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

ABSTRACT:

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 (

SUBMITTER: Schlosser M 

PROVIDER: S-EPMC3198291 | biostudies-literature | 2011 Nov

REPOSITORIES: biostudies-literature