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Updated: May 29, 2026

Electrochemiluminescence Assays for Human Islet Autoantibodies
Published on: March 23, 2018
Diabetes Antibody Standardization Program: First evaluation of assays for autoantibodies to IA-2β
Michael Schlosser1, Patricia W Mueller, Peter Achenbach
1Department of Medical Biochemistry and Molecular Biology, Research Group of Predictive Diagnostics,University ofGreifswald, Karlsburg, Germany. polly.bingley@bristol.ac.uk
Objective:
Autoantibodies to IA-2β (IA-2βA) are important risk markers of type 1 diabetes. We report the first Diabetes Antibody Standardization Program (DASP) evaluation of IA-2βA assays.
Research Design And Methods:
Thirteen laboratories from nine countries received coded sera from 50 patients with newly diagnosed type 1 diabetes and 100 healthy blood donors. IA-2βA results were analyzed using receiver operating characteristic (ROC) curves. Concordance of antibody levels was compared using counts per minute (cpm), local and standard curve-derived common units.
Results:
Median laboratory-assigned sensitivity was 47% (interquartile range [IQR] 45-51), specificity 98% (IQR 95-99), adjusted sensitivity at 95% specificity 50% (IQR 49-53), and area under the ROC curve 0.70 (IQR 0.69-0.73). Use of common IA-2βA units improved concordance between assays compared with local units and cpm (P < 0.0001).
Conclusions:
IA-2βA assays in multiple laboratories worldwide achieved good concordance and high specificity for type 1 diabetes. IA-2βA are suitable for inclusion in autoantibody testing for risk assessment in prediabetes.
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