ArticleClinical trials (London, England)2010
Measurement of islet cell antibodies in the Type 1 Diabetes Genetics Consortium: efforts to harmonize procedures among the laboratories.
Article in Clinical trials (London, England), 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.
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Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Established and emerging biomarkers for the prediction of type 1 diabetes: a systematic review.Translational research : the journal of laboratory and clinical medicine · 2014Pooled it
- Utility of Fasting C-Peptide for the Diagnostic Differentiation of Patients with Type 1, Type 2 Diabetes, MODY, and LADA.Life (Basel, Switzerland) · 2024Article
- Physical activity and progression to type 1 diabetes in children and youth with islet autoimmunity: The diabetes autoimmunity study in the young.Pediatric diabetes · 2022Article
- Islet Autoantibody Standardization Program 2018 Workshop: Interlaboratory Comparison of Glutamic Acid Decarboxylase Autoantibody Assay Performance.Clinical chemistry · 2019Article
- Article
- Alternate Ways to Quantify Antibodies.Diabetes technology & therapeutics · 2015Article
- Changes in Zinc Transporter 8 Autoantibodies Following Type 1 Diabetes Onset: The Type 1 Diabetes Genetics Consortium Autoantibody Workshop.Diabetes care · 2015Article
- Design and Measurement of Nonislet-Specific Autoantibodies for the Type 1 Diabetes Genetics Consortium Autoantibody Workshop.Diabetes care · 2015Article
- A fresh perspective from immunologists and vaccine researchers: active vaccination strategies to prevent and reverse Alzheimer's disease.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2015Review
- Novel Association Between Immune-Mediated Susceptibility Loci and Persistent Autoantibody Positivity in Type 1 Diabetes.Diabetes · 2015Article
- Standards of medical care in diabetes--2015: summary of revisions.Diabetes care · 2015 · on this mapArticle
- Impact of islet autoimmunity on the progressive β-cell functional decline in type 2 diabetes.Diabetes care · 2014Article
- A plasmonic chip for biomarker discovery and diagnosis of type 1 diabetes.Nature medicine · 2014Article
- Autoimmunity against INS-IGF2 protein expressed in human pancreatic islets.The Journal of biological chemistry · 2013Article
- Serum proteomics reveals systemic dysregulation of innate immunity in type 1 diabetes.The Journal of experimental medicine · 2013Article
- Predictors of associated autoimmune diseases in families with type 1 diabetes: results from the Type 1 Diabetes Genetics Consortium.Diabetes/metabolism research and reviews · 2011Article
- Designing and implementing sample and data collection for an international genetics study: the Type 1 Diabetes Genetics Consortium (T1DGC).Clinical trials (London, England) · 2010Article
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Authors and funding
13 authors.
Funding
Abstract
backgroundand PURPOSE: Three network laboratories measured antibodies to islet autoantigens. Antibodies to glutamic acid decarboxylase (GAD65 [GADA]) and the intracellular portion of protein tyrosine phosphatase (IA-2(ic) [IA-2A]) were measured by similar, but not identical, methods in samples from participants in the Type 1 Diabetes Genetics Consortium (T1DGC).
methodsAll laboratories used radiobinding assays to detect antibodies to in vitro transcribed and translated antigen, but with different local standards, calibrated against the World Health Organization (WHO) reference reagent. Using a common method to calculate WHO units/mL, we compared results reported on samples included in the Diabetes Autoantibody Standardization Program (DASP), and developed standard methods for reporting in WHO units/mL. We evaluated intra-assay and inter-assay coefficient of variation (CV) in blind duplicate samples and assay comparability in four DASP workshops.
resultsValues were linearly related in the three laboratories for both GADA and IA-2A, and intra-assay technical errors for values within the standard curve were below 13% for GADA and below 8.5% for IA-2A. Correlations in samples tested 1-2 years apart were >97%. Over the course of the study, internal CVs were 10-20% with one exception, and the laboratories concordantly called samples GADA or IA-2A positive or negative in 96.7% and 99.6% of duplicates within the standard curve. Despite acceptable CVs and general concordance in ranking samples, the laboratories differed markedly in absolute values for GADA and IA-2A reported in WHO units/mL in DASP over a large range of values. LIMITATIONS: With three laboratories using different assay methods (including calibrators), consistent values among them could not be attained.
conclusionsModifications in the assays are needed to improve comparability of results expressed as WHO units/mL across laboratories. It will be essential to retain high intra- and inter-assay precision, sensitivity and specificity and to confirm the accuracy of harmonized methods.
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