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Carina Törn

Coordinator

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Evaluation of the RSR 3 screen ICA™ and 2 screen ICA™ as screening assays for type 1 diabetes in Sweden

Author

  • Carina Törn
  • Fariba Vaziri-Sani
  • Anita Ramelius
  • Helena Elding Larsson
  • Sten Anders Ivarsson
  • Marie Amoroso
  • Jadwiga Furmaniak
  • Michael Powell
  • Bernard Rees Smith

Summary, in English

Aim: The study aim was to evaluate the RSR 3 Screen ICA™ and 2 Screen ICA™ for detection of islet cell autoimmunity in healthy Swedish subjects and patients with newly diagnosed type 1 diabetes (T1D). Methods: 3 Screen is designed for combined detection of autoantibodies to glutamic acid decarboxylase (GADA), to the islet antigen IA-2 (IA-2A) and to zinc transporter 8 (ZnT8A), while 2 Screen detects GADA and IA-2A. Serum samples from 100 T1D patients at onset and 200 healthy controls were studied. Results: 3 Screen achieved 93% assay sensitivity and 97.5% specificity, while 2 Screen achieved 91% assay sensitivity and 98.5% specificity. Samples were also tested in assays for individual autoantibodies. There was only one 3 Screen positive healthy control sample (0.5%) that was positive for multiple autoantibodies (IA-2A and ZnT8A). In contrast, most of the 93 3 Screen positive patients were positive for multiple autoantibodies with 72% (67/93) positive for both GADA and IA-2A and 57% (53/93) positive for three autoantibodies (GADA, IA-2A and ZnT8A). Insulin autoantibodies (IAA, measured by radioimmunoassay) were positive in 13 patients and two healthy controls. Conclusion: 3 Screen achieved high sensitivity and specificity, suitable for islet cell autoimmunity screening in a healthy population. In the case of 3 Screen positivity, further assays for GADA, IA-2A and ZnT8A are required to check for multiple autoantibody positivity, a hallmark for progression to T1D. In addition, testing for IAA in children below two years of age is warranted.

Department/s

  • Celiac Disease and Diabetes Unit
  • EXODIAB: Excellence of Diabetes Research in Sweden
  • Lund University Bioimaging Center
  • The Wallenberg Laboratory, Malmö
  • Systems Virology
  • Cooperation office
  • Paediatric Endocrinology

Publishing year

2022-02-26

Language

English

Publication/Series

Acta Diabetologica

Document type

Journal article

Publisher

Springer

Topic

  • Endocrinology and Diabetes

Keywords

  • GADA
  • IA-2A
  • IAA
  • Sensitivity
  • Specificity
  • ZnT8A

Status

Epub

Research group

  • Celiac Disease and Diabetes Unit
  • Systems Virology
  • Paediatric Endocrinology

ISBN/ISSN/Other

  • ISSN: 0940-5429