ArticleDiabetologia2026
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.
Article in Diabetologia, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
aims/hypothesisThe 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.
methodsBetween 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.
resultsAmong 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/
interpretationPopulation-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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