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Schlosser, M.* ; Mueller, P.W.* ; Achenbach, P. ; Lampasona, V.* ; Bingley, P.J* ; Participating Laboratories*

Diabetes antibody standardization program: First evaluation of assays for autoantibodies to IA-2β.

Diabetes Care 34, 2410-2412 (2011)
DOI
Open Access Green as soon as Postprint is submitted to ZB.
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 Article Number: , Supplement: ,
Publisher American Diabetes Association
Publishing Place Alexandria, Va.
Reviewing status Peer reviewed