New study outlines feasibility of minimal-volume capillary blood screening for type 1 diabetes
Population-wide autoimmunity screening for type 1 diabetes across all age groups is feasible using minimally invasive capillary sampling and advanced immunoassay technology, latest research has claimed.
The substantial prevalence of autoimmunity in clinically unaffected individuals suggests significant opportunities for earlier detection and intervention.
According to researchers, 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.
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.
Secondary objectives of the study were to evaluate the prevalence and age-related distribution of these autoantibodies in a general Northern Italian population.
Between April and October 2023, a total of 1,532 residents were screened (50.1 per cent of eligible population), all of whom were aged between one and 100 years.
Capillary blood samples were collected by fingerpick 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.
Among 1,454 individuals without known diabetes, islet autoantibody prevalence was 2.3 per cent, with 70.6 per cent having single autoantibodies and 29.4 per cent having multiple autoantibodies.
Among 73 individuals with type 2 diabetes, 9.6 per cent were islet autoantibody positive. TGA-IgA prevalence was 3.5 per cent overall, with 3.2 per cent newly identified positivity among those without known coeliac disease.
Capillary–venous sample concordance was high, increasing with antibody level from 66.7 per cent to 100 per cent across terciles.
Venous LIPS to bridge-ELISA concordance ranged from 50 per cent for GADA to 90 per cent for other autoantibodies, with low-affinity GADA partially accounting for discrepancies.
The full study is available here – https://link.springer.com/article/10.1007/s00125-026-06680-y.