ABSTRACT

Glycated hemoglobin (HbA1c) is an additional marker besides the standard glucose and glycemia analyses, which has become a relevant marker in new analytical methods. Point-of-care testing of HbA1c appears to be a suitable approach to timely and accurately revealing diabetes mellitus, and it demonstrates a better quality of diagnosis compared to the standard determination of glycemia. There are three major HbA1c testing methods currently available to clinical laboratories, namely chromatography-based HPLC assay, antibody-based immunoassay, and enzyme-based enzymatic assay. Boronate affinity chromatography is a glycation-specific method based on boronate binding to the unique cis–diol configuration formed by stable glucose attachments to Hb. Recent innovations have yielded a Direct Enzymatic HbA1c AssayTM, which uses a single channel test and reports %HbA1c values directly, without the need for a separate THb test or a calculation step.