title: 3 Screen islet cell autoantibody ELISA: A sensitive and specific ELISA for the combined measurement of autoantibodies to GAD65, to IA-2 and to ZnT8.
abstract: 3 Screen, a new ELISA for the combined measurement of autoantibodies to GAD65, to IA-2 and to ZnT8, has been developed and evaluated. In the assay serum samples were incubated (overnight; 2-8°C) in ELISA plate wells coated with GAD65, IA-2 and ZnT8 followed by a wash step and incubation with biotinylated GAD65, IA-2 and ZnT8 (1h; 2-8°C,). The assay was completed by addition of streptavidin-peroxidase and tetramethylbenzidine. Samples tested in the 3 Screen were also analysed in ELISAs and radiobinding assays for the three individual autoantibodies. 129/132 (98%) samples from newly diagnosed T1DM children and 1/100 non-diabetic children controls were positive in 3 Screen. There was good agreement between 3 Screen and the individual autoantibody assays. Dilution of positive samples showed good linearity characteristics. In the 2015 Islet Autoantibody Standardization Program 3 Screen achieved 94% sensitivity, 95.6% specificity and 0.948 area under curve by ROC analysis. 3 Screen provides a simple and sensitive method for combined measurement of three major diabetes associated autoantibodies in a single sample. The assay should be a useful tool for large scale population screening for individuals at risk of developing T1DM.
authors: FIRS Laboratories, RSR Ltd, Parc Tŷ Glas, Llanishen, Cardiff CF14 5DU, UK.
authors: Marie
authors: M
authors: Amoroso
authors: Institute of Diabetes Research, Helmholtz Zentrum München, and Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Neuherberg, Germany; German Center for Diabetes Research (DZD), Neuherberg, Germany.
authors: Peter
authors: P
authors: Achenbach
authors: FIRS Laboratories, RSR Ltd, Parc Tŷ Glas, Llanishen, Cardiff CF14 5DU, UK.
authors: Michael
authors: M
authors: Powell
authors: FIRS Laboratories, RSR Ltd, Parc Tŷ Glas, Llanishen, Cardiff CF14 5DU, UK.
authors: Rebecca
authors: R
authors: Coles
authors: FIRS Laboratories, RSR Ltd, Parc Tŷ Glas, Llanishen, Cardiff CF14 5DU, UK.
authors: Monika
authors: M
authors: Chlebowska
authors: FIRS Laboratories, RSR Ltd, Parc Tŷ Glas, Llanishen, Cardiff CF14 5DU, UK.
authors: Lorraine
authors: L
authors: Carr
authors: FIRS Laboratories, RSR Ltd, Parc Tŷ Glas, Llanishen, Cardiff CF14 5DU, UK.
authors: Jadwiga
authors: J
authors: Furmaniak
authors: Institute of Diabetes Research, Helmholtz Zentrum München, and Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Neuherberg, Germany.
authors: Marlon
authors: M
authors: Scholz
authors: German Center for Diabetes Research (DZD), Neuherberg, Germany; Center for Regenerative Therapies Dresden, Fetscherstrasse 105, 01307 Dresden, Germany.
authors: Ezio
authors: E
authors: Bonifacio
authors: Institute of Diabetes Research, Helmholtz Zentrum München, and Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Neuherberg, Germany; German Center for Diabetes Research (DZD), Neuherberg, Germany.
authors: Anette-G
authors: AG
authors: Ziegler
authors: FIRS Laboratories, RSR Ltd, Parc Tŷ Glas, Llanishen, Cardiff CF14 5DU, UK.
authors: Bernard
authors: B
authors: Rees Smith
mesh_terms: D000293:Adolescent; D001323:Autoantibodies / Q000097:blood* / Q000276:immunology; D027682:Cation Transport Proteins / Q000097:blood* / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D003922:Diabetes Mellitus, Type 1 / Q000097:blood* / Q000175:diagnosis / Q000276:immunology; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods* / Q000592:standards; D005260:Female; D005968:Glutamate Decarboxylase / Q000097:blood* / Q000276:immunology / Q000378:metabolism; D006801:Humans; D007223:Infant; D007515:Islets of Langerhans / Q000276:immunology*; D008297:Male; D054635:Receptor-Like Protein Tyrosine Phosphatases, Class 8 / Q000097:blood* / Q000276:immunology / Q000378:metabolism; D000075703:Zinc Transporter 8
chemical_list: D001323:Autoantibodies; D027682:Cation Transport Proteins; C492522:SLC30A8 protein, human; D000075703:Zinc Transporter 8; C516862:PTPRN protein, human; D054635:Receptor-Like Protein Tyrosine Phosphatases, Class 8; D005968:Glutamate Decarboxylase
keywords: Autoantibodies; Disease prediction; GAD(65); IA-2; Population screening; Type 1 diabetes mellitus; ZnT8