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Diabetes Antibody Standardization Program: First evaluation of assays for autoantibodies to IA-2{beta}
MedLine Citation:
PMID:  21926293     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
OBJECTIVEAutoantibodies 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 METHODSThirteen 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 operator characteristic (ROC) curves. Concordance of antibody levels was compared using counts per minute (cpm), local and standard curve-derived common units.RESULTSMedian 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).CONCLUSIONSIA-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.
Authors:
Michael Schlosser; Patricia W Mueller; Peter Achenbach; Vito Lampasona; Polly J Bingley;
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-9-16
Journal Detail:
Title:  Diabetes care     Volume:  -     ISSN:  1935-5548     ISO Abbreviation:  -     Publication Date:  2011 Sep 
Date Detail:
Created Date:  2011-9-19     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7805975     Medline TA:  Diabetes Care     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Department of Medical Biochemistry and Molecular Biology, Research Group of Predictive Diagnostics, University of Greifswald, Karlsburg, Germany.
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