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Hörber, S. ; Achenbach, P. ; Schleicher, E. ; Peter, A.

Harmonization of immunoassays for biomarkers in diabetes mellitus.

Biotechnol. Adv. 39:107359 (2020)
Publ. Version/Full Text Article in press DOI PMC
Open Access Gold (Paid Option)
Creative Commons Lizenzvertrag
Harmonization of biomarkers is important for the comparability of laboratory results as it allows the definition of universal reference values and clinical decision limits. In diabetology, immunoassays are widely used to determine HbA1c, C-peptide, insulin, and autoantibodies to beta cell proteins, which are essential biomarkers for the diagnosis and classification of diabetes mellitus. Furthermore, as large clinical studies have identified HbA1c as a predictor for the development of diabetic complications, HbA1c has evolved as the general treatment target. For decades, the use of non-harmonized assays caused confusion. After the standardization of HbA1c, the worldwide comparability improved and increased the confidence in this laboratory biomarker. Insulin and C-peptide are not only valuable biomarkers to assess beta-cell function, but may also be used to evaluate insulin resistance, a metabolic feature of type 2 diabetes often occurring before its manifestation. Long-lasting efforts led to substantial improvements in the harmonization process of C-peptide assays, but harmonization of insulin assays is still ongoing. Therefore, C-peptide is now sometimes used as a surrogate biomarker for insulin. Furthermore, autoantibodies against beta cell components are important biomarkers for the accurate differentiation of type 1, type 2, and other special types of diabetes. Owing to the heterogeneity of these autoantibodies against beta cell proteins, harmonization is very difficult to achieve. International efforts are in progress to harmonize the current assays, as the presence of autoantibodies against beta cell proteins predicts the development of type 1 diabetes in early life. In conclusion, clinical studies linking diagnosis, classification, prediction, and treatment to laboratory values of the respective biomarkers need to be harmonized to avoid misdiagnosis and incorrect clinical decisions, thus improving patient care and safety.
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Publication type Article: Journal article
Document type Review
Corresponding Author
Keywords Autoantibodies ; Biomarker ; Classification ; C-peptide ; Diabetes Mellitus ; Glycated Hemoglobin ; Harmonization ; Immunoassay ; Insulin ; Prediction ; Standardization; Antibody Standardization Program; Reference Measurement System; Glutamic-acid Decarboxylase; Insulin Secretory Dysfunction; Protein-tyrosine-phosphatase; Gad Autoantibody Affinity; Islet-cell Antibodies; C-peptide Measurement; 1st-degree Relatives; Glucose-tolerance
ISSN (print) / ISBN 0734-9750
e-ISSN 1873-1899
Journal Biotechnology Advances
Quellenangaben Volume: 39, Issue: , Pages: , Article Number: 107359 Supplement: ,
Publisher Elsevier
Publishing Place The Boulevard, Langford Lane, Kidlington, Oxford Ox5 1gb, England
Non-patent literature Publications
Reviewing status Peer reviewed
Institute(s) Institute of Diabetes Research and Metabolic Diseases (IDM)
Institute of Diabetes Research Type 1 (IDF)