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Open Access Green as soon as Postprint is submitted to ZB.
Diabetes antibody standardization program: First evaluation of assays for autoantibodies to IA-2β.
Diabetes Care 34, 2410-2412 (2011)
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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Publication type
Article: Journal article
Document type
Scientific Article
Keywords
Rapid progression; Autoantibodies; Risk; Decarboxylase; Autoimmunity; IA-2-Beta; Relatives; Siblings; Antigen; Assays
ISSN (print) / ISBN
0149-5992
e-ISSN
1935-5548
Journal
Diabetes Care
Quellenangaben
Volume: 34,
Issue: 11,
Pages: 2410-2412
Publisher
American Diabetes Association
Publishing Place
Alexandria, Va.
Reviewing status
Peer reviewed
Institute(s)
Institute of Diabetes Research (IDF)