Analytical performances of the D-100TM hemoglobin testing system (Bio-Rad) for HbA1c assay

Glycated hemoglobin (HbA1c) is widely used for the monitoring of glycemic balance in diabetic patients and has also been proposed as a tool for the diagnostic of diabetes mellitus. Accordingly, HbA1c quantification must be performed using robust, reliable and efficient methods. Here are reported the results of the evaluation of a new high performance liquid chromatography (HPLC) system for HbA1c quantification, the D-100TM system from Bio-Rad Laboratories.

The analytical performances of the method as well as the influence of the most frequent interferences regarding HbA1c assays (e.g., labile HbA1c, carbamylated hemoglobin, high HbF) have been tested.

Intra- and between-assay CVs were respectively lower than 0.93% and 1.46% (HbA1c results expressed in NGSP units) and lower than 1.67% and 2.27% (HbA1c results expressed in IFCC units). The linearity proved to be excellent from 15 mmol/mol (3.5%) to 184 mmol/mol (19.0%) (r=0.999). The results were well correlated with those obtained by another HPLC method (VARIANTTM II Hemoglobin A1c Program reorder pack 270-2101NU-Bio-Rad): HbA1c[VARIANTTM II, mmol/mol]=1.013×HbA1c[D-100TM, mmol/mol]+0.637 (r=0.993, n=2000). The D-100TM system provided results consistent with IFCC-assigned external quality control samples and the presence of labile HbA1c, carbamylated hemoglobin and HbF did not interfere with HbA1c measurement.

The D-100 TM system proved to be a robust and reliable method for HbA1c measurement suitable for routine practice in clinical chemistry laboratories.