We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Diabetes Antibody Standardization Program.
- Authors
SCHLOSSER, MICHAEL; MUELLER, PATRICIA W.; ACHENBACH, PETER; LAMPASONA, VITO; BINGLEY, POLLY J.
- 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%speci city 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.
- Subjects
AUTOANTIBODIES; DIABETES; FIRE assay; BLOOD donors; PREDIABETIC state
- Publication
Diabetes Care, 2011, Vol 34, Issue 11, p2411
- ISSN
0149-5992
- Publication type
Article
- DOI
10.2337/dc11-1161