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Updated: Sep 28, 2025
A Precision Medicine Tool for Measurement and Monitoring of Hemoglobin S in Sickle Cell Disease Patients Receiving Transfusion Therapy
Analytical interference of 33 different hemoglobin variants on HbA1c measurements comparing high-performance liquid
Bozena Zechmeister1, Tanja Erden2, Berit Kreutzig3
1Institute for Clinical Chemistry/Interdisciplinary UMG Laboratory, University Medical Center Göttingen, Robert-Koch-Str. 40, 37075 Göttingen, Germany.
Background And Aims:
The concentration of glycated hemoglobin (HbA1c) is an essential diagnostic and therapeutic biomarker in diabetes mellitus. However, it is known that Hb structural variants and synthesis disorders, can affect the HbA1c measurement in different assays. Although the analytical interference of various hemoglobinopathies on the chromatographic measurement of HbA1c using HPLC has been well studied, data on the interference on the enzymatic assay are few.
Materials And Methods:
In this multi-center study, a large number (n = 104) of 33 different hemoglobin variants were collected over a period of one year and compared between an HPLC (Tosoh G8 and G11) and an enzymatic assay (Abbott Alinity c).
Results:
A good comparability between ion-exchange HPLC and the Alinity assay for most Hb variants was found. However, we were able to determine for the first time that certain Hb variants (Hb Okayama, HbAE, Hb Lepore) can lead to clinically relevant discordant results. HbF (>5%) can already cause a relevant aberration.
Conclusions:
Overall, using the Abbott HbA1c assay in the presence of certain hemoglobin variants can induce clinically relevant interference that can affect diagnosis and therapy monitoring decisions, mainly because the enzymatic assay cannot provide any information about Hb variants.
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