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

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...

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Vydáno v:Acta diabetologica Ročník 59; číslo 6; s. 773 - 781
Hlavní autoři: Törn, Carina, Vaziri-Sani, Fariba, Ramelius, Anita, Elding Larsson, Helena, Ivarsson, Sten Anders, Amoroso, Marie, Furmaniak, Jadwiga, Powell, Michael, Smith, Bernard Rees
Médium: Journal Article
Jazyk:angličtina
Vydáno: Milan Springer Milan 01.06.2022
Springer Nature B.V
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ISSN:1432-5233, 0940-5429, 1432-5233
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Shrnutí: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.
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ISSN:1432-5233
0940-5429
1432-5233
DOI:10.1007/s00592-022-01856-5