Diabetes Antibody Standardization Program: First evaluation of assays for autoantibodies to IA-2β

Diabetes Care. 2011 Nov;34(11):2410-2. doi: 10.2337/dc11-1161. Epub 2011 Sep 16.


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.

Publication types

  • Evaluation Study
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Area Under Curve
  • Autoantibodies / blood*
  • Autoantibodies / immunology
  • Case-Control Studies
  • Diabetes Mellitus, Type 1 / blood
  • Diabetes Mellitus, Type 1 / diagnosis*
  • Diabetes Mellitus, Type 1 / immunology
  • Female
  • Humans
  • Immunoassay / standards*
  • Laboratory Proficiency Testing*
  • Male
  • ROC Curve
  • Receptor-Like Protein Tyrosine Phosphatases, Class 8 / analysis*
  • Receptor-Like Protein Tyrosine Phosphatases, Class 8 / immunology
  • Reference Standards
  • Sensitivity and Specificity


  • Autoantibodies
  • Receptor-Like Protein Tyrosine Phosphatases, Class 8