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
Authors' conclusion
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.
Study context
- Population
- Residents of Cantalupo, Milan, Northern Italy, aged 1–100 years (50.1% of eligible population), screened April–October 2023
- Participants
- 1,532 residents
- Outcome
- Feasibility of minimally invasive capillary blood sampling with novel antibody tests for population-wide screening of T1D and coeliac disease autoantibodies
Methodological detailscapillary fingerprick sampling, solid-phase capture luciferase immunoprecipitation system (LIPS) 3-screen assay, confirmatory venous sampling in a subset
- Capillary fingerprick sampling
- Solid-phase capture LIPS 3-screen assay
- Confirmatory venous sampling in a subset
Main finding
As reported in the abstract
Capillary-venous sample concordance (across autoantibodies)
85-95%
Capillary-venous concordance across antibody-level terciles
66.7% to 100%
Venous LIPS to bridge-ELISA concordance
50% for GADA to 90% for other autoantibodies
Observational data: associations, not effects.
Secondary outcomes
| Outcome | Values | P value |
|---|---|---|
| Median islet antibody levels in islet autoantibody-positive individuals (3-screen LIPS), by age>15 years vs ≤15 years · higher with >15 years | >15 years median 53.5 arbitrary units · ≤15 years median 19.3 arbitrary units | P = 0.006 |
| Coeliac disease autoantibody prevalence by age≤15 years vs >75 years · declined markedly with age | ≤15 years 9.1% · >75 years 0.6% | P < 0.001 |
Islet autoantibody prevalence, no known DM (n=1454)
- Islet autoantibody prevalence
- 2.3% (95% CI 1.6, 3.2)
- Single autoantibodies
- 70.6%
- Multiple autoantibodies
- 29.4%
Islet autoantibody positivity in T2D (n=73)
- Islet autoantibody-positive
- 9.6% (95% CI 3.9, 18.8)
Transglutaminase IgA (TGA-IgA) prevalence
- Overall
- 3.5% (95% CI 2.7, 4.6)
- Newly identified, no known coeliac disease
- 3.2% (95% CI 2.3, 4.2)
Coeliac disease autoantibody prevalence by age
- Contrasting with the more stable age distribution of islet autoantibodies
Original publication
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