-To-Lab for providing this research project with technical support (analyzer and reagents). These two companies were not involved in the experimental work, however. The academic authors were responsible for the data analysis, writing the article and the conclusions. S Lehmann and J Ducos are nonmajority stock holders of Spot-To-Lab. The authors thank J Blanc for review of the manuscript.