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

Törn, Carina LU ; Vaziri-Sani, Fariba LU ; Ramelius, Anita LU ; Elding Larsson, Helena LU ; Ivarsson, Sten Anders LU ; Amoroso, Marie ; Furmaniak, Jadwiga ; Powell, Michael and Smith, Bernard Rees (2022) In Acta Diabetologica 59(6). p.773-781
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... (More)

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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author
; ; ; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
GADA, IA-2A, IAA, Sensitivity, Specificity, ZnT8A
in
Acta Diabetologica
volume
59
issue
6
pages
773 - 781
publisher
Springer
external identifiers
  • scopus:85125288104
  • pmid:35220476
ISSN
0940-5429
DOI
10.1007/s00592-022-01856-5
language
English
LU publication?
yes
id
7b464c83-ca32-442b-b166-994ad1fca645
date added to LUP
2022-03-23 10:46:09
date last changed
2024-06-22 21:47:22
@article{7b464c83-ca32-442b-b166-994ad1fca645,
  abstract     = {{<p>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.</p>}},
  author       = {{Törn, Carina and Vaziri-Sani, Fariba and Ramelius, Anita and Elding Larsson, Helena and Ivarsson, Sten Anders and Amoroso, Marie and Furmaniak, Jadwiga and Powell, Michael and Smith, Bernard Rees}},
  issn         = {{0940-5429}},
  keywords     = {{GADA; IA-2A; IAA; Sensitivity; Specificity; ZnT8A}},
  language     = {{eng}},
  month        = {{02}},
  number       = {{6}},
  pages        = {{773--781}},
  publisher    = {{Springer}},
  series       = {{Acta Diabetologica}},
  title        = {{Evaluation of the RSR 3 screen ICA™ and 2 screen ICA™ as screening assays for type 1 diabetes in Sweden}},
  url          = {{http://dx.doi.org/10.1007/s00592-022-01856-5}},
  doi          = {{10.1007/s00592-022-01856-5}},
  volume       = {{59}},
  year         = {{2022}},
}