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Marzinotto, I.* ; Bazzigaluppi, E.* ; Brigatti, C.* ; Martinenghi, S.* ; Laurenzi, A.* ; Ancona, G.* ; Angiulli, S.* ; Borgonovo, E.* ; Spanò, A.* ; Pata, G.* ; Mallus, M.* ; Ulivi, F.* ; Achenbach, P. ; Hagopian, W.* ; Gillespie, K.* ; Lampasona, V.* ; Bosi, E.*

Feasibility and performance of minimal-volume capillary blood screening for type 1 diabetes and coeliac disease autoantibodies across all age groups: The UNISCREEN population study.

Diabetologia 69, 1282-1294 (2026)
Publ. Version/Full Text Research data DOI PMC
Open Access Hybrid
Creative Commons Lizenzvertrag
AIMS/HYPOTHESIS: The UNISCREEN study investigated the feasibility of minimally invasive capillary blood sampling combined with novel antibody tests for population-wide screening of type 1 diabetes and coeliac disease autoantibodies across all age groups, with secondary objectives to evaluate the prevalence and age-related distribution of these autoantibodies in a general Northern Italian population. METHODS: Between April and October 2023, we screened 1532 residents (50.1% of eligible population) of Cantalupo, Milan, aged 1-100 years. Capillary blood samples were collected by fingerprick from all participants. A subset of 20 autoantibody-positive individuals provided confirmatory venous samples. Islet autoantibody screening employed a novel solid-phase capture luciferase immunoprecipitation system (LIPS) 3-screen assay requiring only 1 μl of serum for simultaneous detection of GADA, IA-2A and ZnT8A, plus a separate IAA assay. Positive samples underwent confirmatory testing with individual LIPS assays using truncated GADA to improve specificity. Coeliac disease screening used a tissue transglutaminase IgA (TGA-IgA) LIPS assay. Capillary-venous sample concordance and assay format comparisons validated the methodology. RESULTS: Among 1454 individuals without known diabetes, islet autoantibody prevalence was 2.3% (95% CI 1.6, 3.2), with 70.6% having single autoantibodies and 29.4% having multiple autoantibodies. Among 73 individuals with type 2 diabetes, 9.6% (95% CI 3.9, 18.8) were islet autoantibody-positive. TGA-IgA prevalence was 3.5% (95% CI 2.7, 4.6) overall, with 3.2% (95% CI 2.3, 4.2) newly identified positivity among those without known coeliac disease. Capillary-venous sample concordance was high (85-95% across autoantibodies), increasing with antibody level from 66.7% to 100% across terciles. Venous LIPS to bridge-ELISA concordance ranged from 50% for GADA to 90% for other autoantibodies, with low-affinity GADA partially accounting for discrepancies. Islet autoantibody-positive individuals >15 years (measured by 3-screen solid-phase capture LIPS) had significantly higher median antibody levels than those ≤15 years (53.5 vs 19.3 arbitrary units, p=0.006). Coeliac disease autoantibody prevalence declined markedly with age from 9.1% (≤15 years) to 0.6% (>75 years) (p<0.001), contrasting with the more stable age distribution of islet autoantibodies. CONCLUSIONS/INTERPRETATION: Population-wide autoimmunity screening across all age groups is feasible using minimally invasive capillary sampling and advanced immunoassay technology. The substantial prevalence of autoimmunity in clinically unaffected individuals (2.3% for islet autoantibodies, 3.2% for coeliac disease autoantibodies) suggests significant opportunities for earlier detection and intervention. Age-related differences in antibody levels and the detection of multiple autoantibodies in adults without diabetes warrant longitudinal follow-up to understand natural history and progression risk in older populations.
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Publication type Article: Journal article
Document type Scientific Article
Keywords Autoantibodies ; Autoimmunity ; Capillary Blood Sampling ; Coeliac Disease ; General Population Screening ; Luciferase Immunoprecipitation System (lips) ; Population-based Study ; Tissue Transglutaminase Antibodies ; Type 1 Diabetes ; Uniscreen Study; Islet Autoantibodies; General-population; Progression; Relatives; Prevalence; Children; Risk; Gad; Specificity; Onset
ISSN (print) / ISBN 0012-186X
e-ISSN 1432-0428
Journal Diabetologia
Quellenangaben Volume: 69, Issue: 5, Pages: 1282-1294 Article Number: , Supplement: ,
Publisher Springer
Publishing Place Berlin ; Heidelberg [u.a.]
Reviewing status Peer reviewed
Institute(s) Institute of Diabetes Research (IDF)
Grants Fondazione Italiana Diabete (FID)
Breakthrough T1D
Leona M. and Harry B. Helmsley Charitable Trust