DiaSys publication at ABC Journal

The standardization of HbA1c

In cooperation with Fresenius University of Applied Sciences in Idstein and the Technical University of Darmstadt, DiaSys has published an article in the journal Analytical and Bioanalytical Chemistry about the standardization of HbA1c. For many years, DiaSys enjoys a close cooperation with the University of Applied Science Fresenius in Idstein. Fresenius looks back on more than 160 years of scientific tradition from its foundation as a school of chemistry in 1848 – in fact, the founder Carl Remigius Fresenius is seen as the originator of food and diagnostic analytical sciences.

The published article describes the synthesis of two clinically relevant fructosamines Fru-Val and Fru-Val-His via a protected glucosone intermediate, which is a new, fast and efficient protocol for the synthesis and purification of fructosamines in suitable yield and purity.

For the enzymatic determination of HbA1c, Fru-Val-His is released from intact HbA1c by enzymatic digestion. It is the species, which leads to the color reaction for photometric determination in subsequent reaction steps.

There is a great interest in having Fru-Val-His as the actual analyte of the enzymatic HbA1c measuring system as a pure, matrix-free substance to identify and determine the influence of endogenous constituents in patient specimen with high methodical certainty. Therefore, pure Fru-Val-His is a valuable tool for performance validation and standardization of the HbA1c-Assay in addition to the IFCC-reference material based on whole blood. Standardization for In-Vitro-Diagnostic reagents is an important subject that can help to maximize safety, repeatability and quality of assays, and therefore diagnostics and clinical outcome of patients.

Unfortunately, Fru-Val-His is not available commercially and it is unstable over time. The novel synthesis method is a milestone in order to provide permanent access to this important material.

Fructosylated Valine does not occur during the enzymatic measurement of HbA1c. Nevertheless, it is an appreciated tool for in-process control during the manufacturing process of the enzymatic HbA1c-assay.

The fructosamines can be used for validation and standardization of enzymatic assays for HbA1c quantification, e.g. as independent control material that could be evaluated using IFCC-based reference material and quantification methods in a next step.

This current publication well reflects the central focus of DiaSys on constant quality and up to date assays in clinical chemistry.

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