Evidence map›Paper›PMID 35220476›Full record

ArticleActa diabetologica2022

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

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

Open access · hybridAbstract read
In one paragraph

Article in Acta diabetologica, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Carina TörnDepartment of Clinical Sciences, Lund University, Malmö, Sweden. Carina.Torn@med.lu.se.ORCID http://orcid.org/0000-0003-2421-2633
Fariba Vaziri-Sani, Lund, Sweden.
Anita RameliusDepartment of Clinical Sciences, Lund University, Malmö, Sweden.
Helena Elding LarssonDepartment of Clinical Sciences, Lund University, Malmö, Sweden.
Sten Anders IvarssonDepartment of Clinical Sciences, Lund University, Malmö, Sweden.
Marie AmorosoFIRS Laboratories, RSR Ltd, Llanishen, Cardiff, UK.
Jadwiga FurmaniakFIRS Laboratories, RSR Ltd, Llanishen, Cardiff, UK.
Michael PowellFIRS Laboratories, RSR Ltd, Llanishen, Cardiff, UK.
Bernard Rees SmithFIRS Laboratories, RSR Ltd, Llanishen, Cardiff, UK.
Lund University · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimThe 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).

methods3 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.

results3 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.

conclusion3 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.

Indexed as

Cation Transport ProteinsDiabetes Mellitus, Type 1AutoantibodiesChildGlutamate DecarboxylaseHumansSwedenAutoantibodiesCation Transport ProteinsGlutamate DecarboxylaseGADAIA-2AIAASensitivitySpecificityZnT8A

Identifiers

PMID35220476
PMCPMC9085662
OpenAlexW4214767347

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.