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Open Access Green as soon as Postprint is submitted to ZB.
A comparative analysis of the sensitivity, specificity, concordance, and the 5-year predictive power of diabetes-related autoantibody assays.
Diabetes 74, 1535-1546 (2025)
This study compares novel type 1 diabetes-related autoantibody assays developed to improve upon the standard radiobinding assay (RBA). Samples from 1505 individuals, followed for 5 years or to clinical type 1 diabetes, originally tested by RBA were aliquoted and sent blindly to 5 laboratories (BDC, IDR, DRI, MSD, Enable) to be tested by electrochemiluminescence (ECL) assays, Luciferase Immuno Precipitation System (LIPS) assays, multiplex antibody detection by agglutination-PCR (ADAP) assays, and N-terminally truncated GAD65 or IA2β autoantibody RBAs (tGADA/IA2βA). Findings: The fraction of samples that were concordant for negative/positive interpretations across all assays were 79.7% (GADA), 65.2% (IA-2A), 36.2% (IAA), and 67.5% (ZnT8A). The assays with the highest Youden index for predicting the previous RBA results differed by autoantibody: 0.65 LIPS(IDR) for IAA, 0.91 ECL(BDC) for ZnT8A, 0.82 tGADA RBA(IDR) for GADA, 0.91 ECL(MSD and BDC) for IA-2A. The Youden index for predicting 5-year type 1 diabetes varied significantly across assays and was highest for LIPS(DRI) for all autoantibody combinations, with little variation in the respective maximum Youden index. The discordance between assays makes it problematic to interpret positivity when comparing results from different assays. Longitudinal autoantibody assessments should be tested with the same assay.
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Publication type
Article: Journal article
Document type
Scientific Article
Keywords
Glutamic-acid Decarboxylase; Electrochemiluminescence Assays; Positive Relatives; Improve Prediction; Immune-responses; Risk; Insulin; Gad; Progression; Children
ISSN (print) / ISBN
0012-1797
e-ISSN
1939-327X
Journal
Diabetes
Quellenangaben
Volume: 74,
Issue: 9,
Pages: 1535-1546
Publisher
American Diabetes Association
Publishing Place
Alexandria, VA.
Reviewing status
Peer reviewed
Institute(s)
Institute of Diabetes Research (IDF)
Grants
Eunice Kennedy Shriver National Institute of Child Health and Human Development
National Institute of Allergy and Infectious Diseases
National Institutes of Health (NIH) through NIDDK
National Institutes of Health10.13039/100000002
National Institute of Allergy and Infectious Diseases
National Institutes of Health (NIH) through NIDDK
National Institutes of Health10.13039/100000002