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Ziegler, A.-G. ; Haupt, F. ; Scholz, M. ; Weininger, K. ; Wittich, S. ; Löbner, S. ; Matzke, C. ; Gezginci, C. ; Riethausen, S. ; Beyerlein, A. ; Zillmer, S. ; Amoroso, M.* ; Coles, R.* ; Powell, M.* ; Furmaniak, J.* ; Rees Smith, B.* ; Winkler, C. ; Bonifacio, E. ; Achenbach, P.

3 screen ELISA for high-throughput detection of beta cell autoantibodies in capillary blood.

Diabetes Technol. Ther. 18, 687-693 (2016)
DOI PMC
Open Access Green as soon as Postprint is submitted to ZB.
BACKGROUND: Testing for beta cell autoantibodies is used for wide-scale identification of early stages of type 1 diabetes. This requires suitable screening assays. We aimed to establish screening that utilized a first step assay (3 Screen) able to detect autoantibodies to the target antigens glutamic acid decarboxylase-65 (GAD), insulinoma-associated antigen 2 (IA-2), and zinc transporter 8 (ZnT8) to identify children positive for multiple beta cell autoantibodies. METHODS: An ELISA format was used where plates were coated with a mixture of recombinant GAD, IA-2, and ZnT8325W/R-dimer molecules. The performance was determined in venous blood from 686 first-degree relatives of patients with type 1 diabetes, and 200 patients at onset of type 1 diabetes, and applied as a screening assay in capillary blood from 33,639 general population children. RESULTS: The 3 Screen assay sensitivity for detecting autoantibody-positive patients at onset of type 1 diabetes was similar to that achieved by separate radiobinding assays (RBAs) for antibodies to GAD, IA-2, and ZnT8. Results in venous and capillary serum were correlated (R = 0.987). At a threshold corresponding to the 98th centile (29.1 U/mL) of all 33,639 capillary samples, the 3 Screen was positive in 123 samples with two or more RBA-positive antibodies to insulin, GAD, IA-2, or ZnT8, 146 with one antibody, and 479 that were RBA negative for beta cell autoantibodies. CONCLUSION: A 3 Screen ELISA was developed that was suitable for first step screening of multiple beta cell autoantibodies in capillary blood.
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Publication type Article: Journal article
Document type Scientific Article
Keywords Antibody Standardization Program; Glutamic-acid Decarboxylase; Islet Autoantibodies; General-population; Diabetes Risk; Assays; Insulin; Prediction; Antigen-2; Diseases
Language german
Publication Year 2016
HGF-reported in Year 2016
ISSN (print) / ISBN 1520-9156
e-ISSN 1557-8593
Journal Diabetes Technology & Therapeutics
Quellenangaben Volume: 18, Issue: 11, Pages: 687-693 Article Number: , Supplement: ,
Publisher Mary Ann Liebert
Publishing Place New Rochelle
Reviewing status Peer reviewed
Institute(s) Institute of Diabetes Research (IDF)
Institute of Diabetes and Obesity (IDO)
Institute of Pancreatic Islet Research (IPI)
POF-Topic(s) 30201 - Metabolic Health
90000 - German Center for Diabetes Research
Research field(s) Helmholtz Diabetes Center
PSP Element(s) G-502100-001
G-501900-229
G-502600-007
PubMed ID 27552135
DOI 10.1089/dia.2016.0199
WOS ID WOS:000388572500004
Erfassungsdatum 2016-08-26
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