Evaluation of the RSR 3 Screen ICA™ and 2 Screen ICA™ As Screening Assays for Type 1 Diabetes in Sweden

Overview

Journal Acta Diabetol

Specialty Endocrinology

Date 2022 Feb 27

PMID 35220476

Authors

Carina Torn

Fariba Vaziri-Sani

Anita Ramelius

Helena Elding Larsson

Sten Anders Ivarsson

Marie Amoroso

Jadwiga Furmaniak

Michael Powell

Bernard Rees Smith

Affiliations

Soon will be listed here.

Abstract

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.

Citing Articles

Estimation of Individual Positive Anti-Islet Autoantibodies from 3 Screen ICA Titer.

Kawasaki E, Jinnouchi H, Maeda Y, Okada A, Kawai K Int J Mol Sci. 2024; 25(14).

PMID: 39062856 PMC: 11277171. DOI: 10.3390/ijms25147618.

Enzyme-linked immunosorbent assay of 3 Screen Islet Cell Autoantibody in patients with autoimmune thyroid disease.

Kawasaki E, Tamai H, Fukuyama T, Sagara Y, Hidaka R, Uchida A World J Diabetes. 2024; 15(5):935-944.

PMID: 38766435 PMC: 11099373. DOI: 10.4239/wjd.v15.i5.935.

The prevalence of diabetes and thyroid related autoantibodies in Sri Lankan children with type 1 diabetes and their unaffected siblings - The utility of a new screening assay.

Atapattu N, Amoroso M, Powell M, de Silva D, de Silva K, Furmaniak J Front Endocrinol (Lausanne). 2023; 14:1028285.

PMID: 36814577 PMC: 9939822. DOI: 10.3389/fendo.2023.1028285.

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