Hemoglobin A1c (HbA1c) plays a crucial role in diabetes management. A recent research published in ‘Scientific Reports’ evaluated the analytical performance of a novel enzymatic method kit for HbA1c measurement. The performance of the enzymatic method, including precision, accuracy, and linearity, was evaluated. The interference effect from conventional interferents, Hb derivatives, Hb variants, and common drugs were assessed. In addition, the agreement of HbA1c results was compared between enzymatic methods, cation-exchange high-performance liquid chromatography (HPLC), and immunoassays.

      Performance of Mindray enzymatic method was evaluated using 350 residual whole blood samples in ethylenediaminetetraacetic acid (EDTA)-containing tubes collected from the Laboratory Department of Peking University Shenzhen Hospital. HbA1c was measured using the BS-600M automatic biochemistry analyzer (enzymatic assay), the HLC-723 G8 HbA1c analyzer (HPLC method), and the Roche c501 (Immunoassay). All samples were used in the accompanying glycated hemoglobin assay kits.

      The intra-assay, between-assay, and total precision of HbA1c were lower than 2%. HbA1c showed good linearity within the range of 3.96–20.23%. The enzymatic assay yielded results consistent with the external quality control samples, with a bias of less than ± 6% from the target values. The enzymatic method showed no interference from bilirubin, intralipid, vitamin C, Hb derivatives, common Hb variants, as well as antipyretic analgesics and hypoglycemic drugs. The HbA1c results of the enzymatic assay showed good agreement and accuracy compared to those obtained from the HPLC method and the immunoassay. The researchers concluded that enzymatic method kit performed on the BS-600M chemistry analyzer is a reliable and robust method for measuring HbA1c